Adapting and Implementing a Chronic Disease Self-Management Program for Primary Care Patients With Opioid Use Disorder and Serious Mental Illness

The purpose of this study is to evaluate the feasibility and initial impact of the Chronic Disease Self-Management Program (CDSMP) on the self-management of primary care patients with opioid use disorder (OUD), serious mental illness (SMI), and other chronic health conditions. The CDSMP is a peer-led, group-based program that teaches skills for managing chronic health conditions and for working effectively with health care providers. The program consists of six weekly 2.5 hour sessions focused on skills such as goal setting, action planning, problem solving, medication management, communication, and managing symptoms and difficult emotions. The CDSMP has an established evidence base, but has not been evaluated in a primary care setting for patients with opioid use disorder (OUD) and serious mental illness (SMI). This study will evaluate the feasibility, acceptability, and initial impact of a CDSMP designed to address the health and self-management needs of this population within primary care.

Aim 1: In this aim, we will evaluate the feasibility, acceptability, and initial impact of an adapted CDSMP for primary care patients with opioid use disorder and SMI. Participants will be randomly assigned to receive either the adapted CDSMP or usual primary care plus written information about health self-management. The study will be conducted at one VA primary care clinic and one University of Utah primary care clinic. Participants will complete assessments before, half way through, and after the program to evaluate patient participation, satisfaction, and changes in health self-management and related outcomes such as medication adherence and patient activation. A total of N = 20 patients will be recruited from each site; N = 10 will be randomized to the intervention condition and N = 10 will be randomized to treatment as usual plus self-management information.

Aim 2: In this aim, we will qualitatively study how the CDSMP is implemented in the two primary care settings using the Rapid Assessment Procedure Informed Clinical Ethnography (RAPICE) technique. Researchers will interview participants and clinic staff and observe clinic activities to understand experiences with the program, factors that make delivery easier or more difficult, and differences between the two study settings. This information will help identify ways to improve delivery of the program in primary care.

• The Chronic Disease Self-Management Program (CDSMP) (Other): Participants 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): Participants assigned to this arm will receive treatment as usual plus self-management information

Primary outcomes

• Intervention acceptability as measured by attendance [Weekly during the 6-week intervention period]: 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.

Secondary outcomes

• Patient Activation [Patient Activation will be assessed at baseline, 3 weeks into intervention, end of intervention at 6 weeks, and at 12 weeks]: 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 assessed at baseline, 3 weeks into intervention, end of intervention at 6 weeks, and at 12 weeks]: 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 assessed at baseline, 3 weeks into intervention, end of intervention at 6 weeks, and at 12 weeks]: 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 [Client satisfaction will be assessed at baseline, 3 weeks into intervention, end of intervention at 6 weeks, and at 12 weeks]: 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.

Sex: All, ages: 18 Years to any

Patient Inclusion Criteria Aim 1:

* 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)
* chart diagnosis of chronic disease (e.g. diabetes, hypertension, or others)

To participate in a post intervention qualitative interview, participants must have participated in the clinical trial, either in the intervention arm or the treatment as usual arm.

Exclusion Criteria Aim 1:

* 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
* Plans to relocate during the study
* No locater information,
* Pregnancy
* Current or upcoming incarceration

Patient inclusion criteria Aim 2:

\- Must have participated in Aim 1

• Bodenheimer T, Lorig K, Holman H, Grumbach K. Patient self-management of chronic disease in primary care. JAMA. 2002 Nov 20;288(19):2469-75. doi: 10.1001/jama.288.19.2469. PMID 12435261
• Siantz E, Aranda MP. Chronic disease self-management interventions for adults with serious mental illness: a systematic review of the literature. Gen Hosp Psychiatry. 2014 May-Jun;36(3):233-44. doi: 10.1016/j.genhosppsych.2014.01.014. Epub 2014 Feb 10. PMID 24630896
• Lorig KR, Sobel DS, Stewart AL, Brown BW Jr, Bandura A, Ritter P, Gonzalez VM, Laurent DD, Holman HR. Evidence suggesting that a chronic disease self-management program can improve health status while reducing hospitalization: a randomized trial. Med Care. 1999 Jan;37(1):5-14. doi: 10.1097/00005650-199901000-00003. PMID 10413387
• Lorig KR, Holman H. Self-management education: history, definition, outcomes, and mechanisms. Ann Behav Med. 2003 Aug;26(1):1-7. doi: 10.1207/S15324796ABM2601_01. PMID 12867348

• Elizabeth Siantz, PhD, MSW, Principal investigator, University of Utah

NIH grants: K01DA059641