Frequently Asked Questions about Recruiting, Engaging, and Maintaining Practices for a Clinical Trial in a PBRN
It is critical to include a PBRN core team member (e.g., PBRN Director, PBRN Investigator, PBRN Coordinator) on the clinical trial research team to facilitate practice recruitment. PBRNs have staff members and investigators who have established relationships and garnered the trust of the practices, and will know or can ferret out the research capacities and interests of the practices specific to a clinical trial. The PBRN often will work with community organizations to identify appropriate practices.
The PBRN core team member will be able to evaluate practices for a clinical trial, how the trial might impact usual practice workflow, and consider practices' prior performance in trials, research capabilities, research resource availability, competing research projects, and likely administrative and clinical support for the trial.
Practices that are appropriate for a trial and have signed on will often serve as snowball recruiters, assisting the PBRN in identifying other appropriate practices. To best support such practices, it is important to provide them with a short, one-page information sheet that they can use for recruiting purposes. This one-pager should emphasize the value of the trial to the practice and be clear about the workload required.
2) What do academic investigators need to tell practices about a clinical trial during the recruitment process?
Academic investigators should create a simple one-page information sheet to orient the practices to the clinical trial. This can be the same information sheet that practices can use to recruit other practices to the trial. Why is this research important to primary care practice? What is the "value added" to the practice? These might be funding, personnel such as Practice Facilitators, or technical support such as practice coaching.
Practices need to clearly understand their role in the trial and the expectations on their practice. How will the trial impact the practice and its operations? What practice personnel will be involved? How will the practice benefit from participating? Is there financial compensation for participation in the trial? How will the clinical trial personnel interact with the practice and its personnel?
Investigators need to share information about the methods that will impact clinical care at the practice (e.g., a cluster randomized trial will randomize at the level of the provider or practice rather than patient).
Work with the PBRN core team or PBRN central research project team to make it easy for the practices to learn about the trial. Present the trial at a PBRN meeting, or on-site at a regular practice meeting. Use other communications tools, such as e-mail or newsletters. Highlight the value of their participation in this clinical trial.
Develop the trial idea and methods in collaboration with primary care practices to incorporate the perspectives of the clinicians and practices. This will communicate that the academic research project team cares about the relevance of the clinical trial to primary care.
Work with the PBRN core team or PBRN central research project team to identify practices with clinicians and/or other personnel who have a personal or professional interest in the trial's topic. They will be more enthusiastic about the trial.
Make sure the clinical trial, its intervention, and its results fit with a primary care practice's values.
Provide incentives that have worked for other PBRNs, such as continuing medical education, maintenance of certification (MOC: https://www.theabfm.org/moc/index.aspx), financial incentives, assisting with quality improvement, health information technology assistance or enhancements, or participation in learning groups.
Minimize practices' responsibility for "research" functions (e.g., consent, IRB).
Fit the trial interventions as seamlessly as possible into the usual workflow of a primary care practice. Minimize the time requirements for existing practice personnel, especially the front line care providers like physicians, in the clinical trial intervention and the trial overall. The PBRN core team can often take on tasks that might not be feasible for a busy practice or that the practice may not have expertise in (e.g., IRB, survey dissemination).
Reimburse the practice for the extra work required to participate in a clinical trial. Even if the practices' participation seems minimal, recognize that every additional step or minute with trial participants is over and above usual care, and that this time is precious.
5) What practical factors should be taken into account when recruiting practices to a clinical trial?
Getting through the IRB process at multiple practices can be a significant hurdle that the PBRN central research team will facilitate. Sometimes choosing only those practices that don't have local IRBs can simplify the IRB process. In this way, the investigator's or the PBRN's IRB will serve as the IRB of record for the practices.
Make sure to identify basic practice requirements before starting to recruit -- minimum size of practice, scope of practice, practice research capabilities, ways to identify target patients, resources available and technical capabilities (e.g., wireless internet if tablets or other devices will be used).
Working with large health systems can serve as an advantage or disadvantage. Large health systems may have an involved approval process for clinical trial participation. At the same time, if the health system approves the trial, it may be easier to recruit multiple practices from within a single health system.
- Engage interested practices in an ongoing advisory
or participatory role with the
academic research project team (ideally
established during trial development).
- Work with the PBRN core team or PBRN central research project team to find a subset of practices with physicians or key staff who are interested and willing to shape the conduct of the trial, making sure its procedures are feasible in and relevant to practice settings.
- Develop Practice Lead Physicians/Clinicians who like participating in research by mentoring and training them for their research roles, as well as by encouraging and supporting them to present the research project at research conferences.
- In an intervention trial, consider research methods that allow all practices to get the intervention in a staggered or staged fashion (e.g., stepped wedge design, delayed intervention).
- Establish a clear and trusting connection between
each practice and the
PBRN research project team and the
research project team. These connections will be between
investigators and practice clinicians as well as between the
Research Project Manager and the
Practice Lead Physician/Clinician.
- The PBRN central research project team will identify key contacts for the clinical trial at each practice. These key contacts should include a Practice Lead Physician/Clinician, who will provide leadership for the trial at the practice, and a Practice Liaison/Research Project Coordinator who makes sure the practice follows through on its clinical trial responsibilities. Often physicians are not the best "first" contacts for the trial because of their many competing priorities and long, busy hours.
- Make sure that the PBRN Research Project Manager, often based at an academic institution, has developed a close relationship with the identified Practice Liaison/Research Project Coordinator for the trial.
- Keep the PBRN Investigator involved in all steps that involve the practices to maintain trusting relationships.
- Develop a single point of contact between the practice and the PBRN research project team, usually the PBRN Research Project Manager.
- Support the practices to make their participation
as easy as possible.
- Provide adequate funding for trial participation by the Practice Lead Physician/Clinician, other practice members, and the practice (e.g., FTE for practice personnel, practice participation incentive)
- Reduce the burden of regulatory requirements, such as human subjects training, and the IRB application process (if applicable). Human subjects training can often be shortened and tailored to a particular clinical trial protocol. The PBRN or academic research project team generally will manage the IRB process and complete all IRB forms so that the practice’s responsibility is largely submission of the forms.
- Provide recognition of the participating practice members so that their roles are valued.
- Launch the trial with a training session for key
practice clinicians and staff.
- Conduct face-to-face training, ideally on-site, or else by webinar, with the Practice Lead Physician/Clinician and the Practice Liaison/Research Project Coordinator. Sometimes training can best be accomplished by bringing all practice representatives to a single location. Provide the practice representatives with slide sets that can be used in a train the trainer model on-site at a regular practice meeting. Make sure the academic investigators and key academic research project team members join the training, ideally in person, or by phone.
- Use the training to make sure the practice is clear about the clinical trial expectations, and that the practice has a chance to provide input and ask questions.
- Provide physical reminders of the clinical trial that help the practice identify with the trial – e.g., sweatshirts, pens, mugs.
- Provide a press release that the practice can provide the local media. This can bring positive attention to the practice, and increase the practice’s commitment to the clinical trial.
- Establish clear and regular communications.
- Maintain awareness of the clinical trial at each practice
through having clear communication pathways and regular
communications between the
PBRN Research Project Manager and the
Liaison/Research Project Coordinator and
Practice Lead Physician/Clinician. Easy to use and distribute communications might
- Online surveys such as SurveyMonkey® embedded in e-mails -- an easy way to get initial questions answered from the practices.
- Short, trial relevant, and clinically relevant information in a bulleted, easy-to-read format often is appreciated. Avoid cut-and-pasted information from source websites or hotlinks that require additional clicks or passwords to access material. Make it easy (and interesting!) for the practice to learn what you are sharing.
- Maintain awareness of the clinical trial at each practice through having clear communication pathways and regular communications between the PBRN Research Project Manager and the Practice Liaison/Research Project Coordinator and Practice Lead Physician/Clinician. Easy to use and distribute communications might include:
Many of the activities used to recruit and engage practices continue into the maintenance phase.
- Keep practices interested by reviewing trial
progress with them and asking their advice in problem solving throughout
- The PBRN central research project team will help ensure that there are regular meetings and/or webinars with the Practice Lead Physician/Clinician and the Practice Liaison/Research Project Coordinator. Share issues, preliminary findings, common barriers or answers to FAQs through various e-mail and other communication channels.
- Continue to make participation in the trial as easy
- Continue to manage regulatory requirements such as adverse events reporting and annual IRB status reports.
- Conduct interim trainings as needed (e.g., using
the Case Study format).
- This can be accomplished in the form of a practice Case Study related to a practice-based intervention that is being implemented. A Case Study is a 3-5 minute presentation by a practice physician or nurse about a patient enrolled in the trial. The physician or nurse might present a success story or difficulty related to implementing the practice-based intervention. Other practice clinicians and staff, the Research Team's Principal Investigator (PI) and the PBRN Research Project Manager attend the Case Study. The Principal Investigator attends via conference call. All attendees may ask questions or provide input, such as how the trial intervention was implemented, or how it did or did not affect the patient’s care. The Case Study serves to maintain fidelity of the intervention throughout the trial, problem-solve issues that arise, and maintain communications and practice engagement in the trial.
- Provide recognition for the practice’s
accomplishments (e.g., in recruitment) in the form of simple incentives
that reward individuals as well as the practice as a whole.
- Recognition can come in many forms – e.g., gift cards, presentations, holiday gifts.
- At the end of the trial, provide certificates or plaques of recognition and completion. Practices often display these plaques in their waiting rooms.
- Maintain clear and regular communications, at least
- Provide trial updates and upcoming activities in formats that the Practice Lead Physician/Clinician and the Practice Liaison/Research Project Coordinator can distribute easily (e.g., powerpoints for staff meetings, newsletters, posters). Provide:
- Keep the trial fun and interesting.
- Conduct contests (e.g., which practice enrolls the most trial participants in a month) with a practice-wide prize (e.g., ice cream party, pizza party)
- Send out word puzzles incorporating words that relate to the topic area (e.g., word search, crossword puzzle)
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