Monday, August 3, 2015

Workplace Initiatives That Promote Diversity and Inclusion

Workplace Initiatives That Promote Diversity and Inclusion

As the United States becomes more of a melting pot, encouraging and nurturing a workplace that welcomes the different cultures, ethnicities, and lifestyles of staff are paramount to optimal collaboration, productivity, and success. In health care, where diversity increasingly is exemplified among patients as well as employees, such an embrace is critical to achieving best outcomes.
Health care institutions across the country are heeding the call for inclusion. Many have implemented initiatives to not only attract diverse staff, but also to keep and engage them.
The Mayo Clinic in Rochester, Minnesota, for instance, launched the Multicultural Nurses Mayo Employee Resource Group (MNMERG) in July 2014 to recruit and retain nurses from diverse cultures and offer them professional support and networking opportunities. The MNMERG also mentors and educates Mayo’s diverse nurses and involves them in community programs.
With some 25 members, the MNMERG welcomes all Mayo staff. It meets monthly at the hospital, but this year will add quarterly dinners off site and is evaluating online technologies such as Skype and Sharepoint to “engage a 24/7 workforce,” says MNMERG cochair Deborah A. Delgado, MS, RN-BC, a nursing education specialist in psychiatry.
Mayo Employee Resource Groups (MERGs) have been an important component of Mayo’s overall diversity initiative; the goal is to have the following five core MERGs—African American, LGBTI, Hispanic, Disability, and Veterans—at Mayo’s three major clinical sites. Each MERG has an executive sponsor who is a leader at Mayo, but not a member of the group. For example, the MNMERG’s sponsor is a male cardiologist with experience in developing family/patient advisory groups. All of Mayo’s MERGs have formally chartered to align with at least one of the organization’s strategic diversity goals.
“These range from culturally competent care to inclusion and addressing health disparities,” says Sharonne N. Hayes, MD, FACC, FAHA, director of diversity and inclusion and professor of medicine at the Women’s Heart Clinic at Mayo. She notes that the groups share innovations and hold cross activities. “By that collaboration,” she says, “you get more hands to do the work obviously, but you also get a wonderful side product of some cross-cultural mentoring and some cross-cultural experience.”
While the MNMERG is in its infancy, feedback has been positive. “By being visible, by engaging, and by contributing, it just leads to retainment,” Delgado offers. “People want to stay because they’re able to use all of their gifts and talents to affect the organization’s purpose and goals.”
The Clinical Leadership Collaborative for Diversity in Nursing (CLCDN) at Massachusetts General Hospital in Boston has realized recruitment and retention success with diverse students of nursing. A scholarship and mentoring program established in 2007 by Partners HealthCare (PHC), an integrated system of which Mass General is a member, the CLCDN draws applicants from the nursing program at University of Massachusetts Boston.
Students must demonstrate leadership qualities, have cumulative general and nursing GPAs of 3.0 or higher, and must be entering their junior year of study since the CLCDN will carry them through their senior year. They link with racially and ethnically diverse nurse mentors, attend unit meetings and social and educational events, and observe nurses and nursing leaders in action. Additionally, they receive a stipend and financial support for tuition and fees with the expectation they will pursue employment at a PHC institution after graduating.
“When you’re a minority and you’re going into an environment where you might be the only diverse person on your clinical unit, as an example, it can be really challenging; it can be very lonely,“ says Gaurdia E. Banister, PhD, RN, FAAN, the PHC CLCDN liaison to UMass Boston and executive director of the hospital’s Institute for Patient Care. “We wanted to put mechanisms in place to ensure the success of our students and, certainly once they graduated, the best possible [career] alternatives,” she says.
Mass General diverse nurse leaders who have successfully navigated such waters can “provide these wonderful, wonderful pearls of wisdom and support and encouragement and listening skills,” explains Banister, and they serve as mentors, as do CLCDN graduates. Of the 54 mentors to date (32 from Mass General), some are repeats. Other statistics are just as impressive—such as PHC’s 82.6% hiring rate among the 69 graduates thus far (47.8% of whom have been employed by Mass General) and the almost 80% retention rate for these graduates.
“They love being a nurse. It’s exactly what they anticipated their career to be,” says Banister. “They are constantly promoting how positive it has been for them and that they feel like our organizations are becoming much more of a welcoming and diverse place to work.”
At the Cleveland Clinic, location-specific Diversity Councils at each of the enterprise’s community hospitals and family health centers are effectively supporting and sustaining an inclusive work environment. These employee-led councils implement action plans and sponsor activities based on strategies and goals defined by an Executive Diversity Council, all aimed to enhance employee engagement and cultural competence.
While the Executive Diversity Council works “to set the tone and the agenda,” the location-specific councils “serve as the tactical team,” explains Diana Gueits, director of diversity and inclusion. The main-campus council, for one, formed the Nursing Cultural Competence Committee and the Disability Task Force; the task force, in turn, developed the Disability Etiquette Lunch ’n Learn, a program to assist caregivers in their interaction and communication with disabled individuals that has since been taken enterprise-wide. Gueits notes the councils share and cross-pollinate ideas.
Cleveland Clinic’s chief nursing officer sits on the Executive Diversity Council, and many nurses participate in the location-specific councils with several diverse nurses serving in leadership roles (the councils overall represent a cross-section of the clinic’s workforce). Two cochairs and a cochair-elect lead each council, act as local ambassadors for diversity, engage with executive leadership, and provide feedback to the Office of Diversity and Inclusion, which facilitates the business-like, SMART-goals approach of the councils.
“This is a passion for them,” says Gueits of the cochairs, who are selected based on their experience in leading transformative teams and their commitment to diversity and inclusion. “I think that what the councils provide them is an opportunity to see, to actually be part of an initiative and be part of that process from A to Z.”
Cleveland Clinic has 21 location-specific councils, a number that is sure to increase as the enterprise expands. “That is the intention,” Gueits says, “to make sure that we embed diversity and inclusion in our commitment to all our locations and give an opportunity or platform for all our caregivers to be engaged.”

Julie Jacobs is an award-winning writer with special interest and expertise in health care, wellness, and lifestyle. Visit her at www.wynnecommunications.com.

Julie Jacobs

Tuesday, July 28, 2015

Thought this was interesting.....

When You Can't Turn "Off"

nammi, Nurse, General Practice, 09:33AM Jul 24, 2015

Diane M. Goodman

Nursing is an insidious job. It gets into your blood and your heart, and at some point, it becomes you. You begin to meld into the person with no "off" switch, the one who eats, sleeps, and breathes nursing into everything and everyone around you.
I recently became that person, and I needed a family member to set me straight.
None of us are immune. We could become entwined with our careers after a week on the job or forty years. It could occur after a particularly heart-wrenching loss, or after achieving a longstanding goal or award, but the signs and symptoms are irrefutable: we interrupt our peers at lunch to discuss an interesting case we received, in spite of their sighs of frustration. We resolutely discuss "work" talk at baby showers and bridal events, when everyone else clearly wants to focus on the task at hand. Additionally, we see disease &/or disaster at every corner of life (with a teachable moment attached!).
Once we lose our ability to turn "off", we forget to engage in non-nursing events. Sleep? How silly. Our minds are churning over the events of the previous day, wondering where we could have found an extra five minutes for charting or patient contact. TV and movies? Hah!! We have articles and policies bookmarked that need attention. We'll never get caught up if we sit through several episodes of Shark Tank....
Hopefully, a family member or friend recognizes the ailment and nips it in the bud, as mine did. Sitting at a teaching hospital to review films (as a patient, not a nurse practitioner), I was convinced the wheelchair-bound patient in front of us was speaking to me when she asked for assistance. My husband, ever the logical one, knew she was not in distress and was questioning the group at large. He reminded me to turn my nurse switch "off" for two seconds and put a layman's hat ON, nearly impossible to do. He reminded me I can take the invisible ID tag off and be someone other than a nurse, which it seems I had forgotten how to do. I suffered through it, but he was right. Everyone lived! I had been so quick to bounce off that chair before his arm gently stopped me.
As painful as the experience was for me, I would guess that many readers have lost the "off" switch as well. Am I right?

