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Enrolling by Invitation

NCT Number: NCT06228755

MAGIC Study: More Access to Group Integrative Care

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of North Carolina at Chapel Hill School of Medicine

Chapel Hill, North Carolina, 27517, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: IMGV

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.

Other names: Implementation Strategies Package

Primary outcomes

  1. Reach: Total Patients Reached

    Time frame: through study completion, a total of up to 3 years

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

  2. Reach: Race of Patients Reached

    Time frame: through study completion, a total of up to 3 years

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

  3. Reach: Ethnicity of Patients Reached

    Time frame: through study completion, a total of up to 3 years

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

  4. Reach: Gender of Patients Reached

    Time frame: through study completion, a total of up to 3 years

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

  5. Reach: Age of Patients Reached

    Time frame: through study completion, a total of up to 3 years

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

  6. Adoption

    Time frame: through study completion, a total of up to 3 years

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

  7. Acceptability: Patients

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

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

  8. Acceptability: Clinic Personnel

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

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

  9. Cost: Patient Perspective

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

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

  10. Cost: Clinic Perspective

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

    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).

  11. Fidelity

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

    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.

  12. Maintenance: 6 months

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

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

  13. Maintenance: 12 months

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

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

Secondary outcomes

  1. 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.

    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.

  2. 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.

    Patient report of anxiety will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Item Bank v1.0 Anxiety Short Form 4-a. This includes 4 questions assessing feeling fearful, ability to focus on anything other than anxiety, worries, and feeling uneasy in the past 7 days on a 5-point scale with end points of "never" and "always." Higher scores reflect more difficulty. Raw total scores range from 4-20, where a higher score correlates to a worse outcome for anxiety.

  3. 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.

    Patient report of depression will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Item Bank v1.0 - Emotional Distress-Depression - Short Form 4a. This includes 4 questions assessing feeling worthless, helpless, depressed, or hopeless in the past 7 days on a 5-point scale with end points of "never" and "always." Raw total scores range from 4-20, where a higher score correlates to a worse outcome for depression.

  4. 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.

    Patient report of fatigue will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Item Bank v1.0 -Fatigue - Short Form 4a. This includes 4 questions assessing feeling fatigued, had trouble starting things because of feeling tired, run-down, and fatigued on average in the past 7 days on a 5-point scale with end points of "not at all" and "very much." Raw total scores range from 4-20, where a higher score correlates to a worse outcome for fatigue.

  5. 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.

    Patient report of sleep disturbance will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Item Bank v1.0 -Sleep Disturbance - Short form 4a. This includes 4 questions assessing sleep quality, sleep was refreshing, problem with sleep, or difficulty falling asleep on average in the past 7 days on a 5-point scale with end points of "very poor" "very good" sleep quality and "not at all" and "very much" for all other questions. Raw total scores range from 4-20, where a higher score correlates to a worse outcome for sleep disturbance.

  6. 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.

    Patient report of ability to participate in social roles and activities will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Item Bank v2.0 - Ability to Participate in Social Roles and Activities- Short Form 4a. This includes 4 questions assessing trouble doing regular leisure activities with others, trouble doing family activities, trouble doing usual activities at work, and trouble doing activities with friend on a 5-point scale with end points of "never" and "always." Raw total scores range from 4-20, where a higher score correlates to a better outcome for ability to participate in social roles and activities.

  7. 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.

    Patient report of pain interference will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Item Bank v1.1 - Pain Interference - Short Form 4a. This includes 4 questions assessing pain interfering with day to day activities, work around the home, ability to participate in social activities, and household chores in the past 7 days on a 5-point scale with end points of "not at all" and "very much." Higher scores reflect more difficulty. Raw total scores range from 4-20, where a higher score correlates to a better outcome for pain interference.

  8. 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 intensity will be measured before and after participation in the IMGV and assessed by the Pain Intensity sub-scale of the PROMIS-29 instrument. Pain intensity rating: 1 item from the Patient Reported Outcomes Measurement Information System (PROMIS), with pain intensity rated on 0-10 scale with lower values indicating less pain, or better outcome.

  9. Change in Pain Medication Use

    Time frame: Assessments will be conducted within 4 weeks of the final IMGV session.

    Total pain medication use will be compared through data from the electronic health record (comparing medications listed before initiating and after participation in IMGV).

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Official study title

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

Acronym: MAGIC

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jan 29, 2024
Registry last updated
Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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