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Historically, a single research project involving numerous practice-based research networks (PBRNs) required multiple institutional review boards (IRBs) to be involved in approval of the project. However, to avoid redundancies, federal IRB regulations now allow cooperative research projects that involve more than one institution to use reasonable methods of cooperative IRB review and to cede authority for review and oversight of the project to a single lead IRB. Through ceding, a lead IRB has the authority for review and oversight of the project delegated by all participating sites' IRBs and becomes the IRB of record for the ceded sites. In the conduct of cooperative research projects, each institution or primary care office site is still responsible for safeguarding the rights and welfare of human subjects and for complying with applicable regulations. The purpose of this report is to delineate the process, including cooperation and effort of personnel, for accomplishing IRB approval for the Implementing Networks' Self-management Tools Through Engaging Patients and Practices (INSTTEPP) clinical trial. This process involved 4 PBRNs, 16 family physician offices, 4 academic institution's IRBs, and 4 family practice office external IRBs ceding to the lead IRB. Once ceding was accomplished, subsequent IRB modifications and continuing reviews were the responsibility of the lead IRB, ultimately saving time for all participants and keeping the project on schedule., Competing Interests: Conflicts of Interest None.

Purpose: With one-half of Americans projected to be living with at least one chronic condition before 2020, enhancing patient self-management support (SMS) may improve health-related behaviors and clinical outcomes. Routine SMS implementation in primary care settings is difficult. Little is known about the practice conditions required for successful implementation of SMS tools., Methods: Four primary care practice-based research networks (PBRNs) recruited 16 practices to participate in a boot camp translation process to adapt patient-centered SMS tools. Boot camp translation sessions were held over a 2-month period with 2 patients, a clinician, and a care manager from each practice. Qualitative case comparison and qualitative comparative analysis were used to examine practice conditions needed to implement SMS tools. The Consolidated Framework for Implementation Research guided data collection and analysis., Results: Four different practice conditions affected the implementation of new SMS tools: functional practice organization; system that enables innovation and change; presence of a visible, activated champion; and synergy and alignment of SMS changes with other work. Qualitative comparative analysis suggested that it was necessary to have an enabling system, a visible champion, and synergy for a practice to at least minimally implement the SMS tools. Sufficiency testing, however, failed to show robust consistency to satisfactorily explain conditions required to implement new SMS tools., Conclusions: To implement tailored self-management support tools relatively rapidly, the minimum necessary conditions include a system that enables innovation and change, presence of a visible champion, and alignment of SMS changes with other work; yet, these alone are insufficient to ensure successful implementation., Competing Interests: Conflicts of Interest None.

Purpose: Self-management support (SMS) is a pillar of the well-established chronic care model and a key component of improving outcomes for patients with chronic illnesses. The Implementing Networks' Self-management Tools Through Engaging Patients and Practices (INSTTEPP) trial sought to determine whether a boot camp translation process could assist small to medium-sized primary care practices with care managers implement SMS tools., Methods: INSTTEPP used a stepped-wedge design across 16 practices from 4 practice-based research networks over 12 months. Each network completed a 2-month boot camp translation for creating SMS tools with 16 participants (2 patients, a clinician, and a care manager from each of 4 practices) and subsequent implementation. Outcome measures for patients were the Patient Activation Measure (PAM), self-rated health, and Patient Assessment of Chronic Illness Care (PACIC) process-of-care items at baseline, 1 and 2 months. Clinician Support for Patient Activation Measure (CS-PAM) and theory of planned behavior outcomes were assessed at 5 points over 10 months for clinicians and staff., Results: A total of 297 patients and 89 practice staff and clinicians completed surveys during the study. Over successive 2-month sampling periods, intervention patients experienced greater improvement in PACIC process of care and self-rated health compared to control patients (P<0.0001 and P=0.0273, respectively). PAM (P=0.3515), CS-PAM (P=0.7464), and theory of planned behavior outcomes (P>0.10 for all) were not significantly different., Conclusions: Significant effects on process of care and self-rated health are evidence that the boot camp translation intervention impacted SMS. A larger trial with a typical 6-month boot camp intervention may show significant effects on other outcomes., Competing Interests: Conflicts of Interest None.

Purpose: Patient self-management is an inevitable part of the work of being a patient, and self-management support (SMS) has become increasingly important in chronic disease management. However, the majority of SMS resources available in the Agency for Healthcare Research and Quality SMS Resource Library were developed without explicit collaboration between clinicians and patients., Methods: Translation of SMS tools derived from the library into primary care practices occurred utilizing boot camp translation in four different practice-based research networks (PBRNs). The typical model of boot camp translation was adapted for the purpose of the Implementing Networks' Self-management Tools Through Engaging Patients and Practices (INSTTEPP) study to develop SMS tools for implementation in the participating practices. Clinicians, clinic staff members, and patients were involved throughout the translation process. Existing resources from the SMS library were reviewed and adapted by each boot camp translation group to create tools unique to the patients in each network., Results: There was no preexisting resource within the library that was deemed suitable for implementation without modification. Each network adapted tools from the SMS library to create different products. Common themes emerged from each network's translation process that highlighted the importance of patient engagement in the translation process. Boot camp translation, in conjunction with PBRNs, can be implemented to adapt SMS tools for implementation in member practices., Conclusions: Boot camp translation with a combination of practices and patients can be implemented to facilitate a process of local adaptation that improves the local applicability of SMS tools in primary care clinics., Competing Interests: Conflicts of Interest None.

Purpose: Boot camp translation is a proven process to engage community members and health professionals in translating and disseminating evidence-based "best practices" models for health prevention and chronic illness care. Primary care practice improvement studies, particularly involving patient-driven change, as seen with self-management support (SMS), require engaged practice teams that include patients. Models of engagement such as boot camp translation may be effective., Methods: Four geographically dispersed practice-based research networks (PBRNs) from the Meta-LARC consortium engaged 16 practices to form SMS implementation teams involving a clinician, care manager, and 2 patients in each team. Our study adapted the boot camp translation model to engage the implementation teams in describing patient SMS, studying the Agency for Healthcare Research and Quality's SMS Resource Library, and adapting and implementing self-management tools at each practice site. Testimonials and quotes were collected across the 4 PBRNs through a facilitated brainstorming discussion and consensus model at each PBRN kickoff meeting to address the focused question, "What do patients want and need in order to self-manage their chronic illnesses?", Results: Testimonials collected across the 4 PBRNs and participation levels indicated there was a high degree of engagement in the boot camp translation process across the PBRNs and the practices. Each PBRN developed themes expressed by patients and the practices regarding what patients want and need to self-manage their illnesses. Each practice selected, adapted, and implemented an SMS tool., Conclusions: Results suggest that adapted boot camp translation was effective in guiding multiple practices to implement self-management support tools for the INSTTEPP trial. Additional study of the adapted boot camp translation process in practice quality improvement and practice redesign studies is needed., Competing Interests: Conflicts of Interest None.