Thursday, July 23, 2015

Why write? Nurse stories are about life—its messiness and its truths.

Why write?
 
Nurse stories are about life—its messiness and its truths.
By Karen Roush
photo of laptop
Why write?
is a question that often comes up in my work of mentoring nurses in writing. The question doesn’t arise as often with faculty members, who are expected to disseminate research findings and are required to publish to get tenure. Nor does it come up with nurses working in the policy arena, who understand the necessity of writing to create change and promote a health care agenda. But nurses working as clinicians don’t see writing as integral to what they do.
 
While it’s true that you can provide excellent clinical care without ever publishing an article, writing will enrich your practice, enhance your experience, and create more positive outcomes for your patients. If writing isn’t part of your nursing life, I encourage you to start. And if it is, I encourage you to expand your writing, try a different genre, reach a new audience, or consider a new purpose.
 
Karen RoushWrite to improve patient care.
Nurses do amazing work. We conduct research, develop innovative approaches to care, and carry out quality-improvement projects that change outcomes and make a real difference in patients’ lives. We need to share with other nurses and health care professionals what we observe and learn in our work, and writing is the best way to do that. When you solve a problem, discover previously unseen connections, or find a better way to care for patients, writing enables you to disseminate your knowledge beyond the bedside for the benefit of many.
 
For example, take a quality-improvement project you’ve completed on your unit that has resulted in positive outcomes for your patients. Perhaps they are better able to self-manage their diabetes or are more prepared for a complex surgery, resulting in less fear preoperatively and improved pain management postoperatively. Talking to co-workers spreads the information within your unit or to the wider facility. Presenting at a conference shares it with a few hundred or even a thousand attendees. But publishing has the potential to spread the information to thousands of nurses across the country and around the world. And that means your efforts to improve care for a few will benefit an untold number of patients.
 
Write to bear witness.
As nurses, we are present at the most profound events—from the beginning of life to the end of life and everything in between. We are there with the mother who hears her baby’s first cries, and we are there with the mother whose baby is born in awful silence. We are there with the patient who awakens from surgery to hear his or her prognosis, and we are there as that patient figures out what that prognosis means. We are there when patients recently diagnosed with diabetes realize that, yes, they can administer their own insulin—they’re going to be all right, after all.
 
Sharing these stories offers meaning and insight to other nurses and those who experience situations similar to what we write about. These stories ease suffering and provide paths to new perspectives that help people heal. When people recognize themselves in stories, they realize they are not alone, that others have been where they are and have made it through. Through that recognition, they may come to a place where they are able to say: “I will be OK. I will get through this, too.”
 
Write to share your own stories.
When we write about our own experiences, we communicate the unique perspectives of two worlds—the world of the healer and the world of the sufferer. We cannot separate our stories from what we’ve learned and lived as nurses. When our personal stories are embedded in that knowledge, they gain power and have potential to be transformative.
 
I am a survivor of intimate partner violence (IPV) and, as a nurse, have cared for many patients who have experienced IPV. Writing as both a survivor and nurse gives a weight to what I write that neither perspective alone would have. It engenders trust and credibility and, therefore, creates an opportunity and—I believe—a responsibility to share my personal story for the possibility of change.
 
Recently, I visited a class of graduate students to talk about writing. They had been assigned to read some of the pieces I’ve written about IPV over the years, including opinion pieces, blog posts, poems, and research findings. The responses of two students illustrate the impact writing can have.
 
The first confessed that, when she saw the topic of the reading assignments, she was not happy. “I thought, ‘Oh no, this is going to be such a downer.’” But the insights she gained from reading about IPV in those formats—stories, poems, and opinion pieces—made her realize how little understanding she had of the experience of IPV and how her misconceptions had resulted in her providing poor care to women who suffered from it. She was determined to change her practice.
 
The second student was a woman who was in an undergraduate class I had visited a few years earlier, a class that also had read some of my writing on the subject of IPV. Now, in this graduate-level class, she asked if she could read something she had written. It was a personal essay about reading my stories and how it had given her courage to finally speak about her own experiences as a survivor of IPV. Through writing, she was able to break through the silence and isolation and begin to heal. These two examples illustrate the tremendous power of writing to transform lives, professionally and personally.
 
Write to tell the stories of others.
Nurses have a long history of speaking up for the vulnerable and the voiceless, beginning with Florence Nightingale, a prolific writer, and onward to nurses such as Lillian Wald, the great pioneer and champion of public health nursing. Wald published a series of articles in The Atlantic Monthly that later evolved into her book, The House on Henry Street. In the articles and the book, she told stories of the poor and disenfranchised that she and her organization of nurses cared for, a population of new immigrants to the city who were unable to speak for themselves.
 
As Wald writes in The House on Henry Street, “Conditions such as these were allowed because people did not know, and for me there was a challenge to know and to tell” (p. 8, italics original). Writing is the best way to tell—not only because, as noted above, it can potentially reach so many, but because it endures. Speaking about a story or a project resonates in the moment, but writing can resonate through time. A hundred years after she wrote them, Lillian Wald’s words enhance our understanding of social injustice and move us to do something about the injustices we see today.
 
Write to understand.
Writing forces us to see gaps in our thinking. We cannot write well about a topic unless we understand it completely. When we see gaps, two things may happen: 1) We go out and seek more information, which may cause us to question preconceived ideas, change perceptions, and open ourselves to discovery of new ideas, or 2) we begin to formulate questions that will guide research to help fill the information gaps. Eventually, writing leads to new understanding, not only for ourselves but for other nurses and health care professionals.
 
Book coverWriting also helps us make sense of this world of health and illness, trauma and redemption that we inhabit. We are called upon day after day to deal efficiently and logically with suffering, to apply science and rationality to the irrational. Moving quickly through a morass of tubes and wires, we combine numbers and evidence with the subjectivity of the life in front of us. Amongst all the equipment, diagnostics, and data, writing keeps us connected to humanity. It helps us interpret and analyze our actions and reactions. It helps us see some small part of ourselves in our patients and, as a result, to be that much more empathetic and to go back the next day and do it all again. Maybe better.
 
So, why write?
Our experiences as nurses—our stories—are about life, all of its confused messiness as well as its transcendent truths. Few other professions put members in the thick of it like nursing does. When we write about it, we make connections, improve care, and transform lives. Isn’t that the very essence of what nursing is? RNL
 
Karen Roush, PhD, APN, assistant professor of nursing at Lehman College in the Bronx, New York, USA, is the author of A Nurse’s Step-by-Step Guide to Writing Your Dissertation or Capstone. Roush served for many years as editorial director and clinical managing editor for the American Journal of Nursing (AJN) and continues her affiliation with the journal as an editorial consultant. The founder of The Scholar’s Voice, established to help professionals and scholars in the health sciences, particularly nurses, become skilled, confident writers, Roush blogs regularly for AJN’s “Off the Charts” and advocates against gender-based violence by writing and speaking on the topic.

