Introduction
Most physician assistant (PA) students choose to study to become PAs because they want to care for patients. If they had wanted to study for a research-oriented degree, they would have applied for MS or PhD programs in biochemistry, biology, public health, or experimental psychology. Nevertheless, PAs cannot avoid research. To provide high-quality, evidence-based patient care, PAs need to consult research daily. PAs who are interested in improving the quality of care given to patients may become part of a team that conducts new clinical research. PAs who become educators will engage in research on how to better educate students or deploy PA graduates. In short, no PA can escape research.
What is research?
Webster ’s New World Collegiate Dictionary defines research as “careful, systematic, patient study and investigation of some field of knowledge, undertaken to discover or establish facts or principles.” Research can take many forms: basic science research in the laboratory setting, survey research, clinical research, policy research, public health or epidemiologic research, anthropologic research, educational research, sociologic or psychological research, or workforce research. Most PAs will use or perform only a few of these subtypes of research. The research PAs most commonly use and conduct are outlined in the next section.
Types of research
Basic science biomedical research
Basic science research performed at many medical schools and research universities and by pharmaceutical companies is the first building block of understanding the pathogenesis of disease, diagnostic strategies, and treatments. These studies are performed at the atomic, molecular, genetic, or cellular levels. They may also involve animal models of anatomy, physiology, genetics, pathophysiology, and treatment. Biomedical research has produced many of the tools we use in the practice of clinical medicine, but much of what has turned out to be useful for clinicians has actually come from fields other than direct biomedical research. X-rays and magnetic resonance imaging both came from physics. Genetics originated in botany. Discovery of the Ebola virus came from a combination of epidemiology and virology. There is a growing emphasis placed on connecting basic science researchers with clinicians to move basic science discoveries “from bench to bedside” more quickly, and many funding agencies, such as the National Institutes of Health, are requiring investigators to collaborate more effectively to make this happen. This new approach to biomedical science is called “translational research.”
Unlike many physicians at academic medical centers, PAs traditionally have not been very involved in basic science research. Some PAs have worked in a basic science laboratory while studying at a university, but few PAs have the advanced training needed for basic science research. PAs generally choose to become PAs because they are interested in caring for people and are less interested in bench work. A few PAs have basic science PhDs and combine clinical practice and basic science research at academic medical centers, but this arrangement is fairly uncommon. More common are PAs at academic medical centers who are part of teams that engage in translational research. PAs may be involved in advising basic science teams on the clinical implications of a new basic science finding and are often involved in the clinical trials used to assess the innovation.
Clinical research
Research performed on human subjects with the goal of developing more effective therapies, better diagnostic tests, or better understanding of the pathophysiology of disease is called clinical research. These are the kind of studies that are often highlighted in the health section of newspapers or in online reports of “breaking health news.” Clinical trials, cohort studies, and case-control studies are just some of the types of studies included under the banner of clinical research. It is typically not difficult to convince PA students that clinical research is relevant to their practice. Every PA would like to know which chemotherapy regimen is best for stage III breast cancer. All PAs would be thrilled to see an effective vaccine for an illness that has thus far not been preventable. Practicing PAs consume clinical research each day if they are seeking to provide evidence-based care to their patients.
Even though all PAs are consumers of clinical research, some PAs are also producers of clinical research. PAs who work at medical schools are often involved in the research mission of the university. Many clinical trials, cohort studies, and case-control studies employ PAs to conduct physical examinations, psychiatric interviews, neuropsychological testing, medication monitoring, observation of participants for adverse events, and performance of many other types of data collection. Doctors often appreciate the generalist background of PAs for these tasks. For example, an orthopedist conducting a clinical trial of a new type of prosthetic hip joint typically does not have much experience in managing diabetes; however, glucose control can substantially affect wound healing rates. Having a PA on the team who can not only assess the effectiveness of the hip prosthesis but also monitor the patient’s glucose control expands the range of clinical skills on the research team and provides better quality care for the study patient.
