Clinical trial NCT06228755: MAGIC Study: More Access to Group Integrative Care
Official title: Scaling-Up Integrative Pain Management in Federally-Qualified Health Centers
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Chronic Pain
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2024-01-29
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


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.

Primary outcomes:
measure: Reach: Total Patients Reached
timeFrame: through study completion, a total of up to 3 years
measure: Reach: Race of Patients Reached
timeFrame: through study completion, a total of up to 3 years
measure: Reach: Ethnicity of Patients Reached
timeFrame: through study completion, a total of up to 3 years
measure: Reach: Gender of Patients Reached
timeFrame: through study completion, a total of up to 3 years
measure: Reach: Age of Patients Reached
timeFrame: through study completion, a total of up to 3 years
measure: Adoption
timeFrame: through study completion, a total of up to 3 years
measure: Acceptability: Patients
timeFrame: within 1 month of final IMGV session participation, approximately 10 weeks
measure: Acceptability: Clinic Personnel
timeFrame: within 1 month of final IMGV session participation, approximately 10 weeks
measure: Cost: Patient Perspective
timeFrame: within 1 month of final IMGV session participation, approximately 10 weeks
measure: Cost: Clinic Perspective
timeFrame: within 1 month of final IMGV session participation, approximately 10 weeks
measure: Fidelity
timeFrame: Through completion of IMGV delivery, a total of up to two years
measure: Maintenance: 6 months
timeFrame: Six months after the first IMGV session at clinic
measure: Maintenance: 12 months
timeFrame: Twelve months after the first IMGV session at clinic
Secondary outcomes:
measure: Change in Physical Function
timeFrame: 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.
measure: Change in Anxiety
timeFrame: 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.
measure: Change in Depression
timeFrame: 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.
measure: Change in Fatigue
timeFrame: 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.
measure: Change in Sleep Disturbance
timeFrame: 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.
measure: Change in Ability to Participate in Social Roles and Activities
timeFrame: 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.
measure: Change in Pain Interference
timeFrame: 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.
measure: Change in Pain Intensity
timeFrame: 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.
measure: Change in Pain Medication Use
timeFrame: Assessments will be conducted within 4 weeks of the final IMGV session.
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill School of Medicine
state: North Carolina
Study officials:
affiliation: University of North Carolina at Chapel Hill School of Medicine
name: Isabel J Roth, DrPH, MS
role: PRINCIPAL_INVESTIGATOR
References: