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Past Opportunities to Provide Input
- Patient-Centered Economic Outcomes Landscape (2023-2024)
- Systematic Review of Audio Care for the Management of Mental Health and Chronic Conditions (2023) -- Draft Key Questions
- Proposed New Methodology Standards for Usual Care as a Comparator (2023)
- Stakeholder Views on Components of 'Patient-Centered Value' in Health and Health Care (2023)
- PCORI's Proposed Research Agenda (2021-2022)
- Proposed National Priorities for Health (2021)
- Proposed Principles for the Consideration of the Full Range of Outcomes Data in PCORI-Funded Research (2020)
- Proposed New PCORI Methodology Standards (2018)
- Data Access and Data Sharing Policy: Public Comment (2017)
- Proposed New PCORI Methodology Standards (2017)
Comment on the Proposed New and Revised PCORI Methodology Standards (2016)
- 1. Standards for Formulating Research Questions
- 10: Standards for Studies of Diagnostic Tests
- 12. Standards on Research Designs Using Clusters
- 13: General Comments on the Proposed Revisions to the PCORI Methodology Standards
- 2: Standards Associated with Patient-Centeredness
- 3: Standards for Data Integrity and Rigorous Analysis
- 4: Standards for Preventing and Handling Missing Data
- 5: Standards for Heterogeneity of Treatment Effects
- 6: Standards for Data Registries
- 7: Standards for Data Networks as Research-Facilitating Structures
- 8. Standards for Causal Inference Methods
- 9. Standards for Adaptive Trial Designs
- Peer-Review Process Comments (2014)
- Draft Methodology Report Public Comment Period (2012)
- Past Opportunities to Provide Input
Doing patient-centered research involves more people than simply patients and researchers. Many studies include clinical staff: physicians, nurses, physician assistants, administrators, and others. They can make research protocols relevant to real-world settings by providing unique insights into effective ways to provide patients with treatments or services. Clinicians can also play a central role in recruiting patients to serve as participants in studies.
But, as we all know, clinicians are already overwhelmed with the responsibilities their important jobs demand. To engage them in research, investigators must demonstrate how a project can benefit their practices and their patients. Below, we highlight three PCORI-funded projects that have used creative means to engage clinicians in their studies. The researchers also offer advice to other projects (see sidebar).
Five Steps for Engaging Clinicians
Three PCORI-funded principal investigators offer advice for engaging doctors, nurses, and other clinical staff in patient-centered outcomes research:
- Develop relationships before a study begins
“Start engaging clinicians early in the planning process, so that you can be realistic about their needs,” says Diane McKee, MD, MS, of Albert Einstein College of Medicine. “We came to them with ideas about the project before we even submitted the proposal to PCORI.”
- Make it easy for clinicians to participate
“Make sure that you’ve designed the study so that the burden for clinicians is very, very low. They are so busy with patients that they don’t have the bandwidth to take on research activities,” McKee says. “We’ve tried to make their engagement with the study not take any longer than any other clinical decision making.”
- Identify project champions
“A champion is a physician or nurse practitioner in charge of the study at each site,” says Paula Gardiner, MD, MPH, of Boston Medical Center. “We didn’t bring in our own—we hired health-center employees to work on our project. It absolutely improved buy-in at each site.”
- Bring together stakeholders to learn from each other
“Schedule town hall meetings to engage patients and clinical staff and providers,” says Judith Long, MD, of the University of Pennsylvania. “It helps us hear what they are experiencing and think about sustainability at the end of the project.”
- Express gratitude
“It sounds simple, but it’s important: Say thank you,” Gardiner says. “After recruiting patients was done, we sent hand-written notes and we brought chocolate or homemade cookies. It’s meaningful to the people at the health centers who are working so hard. Their lives are complicated, and their patients are complicated. They need to be appreciated.”
Making Research Easy for Clinicians
Two of these projects work with urban community health centers treating patients with chronic pain, many of whom are from minority groups and live in poverty. The investigators are testing acupuncture and other integrative treatment approaches to address pain. “Clinicians really want another tool in the toolkit,” says Diane McKee, MD, MS, of Albert Einstein College of Medicine in New York City. “They struggle to find ways to decrease pain and improve function.”
