Discussion
depression, OUD, overdose, diabetes
DISORDER, EMA, PCP, LITTLE, DIABETES
This paper describes the design and protocol of one of the first multi-site randomized controlled trials to examine interventions for adults presenting in primary care settings with subthreshold opioid use disorder [Little is currently known about the trajectories of individuals who have subthreshold OUD, including how likely, and within what timeframe, they may develop a more severe OUD or experience opioid-related overdose or other serious negative health impacts. OUD prevention efforts have focused on regulatory efforts and published guidelines about prescribing opioid analgesics, particularly by primary care physicians [In its 2020 recommendation to screen adult primary care patients for drug use, the US Preventive Services Task Force (USPSTF) noted critical gaps in the evidence for interventions to reduce drug use, risk behaviors, and negative health consequences. In particular, evidence was noted to be lacking for treatment interventions among non-treatment seeking patients who are identified via screening.[The STOP collaborative care model brings together intervention components that individually improved outcomes in opioid prescribing and substance use but have not previously been tested in combination or with a focus on subthreshold OUD. Collaborative care has been shown to improve patient outcomes and increase quality of care for a variety of conditions, including alcohol use disorder and depression [The intervention is designed to be integrated into regular primary care practice in clinical settings with collaborative care teams, which are increasingly common in primary care practices, but generally focus on mental health rather than substance use. The telephone health coach is also scalable in that a single health coach can service multiple sites. A strength of the STOP intervention model is that it avoids over-burdening the PCP and makes use of existing resources. Apart from the brief advice, the case management and health coaching do not require direct PCP involvement and can offload some of the work that generally falls to the PCP. Many primary care practices have allied health resources to assist with chronic care management, (for example, diabetes educators) that could be trained in providing case management and support for these high-risk patients. Telephone health coaching is commonly available through health insurance plans or large health systems. Health insurance companies could contract with national experts who do short term coaching telephonically who also collaborate with the affiliated clinical nursing resources. Should our trial have positive findings, there is thus potential for adapting and integrating the STOP intervention into existing team-based primary care models.A notable aspect of the study design is the use of monthly self-administered assessments of opioid misuse, which can avoid recall bias and offers multiple opportunities for data collection. The strategy of inviting patient participants by text message or email to complete brief self-administered assessments that can be completed on their phone or computer has similarities to ecological momentary assessment (EMA) approaches, which often achieve high rates of completion. One of the longest duration EMA studies in the literature was an alcohol study that used weekly assessments collected by text message for 25 weeks and found that 82% of participants completed all 25 of the assessments [