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INTRODUCTION: At the beginning of the COVID-19 pandemic, federal agencies permitted telehealth initiation of buprenorphine treatment for opioid use disorder (OUD) without in-person assessment. It remains unclear how telehealth-only buprenorphine treatment impacts time to discontinuation and patient reported treatment outcomes. METHODS: A longitudinal observational cohort study conducted September 2021 through March, 2023 enrolled participants with OUD initiating buprenorphine (≤ 45 days) with internet and phone access in Oregon and Washington. The intervention was a fully telehealth-only (THO) app versus treatment as usual (TAU) in office-based settings with some telehealth. We assessed self-reported buprenorphine discontinuation at 4-,12-, and 24-weeks. Generalized estimating equations (GEE) calculated unadjusted and adjusted relative risk ratios (RR) for discontinuation averaged over the study period. Secondary outcomes included change in the Brief Addiction Monitor (BAM) and the visual analogue craving scale. Generalized linear models estimated average within-group and between-group differences over time. RESULTS: Participants (n = 103 THO; n = 56 TAU) had a mean age of 37 years (SD = 9.8 years) and included 52 % women, 83 % with Medicaid insurance, 80 % identified as White, 65 % unemployed/student, and 19 % unhoused. There were differences in gender (THO = 54 % women vs. TAU = 44 %, p = .04), unemployed status (60 % vs 75 %, p = .02), and stable housing (84 % vs 73 %, p = .02). Rates of buprenorphine discontinuation were low in the THO (4 %) and TAU (13 %) groups across 24 weeks. In the adjusted analysis, the risk of discontinuation was 61 % lower in the THO group (aRR = 0.39, 95 % CI [0.17, 0.89], p = .026). Decreases occurred over time on the harms subscale of the BAM (within-group difference - 0.85, p = .0004 [THO], and - 0.68, p = .04 [TAU]) and cravings (within-group difference - 13.47, p = .0001 [THO] vs -7.65, p = .01 [TAU]). CONCLUSIONS: A telehealth-only platform reduced the risk of buprenorphine discontinuation compared to office-based TAU. In-person evaluation to receive buprenorphine may not be necessary for treatment-seeking patients. CLINICAL TRIALS IDENTIFIER: NCT03224858.
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Background: The COVID-19 pandemic presents challenges in participant recruitment strategies for clinical research involving people with opioid use disorders recently engaged in treatment. We describe challenges to participant recruitment in a trial comparing virtual buprenorphine treatment platform to office-based buprenorphine treatment. Methods: The parent study was a cohort trial of telehealth delivered buprenorphine treatment compared to office-based buprenorphine treatment, however, due to the pandemic potential participant recruitment for both arms became virtual. Between 9/27/2021 and 7/11/2022, telephone, email, flyers, and word-of-mouth were used to recruit study participants from each treatment setting. Recruitment tracking documents recorded the primary outcomes: number of outreach attempts and most effective contact methods. Results: Treatment settings provided contact information for 1485 potential study participants. Information was incorrect or disconnected for 282 (19%) individuals, 695 (47%) did not respond to outreach, and 508 (34%) responded to outreach. Of these responders, 369 were interested in study participation, 259 completed the online informed consent and screening assessment, and 148 met eligibility criteria and enrolled in the study. A total of 3804 virtual outreach attempts across 1485 potential participants were made, resulting in an average of 2.7 attempts per contact and a mean of 25.7 attempts per enrolled participant (n = 148). Conclusion: Conducting research during the COVID-19 pandemic required shifting from in-person to virtual recruitment strategies to contact and engage potential study participants. Virtual recruitment for this population during a pandemic appears to be less efficient and hindered efforts to meet recruitment goals.
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BACKGROUND: People with opioid use disorder (OUD) face barriers to entering and remaining in life-saving treatment (e.g., stigma, detrimental interactions with health care, and privacy concerns). Telehealth and related technology can reduce barriers to entering and staying in care. Patient feedback is critical to the development of these newer treatment approaches to ensure they are usable and do not inadvertently recreate treatment barriers. PURPOSE: Evaluate the perceived usability of existing and planned features of a mobile application (app) that facilitates delivery of OUD treatment via telehealth. METHODS: People with current or prior experience with OUD treatment were eligible for the study. Participants (n = 31; 55% women) provided feedback on an interactive prototype demonstration via individual qualitative interviews and completed a quantitative survey on the app's perceived usability. Descriptive statistics summarized the usability survey. We analyzed qualitative interview transcripts to elicit common themes. RESULTS: Participants were primarily white (77%) with a mean age of 42.2 years (range 22-69). Participants rated the six major features of the current app as helpful (median response 5 out of 5) and appreciated the flexibility of conducting a visit from a place of their choosing. Participants regarded the five proposed components of the app, such as daily affirmations and medication treatment-related reminders (e.g., pick up medication at pharmacy, medication schedule), as useful features with medians 5 out of 5, and reported they would recommend the app to others for OUD care. Participant qualitative interviews provided additional information on perceived usability of existing and proposed app features. CONCLUSION: Our study suggests that an appealing, easy-to-use app-with tools and features that effectively support care-could circumvent existing barriers and foster sustained recovery.