Tuesday, July 7, 2015

Personal Safety for Nurses


Data from the Bureau of Labor Statistics (BLS) show that the health care sector continues to be the most dangerous place to work in America. According to the Occupational Safety and Health Administration (OSHA), health care workers are confronted with the following job hazards: bloodborne pathogens and biological hazards; potential chemical and drug exposures; waste anesthetic gas exposures; respiratory hazards; ergonomic hazards from lifting and repetitive tasks; laser hazards; workplace violence; hazards associated with laboratories; and radioactive material and X-ray hazards. In 2010, there were 653,900 workplace injuries and illnesses in the health care sector, which is more than 152,000 more injuries than the manufacturing sector, according to a 2013 Public Citizen report.
The paradigm for promoting nurse safety is changing, but slowly, and has not kept up with the technology to prevent injury, says Amber Hogan Mitchell, DrPH, MPH, CPH, president and executive director of the International Safety Center. “There have been a lot of advances over the last few decades to significantly improve nurses’ safety, but more can be done to collect and analyze data that would help speed adoption of innovative technology and spur swifter action to revise and implement stronger safety-related best practices and policies.”
The issue of nurse safety is pervasive. Unfortunately, musculoskeletal injuries are common from lifting patients without enough assistance. Nurses lift the equivalent of 1.8 tons every eight hours. Unanticipated exposures to blood and body fluids (BBFs) pose infection and illness risks to nurses on a daily basis. In the process of caregiving, patients or family members occasionally strike out at the nursing staff. Assaults from patients and patient visitors are far from being listed as isolated incidents. 
“Health care has reached a critical tipping point,” says Alexandra Robbins, author of the New York Times bestseller The Nurses: A Year of Secrets, Drama, and Miracles with the Heroes of the Hospital. “With looming physician shortages and an increasing demand for services, workplaces will have no choice but to make changes to accommodate nurses, our largest health care provider.”
Clinically Proven Textile Technology
About one in two nurses experience blood exposure, other than from a needle stick, on their skin or in their eyes, nose, or mouth at least once a month, according to a 2012 study by the International Healthcare Worker Safety Center at the University of Virginia. In fact, nurses experience these exposures most often while providing direct care, when they are least expecting it and not wearing protective clothing, according to data from the International Safety Center’s Exposure Prevention Information Network (EPINet).
In order to better protect nurses from unexpected exposures to harmful pathogens, we need to first address the role their daily attire can play in protecting them, says Barbara DeBaun, RN, MSN, CIC, consulting vice president of clinical affairs at Vestagen Technical Textiles, Inc. When exposure is unexpected and nurses are not donning personal protective equipment (PPE), traditional scrubs leave nurses vulnerable to direct contact with harmful contaminants that stay with them all shift long.
“Traditional scrubs allow micro-organisms, blood, and other body fluids to leach through the fabric, resulting in nurses carrying contaminants from patient to patient and home to their families,” DeBaun says. “New ‘active-barrier’ textile technologies, made with fabric such as Vestex, contain fluid-repellent, antimicrobial, and breathability properties.”
Debaun explains that this innovative fabric technology combination is key in helping reduce the acquisition, retention, and transmission of harmful pathogens on health care worker attire. Working together, the fluid-repellent barrier causes harmful contaminants to bead up and roll off the fabric, and the antimicrobial agent limits growth of bacteria on the fabric. Vestex’s active-barrier apparel is currently the only textile technology that has shown clinical effectiveness at reducing MRSA infections by 99.9%, in comparison to traditional attire.
Active-barrier apparel is already available in scrubs and white coats for health care workers and health care facilities to purchase. Hospitals such as Baptist Health in Jacksonville, Florida, have already established a systemwide uniform policy that requires staff to wear active-barrier protective uniforms. The organization made a commitment in 2014 to transition more than 6,000 workers, and all patient attire, to Vestex garments to enhance their culture of safety.
“As more data shows the risk that attire can play in transferring harmful contaminants, we believe that advancements in textile technologies will soon become the new industry standard for nurses in all health care settings,” DeBaun says.
Better Security
Nursing is the third most dangerous profession in the country because the vast majority of nurses are attacked by the people they are trying to help. According to data from the BLS, U.S. health care workers experience the most nonfatal workplace violence compared to other professions by a wide margin, with attacks on them accounting for almost 70% of all nonfatal workplace assaults and causing days away from work.
In 2014, 68-year-old Charles Emmett Logan, a patient at a Minnesota hospital, attacked a group of nurses with a pipe pulled from his hospital bed. The incident, which was caught on video, showed Logan running through the nurse’s station wielding a metal pole, hoisting it over his head, and hitting nearby nurses who attempted to flee the scene. One nurse suffered a collapsed lung, another fractured her wrist, and others had cuts and bruises. Medical staff told police that Logan, who died in police custody, suffered from paranoia.
“Hospitals do not protect their nurses, and it’s time they do,” says Robbins. “There is so much more that can be done, both tangible changes and major shifts in attitudes.”
Some hospitals believe that posting security personnel near triage looks negative, so they don’t put enough security staff at the entry points to the hospital and near triage. This puts the triage staff at risk when patients who are high, drunk, or psychotic come in the door, explains Robbins.
After the episode in Minnesota, the hospital initiated a training program to teach workers how to recognize and de-escalate potentially violent situations. However, many hospitals lack this basic safety measure — an oversight that leaves caregivers vulnerable.
“Understandably, nurses are focused on providing the highest quality and safest care to their patients, and often at the unintended risk of not protecting themselves,” Mitchell says. “A shift towards promoting a culture of safety that encompasses both patient and worker safety and security can create an overall better, more effective health care environment.”
To help promote a culture of safety, Robbins recommends that hospitals take the following steps:
• Install metal detectors to reduce the chances of patients or visitors injuring nurses and other staff members with weapons.
• Keep a computer database that flags patients known to be belligerent or aggressive.
• Install bulletproof glass and beef up security.
• Practice safe staffing and hire enough nurses so that the nurse–patient ratios are safe.
“The secret to improving American health care is to hire more nurses and insist that workplaces do a better job of protecting our frontline responders,” Robbins adds.
New Policies and Procedures
Exposures to BBFs pose a very large safety risk to nurses. According to data from EPINet, 47.7% of nurses were exposed to BBFs while on the job in 2012. Perhaps even more alarming, from 2003 to 2012, 83.9% had BBFs touch unprotected skin. These rates are high because nurses aren’t protected from unanticipated exposures, and compliance with PPE is surprisingly low. There is mounting evidence as well that nurses’ attire is contaminated with pathogens and can thus become a vector of transmission to other nurses as well as the patients they treat.
Mitchell believes that hospitals need to have programs in place that not only promote the use of PPE, but also measure compliance. This type of surveillance can allow the facility to identify where risks are high and compliance is low, and target programs in those areas, thus reducing exposures and reducing risk.
“EPINet is free to use and is an example of a surveillance system that can help hospitals to reduce risks,” Mitchell says. “The National Institute for Occupational Safety and Health [NIOSH] is launching a national system called the Occupational Health Safety Network [OHSN], and it is compatible with EPINet. Using systems like these allow facilities to compare themselves to others like them and to constantly improve.”
It is important to remember that safety is guided by a hierarchy of controls, which means that it is important first to eliminate hazards and risks to the lowest possible extent. Mitchell says this is done using engineering controls such as safety-engineered devices that eliminate or protect needles (e.g., needleless IV systems, retracting or shielded needles used on syringes, and blunt suture needles). For exposures to BBFs that splash and splatter, engineering controls might include closed systems for suction canisters or spill-resistant specimen containers. It may even include the use of new innovations in textiles, including those that are fluid-repellent and antimicrobial so that BBFs run right off of them, and fluids don’t soak in to the skin.
There will always be more that can be done to address nursing safety risks, Mitchell believes. Organizations like OSHA, NIOSH, and the Association of PeriOperative Registered Nurses, are always open to feedback, and it is only in providing them with your experiences and opinions that they can provide better guidance.
Mitchell adds that addressing nursing safety risks means creating the safest possible working environments and identifying and measuring hazards, so that programs and interventions can be designed to target and prevent them.
“This involves frontline nurses contributing to the review, evaluation, and selection of engineering controls, medical devices, and even textiles used in their hospitals,” Mitchell says. “Finally, it means working together across specialties, across units, across facilities, and across disciplines to share ideas, foster collaboration, and learn from each other.”

