A pharmacy liaison-patient navigation intervention to reduce inpatient and emergency department utilization among primary care patients in a Medicaid accountable care organization: A pragmatic trial protocol.

OBJECTIVE: To determine whether employing the services of a pharmacy liaison to promote medication adherence (usual care), relative to a pharmacy liaison with training in motivational interviewing and as a patient navigator who systematically screens for health-related social needs and provides targeted navigation services to connect patients with appropriate community resources in partnership with a community-based organization (enhanced usual care), will reduce inpatient hospital admissions and emergency department visits among patients who are members of a Medicaid ACO and receive primary care at a large urban safety-net hospital. BACKGROUND: Prior studies have demonstrated only modest effects in reducing utilization among safety-net patient populations. Interventions that address health-related social needs have the potential to reduce utilization in these populations. DESIGN/METHODS: Assignment to treatment condition is by medical record number (odd vs. even) and is unblinded (NCT03919084). Adults age 18-64 within the 3rd to 10th percentile for health care utilization and cost among Medicaid Accountable Care Organization membership attending a primary care visit in the general internal medicine practice at Boston Medical Center enrolled. DISCUSSION: Our study will advance the field in two ways: 1) by providing evidence about the effectiveness of pharmacy liaisons who also function as patient navigators; and 2) by de-implementing patient navigators. Patients in the enhanced usual care arm will no longer receive the services of a clinic-based patient navigator. In addition, our study includes a novel collaboration with a community-based organization, and focuses on an intermediate-cost patient population, rather than the most costly patient population.

Development of a plain-language library of educational resources for research participants.

There is a paucity of educational resources for potential clinical trial participants, particularly resources in plain language, attentive to health literacy principles and translated into native languages. The New England Research Subject Advocacy Group was formed to explore common issues, interests, and concerns related to the experience of participation in clinical research and research participant safety. Specifically, the group sought to increase community awareness and trust through the development and distribution of publicly accessible informational resources. In support of these aims, the group developed a robust library of high-quality, plain-language educational materials covering topics in health research, research participation, and common research procedures, and translated the majority of the materials into an additional 15 languages. These resources have been downloaded over 130,000 times. After English, the most common languages downloaded are Vietnamese, Spanish, and Korean.

Best Practices in Social and Behavioral Research: A multisite pilot evaluation of the good clinical practice online training course.

INTRODUCTION: The Best Practices in Social and Behavioral Research Course was developed to provide instruction on good clinical practice for social and behavioral trials. This study evaluated the new course. METHODS: Participants across 4 universities took the course (n=294) and were sent surveys following course completion and 2 months later. Outcomes included relevance, how engaging the course was, and working differently because of the course. Open-ended questions were posed to understand how work was impacted. RESULTS: Participants rated the course as relevant and engaging (6.4 and 5.8/7 points) and reported working differently (4.7/7 points). Participants with less experience in social and behavioral trials were most likely to report working differently 2 months later. DISCUSSION: The course was perceived as relevant and engaging. Participants described actions taken to improve rigor in implementing trials. Future studies with a larger sample and additional participating sites are recommended.

Research participant-centered outcomes at NIH-supported clinical research centers.

BACKGROUND: Although research participation is essential for clinical investigation, few quantitative outcome measures exist to assess participants' experiences. To address this, we developed and deployed a survey at 15 NIH-supported clinical research centers to assess participant-centered outcomes; we report responses from 4,961 participants. METHODS: Survey questions addressed core aspects of the research participants' experience, including their overall rating, motivation, trust, and informed consent. We describe participant characteristics, responses to individual questions, and correlations among responses. RESULTS: Respondents broadly represented the research population in sex, race, and ethnicity. Seventy-three percent awarded top ratings to their overall research experience and 94% reported no pressure to enroll. Top ratings correlated with feeling treated with respect, listened to, and having access to the research team (R(2) = 0.80-0.96). White participants trusted researchers more (88%) than did nonwhite participants collectively (80%; p < 0.0001). Many participants felt fully prepared by the informed consent process (67%) and wanted to receive research results (72%). CONCLUSIONS: Our survey demonstrates that a majority of participants at NIH-supported clinical research centers rate their research experience very positively and that participant-centered outcome measures identify actionable items for improvement of participant's experiences, research protections, and the conduct of clinical investigation.

Warning letters to sponsor-investigators at academic health centres - the regulatory "canaries in a coal mine".

PURPOSE: This study highlights Warning Letter (WL) findings issued to sponsor-investigators (S-Is) by the Food and Drug Administration (FDA). METHODS: The online index of WLs issued from October 1, 2007 through September 30, 2012 was reviewed [1]. Through a manual screening process, letters were evaluated if specifically issued to 'clinical investigators', 'sponsors' or 'sponsor-investigators'. A particular focus was given to S-Is at Academic Health Centres (AHCs). Each letter was scored for the presence of violations in 40 general regulatory categories. RESULTS: A review of FDA WLs issued over a five-year period (FDA Fiscal Years 2008-2012) revealed that WLs to S-Is represent half of the WLs issued to all sponsors (16 of 32 letters). A review of these letters indicates that S-Is are not aware of, or simply do not meet, their regulatory responsibilities as either investigators or sponsors. In comparing total sponsor letters to those of S-Is, the most cited violation was the same: a lack of monitoring. A review of publicly available inspection data indicates that these 16 letters merely represent the tip of the iceberg. CONCLUSION: This review of the WL database reveals the potential for serious regulatory violations among S-Is at AHCs. Recent translational funding initiatives may serve to increase the number of S-Is, especially among Academic Health Centres (AHCs) [2]; thus, AHCs must become aware of this S-I role and work to support investigators who assume both roles in the course of their research.