The purpose of this study is to evaluate a self-management education program designed to help people with opioid use disorder (OUD), serious mental illness (SMI), and other chronic health conditions better manage their health. The program, called the Chronic Disease Self-Management Program (CDSMP), teaches self-management skills such as setting health goals, solving problems, managing symptoms, and working with health care providers. Participants will be randomly assigned to either participate in the CDSMP or receive usual primary care along with written information about managing their health. The study has two aims: Aim 1) The study will examine whether it is possible to deliver this program for primary care patients with OUD and SMI and whether patients find it helpful and acceptable. We will also look at early changes in participants' ability and confidence to manage their health conditions. Aim 2) The study will also examine how the program is delivered in each health care setting. Researchers will talk with patients and clinic staff and observe activities in the clinics to better understand what helps or makes it difficult to offer the program. This information will help researchers identify ways to improve the program and its delivery in primary care.
On the roster of active patients
Age 18 years or older,
Have a chart diagnosis of opioid use disorder
chart diagnosis of serious mental illness (e.g. schizophrenia, bipolar disorder, major depressive disorder, post traumatic stress disorder, or severe anxiety that causes functional impairment)
Cognitive impairment based on a score of 3 on the 6-item validated screener developed for clinical research
Active suicidal ideation,
Health complications that would preclude participation.
Active psychosis or mania
Parallel
The Chronic Disease Self-Management Program (CDSMP)
Other interventionParticipants randomized to the intervention group will participate in the CDSMP program, which consists of six weekly 2.5 hour group sessions that provide education on self-management tasks across various conditions. The CDSMP is based on self-efficacy theory and incorporates skills mastery, reinterpretation of symptoms, modeling, and social persuasion to enhance a personal efficacy (i.e., confidence to manage aspects of one's health functioning). The CDSMP occurs in a group format, and sessions are led by two peer educators who have chronic medical conditions. CDSMP groups can include individuals with a range of chronic diseases. Example session topics include managing fatigue, the mind-body connection, action planning, problem-solving, dealing with difficult emotions, physical activity and exercise Making decisions, pain management, healthy eating.
Treatment as Usual plus self-management information
Other interventionParticipants assigned to this arm will receive treatment as usual plus self-management information
Intervention acceptability as measured by attendance
Acceptability of the CDSMP intervention will be assessed by participant attendance at the six scheduled intervention sessions. Attendance will be calculated as the number and proportion of scheduled sessions attended by participants assigned to the CDSMP intervention.
Patient Activation
Patient activation will be evaluated using the Patient Activation Measure (PAM). PAM is a validated self-report measure of an individual's knowledge, skill, and confidence in managing their health and healthcare. It assesses patients' beliefs and behaviors related to taking an active role in managing their health, including engaging with healthcare providers, adhering to treatment plans, and maintaining healthy behaviors. The PAM is available in different versions, with the 13-item PAM commonly used in research and clinical settings. Higher scores indicate greater patient activation.
Medication adherence
Medication adherence will be evaluated using the Morisky Medication Adherence Scale (MMAS-4). The MMAS-4 is a 4-item self-report measure of medication-taking behavior. It assesses common reasons for nonadherence, including forgetting to take medications, carelessness, stopping medications when feeling better, and stopping medications when feeling worse. Scores range from 0 to 4, with higher scores indicating greater medication adherence.
Client Satisfaction
Client satisfaction will be measured using the Client Satisfaction Questionnaire (CSQ-8). CSQ-8 is an 8-item self-report measure of clients' satisfaction with health and human services. It assesses overall satisfaction with the service received, including perceived quality, usefulness, and whether the client's needs were met. Items are rated on a 4-point response scale, with total scores ranging from 8 to 32; higher scores indicate greater satisfaction.
Health-related quality of life
Health-related quality of life will be measured using the SF-12. The SF-12 is a 12-item self-report measure of health-related quality of life. It assesses physical and mental health across domains including physical functioning, role limitations, pain, general health, vitality, social functioning, and emotional and mental health. Responses are summarized into Physical Component Summary (PCS) and Mental Component Summary (MCS) scores, with higher scores generally indicating better health-related quality of life.
Click on the lead sponsor to view all of their trials.
University of Utah
Lead sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