Terah Shelton Harris is a freelance writer based in Alabama.

Tuesday, June 23, 2015

Recharge Your Energy With Less Stress

Recharge Your Energy With Less Stress

Nurses know stress.
In a job that is often 24/7 and requires the most technical and most empathetic skills to be used simultaneously and at a moment’s notice and often in less-than-ideal and sometimes dangerous conditions, a nurse’s job is hardly peaceful.
But Amiee Bernstein, author of Stress Less. Achieve More. and president of Open Mind Adventures, says you can use that ramped-up adrenaline to actually get more done. If you can stop fighting against the constant demands, you can actually get into a healthier zone where you can be more productive and more centered.
There’s a difference between stress and pressure, says Bernstein, and understanding how each impacts your typical day is important. “Webster defines pressure as a force or a power or energy that comes in contact with a surface, fluid, or object,” she says. “I use pressure as energy. Pressure is our energy, our life force, and the energy of change.”

Pressure vs. Stress
But stress is something entirely different and most of us want less stress. “Pressure is good,” she says. “Stress is not good. When you are open to pressure, your capacity increases and your perception is enhanced.” Stress is the opposite – it depletes your energy.
As an example, Bernstein says no matter how tired you are, when there’s an emergency at work, your body provides that rush of energy to help you do your job. “As a nurse, if you are open to it, you will perform very well,” she says. “If you resist it, you will feel discomfort and distress.”
You can use these tips for deciding what’s pressure in your life and what causes you stress and how you can choose to change how you react.

Awareness
Bernstein says is helps to become aware of your own stress triggers. A coworker might thrive under a huge list of expectations, while that same task list makes you feel resentful. No one is right or wrong about a trigger, but it helps to know what makes your stress rise. If you know your triggers, says Bernstein, you then have the power to choose how you will let it affect you.

Presence
Bernstein refers to this as “hereness,” which is how you assess before you react. Workers in stressful roles – nurses, physicians, military personnel – act from their bodies in an emergency. Being present means you listen to your intuition first, often before you have time to think through a scenario. You react based on experience. But your intuition isn’t just guessing. “You have to practice it,” says Bernstein, so you can determine if your attention is focused within yourself (only on what you are feeling), out of yourself (only on what others are feeling), or a balance of both (when you can attend to others’ needs while recognizing your own).
Wherever your attention is, that’s your center,” says Bernstein. Once you are aware and present, controlling the stress and opening to pressure so you can function at your best means noticing when there’s an imbalance so you can find your center.

You don’t have to be tension free to function at your best, she says, but you do have to work so that the tension doesn’t overtake your energy. How can you tell is you need less stress? Is your back tight? Are your shoulders hunching? Is your stomach in knots? If that’s happening, taking deep breaths (Bernstein even recommends holding your breath for just a bit to break out of the cycle) and realizing the source of stress and how it’s beginning to impact you is necessary. “That’s your yellow light flashing,” Bernstein says.

No one can have a life free of stress and pressure, but you can learn how to manage them. “When you are working without pressure, there’s no motivation or drive,” says Bernstein. “That’s when you fall into complacency.”
Instead, notice when you react negatively and respond in ways that make you feel better. You can’t strike a yoga pose in the middle of the ER, but you can notice how you feel and train your body to react differently and your experience, although pressured, will be less stressful. You can even talk about individual triggers as a team so there’s more awareness at work of what might affect the team.
You will turn pressure into a positive force in your life,” says Bernstein.

Julia Quinn-Szcesuil

Thursday, June 11, 2015

Molly’s perspective: How I applied No. 4 of Cindy’s ‘Five RITES’ Part Three

Molly’s perspective: How I applied No. 4 of Cindy’s ‘Five RITES’
Or, What I learned in my first job after nursing school. Part Three of three-part series.
By Molly Clark

During my years as a nursing student, civility was not formally addressed in our classroom or clinical settings. It was implied that we were to treat professors and fellow students with respect, but we were not taught skills to deal with matters of incivility. It is important that nursing students and recent graduates recognize incivility and learn skills to deal with these issues because, although it can be very challenging to confront professors, co-workers, and managers about such matters, it is crucial to successful practice of our profession.
Although our professors did not teach us about civility, I talked with my mom [Cindy Clark, creator of Clark’s Five RITES of Civility] about the importance of civility and why it matters. And as I matured as a nursing student and began my career as a young nurse, I felt equipped to recognize incivility and address the problems I encountered.
I had proven I could talk to my manager about important matters without succumbing to intimidation or fear.
After graduating from nursing school, I started my first job as a psychiatric nurse, working with troubled adolescents. After three weeks of general orientation, I was on my own and, within four weeks, had become a charge nurse on the unit. For a new graduate, this was a lot of pressure. At times, I was left in charge of 24 teens, while supervising five staff members. This was stressful enough, but we were working with some adolescents who were violent and seriously mentally ill. The unit could change from complete calm to mass chaos in a minute, and it was my job to prevent that from happening.
I remember very vividly the first day I cried on the job. The morning started out quietly but, just before lunch, the calm was shattered with screams, shouts, and threats. What had been a relatively quiet setting suddenly crumbled around me and, to my surprise, I found that it was prompted by my manager’s actions. For some unknown reason, he purposely antagonized some of the patients, then walked off the unit and left me to deal with the aftermath.
In that moment, five seasoned staff members looked at me, expecting me to handle the volatile situation. I had to make some very difficult decisions that day, not black-and-white decisions but ones that required me to use all the critical thinking skills I had developed in nursing school and, up to that point, on the job. Throughout the entire episode, I was running on pure adrenaline, and it wasn’t until I was reporting to the next shift that I broke down. Yes, I was upset about what had happened, but mostly I was very frustrated.

After leaving work that day, I called my mom to talk about what had happened. I realized that most of my frustration boiled down to my manager’s involvement in the situation, topped off by my lack of training and experience in making difficult decisions. Mom and I discussed ways to address this particular situation to prevent it from happening in the future—not only for myself but also for other new graduates and, especially, for the patients.

Rite No. 4: Engage and commit to personal and organizational change
The next day, I asked my manager if I could talk with him about what happened the day before. I was very nervous going into the meeting, because I did not know how he was going to react to what I had to say. During our meeting, I talked about his involvement in the situation and how I felt as though he had walked off the unit at the very time we needed his help. Surprisingly, he completely accepted responsibility, and we discussed what he could have done differently. We spoke candidly and talked about how we would handle future situations. I expressed concern about my inexperience as a charge nurse and shared how my lack of training hampered my ability to make immediate decisions amidst a crisis situation.

I left that meeting feeling a lot better about myself and better prepared to deal with similar situations that may occur in the future. I had proven I could talk to my manager about important matters without succumbing to intimidation or fear. From that point on, I talked to my manager about ways to improve my work, and it made my transition much smoother. I was able to voice my concerns and stand up for myself and other new nurses.
Shortly after my meeting with my manager, the hospital implemented a “new-graduate meeting” every other week in which we are encouraged to discuss concerns, fears, and issues we are facing. I soon realized that several other new grads had the same concerns I did, and we now had a voice to make changes.

Looking back, if I had not talked with my manager about my concerns, my first work experience would have been very different. Instead, I was able to address the problem early and not let it fester. Yes, it takes courage to meet with a manager and express your true feelings, but it’s worth it. That’s why it’s important for nursing students to learn how to handle acts of incivility during their academic education and to learn skills needed to address issues they will face during their nursing education and throughout their career as nurses.
Students and new graduates are nursing’s future. If we can teach them about civility and how to advocate for change, the nursing profession will be in excellent hands. RNL
Part Two: Cindy’s ‘Five RITES’ for fostering student-driven civility (article by Molly Clark's mom)
For another article by Cindy Clark on civility and nursing students, see What students can do to promote civility.  
Molly Clark, BSN, RN, a 2011 graduate of Carroll College School of Nursing in Helena, Montana, USA—she played soccer for the Fighting Saints!—was recently commissioned as an ensign in the U.S. Navy Nurse Corps. After completing Officer Development School in March, Clark will be stationed at the Naval Medical Center in Portsmouth, Virginia.

