Contemporary Clinical Trials 2015 (in press). [doi: 10.1016/j.cct.2015.11.009]
Li-Tzy Wu, ScD, RN, MA (Duke University Medical Center, SC Node), Kathleen T. Brady, MD, PhD (Medical University of South Carolina, SC Node), Susan E. Spratt, MD (Duke University Medical Center, SC Node), Ashley A. Dunham, MSPH, PhD (Duke University Medical Center, SC Node), Brooke Heidenfelder, PhD (Duke University, SC Node), Bryan C. Batch, MD (Duke University Medical Center, SC Node), Robert Lindblad, MD (EMMES Corporation, NIDA CCC), Paul C. VanVeldhuisen, PhD (EMMES Corporation, NIDA CCC), Shelley A. Rusincovitch (Duke University, SC Node), Therese K. Killeen, PhD, APRN (Medical University of South Carolina, SC Node), Udi E. Ghitza, PhD (NIDA Center for the Clinical Trials Network).
The Affordable Care Act encourages healthcare systems to integrate behavioral and medical healthcare, as well as to employ electronic health records (EHRs) for health information exchange and quality improvement. Pragmatic research paradigms that employ EHRs in research are needed to produce clinical evidence in real-world medical settings for informing learning healthcare systems. Adults with comorbid diabetes and substance use disorders (SUDs) tend to use costly inpatient treatments; however, there is a lack of empirical data on implementing behavioral healthcare to reduce health risk in adults with high-risk diabetes. Given the complexity of high-risk patients' medical problems and the cost of conducting randomized trials, a feasibility project is warranted to guide practical study designs.
This paper describes the study design for such a project, a new study in the NIDA Clinical Trials Network (CTN-0057) aimed at exploring the feasibility of implementing substance use Screening, Brief Intervention, and Referral to Treatment (SBIRT) among adults with high-risk type 2 diabetes mellitus (T2DM) within a home-based primary care setting. The study includes the development of an integrated EHR datamart to identify eligible patients and collect diabetes healthcare data, and the use of a geographic health information system to understand the social context in patients' communities. Analysis will examine recruitment, proportion of patients receiving brief intervention and/or referrals, substance use, SUD treatment use, diabetes outcomes, and retention. By capitalizing on an existing T2DM project that uses home-based primary care, this study's results will provide timely clinical information to inform the designs and implementation of future SBIRT studies among adults with multiple medical conditions. (Article (Peer-Reviewed), PDF, English, 2015)
Keywords: Co-occurring disorders | CTN protocol development | Diabetes | Electronic health records (EHR) | Primary care | Screening, Brief Intervention, Referral to Treatment (SBIRT) | Contemporary Clinical Trials (journal)
Document No: 1178, PMID: 26563446, PMCID: PMC4695300.
Submitted by Li-Tzy Wu, ScD, RN, MA (SC Node), 11/18/2015.