MAGIC Study: More Access to Group Integrative Care

NCT06228755 | Enrolling By Invitation

• 2 other identifiers: 23-24815K01AT011578-02
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic pain impacts about 20% of US Adults. Though non-pharmacologic, integrative pain management therapies are now considered first-line treatment by clinical guidelines, these therapies are still rarely covered by health insurance and therefore inaccessible to lower-income individuals. The Integrative Medical Group Visit (IMGV) program was developed to offer low-income, diverse patients with chronic pain an introduction to integrative pain management approaches, through a model that is covered by health insurance under existing billing codes. An initial pragmatic randomized control trial found that IMGV led to significant improvement in mental health related quality of life and lower use of high-cost care. However, there has been little research investigating the implementation of IMGV, and none in Federally-Qualified Health Centers (FQHCs), where the program was initially designed to be implemented. In this study, the investigators test strategies to implement IMGV in FQHCs, including training and coaching clinic staff, and measure the effectiveness of the IMGV on health outcomes for patients with chronic pain.

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (13)

• Reach: Total Patients Reached

  Number of patients who enroll in IMGV at each clinical site.

  through study completion, a total of up to 3 years

• Reach: Race of Patients Reached

  Race of patients who enroll in IMGV at each clinical site.

  through study completion, a total of up to 3 years

• Reach: Ethnicity of Patients Reached

  Ethnicity of patients who enroll in IMGV at each clinical site.

  through study completion, a total of up to 3 years

• Reach: Gender of Patients Reached

  Gender of patients who enroll in IMGV at each clinical site.

  through study completion, a total of up to 3 years

• Reach: Age of Patients Reached

  Age of patients who enroll in IMGV at each clinical site.

  through study completion, a total of up to 3 years

• Adoption

  Number of clinic staff willing to form an implementation team to participate in delivering and implementing the IMGV at each clinical site.

  through study completion, a total of up to 3 years

• Acceptability: Patients

  Number of patients who perceive the IMGV to be acceptable based on qualitative data analysis.

  within 1 month of final IMGV session participation, approximately 10 weeks

• Acceptability: Clinic Personnel

  Number of clinic personnel who perceive the implementation of IMGV to be acceptable based on qualitative data analysis.

  within 1 month of final IMGV session participation, approximately 10 weeks

• Cost: Patient Perspective

  Total cost of participation in the IMGV from the perspective of patients (ie total cost of time, accessing technology, childcare, out-of-pocket costs).

  within 1 month of final IMGV session participation, approximately 10 weeks

• Cost: Clinic Perspective

  Total cost of implementation in the IMGV from the perspective of the clinic (ie total cost of staff time to implement the program, material costs).

  within 1 month of final IMGV session participation, approximately 10 weeks

• Fidelity

  Score on the Integrative Medical Group Visit (IMGV) Fidelity rating scale, measuring the extent to which core functions of the IMGV were delivered as intended by the clinic personnel. The scale includes 5 questions using a 0-3 point scale. Questions measure the constructs: fostering a safe and positive environment, fostering social support through the group, providing evidence-based medical advice, fostering collaboration, and providing access to integrative therapy experiential practice. Total range is from 0-15 with 0 representing the lowest and 15 representing the highest possible fidelity.

  Through completion of IMGV delivery, a total of up to two years

• Maintenance: 6 months

  Number of IMGV sessions held at the clinic at 6 months since the first IMGV session at that clinic.

  Six months after the first IMGV session at clinic

• Maintenance: 12 months

  Number of IMGV sessions held at the clinic at 12 months since the first IMGV session at that clinic.

  Twelve months after the first IMGV session at clinic

Secondary Outcomes (9)

• Change in Physical Function

  Pre-assessments will be conducted within 4 weeks of the first IMGV session, Post assessments will be conducted within 4 weeks of the final IMGV session.

• Change in Anxiety

  Pre-assessments will be conducted within 4 weeks of the first IMGV session, Post assessments will be conducted within 4 weeks of the final IMGV session.

• Change in Depression

  Pre-assessments will be conducted within 4 weeks of the first IMGV session, Post assessments will be conducted within 4 weeks of the final IMGV session.

• Change in Fatigue

  Pre-assessments will be conducted within 4 weeks of the first IMGV session, Post assessments will be conducted within 4 weeks of the final IMGV session.

• Change in Sleep Disturbance

  Pre-assessments will be conducted within 4 weeks of the first IMGV session, Post assessments will be conducted within 4 weeks of the final IMGV session.

Study Arms (1)

Training, Coaching, and Orientation

EXPERIMENTAL

Clinic personnel will receive training for delivering integrative medicine group visits (IMGV) and ongoing coaching in delivering IMGV for patients with chronic pain. Clinic patients will participate in orientation and the 9-week IMGV.

Behavioral: Integrative Medicine Group Visit; Other: Implementation Strategies

Interventions

Implementation Strategies OTHER

Package includes: * Patient strategies will include an orientation session to introduce patients to the IMGV model. * Provider strategies include training in delivery of IMGV with continuing education credits. Training may be delivered on-line or in-person. Ongoing coaching in the first year of IMGV implementation will also be offered to providers leading IMGV, to increase self-efficacy to deliver the curriculum, and enhance fidelity.

Also known as: Implementation Strategies Package

Training, Coaching, and Orientation

Integrative Medicine Group Visit BEHAVIORAL

Integrative Medicine Group Visit (IMGV) is a 9-week group visit series co-facilitated by a billing primary care provider and a trained co-facilitator (such as a behavioral health provider, mindfulness instructor, or yoga teacher). The IMGV will be delivered virtually over a secure telehealth platform for 2 hours weekly. The IMGV curriculum focuses on principles of mindfulness-based stress reduction, and includes patient education on pain, insomnia, nutrition, yoga, depression, self-massage, and self-acupressure.

Also known as: IMGV

Training, Coaching, and Orientation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Staff and clinicians at each clinic who are involved in implementation of the IMGV.
• Only patients who have enrolled in the Integrative medical group visit (IMGV) programs for patients with chronic pain at their Federally Qualified Health Center will be eligible for enrollment in the study. Physicians at each clinical site will determine enrollment criteria for their IMGV program specific to their clinical site--patients who are enrolled in the program will then be invited to participate in the research study.

You may not qualify if:

• All staff, clinicians, and patients who are not involved in the IMGV at the specific clinical sites are excluded from participation.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

University of North Carolina at Chapel Hill School of Medicine

Chapel Hill, North Carolina, 27517, United States

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Isabel J Roth, DrPH, MS

  University of North Carolina at Chapel Hill School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2024
• First Posted: January 29, 2024
• Study Start: January 26, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Time Frame: beginning 9 and continuing for 36 months following publication
• Access Criteria: Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.

Locations

US (1)