MAGIC Study: More Access to Group Integrative Care

Official title

Scaling-Up Integrative Pain Management in Federally-Qualified Health Centers

Overview

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.

Interventions

• Behavioral Integrative Medicine Group Visit
  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
• Other Implementation Strategies
  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.

Primary outcome measures

• Reach: Total Patients Reached [Time frame: through study completion, a total of up to 3 years]
• Reach: Race of Patients Reached [Time frame: through study completion, a total of up to 3 years]
• Reach: Ethnicity of Patients Reached [Time frame: through study completion, a total of up to 3 years]
• Reach: Gender of Patients Reached [Time frame: through study completion, a total of up to 3 years]
• Reach: Age of Patients Reached [Time frame: through study completion, a total of up to 3 years]
• Adoption [Time frame: through study completion, a total of up to 3 years]
• Acceptability: Patients [Time frame: within 1 month of final IMGV session participation, approximately 10 weeks]
• Acceptability: Clinic Personnel [Time frame: within 1 month of final IMGV session participation, approximately 10 weeks]
• Cost: Patient Perspective [Time frame: within 1 month of final IMGV session participation, approximately 10 weeks]
• Cost: Clinic Perspective [Time frame: within 1 month of final IMGV session participation, approximately 10 weeks]

Secondary outcome measures (9)

• Change in Physical Function [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 Ability to Participate in Social Roles and Activities [Time frame: 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 Pain Interference [Time frame: 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 Pain Intensity [Time frame: 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 Pain Medication Use [Time frame: Assessments will be conducted within 4 weeks of the final IMGV session.]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Health services research

Study locations

United States · 1 center

• University of North Carolina at Chapel Hill School of Medicine — Chapel Hill

Identifiers

NCT: NCT06228755 · 23-2481 · 5K01AT011578-02

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