Friday, June 5, 2015

Fostering Professional Relationships and a Productive Workplace Environment

Fostering professional relationships in research
Chapter from Business Administration for Clinical Trials, an STTI book.
By R. Jennifer Cavalieri and Mark E. Rupp

This chapter from Business Administration for Clinical Trials: Managing Research, Strategy, Finance, Regulation, and Quality is about cultivating good relationships with colleagues and research subjects. Authors Cavalieri and Rupp discuss the "people part," one of the most rewarding and challenging parts of research. The chapter explains how to take unique perspectives and needs of colleagues and subjects into consideration to overcome barriers to finding common ground.

  
Chapter 4: Fostering Professional Relationships and a Productive Workplace Environment

Book: Business Administration for Clinical TrialsThe most rewarding and challenging part of research is the “people part.” An intimate understanding of human nature is at the heart of good practices for managing professional research relationships between supervisors and staff. There are, of course, many other factors influencing the research professional’s work relationships, including institution policies, the scope of practice, and state and federal laws, but it’s the “people part” that is meaningful and memorable. This chapter explores ways the research professional can foster relationships with colleagues and research subjects, as well as provides some suggestions on creating firewalls.
Finding common ground and understanding
Working with colleagues and research subjects is required. Doing it well is an art. If you take the unique perspectives and needs of each of your colleagues and subjects into consideration, you have overcome the biggest barrier to finding common ground.
Research subjects
Research subjects have a relationship with research professionals that is similar to their relationship with their medical providers. There is a fundamental similarity between a patient and research subject in the healthcare setting because both are involved in activities and testing within a medical environment. But there are also a host of differences.
Table 4.1 shows these similarities and differences
.
TABLE 4.1 The Similarities and Differences Between Patients and Research Subjects
Both Groups Are...
Patient
Research Subject
Vulnerable
Illness and care requirements may be creating stress and disruption of their normal lives.
They may feel too weak or ill to question or comparison-shop for medical services.
They may need to use preferred medical providers due to the requirements of their medical insurance plan.
They may feel stressed by their medical condition and care.
They may be desperate for treatment options.
The subject may not understand the difference between standard of care or optional research activities.
Dependent
They need professional medical treatment.
They may have exhausted available approved medical therapies.
Interacting With You Over a Period of Time
Outpatient clinical care is usually intermittent and ongoing.
Inpatient care is usually a short-term situation until the patient is medically stable and released from the hospital.
The relationship between research professionals and research subjects is based on the research protocol and last for a day, a week, or years.
Located
Treatment may take place in a medical clinic, hospital ward in an acute care hospital, or a longterm care facility. Medical professionals may provide services in the patient’s home.
The study may take place in a clinic, hospital ward, long-term care facility, or community-based ward, medical office, or in the community.
Simply put, patients need clinical care, but research subjects do not need to participate in research. The importance of establishing rapport and a positive working relationship with research subjects cannot be overstated.
Why do patients agree to participate? Despite strict research regulations to the contrary, some patients may feel pressured to participate. They may want to “please” their physician or feel obligated to go along with their family’s wishes.
What are the direct and indirect benefits a subject may receive from participating in a clinical trial? Directly, they may be receiving access to innovative medications or interventions. It is important for research professionals to clarify the difference between clinical care and research participation. Therapeutic misconception is when a subject believes their research participation is medical therapy with a medical provider following a treatment plan with interventions and medications that have already undergone the scrutiny of the clinical trial process. Sometimes subjects choose to participate and lose sight of the research aspects of the study interactions and consider it a social relationship.

EXAMPLE

Family members were participating in a research study in which blood samples were collected for genetic analysis. The investigator used a group consent process to thoroughly explain the study and answer questions. Family members had as much time as they needed to consider participation, and those individuals who agreed proceeded from the conference room one by one to the clinic room, where a blood sample was taken.
In the clinic room, one consented subject told the research nurse how much he hated needle sticks and that, although he was perfectly willing to participate in the study, he did not want a phlebotomy procedure. “If I don’t do this, my family will be angry and keep trying to convince me to do it. They are going to know I didn’t do this.” The investigator spoke with the subject privately, supported the subject’s right to privately decline to continue participation, and provided the subject with an “out”—the option of placing a bandage on his arm so that he appeared to have had a blood sample collected.
Because all results were confidential, the family members did not find out that one of them did not participate. Could the investigator have re-explained the optional nature of research to the group? Sure, but some family members might have continued to pressure the person who didn’t want the needle stick.

It is not unusual for us to hear subjects say that they consider their study participation as beneficial from the standpoint of having an extra set of eyes looking over their clinical condition. Some patients and their families, facing teams of medical specialists, may see the investigator and his research team as a stable resource.

 EXAMPLE

A clinical trial for osteoporosis was conducted over a 4-year period. The sponsor, wanting long-term efficacy and safety data, offered the participants the opportunity to continue on in a 2-year extension study. As the primary study neared completion, the subjects were offered information about the extension study, and the informed consent process was conducted. The investigator realized the subjects needed additional reminders and explanations about the research when he saw that the majority of participants had, over time, actually forgotten that they were participating in a clinical research trial and regarded their quarterly study visits as clinical care with a social benefit. They looked forward to their interactions with the research staff just as they looked forward to their aquatic exercise programs and their church activities.

