Dataset Information

Video directly observed therapy intervention using a mobile health application among opioid use disorder patients receiving office-based buprenorphine treatment: protocol for a pilot randomized controlled trial.

ABSTRACT: BACKGROUND:Office-based buprenorphine treatment of opioid use disorder (OUD) does not typically include in-person directly observed therapy (DOT), potentially leading to non-adherence. Video DOT technologies may safeguard against this issue and thus enhance likelihood of treatment success. We describe the rationale and protocol for the Trial of Adherence Application for Buprenorphine treatment (TAAB) study, a pilot randomized controlled trial (RCT) to evaluate the effects of video DOT delivered via a smartphone app on office-based buprenorphine treatment outcomes, namely illicit opioid use and retention. METHODS:Participants will be recruited from office-based opioid addiction treatment programs in outpatient clinics at two urban medical centers and randomized to either video DOT (intervention) delivered via a HIPAA-compliant, asynchronous, mobile health (mHealth) technology platform, or treatment-as-usual (control). Eligibility criteria are: 18 years or older, prescribed sublingual buprenorphine for a cumulative total of 28 days or less from the office-based opioid treatment program, and able to read and understand English. Patients will be considered ineligible if they are unable or unwilling to use the intervention, provide consent, or complete weekly study visits. All participants will complete 13 in-person weekly visits and be followed via electronic health record data capture at 12- and 24-weeks post-randomization. Data gathered include the following: demographics; current and previous treatment for OUD; self-reported diversion of prescribed buprenorphine; status of their mental and physical health; and self-reported lifetime and past 30-day illicit substance use. Participants provide urine samples at each weekly visit to test for illicit drugs and buprenorphine. The primary outcome is percentage of weekly urines that are negative for opioids over the 12-weeks. The secondary outcome is engagement in treatment at week 12. DISCUSSION:Video DOT delivered through mHealth technology platform offers possibility of improving patients' buprenorphine adherence by providing additional structure and accountability. The TAAB study will provide important preliminary estimates of the impact of this mHealth technology for patients initiating buprenorphine, as well as the feasibility of study procedures, thus paving the way for further research to assess feasibility and generate preliminary data for design of a future Phase III trial. Trial Registration ClinicalTrails.gov, NCT03779997, Registered on December 19, 2018.

SUBMITTER: Schramm ZA

PROVIDER: S-EPMC7393902 | biostudies-literature | 2020 Jul

REPOSITORIES: biostudies-literature

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Video directly observed therapy intervention using a mobile health application among opioid use disorder patients receiving office-based buprenorphine treatment: protocol for a pilot randomized controlled trial.

Schramm Zachery A ZA Leroux Brian G BG Radick Andrea C AC Ventura Alicia S AS Klein Jared W JW Samet Jeffrey H JH Saxon Andrew J AJ Kim Theresa W TW Tsui Judith I JI

Addiction science & clinical practice 20200731 1

<h4>Background</h4>Office-based buprenorphine treatment of opioid use disorder (OUD) does not typically include in-person directly observed therapy (DOT), potentially leading to non-adherence. Video DOT technologies may safeguard against this issue and thus enhance likelihood of treatment success. We describe the rationale and protocol for the Trial of Adherence Application for Buprenorphine treatment (TAAB) study, a pilot randomized controlled trial (RCT) to evaluate the effects of video DOT de ...[more]

PMID: 32736660

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Project description:CONTEXT: Although office-based opioid treatment with buprenorphine (OBOT-B) has been successfully implemented in primary care settings in the US, its use has not been reported in homeless patients. OBJECTIVE: To characterize the feasibility of OBOT-B in homeless relative to housed patients. DESIGN: A retrospective record review examining treatment failure, drug use, utilization of substance abuse treatment services, and intensity of clinical support by a nurse care manager (NCM) among homeless and housed patients in an OBOT-B program between August 2003 and October 2004. Treatment failure was defined as elopement before completing medication induction, discharge after medication induction due to ongoing drug use with concurrent nonadherence with intensified treatment, or discharge due to disruptive behavior. RESULTS: Of 44 homeless and 41 housed patients enrolled over 12 months, homeless patients were more likely to be older, nonwhite, unemployed, infected with HIV and hepatitis C, and report a psychiatric illness. Homeless patients had fewer social supports and more chronic substance abuse histories with a 3- to 6-fold greater number of years of drug use, number of detoxification attempts and percentage with a history of methadone maintenance treatment. The proportion of subjects with treatment failure for the homeless (21%) and housed (22%) did not differ (P = .94). At 12 months, both groups had similar proportions with illicit opioid use [Odds ratio (OR), 0.9 (95% CI, 0.5-1.7) P = .8], utilization of counseling (homeless, 46%; housed, 49%; P = .95), and participation in mutual-help groups (homeless, 25%; housed, 29%; P = .96). At 12 months, 36% of the homeless group was no longer homeless. During the first month of treatment, homeless patients required more clinical support from the NCM than housed patients. CONCLUSIONS: Despite homeless opioid dependent patients' social instability, greater comorbidities, and more chronic drug use, office-based opioid treatment with buprenorphine was effectively implemented in this population comparable to outcomes in housed patients with respect to treatment failure, illicit opioid use, and utilization of substance abuse treatment.

Project description:ObjectiveThis study aimed to compare two methods of feedback: verbal face-to-face feedback after direct observation (F2F-feedback) versus electronic-written feedback after observation of recorded-VDO of student's performance (VDO-feedback), in terms of effectiveness in improving skill, effects on motivation and satisfaction.BackgroundMedical schools are responsible for teaching and ensuring proficiency of basic surgical skills. Feedback is effective in developing psychomotor skills; by providing information of learner's current performance, how to improve, and enhancing motivation.Materials and methodFifty-eight medical students (3rd- 4th year) were trained to perform vertical mattress suture in small groups. Then, during 6-week period of self-directed practice, students were randomized into group1 VDO-feedback (male:female = 21:8) and group 2 F2F-feedback (male:female = 20:9). Feedbacks were provided once every 2 weeks (Week2, Week4). End-of-rotation OSCE was at Week6, and retention tested was at Week8. Performance checklist (Cronbach's Alpha 0.72) was used to assess skill at 4 timepoints; pre- and post- small group learning, OSCE, and retention phase. Questionnaire was used to assess motivation, learning strategies and satisfaction (Cronbach's Alpha 0.83).ResultAfter in-class learning, further significant improvement of skills could be gained by both F2F- and VDO- feedbacks (p < 0.0001). Both could similarly retain skill for at least 4 weeks later without additional practice. Self-efficacy, test anxiety, and cognitive strategies scores were significantly increased in both groups (p < 0.05). Extrinsic motivation was increased in VDO-feedback group. No difference in satisfaction between groups was observed.Discussion and conclusionVDO-feedback could be alternative to F2F-feedbacks for basic surgical skill training when limitation for simultaneous meeting of teacher and students occurs.Trial registrationThis study has been registered to Thai Clinical Trial Registry (WHO International Clinical Trial Registry Platform) on 11/07/2023 (TCTR20230711005).

Dataset Information

Video directly observed therapy intervention using a mobile health application among opioid use disorder patients receiving office-based buprenorphine treatment: protocol for a pilot randomized controlled trial.

Publications

Video directly observed therapy intervention using a mobile health application among opioid use disorder patients receiving office-based buprenorphine treatment: protocol for a pilot randomized controlled trial.

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