Challenges Associated with Multi-institutional Multi-site Clinical Trial Collaborations: Lessons from a Diabetes Self-Management Interventions Study in Primary Care

Purpose: Project management for multi-institutional, multi-site clinical trials poses significant challenges. We describe the response to challenges encountered in a 5-year National Institutes of Health multi-institutional 7-site randomized controlled trial of type 2 diabetes (T2DM) self-management interventions study. Methods: The collaborating institutions consisted of a large 220,000-member integrated healthcare system and a university academic health science center partner. The clinical team comprised the principal investigator and research coordinators covering 6 of the 7 clinical sites, while the academic team comprised the co-principal investigator, coinvestigators, and other research and clinical coordination staff. Subjects recruited for the study had a glycosylated hemoglobin ≥ 7.5 within the last 6 months and received primary care at the participating clinics. Patients who met the inclusion criteria were consented at private orientation meetings, randomized into one of 4 study arms, and followed every 6 months over a 24-month period for data collection. Results: The encountered challenges concerned: 1) communication across the multiple clinic sites; 2) multiinstitutional coordinator training; 3) multiple record-keeping methods; 4) clinical access for academic personnel; 5) unanticipated clinical coordinator turnover; 6) subject recruitment and retention; and 7) multiple Institutional Review Boards (IRBs). Solutions included conducting full team weekly or bimonthly research meetings, coordinator crosstraining, adding study-specific templates with downloadable fields, developing a protocol for working with single point of contact in each clinic, securing commitment from the centralized clinical system to dedicate coordinator(s) to the project for the duration of the study period, setting explicit monthly recruitment goals for each clinic, and establishing a lead IRB up-front. Conclusion: Our challenges reflect the complexity of clinical trial collaborations across clinical and academic partners. Of critical importance to the success of clinical/academic collaborations is the commitment by all institutions for advance determination of communication strategies, IRB processes, records access and storage systems, and online training needs. Trial Registration Number/Site: NCT01221090, https://clinicaltrials.govThe open access fee for this work was funded through the Texas A&M University Open Access to Knowledge (OAK) Fund

Primary care providers\u27 perspectives on online weight-loss programs: a big wish list

BACKGROUND: Integrating online weight-loss programs into the primary care setting could yield substantial public health benefit. Little is known about primary care providers\u27 perspectives on online weight-loss programs. OBJECTIVE: To assess primary care providers\u27 perspectives on online weight-loss programs. METHODS: We conducted focus group discussions with providers in family medicine, internal medicine, and combined internal medicine/pediatrics in Texas and Pennsylvania, USA. Open-ended questions addressed their experience with and attitudes toward online weight-loss programs; useful characteristics of existing online weight-loss programs; barriers to referring patients to online weight-loss programs; and preferred characteristics of an ideal online weight-loss program. Transcripts were analyzed with the grounded theory approach to identify major themes. RESULTS: A total of 44 primary care providers participated in 9 focus groups. The mean age was 45 (SD 9) years. Providers had limited experience with structured online weight-loss programs and were uncertain about their safety and efficacy. They thought motivated, younger patients would be more likely than others to respond to an online weight-loss program. According to primary care providers, an ideal online weight-loss program would provide-at no cost to the patient-a structured curriculum addressing motivation, psychological issues, and problem solving; tools for tracking diet, exercise, and weight loss; and peer support monitored by experts. Primary care providers were interested in receiving reports about patients from the online weight-loss programs, but were concerned about the time required to review and act on the reports. CONCLUSIONS: Primary care providers have high expectations for how online weight-loss programs should deliver services to patients and fit into the clinical workflow. Efforts to integrate online weight-loss programs into the primary care setting should address efficacy and safety of online weight-loss programs in clinic-based populations; acceptable methods of sending reports to primary care providers about their patients\u27 progress; and elimination or reduction of costs to patients