MAGIC Study: More Access to Group Integrative Care

N/AEnrolling By InvitationNCT06228755

University of North Carolina, Chapel Hill70 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

Conditions

Chronic Pain

Interventions

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.

Implementation StrategiesOTHER

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Reach: Total Patients Reached

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

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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).

Time frame: 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).

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Twelve months after the first IMGV session at clinic

Secondary Outcomes

Change in Physical Function

Patient report of physical function will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Item Bank v2.0 Physical Function Short Form 4-a. This includes 4 questions assessing chores, ability to use stairs, walking, and running errands on a 5-point scale with end points of "without any difficulty" and "unable to do." Raw total scores range from 4-20, where a higher score correlates to a better outcome for physical function.