Background The Department of Health and Human Services recently called for public comment on human subjects research protections. Objective (1) To assess variability in reviews across Institutional Review Boards (IRBs) for a multisite minimal risk trial of financial incentives for evidence-based hypertension care. (2) To quantify the impact of review determinations on site participation, budget, and timeline. Design A natural experiment occurring from multiple IRBs reviewing the same protocol for a multicenter trial (May 2005–October 2007). Participants 25 Veterans Affairs Medical Centers (VAMCs). Measurements Number of submissions, time to approval, and costs were evaluated. We compared patient complexity, academic affiliation, size, and location (urban/rural) between participating and non-participating VAMCs. Results Of 25 eligible VAMCs, 6 did not meet requirements for IRB review, and 2 declined participation. Of 17 applications, 14 were approved. This process required 115 submissions, lasted 27 months, and cost close to $170,000 in staff salaries. One IRB’s concern about incentivizing a particular medication recommended by national guidelines prompted a change in our design to broaden our inclusion criteria beyond uncomplicated hypertension. The change required amending the protocol at 14 sites to preserve internal validity. The IRBs that approved the protocol classified it as “minimal risk”. The 12 sites that ultimately participated in the trial were more likely to be urban, academically affiliated, and care for more complex patients, limiting the external validity of the trial’s findings. Limitations Because data came from a single multisite trial in the VA, which uses a two-stage review process, generalizability is limited. Conclusions Complying with IRB requirements for this minimal risk study required substantial resources and threatened the study’s internal and external validity. The current review of regulatory requirements may address some of the problems. Primary Funding Sources Veterans Affairs Health Services Research & Development and National Institutes of Health, National Heart, Lung, and Blood Institute
Increasing numbers of research studies test interventions for clinicians in addition to or instead of interventions for patients. Although previous studies have enumerated barriers to patient enrolment in clinical trials, corresponding barriers have not been identified for enrolling clinicians as subjects. We propose a framework of metrics for evidence-based estimation of time and resources required for recruiting clinicians as research participants, and present an example from a federally funded study. Our framework proposes metrics for tracking five steps in the recruitment process: gaining entry into facilities, obtaining accurate eligibility and contact information, reaching busy clinicians, assessing willingness to participate, and scheduling participants for data collection. We analyzed recruitment records from a qualitative study exploring performance feedback at US Department of Veterans Affairs Medical Centers (VAMCs); five recruiters sought to reach two clinicians at 16 facilities for a one-hour interview. Objective metrics were calculable for all five steps; metric values varied considerably across facilities. Obtaining accurate contact information slowed down recruiting the most. We conclude that successfully recruiting even small numbers of employees requires considerable resourcefulness and more calendar time than anticipated. Our proposed framework provides an empirical basis for estimating research-recruitment timelines, planning subject-recruitment strategies, and assessing the research accessibility of clinical sites.
BACKGROUND: What patients perceive and experience within a patient-centered medical home (PCMH) is an understudied area, and to date, the patient perspective has not been an integral component of existing PCMH measurement standards. However, upcoming guidelines necessitate the use of patient-reported experiences and satisfaction in evaluations of practice and provider performance. OBJECTIVE: To characterize patients' experiences with care after PCMH adoption and their understanding and perceptions of the PCMH model and its key components, and to compare responses by degree of practice-level PCMH adoption and patient race/ethnicity. DESIGN: Qualitative study. PARTICIPANTS: Adult patients with diabetes and/or hypertension (n=48). APPROACH: We surveyed and ranked all PCMH adult primary care practices affiliated with one academic medical center with at least three providers (n=23), using an instrument quantifying the degree of PCMH adoption. We purposively sampled minority and non-minority patients from the four highest-ranked and four lowest-ranked PCMH-adopting practices to determine whether responses varied by degree of PCMH adoption or patient race/ethnicity. We conducted semi-structured telephone interviews with patients about their experiences with care and their perceptions and understanding of key PCMH domains. Interviews were recorded, transcribed, and imported into NVivo 10 for coding and analysis, using a modified grounded theory approach. KEY RESULTS: We found that patients uniformly lacked awareness of the PCMH concept, and the vast majority perceived no PCMH-related structural changes, regardless of the degree of practice-reported PCMH adoption or the patient's race/ethnicity. Despite this lack of awareness, patients overwhelmingly reported positive relationships with their provider and positive overall experiences. CONCLUSIONS: As we continue to redesign primary care delivery with an emphasis on patient experience measures as performance metrics, we need to better understand what, if any, aspects of practice structure relate to patient experience and satisfaction with care.
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