Their decision to participate may be based on a desire for more medical attention. Because research visits can take much longer and happen at more frequent intervals than clinical care appointments, this extra time may mean additional education, reassurance, and encouragement.
These days, when clinicians are so busy, patients may want providers to slow down and explain (and re-explain) medical information in more detail or provide reassurance about symptoms. Time and attention may be the only “carrots” a research professional can provide.
Attaining access to medical caregivers and services in large hospitals and clinic systems can take considerable effort and time waiting for an open appointment time. During a research study, subjects usually have direct access to the investigator and his team because they are responsible for closely monitoring the subjects’ status. Subjects can become very dependent on the research staff to help them navigate the complex healthcare system and get quicker access to help.
Adverse events are assessed quickly, and the research team will intervene when the subject has concerns or symptoms of an adverse event.
When their study participation ends, patients and family members may still want to leverage their relationship with the clinical research team to help them cut through red tape and schedule quicker visits and medical attention. They may call to update the investigator on their medical progress, notify the investigator when they have been admitted, or simply drop by to visit. These actions can stem from a former subject’s normal desire for assistance and attention. We have done many studies and worked with wonderful research subjects, and we’re always sorry to see a study end. We do frequently run into former subjects, and they often ask about study outcomes.
Helping subjects to transition from their active to completed status in the research relationship will need to be handled respectfully and tactfully.
Strategies for working with subjects include: 
  • Regularly refer to their research participation and obtain and document their verbal assent to continue.
  • Use dedicated research telephone numbers and cell phones for all interactions. Never give out your personal cell phone or information about your residence.
  • Clearly identify what you can and cannot do for former subjects. For example, say, “I am sorry to hear that (former subject) was admitted to the hospital. The investigator is available if (former subject’s) medical providers have any questions about the research.”
  • Consider sending a study closure letter to subjects from the investigator. This provides a final formal thank you to the subject for their involvement in the study, clearly closes the formal study relationship, and gives them a route to contact the investigator and research personnel within the confines of study follow-up.
  • Research offices and clinics should maintain controlled access at all times in order to protect the integrity of the research records. Front desk personnel should not grant access to these areas without scheduled appointments or calling the research personnel to the front desk. 
Sponsors and their representatives
One of all sponsors’ cardinal priorities is to understand what is happening at their research sites and make sure they are in compliance with GCP and the research protocol (International Conference on Harmonisation, 1996). It is the sponsor’s goal to develop a positive working relationship with the investigator and the investigator’s research staff. The days when they were permitted to bring in refreshments and provide small gifts such as tote bags and office supplies to research personnel are long gone due to federal anti-kickback statutes (Burgess, 2014).
Industry sponsors and their representatives, contract research organizations (CROs), may use standard business practices to provide incentives and reward their own employees by using gifts of products, financial bonuses, and paid expenses, but this is not the case for the research sites. Sponsors and their representatives must build rapport with the investigators and their research personnel without gifts. They rely on establishing a firm connection with site personnel in order to understand how the research site operates and will provide feedback and liberally praise achievements in order to encourage performance.
Sponsors are in the business of developing products. Investigators are in the business of providing medical care, teaching, and publishing, but there is common ground between the two. Sponsors have business goals, and the investigators have professional goals. The common ground is that both want subject safety, to reach study enrollment goals, to maintain protocol compliance, and ultimately to have the research question, the purpose of the study, answered.
Building a positive and productive relationship with the study sponsor makes good business sense, but the integrity of the research data must be maintained and the results must avoid any appearance of influence from the sponsor.
Here are some important strategies you can put into practice:
  • Use caution when the sponsor or their CRO offers to provide direct support for site activities.
    • Do not allow the sponsor or CRO to prepare local IRB documents. The IRB submission process is the investigator’s responsibility.
    • Refrain from releasing any prescreening information about the investigator’s patients because these persons have not signed consent. It would be a Healthcare Insurance Portability and Accountability Act (HIPAA) violation to even report the sex or age of patients who were evaluated for eligibility.
    • Providing colleagues’ contact information for the sponsor to use for study communication may seem like a supportive suggestion, but the investigator’s IRB will need to be informed that this is part of the study recruitment plan. Remember, after the contact information is provided to the sponsor or CRO, there is nothing to stop them from sending study-specific information as often as they choose to busy colleagues who may view this as spam at best. In addition, there is nothing to stop the sponsor from using the contact information for their own purposes.
  • Use caution when the sponsor or their CRO requests participation in surveys comparing their systems with the systems other sponsors are using. Investigators are required to maintain the confidentiality of their studies.
  • Use the dedicated research addresses, telephone numbers, and cell phones provided as a part of the investigator’s institution for all interactions.
  • Check your institution’s and IRB’s policies on recruitment bonuses and gifts. Expect them to be prohibited and be thoroughly familiar with the institution and IRB policies. The IRB’s interpretation of bonuses may include more than prohibiting direct payments. It may also prohibit “educational grants” and “finders’ fees” for clinical personnel.
  • Keep study documents in secure cabinets and maintain confidentiality with all study information. Monitors know better than to ask for details about other study commitments, but especially those who are industry-sponsored will be keeping their eyes and ears open for evidence of competing commitments at the sites.
  • Keep meals and coffee breaks Dutch treat. Make sure the monitors know where the cafeteria and restrooms are located.
  • There is no need to establish the expectation of continuously being together during their entire visit. Their goal is to establish rapport, and they will be maintaining a file with notes about the investigator and site staff. Your goal is to establish a positive working relationship. Always remember that you are in control of how much personal information you want to share about yourself. 
Clinical stakeholdersThe support and engagement of clinical stakeholders who oversee the clinical and ancillary areas in the institution are critical to the success of a study. They will likely want to know about the results of the data collection long before the research analysis is complete. Their clinical world moves at breakneck speed, and their priority is the use of the data for their reports and initiatives. 

EXAMPLE

An investigator conducted a clinical trial for an investigational device that evaluated levels of bioburden (essentially dirt, debris, and germs) in patient rooms over a 2-year period. Although the clinical staff was fully informed of the study plan and activities, over time, they made assumptions about the reliability of the device’s data for the cleaning status of the room. The investigator had to explain and re-explain that the study results were not yet available—the study data had not yet been analyzed and could not be used to make clinical decisions (Smith et al., 2014).

  
Here are some strategies for working with clinical stakeholder:
  • Include clinical stakeholders in planning, updating, and sharing results.
  • Include support for them in a study budget where appropriate, especially when the research disrupts their workflow or consumes some of their resources such as staff time.
  • Let them know that their involvement is appreciated and that long-term success of the organization’s mission depends on their goodwill and support. 
Research colleagues
Adults are free to choose whether to establish personal relationships with co-workers, when this is going to happen, and how much of their life outside of work they are going to discuss. Colleagues have a natural interest in each other and getting to know new employees. New employees may be anxious to fit in as they start in their new position. Co-workers will almost certainly ask them to talk about themselves and their interests. A proactive strategy is to prepare an “elevator speech” of some very general comments about yourself to use for these early meetings with your new colleagues.
Matters can become very personal if family members are employed at the same institution or research professionals are receiving healthcare services at the institution where they work. Family may work at the same institution; however, there are usually policies that prohibit their working in the same department or supervising relatives.
Research professionals may work and receive healthcare services at academic medical centers. Their privacy is protected by HIPAA privacy laws, and there are strict policies on how and when medical records can be accessed. Surveillance and audits are conducted to ensure every patient’s, employee or not, privacy.
It is not uncommon for clinical personnel to participate in clinical research. Clinical personnel may have a better fundamental understanding and, in general, a greater trust of research. They may be curious and altruistic and see their participation as an avenue to contribute to medical knowledge. Strive to maintain the employee–subject’s confidentiality, especially during testing and study visits.
Expect the employee–subject to experience some role confusion. They may be uncomfortable with the role reversal. Do not assume that the employee–subject already knows anything at all about the disease process under study or the mechanics of daily research activities.
Often investigators and institutions have policies prohibiting family members or direct employees from participating in their clinical trials in order to avoid or avoid the appearance of coercion and breach of privacy. Research protocols may also include enrolling family members or employees as exclusion criteria.
Strategies for working with colleagues include: 
  • It is important to block potential conflicts of interest or breaches in confidentiality before they happen. Check your institution for policies related to enrolling relatives into trials. Institutional review boards (IRB) and the principal investigator’s research enterprise usually have a standard operating procedure (SOP) and policies in place addressing issues related to members of the research team or their family members participating.
  • If such policies do not exist, draft a policy for the research enterprise to address this. 
Facing the grim realities of life
The mission of research professionals is to find answers to treat and mitigate the effects of illness, better understand ways to prevent illness, and provide a measure of hope that what we learn can help ease the suffering of others. The passion and compassion of research professionals can lead to the very real effects of sadness, depression, and feeling burned out over time as they face the needs and loss of so many medically ill people.
Because a significant number of waking hours are spent with colleagues, these relationships are important and valuable and can be a source of tremendous joy and pain. The change in relationships with our colleagues due to career moves, retirement, or illness is inevitable. These changes can also lead to feelings of sadness and loss.
Here are some strategies you can use for taking care of yourself:
  • Appreciate today. Remind yourself that today, what you are working on now, and the people you are working with are a part of “the good old days” you will look back on in the future.
  • Work on the coping skills necessary for facing death and dying. We should recognize the signs of burnout in ourselves and colleagues and take steps to cope.
  • A change in research specialty may be in order. Not all clinical trials are working with seriously ill subjects. There are many research roles, and some involve no patient contact. 
Be (almost) indispensable
The people within a research enterprise, like people in any business, need to work at building productive working relationships. Productive research relationships are grounded in communication, team effort, and compliance, and this chapter has presented some research-specific ideas to consider. How are productive relationships built? One way to look at working relationships at an academic research site is to recognize that everyone, even the principal investigator, has a boss and is expected to contribute to the success of the research enterprise. Adopting the strategy of becoming (almost) indispensable to your boss and your colleagues benefits everyone on the team.
Why is indispensable status risky? First, you should never be truly indispensable because this can hold you back from developing and taking on new opportunities. People may also ask you to do unreasonable things because you are the supposedly the only one who can do them. Being indispensable is a sign of poor planning on the part of all parties involved. Having indispensable people will backfire when they have an illness or family emergency, as everyone does at some point. Finally, people with “indispensable” labels can get a falsely elevated impression of themselves.
No one is indispensable.
That said, here are some ways to be (almost) indispensable: 
  • Consider ways to work collaboratively and build a strong study team. Mentoring the less-experienced members of the research team or coaching a colleague through the research certification process helps to reduce the frequency and seriousness of mistakes and improve efficiency. Supporting and advising a peer while they prepare for research certification creates a sense of shared accomplishment and fosters the spirit of teamwork.

