Effectiveness of 2 methods of promoting physical activity, healthy eating, and emotional well-being with the americans in motion--healthy interventions approach.

PURPOSE: An increasing number of Americans are putting their health at risk from being overweight. We undertook a study to compare patient-level outcomes of 2 methods of implementing the Americans In Motion-Healthy Interventions (AIM-HI) approach to promoting physical activity, healthy eating, and emotional well-being. METHODS: We conducted a randomized trial in which 24 family medicine practices were randomized to (1) an enhanced practice approach in which clinicians and office staff used AIM-HI tools to make personal changes and created a healthy environment, or (2) a traditional practice approach in which physicians and staff were trained and asked to use the tools with patients. Of the 610 patients enrolled, 331 were in healthy practices, and 279 were in traditional practices. At 0, 4, and 10 months we assessed blood pressure, body mass index, fasting blood glucose and insulin levels, nuclear magnetic resonance lipoprotein profiles, fitness, dietary intake, physical activity, and emotional well-being. Outcome data were analyzed using linear, mixed-effects multivariate models, adjusting for practices as a random effect. RESULTS: Regardless of patient group, 16.2% of patients who completed a 10-month visit (n = 378 patients, 62% of enrollees) and 10% of all patients enrolled lost 5% or more of their body weight; 16.7% of patients who completed a 10-month visit (10.3% of all enrollees) had a 2-point or greater increase in their fitness level; and 29.2% of 10-month completers (18.0% of all enrollees) lost 5% or more of their body weight and/or increased their fitness level by 2 or more points. There were no significant differences in these outcomes between groups. CONCLUSIONS: There was no difference between the 2 groups in the primary and most secondary outcomes. Both patient groups were able to show significant before-after improvements in selected patient-level outcomes.

Inducing sustainable improvement in depression care in primary care practices.

BACKGROUND: Improving primary care depression care is costly and challenging to sustain. The feasibility and potential success ofa modified improvement collaborative model to create sustained improvements in depression care was assessed. METHODS: Sixteen practices from the American Academy of Family Physicians National Research Network and the American College of Physicians Practice-based Research Network completed a nine-month program. Two practice champions (PCs) from each practice attended three two-day learning sessions, where practice change strategies and key depression care elements were discussed. The nine-item Patient Health Questionnaire (PHQ-9) was used for screening, diagnosis, surveillance, tracking and care management, and self-management support. Pre- and postintervention depression care survey data were gathered from all practice clinicians, and qualitative data were collected via interviews with PCs and field notes from learning sessions. RESULTS: On the basis of PC reports at nine months, 16 practices had implemented the PHQ-9 for depression case-finding and 13 for monitoring severity; 5 practices had implemented tracking and care management and 1, self-management support. At the 15-month follow-up, nearly all changes had been sustained, and additional practices had implemented tracking/care management and self-management support. Significant pre-post improvements were reported on several subscales of the clinician survey, demonstrating substantial diffusion from the PC to other clinicians in the practice. DISCUSSION: The program led to measurable improvements in implementation of office procedures and systems known to improve depression care. The improvements were both sustained beyond the end of the program and substantially diffused to the other clinicians in the practice.

Guidance for researchers developing and conducting clinical trials in practice-based research networks (PBRNs).

BACKGROUND: There is increased interest nationally in multicenter clinical trials to answer questions about clinical effectiveness, comparative effectiveness, and safety in real-world community settings. Primary care practice-based research networks (PBRNs), comprising community- and/or academically affiliated practices committed to improving medical care for a range of health problems, offer ideal settings for these trials, especially pragmatic clinical trials. However, many researchers are not familiar with working with PBRNs. METHODS: Experts in practice-based research identified solutions to challenges that researchers and PBRN personnel experience when collaborating on clinical trials in PBRNs. These were organized as frequently asked questions in a draft document presented at a 2013 Agency for Health care Research and Quality PBRN conference workshop, revised based on participant feedback, then shared with additional experts from the DARTNet Institute, Clinical Translational Science Award PBRN, and North American Primary Care Research Group PBRN workgroups for further input and modification. RESULTS: The "Toolkit for Developing and Conducting Multi-site Clinical Trials in Practice-Based Research Networks" offers guidance in the areas of recruiting and engaging practices, budgeting, project management, and communication, as well as templates and examples of tools important in developing and conducting clinical trials. CONCLUSION: Ensuring the successful development and conduct of clinical trials in PBRNs requires a highly collaborative approach between academic research and PBRN teams.

Sustainability of depression care improvements: success of a practice change improvement collaborative.

BACKGROUND: Long-term sustainment of improvements in care continues to challenge primary care practices. During the 2 years after of our Improving Depression Care collaborative, we examined how well practices were sustaining their depression care improvements. METHODS: Our study design used a qualitative interview follow-up of a modified learning collaborative intervention. We conducted telephone interviews with practice champions from 15 of the original 16 practices. Interviews were conducted during a 3-month period in 2008, and were recorded and professionally transcribed. Data on each of the depression care improvements and the change management strategy emphasized during the learning collaborative were summarized after review of the primary data and a consensus process to resolve differing interpretations. RESULTS: During the period from 15 months to 3 years since our project began, depression screening or case finding was sustained in 14 of 15 practices. Thirteen practices sustained use of the 9-item Patient Health Questionnaire for depression monitoring, and one additional practice initiated it. Seven practices initiated self-management support and 2 of 3 practices sustained it. In contrast, tracking and case management proved difficult to sustain, with only 4 of 8 practices continuing this activity. Diffusion of use of the 9-item Patient Health Questionnaire to other clinicians in the practice was maintained in all but 3 practices and expanded in one practice. Six of the practices continued to use the change management strategy, including all 4 of the practices that sustained tracking. CONCLUSIONS: Practices demonstrated long-term sustained improvement in depression care with the exception of tracking and care management, which may be a more challenging innovation to sustain. We hypothesize that sustaining complex depression care innovations may require active management by the practice.

