Abstract:
Background
Substance use disorders (SUDs) result in individual and societal burden. However, most individuals with SUD receive no treatment. Implementing SUD interventions in primary care could address this population's treatment needs. In the USA, reSET® and reSET-O® were the first prescription digital therapeutics (PDTs) for SUDs and opioid use disorder (OUD), respectively. The Digital Treatments for Substance Use Disorder (DIGITS) study tested the effectiveness of practice facilitation and health coaching strategies to support reSET and reSET-O implementation into primary care. A formative evaluation was conducted to monitor implementation, inform adaptations, and learn what promotes PDT sustainment.
Method
The Dynamic Sustainability Framework and the Framework for Reporting Adaptations and Modifications to Evidence-based Implementation Strategies guided the evaluation. Using rapid qualitative methods, we collected and analyzed observational fieldnotes, key informant interviews, and document sources (e.g., meeting minutes) for synthesis and dissemination to clinical partners and the study team via formative reports. We analyzed the reports to generate evaluation results.
Results
Twenty-four primary care clinics participated. Evaluation data included 98 observational fieldnotes, 16 interviews, and 253 document sources. We produced nine formative reports. The study encountered barriers and facilitators in each DSF domain (ecological system, practice setting, and intervention). In the ecological system, the PDT vendor enabled the study, but the COVID-19 pandemic, laws, regulations, and contracting delayed implementation. In the practice setting, staff shortages and low clinic capacity were implementation challenges, while electronic health record capabilities were both barriers and facilitators. At the intervention level, non-routine workflows, clinician burden, and low patient engagement were barriers despite clinicians’ efforts.
Conclusions
Digital therapeutics are promising SUD and OUD treatments, but integration into primary care requires conducive laws and regulations, organizational capacity, and patient and clinician engagement. Formative evaluation identified important lessons for future PDT implementation.
Plain Language Summary
Evaluation of the integration of digital treatments for opioid and other substance use disorders in primary care
Most people with substance use disorders (SUDs) receive no treatment. In the USA, two smartphone app-based digital treatments for SUD and opioid use disorders (OUDs) became available by prescription. The Digital Treatments for Substance Use Disorder (DIGITS) study, a randomized implementation trial, tested how best to integrate these digital treatments for SUD and OUD into primary care. Throughout the study, we conducted a formative evaluation to observe progress, recommend implementation improvements, and understand how digital treatments could be offered to patients after the study ended. For this evaluation, we collected qualitative data through observing study meetings and interviewing primary care leaders, clinicians, and clinical and study staff. The data were regularly summarized and reported to our clinical partners and the study team. We used two implementation frameworks to interpret the data: the Dynamic Sustainability Framework and the Framework for Reporting Adaptations and Modifications to Evidence-based Implementation Strategies. The evaluation revealed factors that helped and hindered implementation. Obstacles from outside the health care system included the COVID-19 pandemic, laws, regulations, and delays in setting up contractual agreements, whereas a partnership with the digital treatment vendor proved helpful. Clinics had difficulties with clinician burden, staff shortages, lack of time and available appointments, and performing new and unfamiliar tasks. The electronic health record system both supported and impended implementation. Last, few patients accepted the offered digital treatment, or used it persistently. Formative evaluation results suggest that digital treatments for SUD and OUD in primary care are promising, however their successful use requires supportive laws and regulations, health system resources, and increased patient and clinician engagement.
**This abstract is posted with permission under the Creative Commons Attribution 4.0 International License**