Brown University School of Public Health, 121 South Main Street, Providence, RI, 02903, USA.
Alpert Medical School of Brown University, 222 Richmond Street, Providence, RI, 02903, USA.
Addict Sci Clin Pract. 2022 Aug 19;17(1):44. doi: 10.1186/s13722-022-00327-0.
Psychosocial interventions are needed to enhance patient engagement and retention in medication treatment within opioid treatment programs. Measurement-based care (MBC), an evidence-based intervention structure that involves ongoing monitoring of treatment progress over time to assess the need for treatment modifications, has been recommended as a flexible and low-cost intervention for opioid treatment program use. The MBC2OTP Project is a two-phase pilot hybrid type 1 effectiveness-implementation trial that has three specific aims: (1) to employ Rapid Assessment Procedure Informed Clinical Ethnography (RAPICE) to collect mixed methods data to inform MBC implementation; (2) to use RAPICE data to adapt an MBC protocol; and (3) to conduct a hybrid type 1 trial to evaluate MBC's preliminary effectiveness and implementation potential in opioid treatment programs.
This study will be conducted in two phases. Phase 1 will include RAPICE site visits, qualitative interviews (N = 32-48 total), and quantitative surveys (N = 64-80 total) with staff at eight programs to build community partnerships and evaluate contextual factors impacting MBC implementation. Mixed methods data will be analyzed using immersion/crystallization and thematic analysis to inform MBC adaptation and site selection. Four programs selected for Phase 2 will participate in MBC electronic medical record integration, training, and ongoing support. Chart reviews will be completed in the 6 months prior-to and following MBC integration (N = 160 charts, 80 pre and post) to evaluate effectiveness (patient opioid abstinence and treatment engagement) and implementation outcomes (counselor MBC exposure and fidelity).
This study is among the first to take forward recommendations to implement and evaluate MBC in opioid treatment programs. It will also employ an innovative RAPICE approach to enhance the quality and rigor of data collection and inform the development of an MBC protocol best matched to opioid treatment programs. Overall, this work seeks to enhance treatment provision and clinical outcomes for patients with opioid use disorder. Trial registration This study will be registered with Clinicaltrials.gov within 21 days of first participant enrollment in Phase 2. Study Phase 1 (RAPICE) does not qualify as a clinical trial, therefore Phase 2 clinical trial registration has not yet been pursued because all elements of Phase 2 will be dependent on Phase 1 outcomes.
需要心理社会干预来增强参与阿片类药物治疗计划的患者的参与度和保留率。基于测量的护理（MBC）是一种循证干预结构，涉及随着时间的推移对治疗进展进行持续监测，以评估治疗修改的需求，它被推荐为一种灵活且低成本的阿片类药物治疗计划使用干预措施。MBC2OTP 项目是一个两阶段的试点混合 1 型有效性实施试验，有三个具体目标：（1）采用快速评估程序知情临床民族志（RAPICE）收集混合方法数据，为 MBC 的实施提供信息；（2）使用 RAPICE 数据来调整 MBC 方案；（3）进行混合 1 型试验，评估 MBC 在阿片类药物治疗计划中的初步有效性和实施潜力。
本研究将分两个阶段进行。第一阶段将包括 RAPICE 现场访问、定性访谈（共 32-48 人）和定量调查（共 64-80 人），与 8 个项目的工作人员合作，建立社区合作伙伴关系，并评估影响 MBC 实施的背景因素。使用沉浸/结晶和主题分析混合方法数据来为 MBC 调整和现场选择提供信息。四个选定参加第二阶段的项目将参与 MBC 电子病历整合、培训和持续支持。在 MBC 整合前（6 个月内）和整合后（共 160 份图表，80 份前和后）将完成图表审查，以评估效果（患者阿片类药物戒断和治疗参与）和实施结果（辅导员 MBC 暴露和保真度）。
这项研究是首批实施和评估阿片类药物治疗计划中 MBC 的研究之一。它还将采用创新的 RAPICE 方法来提高数据收集的质量和严谨性，并为最适合阿片类药物治疗计划的 MBC 方案的发展提供信息。总的来说，这项工作旨在改善患有阿片类药物使用障碍的患者的治疗服务和临床结果。
本研究将在第二阶段的第一位参与者入组后 21 天内在 Clinicaltrials.gov 进行注册。研究阶段 1（RAPICE）不符合临床试验的资格，因此尚未寻求第二阶段临床试验的注册，因为第二阶段的所有要素都将取决于第一阶段的结果。