It takes two: using coleaders to champion improvements in small primary care practices.

BACKGROUND: Making the kind of improvement changes necessary to move toward a patient-centered medical home will continue to challenge small, independent primary care practices. Here we describe further analysis of a successful program to understand the roles of coleaders of a change management process. METHODS: Through an improvement collaborative we trained 2 coleaders (a physician and a non-physician) from 16 small primary care practices to institute depression care improvements. These coleaders participated in 3 learning sessions that provided depression care content as well as skills to implement a change management strategy. Qualitative data were collected by observation during the learning sessions and through in-depth interviews conducted at baseline, between each learning session, at the end of the project, 6 months after the project ended, and, finally, 26 months after the project's end. RESULTS: Interview results with the coleaders affirmed that a team approach is a viable strategy for practice improvement. The 2 coleaders used their complementary skills, relationships, and credibility among the practice staff to implement and sustain practice improvements. In their differing roles, they varied in how they perceived barriers to change and how they assessed their team's progress. CONCLUSIONS: Involving both a physician and a non-physician as coleaders enables improvement teams in small primary care practices to make progress both in the clinical content of their work and in the critical change management activities involved with creating a team, managing meetings, and coordinating work between meetings. Using a coleader structure enriches the improvement process, broadens participation in the change process, and helps to sustain these efforts over time.

Practice-based research network studies and institutional review boards: two new issues.

BACKGROUND: Practice-based research network (PBRN) study investigators must interface with multiple Institutional Review Boards (IRBs), many of which are unfamiliar with PBRN research. OBJECTIVE: To present 2 IRB-related issues that have not appeared in the literature but occurred during the course of a large 5-year PBRN study involving 32 sites dispersed around the United States. RESULTS: Our study required IRB approval from a total of 19 local, hospital, academic center, and professional organization-based IRBs that reviewed a protocol of postpartum depression screening and follow-up completed in English or Spanish. Initial approval of the protocol and consent forms proceeded with only the usual barriers of submitting 19 different forms, and no protocol amendments were required. However, 2 unanticipated IRB issues provided significant additional work for the study team and the local practice sites. First, several IRBs required staff to repeat human subjects training every 1 to 2 years, resulting in 92 practicing physicians, residents, and members of the nursing staff spending time completing the exact same human subjects' training at least twice during the course of this study. Second, 17 of the 19 IRBs required that the patient be given consent forms that were newly stamped and dated each year, requiring the central site to reprint and replace consent forms yearly. Because not all IRBs returned the newly stamped and dated forms in a timely fashion, study enrollment with valid consent forms was interrupted in 4 sites for periods of 2 to 13 weeks. CONCLUSIONS: IRB requirements not directly responsive to federal regulations can add significant costs, frustrations, and burdens to PBRN studies. Non-federally mandated IRB requirements should be based on an identified need with evidence to support the solution.

The IRB challenge for practice-based research: strategies of the American Academy of Family Physicians National Research Network (AAFP NRN).

Investigators for multisite research studies conducted in practice-based research networks face numerous challenges associated with Institutional Review Boards (IRBs) and human subjects protection. The American Academy of Family Physicians National Research Network (AAFP NRN) has adopted strategies to deal with some of these challenges, including creating an open, honest relationship with the new American Academy of Family Physicians Institutional Review Board (AAFP IRB); creating procedures for members who are not required to report to a local IRB; handling most of the IRB application submission and tracking tasks for our members who must submit applications to local IRBs; and working with the AAFP IRB to make required human subjects training relevant to our practices. However, these are only temporary solutions. It is time to begin working toward a permanent solution. As such, the AAFP, the AAFP NRN, and the AAFP IRB have begun discussing the possibility of adopting an alternative model of central IRB review, which would facilitate practice-based research in family medicine and which would encourage rather than discourage family medicine practices to participate in research studies that will further the discipline.

Strategies for planning and launching PBRN research studies: a project of the Academy of Family Physicians National Research Network (AAFP NRN).

Research conducted in a practice-based research network (PBRN) differs from other multisite research and presents particular planning challenges. The American Academy of Family Physicians National Research Network (AAFP NRN) has developed a number of procedures used for planning and implementing studies, which address the challenges of national PBRN studies. In this study, we highlight challenges common to PBRN research and describe the methods used by the AAFP NRN to address those challenges. The following tasks were identified as important to implementing PBRN research studies: (1) selecting fundable, feasible studies that interest members and have the potential to improve quality of care; (2) creating a practical budget that covers the costs of the study; (3) composing study teams and securing written agreements between team members; (4) recruiting and selecting study sites; and (5) training practice staff and physicians. Striking the balance of scientific rigor with practical application of PBRN studies must be addressed throughout these tasks. Proper planning for PBRN studies significantly affects the success of study implementation. Although developed by a national PBRN, the planning procedures described in this study may be adapted for state or regional PBRNs.