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Background: The National Institute on Drug Abuse (NIDA) Clinical Trials Network (CTN) has supported clinical trials of substance use disorder (SUD) interventions for 25 years. This review describes the use of implementation outcomes across CTN trials, characterizes outcomes included, and identifies gaps and potential opportunities to strengthen implementation research within the CTN and the field of SUD treatment.
Methods: This systematic review included active or completed studies listed on the CTN Dissemination Library webpage as of August 18, 2021, and approved by the CTN for development by January 1, 2022. Study summaries and protocols were reviewed if they: 1) measured at least one implementation outcome and 2) examined a practice change, intervention, or process. Extracted data elements included trial design characteristics, implementation frameworks, and outcome assessment domains informed by the RE-AIM and Proctor Implementation Outcomes Frameworks.
Results: 114 protocols were considered, 42 full-text protocols were screened, and 25 were included for data extraction. Start dates of trials spanned a 20-year period (2004–2024) with latter studies including more implementation outcomes. Fidelity (n = 29) and reach/penetration (n = 26) were the most included implementation outcomes. Equity was not identified in any protocols. Methods of defining, capturing, and evaluating outcomes data varied across trials and outcomes.
Conclusions: The inclusion of implementation outcomes increased over time, perhaps reflecting a growing emphasis on implementation research. Incorporating measures of equity could advance knowledge about differential receipt or effectiveness of SUD interventions. Future research should seek to improve the consistency and comprehensiveness in descriptions of implementation science elements.
Related protocols: CTN-0016, CTN-0056, CTN-0062-Ot, CTN-0064, CTN-0065, CTN-0069, CTN-0074, CTN-0074-A-1, CTN-0075, CTN-0076-Ot, CTN-0079, CTN-0079-A-1, CTN-0088, CTN-0090, CTN-0091, CTN-0095, CTN-0096, CTN-0097, CTN-0098, CTN-0099, CTN-0102, CTN-0103, CTN-0107, CTN-0116, CTN-0121
Clinical decision support (CDS) tools are designed to help primary care clinicians (PCCs) implement evidence-based guidelines for chronic disease care. CDS tools may also be helpful for opioid use disorder (OUD), but only if PCCs use them in their regular workflow. This study’s purpose was to understand PCC and clinic leader perceptions of barriers to using an OUD-CDS tool in primary care.
PCCs and leaders (N = 13) from clinics in an integrated health system in which an OUD-CDS tool was implemented participated in semi-structured qualitative interviews. Questions aimed to understand whether the CDS tool design, implementation, context, and content were barriers or facilitators to using the OUD-CDS in primary care. Recruitment stopped when thematic saturation was reached. An inductive thematic analysis approach was used to generate overall themes.
Five themes emerged: (1) PCCs prefer to minimize conversations about OUD risk and treatment; (2) PCCs are enthusiastic about a CDS tool that addresses a topic of interest but lack interest in treating OUD; (3) contextual barriers in primary care limit PCCs’ ability to use CDS to manage OUD; (4) CDS needs to be simple and visible, save time, and add value to care; and (5) CDS has value in identifying and screening patients and facilitating referrals.
Conclusions: This study identified several factors that impact use of an OUD-CDS tool in primary care, including PCC interest in treating OUD, contextual barriers, and CDS design. These results may help others interested in implementing CDS for OUD in primary care.
Related protocols: CTN-0076-Ot
Elimination of the X-waiver increased potential buprenorphine prescribers 13-fold, but growth in prescribing will likely be much lower. We explored self-assessments of nonwaivered primary care clinicians (PCCs) for factors affecting their likelihood to prescribe buprenorphine were the X-waiver eliminated (since realized January 2023) and the potential impacts of a clinical decision-support (CDS) tool for opioid use disorder (OUD). Cross-sectional survey data were obtained between January 2021 and March 2022 from 305 nonwaivered PCCs at 3 health systems. Factors explored were patient requests for buprenorphine, PCC access to an OUD-CDS, and PCC confidence and abilities for 5 OUD-care activities. Relationships were described using descriptive statistics and odds ratios. Only 26% of PCCs were more likely to prescribe buprenorphine upon patient request, whereas 63% were more likely to prescribe with the OUD-CDS. PCC confidence and abilities for some OUD-care activities were associated with increased prescribing likelihood from patient requests, but none were associated with the OUD-CDS. The OUD-CDS may increase buprenorphine prescribing for PCCs less likely to prescribe upon patient request. Future research is needed to develop interventions that increase PCC buprenorphine prescribing.
Related protocols: CTN-0076-Ot
This is the Primary Outcomes Article for CTN-0076-Ot.
Most Americans with opioid use disorder (OUD) do not receive indicated medical care. A clinical decision support (CDS) tool for primary care providers (PCPs) could address this treatment gap. The primary objective of this study was to build an OUD-CDS tool, based on a NIDA Blending Initiative paper, and demonstrate its functionality and accuracy. Secondary objectives were to achieve high use and approval rates and improve PCP confidence in diagnosing and treating OUD.
A convenience sample of 55 PCPs participated. Buprenorphine-waivered PCPs (n=8) were assigned to the intervention. Non-waivered PCPs (n=47) were randomized to intervention (n=24) or control (n=23). Intervention PCPs received access to the OUD-CDS, which alerted them to patients at potentially increased risk for OUD or overdose and guided diagnosis and treatment. Control PCPs provided care as usual.
The OUD-CDS was functional and accurate following extensive multi-phased testing. PCPs used the OUD-CDS in 5% of encounters with at-risk patients, far less than the goal of 60%. OUD screening confidence increased for all intervention PCPs and OUD diagnosis increased for non-waivered intervention PCPs. Most PCPs (65%) would recommend the OUD-CDS and found it helpful with screening for OUD and discussing and prescribing OUD medications.
Conclusions: The OUD-CDS tool was functional and accurate, but PCP use rates were low. Despite low use, however, the OUD-CDS improved confidence in OUD screening, diagnosis, and use of buprenorphine. A large multi-site study (CTN-0095) is in progress that will incorporate PCP feedback to make the OUD-CDS more intuitive and simple and will include implementation strategies to achieve higher CDS use.
Related protocols: CTN-0076-Ot