Although PAs often start out in clinical research as simply the person who performs the physicals, monitors the laboratory results, or collects other data, some of these PAs move up to become investigators themselves. Federal funders and pharmaceutical companies do not typically allow PAs to be principal investigators, but a PA can be one of a group of investigators on the team. To be an investigator, the PA needs to make substantial contributions to the development of the research question, as well as the design and evaluation of the research project. Simply collecting a large amount of data according to someone else’s protocol does not confer investigator status. PAs who become investigators often have the opportunity to collaborate with investigators from other institutions, to present their work at scientific meetings, and to publish their findings in peer-reviewed journals. Getting involved in clinical research gives PAs a chance to develop new skills, share their knowledge with others, and bring cutting-edge treatments back to their clinics to share with patients ( Case 42.1 ).
Bryan Walker ( Figs. 42.1 and 42.2 ) has served as a clinical research PA in two very different environments. When he started as a clinical PA at a general neurology practice in Maryland the practice did not participate in any clinical trials. Through Bryan’s initiative, his practice began to serve as a site for multiple sclerosis (MS) clinical trials. The doctors with whom Bryan worked were pleasantly surprised at the benefits this participation brought to their practice. The sponsors of the trials paid the practice for recruiting patients and enrolling them in the trial. Patients at the practice were delighted by the opportunity to be included in cutting-edge research without having to travel to the large academic medical center in the next city. Participating with clinical trials also brought benefits to Bryan. To accurately collect data, the studies required that all investigators and subinvestigators become certified in administration of common MS research outcome measures. Obtaining certifications to administer these research tests has increased Bryan’s marketability as a research-oriented PA and allowed his practice to be eligible to become a clinical site for even more clinical trials.
Currently, Bryan practices neurology and participates in clinical research at Duke University Hospital in Durham, North Carolina. There he practices clinically for approximately 70% of his time and works on administrative and research tasks for about 30% of his time. His clinical trial work is multifaceted. Bryan identifies patients for potential involvement in the trials, consents them for inclusion in the studies, performs detailed histories, conducts standardized physical examinations, and works with the other investigators on protocol development and data analysis. Brian also serves as a member of the Duke Institutional Review Board, which ensures that all research conducted at Duke adheres to rules for protection of human subjects.
Bryan enjoys several aspects of his role as a clinical research PA. He loves the prospect of helping to generate new therapeutic options for patients with MS. Although substantial improvements have been made in MS care in the past 15 years, better options are still needed. Enrolling patients in clinical trials sometimes enables him to get care for patients that they would not otherwise receive because of insurance or financial limitations. Investigators have an ethical responsibility to provide the very best care for patients in studies. Sometimes this means that study patients are eligible to receive other services, such as lower cost care by other specialties within the Duke system.
Bryan says the main drawback to his role as a research PA is “paperwork, paperwork, paperwork.” The forms that need to be completed for research patients are far more detailed than those required for clinical care and completing them can be mind-numbing sometimes. Performing research is very time-consuming, and as with patient care, he is not always assured of getting out of work right on time.
Bryan’s words of wisdom for those considering initiating involvement in research are, “Just do it. You will never regret it.” He points out that there are many PAs, doctors, and PhDs who are willing to mentor those who are interested in research. Bryan does not hold an MPH or a PhD; he has been trained for his work on the job. He is quick to point out that he, not the doctor, started his practice’s involvement in clinical research at his private practice in Maryland and that PAs are ideally suited for being both clinicians and clinical researchers because of the combination of their medical training and their training in team-based care of the patient.
Stephanie Figueroa ( Fig. 42.3 ) has practiced emergency medicine at the Johns Hopkins Hospital, a large urban hospital in Baltimore, Maryland, for nearly 20 years. She serves as the lead PA and Director of Observation Medicine within the Johns Hopkins Department of Emergency Medicine. Stephanie had the opportunity to complete a fellowship within the Leadership Academy of the Johns Hopkins Armstrong Institute for Patient Safety and Quality. While working with the Armstrong Institute, she developed and implemented a project to improve the way care is delivered to patients with sickle cell disease who come to the emergency department (ED) for their care. Her project was a classic implementation science project in that she was given no extra financial or clinical resources with which to improve the quality of care.