The project she leads is comparing group acupuncture—providing this treatment to multiple patients in a single room—with traditional one-on-one acupuncture.
Offering acupuncture to patients who wouldn’t otherwise have access to it was not a hard sell to the clinics’ doctors, McKee reflects. Trickier was squeezing the service into the bustling clinic.
“A day-to-day struggle is that these health centers have no space,” McKee says. Early in the study, the research team met with clinical staff to find evening and weekend times when conference rooms or other group settings would be available for acupuncture sessions.
The team also made it easy for clinicians to refer patients to the study. “They just identify patients with chronic pain and discuss with them whether they would be interested in acupuncture,” McKee says. “That’s it. We do everything else.”
The researchers and acupuncturists attend clinic meetings, keeping the clinicians up-to-date on what the research team is doing, and relating stories about how the patients are experiencing the acupuncture treatments.
Another study, at Boston health centers, also seeks to bring integrative medicine to patients with chronic pain. This study is testing group medical visits—8 to 12 patients see a clinician at once—focusing on nonpharmacological techniques for relieving pain, such as acupressure, meditation, yoga, and massage.
“We first needed to build bridges with the community health centers,” reflects Paula Gardiner, MD, MPH, of Boston Medical Center. “In our community health centers, patients with chronic pain did not have options for non-opioid treatments,” she says. “They can’t afford an acupuncturist; they can’t afford yoga classes.”
A family medicine physician herself, Gardiner well understood clinicians’ needs. Doctors were trying to handle complicated medical problems in quick visits, she notes. “I met with the clinics’ upper leadership and with the clinicians,” Gardiner says. “I said, Will you partner with me? Will you sit at the table with me to figure this out?”
The clinicians and a patient advisory group helped shape the integrated medical group visit, revising the curriculum and creating videos. “In the beginning, we had an intervention that was A, but when we ended the design, we were at Z,” Gardiner reflects. For instance, the doctors suggested that, to help them identify patients who might join the study, a research team member should attend every morning huddle of physicians and medical assistants at which they plan their daily schedule.
“We changed our recruitment and workflow plans based on the workflow of the community health centers,” Gardiner says.
Although the project required time from busy clinicians, it is likely to benefit the clinics after the study is over. The doctors will be able to continue using their training in nonpharmacological techniques for managing pain. “This could be a long-term solution to help their chronic pain patients,” Gardiner says.
Coming Together in Town Halls
A project in Philadelphia is examining whether community health workers—trained laypeople who help patients address the social determinants of health as a means to achieving health goals—can improve outcomes for people with chronic diseases. (See related article, Between Clinicians and Patients, Trained Community Members May Provide a Key Link.) The research team’s idea for better engaging clinicians grew out of a sense that the team wasn’t doing enough to involve doctors.
“We were in the throes of the study,” recalls principal investigator Judith Long, MD, of the University of Pennsylvania. The group was meeting with their patient advisors and clinicians separately. “There was something missing from these discussions—they didn’t get at specific logistical details of the intervention and improvements we might make,” Long says.
So the investigators decided to try a town hall meeting in which study participants could describe their experience, community health workers could explain their work, and the patient advisors and clinicians could ask questions and exchange ideas. The meetings ended up helping the research group work out logistical problems and shed light on what the stakeholders valued.
An added benefit was that the town hall meetings turned to discussing sustainability: How would the clinics continue the community health worker program once the study ended? “We laid the groundwork for the future through these meetings that really allowed us to hear from the patients and the providers,” Long says.
Engaging clinicians is a crucial element of patient-centered outcomes research. We encourage all researchers to think about how to involve both parts of the patient-clinician dyad while planning and executing clinical comparative effectiveness research.
December 18, 2016, 7:44 PM
Comment by PCORI,
Hi Andrew. Thank you for your comment. A member of the PCORI staff will be contacting you for more details about your query to provide a response.
December 14, 2016, 2:31 AM
Comment by Andrew Talal,
How have you dealt with the issue of IRB educational requirements for clinicians?
October 5, 2016, 12:46 PM
Comment by fitriulina,
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