TIP
Research professionals can contribute to developing orientation processes and tools, create an intranet site for research resources, or hold periodic meetings for education and fellowship.
Helping a new colleague can be as simple as an experienced coordinator taking a new coordinator under her wing and mentoring her through her first weeks and months as a study coordinator. Explaining, identifying references, and listening in these early days can be the difference for successfully acclimating to the new position.  


 EXAMPLE

If the principal investigator needs some backup on study activities, having the secondary investigator assume responsibility from beginning to end on the next subject being enrolled is an excellent orientation to the study. It will become much easier for them to step in and out of the process for backing up the study activities going forward. 
Recognize that recruitment and retention of subjects is everyone’s job. Subject recruitment and retention are prime examples of the value of teamwork. Each member of the research team has a part to play, from the investigator administering informed consent to the research coordinator handling the logistics and education to the research assistant who efficiently collects and processes specimens. If a subject doesn’t understand what they have consented to, if parking or finding the research office is too frustrating, or they have to return for a repeat blood collection, study retention is in jeopardy. 

 EXAMPLE

Consider the impact of a friendly receptionist, a research assistant who provides clear directions to the study visit location, and the value of updates on study progress to clinical personnel in ancillary areas. Your subjects as well as the study coordinator and investigator will have regular interaction with them. Completed subjects and even patients who do not qualify for study participation can become ambassadors. We consider it high praise when qualifying medical professionals choose to participate in our clinical trials.

Thorough pre-study and ongoing targeted education makes a difference in retaining research subjects. Telling a subject that there are 13 study visits as a part of the informed consent discussion may be honest, but he may consider this too much of a commitment. If the information is presented as five study visits and eight telephone study visits over 3 months, the subject may find this less daunting. With so many visits over several months, providing a simple calendar with appointments plotted out or a list of appointments can help the subject stay organized.
At each study visit, be sure to remind the subject of where they are on the study timeline. For example, reference the study visit calendar and tell the subject, for example, that today is study visit three, and that his next study visit is a telephone visit that should be done either Thursday or Friday. Ask if it would be convenient for you to telephone him in the morning on Thursday, for example. 
  • Go the extra mile. Successful research professionals look for ways around, over, or through obstacles. 

EXAMPLE

Interactive systems (historically called interactive voice-recognition systems or IVRS) are commonly used in research for managing investigational product and supplies. They have been in place for more than a decade and have evolved from telephone and fax to web-based systems. These systems efficiently track inventory and study milestones such as screening visits and may be a tool for implementing the randomization process of subjects for multisite trials. Research professionals receive training on how to use the system, but should be prepared to think and work through logistical glitches.
During the final months in a recent clinical trial, the remaining amount of limited investigational product was being redistributed among sites and several boxes were removed from our site’s stock. Shortly after this transfer, a system error in the IVRS was discovered at an early morning study visit. One of the redistributed boxes of investigational product was still listed as our site’s stock, and the IVRS assigned it to our subject. Our dilemma was to reschedule the subject’s study visit or attempt to work around an automated system.
Rescheduling subjects for study visits is a risk to their compliance. Will the inconvenience cause the subject to consider withdrawing from study? Will the subject return for a repeat study visit within the protocol-mandated schedule? Will the delay result in a delay of the study drug start or a protocol deviation due to the timing of doses?
The study visit was scheduled for 7:00 a.m. Central time because the subject and her parent needed to get to school and work on time. Telephone calls to the IVRS are usually done after a subject arrives for the visit because this centralized system is working with dozens of study sites and is designed to take global and site variables into consideration for study drug assignment.
The study sponsor was based in the Pacific time zone. The investigator was in route and unavailable by telephone. Calls to the IVRS help line and study monitor were unanswered. With minutes left to decide whether this issue could be resolved to salvage the study visit or reschedule the study visit, the research coordinator made a call to the sponsor’s project leader. This person was available and had the authority to provide immediate authorization to assign an alternate investigational product kit, and the study visit was completed.
The take-away message is that technology is great, but clinical trials call for sharp critical-thinking skills to keep subjects engaged and maintain protocol compliance. Technology will keep up with the clinical trial needs, but cannot always anticipate all of the real-life challenges that arise. Several years have gone by, and our latest clinical trial IVRS system has an automated choice for kit replacement to address lost or damaged kits.

  

 EXAMPLE

Study monitors, the sponsors’ representatives, are responsible for supervision of the overall conduct of the trial. Their visits to the study site are part of these responsibilities. They will send confirmation letters for scheduled study visits and provide a description of what they plan to review. The monitor will interact with the investigator and study coordinator during the visit and works to clarify and resolve any data discrepancies. They may also provide additional protocol and GCP-related education.
Our investigators rely on email or verbal updates on the progress of a site visit from the research coordinator. Emails are a handy documentation tool for the research coordinator to use. Formal meetings with the investigator are customarily done toward the end of the monitor’s visit. By remaining in close contact with their study staff, the investigator can intervene in a more timely manner and as needed.
Monitoring visits are a significant investment of coordinator time. The coordinator will prepare for the visit, making sure that the items listed in the monitor’s confirmation letter are ready for their review.
Action items presented at the final meeting with the investigator and listed in the follow-up monitor letter will need to be addressed.
The dilemma for the research professional is that the monitor’s follow-up letter may be 4 to 6 weeks in coming. The solution for the research coordinator is to use the investigator’s update emails to create a short summary of the activities and create a punch list (a to-do list of items commonly used in construction or project management) so that the needed items are not forgotten. Site personnel should carefully review the monitor’s follow-up letter to make sure all of the noted items are addressed. On the rare occasion that the monitor’s letter does not arrive, is misdirected, or is very tardy, the investigator can rely on their documentation.

  
It is essential that research professionals understand their study responsibilities and regularly review GCP guidelines to ensure compliance (U.S. Department of Health and Human Services, 1996). 
  • Understand that research professionals on the front lines often have the best perspective on improving operations. 