Previously, patients who came to the ED at Hopkins may have been seen by a number of different providers who, in the chaos of the ED, would provide inconsistent care. Nurses varied in their willingness to provide opiate pain control to patients who did not yet have a bed assignment in the ED. This inconsistency of treatment led to frustration among the patients and the clinical staff alike because neither group knew what to expect from the other at each visit.
Stephanie’s project aimed to limit the number of different doctors, PAs, and nurses who would care for patients with sickle cell disease. Patients were routinely assigned to the observation unit portion of the ED, which is staffed by PAs. This first step was the cornerstone in providing more consistent care to this patient population. In addition, personalized care plans were developed for patients who came to the ED frequently, allowing patients and providers alike to know what the treatment delivered for a typical pain crisis would be. An alternative assessment and treatment space was designated in the observation unit where patients with sickle cell could receive a prioritized medical screening by PAs familiar with sickle cell disease. In addition, PAs would initiate appropriate pain management, allowing patients to receive opiate treatment even if there were no open beds in the ED. There, nurses could begin to provide narcotic pain medication in a supervised setting while the patient was waiting for a bed to become available. A patient-controlled analgesia (PCA) pump protocol was developed as well. PCAs not only decrease work for nurses but also provide safer opiate pain medication administration. Standardization of the overall treatment approach to patients with sickle cell disease presenting to the ED in crisis led to consistency in care, thus decreasing the need to negotiate how pain medication would be administered across ED visits.
Removing barriers to aggressively managing patients’ pain early in their presentation to the ED has paid substantial benefits for Hopkins patients. Patients now receive their first dose of medication more quickly and are less likely to be admitted to the hospital than before. The team improved the care provided by analyzing sickle cell patient data, working with all the stakeholders to identify barriers to providing more timely care, developing new protocols and work flow plans to remove these barriers, collaborating with the hematology service to develop individualized patient care plans, and getting both nurses and providers to take ownership of the project. No one—not patients, not nurses, and not providers—wants to go back to the days before this project was implemented. Patients are getting improved care, and providers and nurses are spending much less time negotiating with patients about their care. Instead they are engaging patients in their care and helping align patients with resources provided by the hematology sickle cell care team to reduce the need for ED visits.
Stephanie has found several sources of satisfaction with becoming a quality improvement researcher. Most of all, she is thrilled with the chance to provide higher quality care for patients, along with a better experience for nurses and providers. She loves the opportunity to demonstrate how PAs can be the bridge between the clinical team and the research team. She has told many high-level leaders at the Johns Hopkins that “PAs are an untapped resource for quality improvement work” and has encouraged them to look within the group of 400+ Hopkins PAs for others who may be able to conduct projects similar to the one Stephanie headed. Stephanie has also enjoyed collaborating with other health professionals within emergency medicine and hematology to refine her project. Stephanie believes that getting PAs involved in quality improvement work can contribute to professional satisfaction and longevity and that PAs who do this work can really raise the profile of PAs within their institutions.
The difficulties Stephanie finds with this type of work stem predominantly from the lack of visibility of PAs within the health system and the lack of PA role models. PAs who get involved in leadership usually have to blaze their own trail. When PAs are included in committees or are recruited to be part of a quality improvement team, they are often required to do this in addition to their other duties and are often not paid for the time they put into this work. Stephanie says that she “often felt like an eager little dog, nipping at their heels and trying to squeeze my way into the committee room.” Her persistence and that of other PAs at Hopkins has paid off because PAs are beginning to be included to a greater degree on health system committees and in quality improvement teams at Hopkins. Stephanie has been energized by her new roles and believes other PAs would have the same positive experience by contributing to health care quality improvement, using innovation steeped in knowledge gained from the clinical practice of medicine.
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