A facilitation model for implementing quality improvement practices to enhance outpatient substance use disorder treatment outcomes: a stepped-wedge randomized controlled trial study protocol.

BACKGROUND: The misuse of and addiction to opioids is a national crisis that affects public health as well as social and economic welfare. There is an urgent need for strategies to improve opioid use disorder treatment quality (e.g., 6-month retention). Substance use disorder treatment programs are challenged by limited resources and a workforce that does not have the requisite experience or education in quality improvement methods. The purpose of this study is to test a multicomponent clinic-level intervention designed to aid substance use disorder treatment clinics in implementing quality improvement processes to improve high-priority indicators of treatment quality for opioid use disorder. METHODS: A stepped-wedge randomized controlled trial with 30 outpatient treatment clinics serving approximately 2000 clients with opioid use disorder each year will test whether a clinic-level measurement-driven, quality improvement intervention, called Coaching for Addiction Recovery Enhancement (CARE), improves (a) treatment process quality measures (use of medications for opioid use disorder, in-treatment symptom and therapeutic progress, treatment retention) and (b) recovery outcomes (substance use, health, and healthcare utilization). The CARE intervention will have the following components: (1) staff clinical training and tools, (2) quality improvement and change management training, (3) external facilitation to support implementation and sustainability of quality improvement processes, and (4) an electronic client-reported treatment progress tool to support data-driven decision making and clinic-level quality measurement. The study will utilize multiple sources of data to test study aims, including state administrative data, client-reported survey and treatment progress data, and staff interview and survey data. DISCUSSION: This study will provide the field with a strong test of a multicomponent intervention to improve providers' capacity to make systematic changes tied to quality metrics. The study will also result in training and materials that can be shared widely to increase quality improvement implementation and enhance clinical practice in the substance use disorder treatment system. TRIAL REGISTRATION: Trial # NCT04632238NCT04632238 registered at clinicaltrials.gov on 17 November 2020.

Modified cognitive behavioral therapy (M-CBT) for cocaine dependence: Development of treatment for cognitively impaired users and results from a Stage 1 trial.

Cognitive impairments are associated with poor outcomes when treating cocaine dependent patients, but behavioral interventions to mitigate this impact have not been developed. In this Stage 1A/1B treatment development study, several compensatory strategies (e.g., content repetition, daily logs, diaries, visual presentation) were combined to create a modified cognitive behavioral therapy (M-CBT) for treating cocaine dependence. Initially, a select group of therapists, neuropsychology experts, and patients were asked to provide input on early drafts of the treatment manual and companion patient workbook. After an uncontrolled small trial (N = 15) and two rounds of manual development (Stage 1A), a pilot randomized clinical trial (N = 102) of cocaine dependent outpatients with and without cognitive impairments was conducted (Stage 1B). Participants were randomized to M-CBT (N = 52) or CBT (N = 50). Both treatments were individually delivered over 12 weeks with assessments conducted at baseline, end-of-treatment, and 3-month follow-up. The primary outcome was frequency of cocaine use, measured by number of days used in the prior 7 days. Participants in the two treatment groups did not differ significantly on drug use reduction or retention in treatment. However, among participants who completed at least 9 weeks of treatment, those in M-CBT showed a trend toward greater reduction in cocaine use compared to those in the CBT group. M-CBT is feasible for impaired and nonimpaired cocaine dependent participants. However, M-CBT treatment did not show significant superiority over standard CBT in the present sample. (PsycINFO Database Record (c) 2018 APA, all rights reserved).