 EXAMPLE

A clinical trial for a new drug to treat osteopenia (low bone-density) needed participants. Because most women have never had a bone-density measurement (a low-risk radiology procedure), their bone density was usually unknown.
Because the investigator had been conducting these types of trials for many years, the experienced team of research professionals at an academic research site had efficient processes in place for conducting outpatient osteoporosis clinical trials.
Their standard recruitment plan was to inform potential subjects of the study and then filter qualifying subjects from a large pool of interested women. The dedicated recruitment nurse was responsible for managing all outreach efforts, including giving community-based presentations, arranging the advertising and public relations messages, phone triage, and scheduling screening visits. The recruitment nurse frequently used staggered advertising strategies to achieve 50 to 75 telephone calls per week and, of these, an average of 10 screening study visits were scheduled, with the goal of scheduling them within a few days of the telephone call. The research nurse coordinator was responsible for conducting the screening visits, enrollment, and study visits.
As enrollment steadily increased, the research coordinator’s schedule was quickly filled, and the processes needed improvement. The original thinking was that a positive working relationship between the research coordinator and a subject is established at the time of the screening visit. When we analyzed our screen-fail ratio, it became clear that only one to two subjects out of every 10 scheduled visits qualified for the study. The 30-minute screen visits for the other eight screen failures were a poor investment of the research nurse coordinator’s limited time. She needed to spend her time working with the subjects who qualified and chose to continue on in the study.
The recruitment nurse and research nurse coordinator re-examined their usual tasks and formulated a process change to let the recruitment nurse assume responsibility for the conduct of the screening visits. After study eligibility was confirmed, the research nurse coordinator stepped in to complete the visit and move forward with the study activities. The recruitment nurse completed the screen visits for the subjects who, based on their bone-density results, did not qualify to participate. After a brief trial, the investigator agreed to this plan. Subjects were more accepting of this process than we had anticipated. 
  • Strengthen your research team by understanding your weaknesses and working together to bridge the gaps.
Teaching and sharing educational resources can help make the research team well rounded. Investigators who make an educational investment in their staff by explaining the medical condition and related testing will reap the benefits of personnel who are better equipped to support the screening, recruitment, and study visit processes. They have a better understanding of what to report and can identify options and solutions for process improvements.
Colleagues can use “teaching moments” to explain software programs and share documentation tools and tips. It can be uncomfortable to admit that you aren’t an expert at creating graphs or aren’t familiar with the medical symptoms or tests associated with the study’s disease process. Keeping abreast of dynamic regulations and the latest ethical issues is a challenge every research professional faces. Subject safety is promoted in a work environment where research professionals are encouraged to ask questions and share mistakes. 
  • Understand that knowledge and information is power.
  • Operations can be slowed or halted when key personnel are absent or knowledge is hoarded by insecure members of the team. 

EXAMPLE

All of the members of the research team can contribute to centralized references for resources such as organizational charts listing key contact personnel, detailed standard operating procedures (SOPs), policies, and crisis plans. This is essential for both a small research enterprise and the campus-wide research community. 

  • Maximize available resources. Research teams may have limited surge capacity, ability to suddenly handle significant increases in the workload such as multiple eligible subjects at the same time, as investigators balance funding and personnel logistics. There are times when redirecting efforts and working as a team can make a significant impact on recruitment efforts and coverage for personnel illness and family events. For example, investigators may work collaboratively with other investigators within their department or other specialties. Their research coordinators may serve as secondary personnel for multiple investigators. It is critical to clarify delegation and define the expectations and SOPs for this collaborative work.
  • Set and reach stretch goals. When the question is, “How much effort is enough?” the answer becomes, “Just a little bit more.” Setting a study enrollment goal is a good idea. Setting a stretch goal, one that requires extra effort, is a standard performance practice that supervisors implement. The research professional may be able to enjoy some flexibility with their schedule, which can sometimes translate into a little downtime during an investigator meeting in Miami during January, or coming into the office a little later or leaving a little early to balance out some unavoidably long days.

EXAMPLE

It is common for a sponsor to designate the date when study enrollment will close. At that point, the priority focuses on a final push to enroll subjects. For a recent study, the final enrollment date was on a Friday. A potentially eligible subject was contacted on Thursday afternoon, and a message was left using the call-back phone number for the dedicated research cell phone instead of the research office phone.
When the potential subject returned the call at 6 p.m., the research coordinator was walking from the office into the parking garage. The potential subject was willing to come in the following morning for a screening visit to learn more about the study, qualified for participation, consented, and was the final subject enrolled in the study.

  • Recognize that appreciation, optimism, enthusiasm, and the willingness to take on new challenges can be as infectious as pessimism. We are human and need recognition for our ideas, contributions, and achievements. The best recognition doesn’t have to be a trumpet fanfare. 
A handwritten note is a quiet acknowledgement of a job well done or milestone achieved and can go a long way toward building morale. A “wall of fame” in the research offices can display certificates for milestone service anniversaries, the names of certified research professionals, and internal publications. Employee-of-the-month awards may not be appropriate for very small research enterprises and may result in unintended consequences such as resentment and disappointment for those who are not recognized. Customizing ways to recognize and reward team effort makes sense in most settings.
Quality Connection
So let’s look at a risk the investigator might identify, which involves a scenario of working with multiple personnel at multiple research sites: 
What exists: An experienced investigator has just learned that a federal research proposal has been funded. This multiyear, multisite protocol will involve more than a dozen specialized team members.
The risk: Assuring regulatory compliance and maintaining required documentation across three study sites. 
First, the investigator can create some quality objectives to address the risk: 
1. Assign study regulatory responsibilities and accountabilities for supporting the approval and reporting processes.Assign study regulatory responsibilities and accountabilities for supporting the approval and reporting processes.
2. Assure compliance with sponsor-mandated progress and financial reports and regulatory approvals from federal and local IRB groups.
3. Create and conduct surveillance and monitoring plans.Create and conduct surveillance and monitoring plans.
Next, fill in the details of how these quality objectives will be measured and the set up the QC processes:
1. Assign study regulatory responsibilities and accountabilities for supporting the approval and reporting processes.
  • The regulatory specialist is responsible for daily document and file management. Quality indicators include checking the contents of the files against a standard checklist of “essential file documents,” dated communication demonstrating study activities such as meetings and instructions from the investigator, and evidence that the documents are maintained securely, such as document storage in rooms accessible only to the investigator’s designated personnel. 
2. Assure compliance with sponsor-mandated progress and financial reports and regulatory approvals from federal and local IRB groups.
  • Under the direction of the principal investigator, the regulatory specialist is to create schedules, report templates, and checklists. Quality indicators include a comparison of the schedule and report submissions.
  • The regulatory specialist is responsible for drafting reports and correspondence for the principal investigator. Quality indicators include investigator and sponsor satisfaction with report contents.
3. Create and conduct surveillance and monitoring plans.
    • A written monitoring plan will be included in the study-specific manual of procedures (MOP) and the research enterprise’s SOPs. Quality indicators include verification of the presence of the MOP and SOPs.
    • Principal investigator oversight will consist of formal and informal contact with all participating research sites on a quarterly, monthly, weekly, and as-needed basis with the hospital and research personnel at each participating research site. Quality indicators include review of the documentation of written, electronic, and notes to file on telephone conversations between the principal investigator and the site personnel.
    • The principal investigator will visit each participating research site to conduct a site monitoring visit on a quarterly schedule. Quality indicators may include a review of the monitoring report for each visit.
    • The principal investigator will conduct “for cause” visits without prenotification as needed. Quality indicators may include a review of the documentation of the circumstances associated with triggering the visit.
Again, these objectives contain some very general descriptions of the QC activities and quality indicators for a typical clinical trial scenario.
Key take-aways
  • The research environment is not immune to the dynamics of unprofessional behavior, personal differences, conflict, and ambition.
  • General principles of managing people are relevant to the research environment.
  • Research professionals can benefit from firewalls
  • Quality control and quality assurance activities are directly connected to the work performed by multiple members of the research team. RNL
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References
International Conference on Harmonisation. (1996, June). ICH harmonised tripartite guideline: Guideline for good clinical practice. Retrieved from http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/
Guidelines/Efficacy/E6/E6_R1_Guideline.pdf

Smith, P. W., Beam, E., Sayles H., Rupp, M. E., Cavalieri, R. J., Gibbs, S., & Hewlett A. (2014). Impact of adenosine triphosphate detection and feedback on hospital room cleaning. Infection Control and Hospital Epidemiology, 33(5), 564-569.
U.S. Department of Health and Human Services, HRSA. (2014). Guidance on the federal anti-kickback law. Retrieved from http://bphc.hrsa.gov/policiesregulations/policies/pal199510.html
U.S. Department of Health and Human Services, U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research (1996, April). Guidance for industry E6 good clinical practice: Consolidated guidance. Retrieved from http://www.fda.gov/downloads/Drugs/Guidances/ucm073122.pdf