University of North Carolina at Chapel Hill School of Medicine
Chapel Hill, North Carolina, 27517, United States
NCT Number: NCT06228755
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Chapel Hill, North Carolina, 27517, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Package includes:
Other names: Implementation Strategies Package
Time frame: through study completion, a total of up to 3 years
Number of patients who enroll in IMGV at each clinical site.
Time frame: through study completion, a total of up to 3 years
Race of patients who enroll in IMGV at each clinical site.
Time frame: through study completion, a total of up to 3 years
Ethnicity of patients who enroll in IMGV at each clinical site.
Time frame: through study completion, a total of up to 3 years
Gender of patients who enroll in IMGV at each clinical site.
Time frame: through study completion, a total of up to 3 years
Age of patients who enroll in IMGV at each clinical site.
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.
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.
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.
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).
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).
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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).
University of North Carolina, Chapel Hill
Other
Scaling-Up Integrative Pain Management in Federally-Qualified Health Centers
Acronym: MAGIC
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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