Nonpharmacologic Pain Management in FQHC Primary Care Clinics
- Conditions
- Low Back PainChronic Pain
- Interventions
- Behavioral: Brief Pain TeleconsultBehavioral: Telehealth Physical Therapy
- Registration Number
- NCT04923334
- Lead Sponsor
- University of Utah
- Brief Summary
The goal of this study is to improve pain management and reduce opioid reliance for patients with chronic back pain in Utah Federally-Qualified Health Centers (FQHCs). The study compares the effectiveness of nonpharmacologic pain treatments using telehealth to overcome access barriers. We will use automated EHR reminders for electronic referral to teleconsult services. Our project tests adaptive treatments and uses a hybrid type I design - focused on effectiveness outcomes while gathering implementation data to inform future efforts to scale effective strategies.
- Detailed Description
This randomized clinical trial compares the effectiveness of different strategies to provide efficacious nonpharmacologic interventions to patients with back pain seeking care in FQHCs throughout the state of Utah. The strategies evaluated are designed to overcome the barriers specific to rural and low income communities served by FQHC clinics through innovative use of telehealth resources. The randomized trial will randomize individual participants to one of two interventions strategies, one providing both a brief pain teleconsult with a 10-week telehealth physical therapy, the other uses an adaptive strategy - providing the brief pain teleconsult first, followed by the 10-week telehealth physical therapy only among those non-responsive to the brief teleconsult treatment. We will also evaluate outcomes related to the efforts to implement strategies in FQHC clinics in order to provide valuable information for future efforts to scale effective strategies into other low resource health care settings. Assessments will occur at baseline and after 12-, 26- and 52-weeks.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 500
- Able to communicate in English or Spanish
- Age between 18-80
- Visit with an FQHC provider (in-person or via telehealth) in past 90 days
- Back pain has been an ongoing problem for at least the past 3 months, and has been a problem on at least half the days in the past 6 months
- Access to resources necessary to receive telehealth sessions (phone or 2-way video)
- Currently pregnant
- Currently involved in active substance use disorder treatment (other than peer support groups, AA, etc.)
- History of spine surgery in past 6 months
- Has a condition restricting participation in physical activity (i.e., unable to ambulate independently (with or without assistive device) for at least 5 minutes.
- Reason for back pain is a fracture or non-musculoskeletal condition (i.e., spinal tumor, inflammatory disorder, etc.)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Brief Pain Teleconsult Telehealth Physical Therapy Participants randomized to Brief Pain Teleconsult will receive the brief teleconsult intervention in Phase 1 (1-12 weeks) Responder status to the Phase 1 treatment will be examined at the 12 week assessment. Participants determined to be non-responders will receive the Telehealth Physical Therapy intervention. Responders receive no additional treatment. Brief Pain Teleconsult Brief Pain Teleconsult Participants randomized to Brief Pain Teleconsult will receive the brief teleconsult intervention in Phase 1 (1-12 weeks) Responder status to the Phase 1 treatment will be examined at the 12 week assessment. Participants determined to be non-responders will receive the Telehealth Physical Therapy intervention. Responders receive no additional treatment. Brief Pain Teleconsult plus Telehealth Physical Therapy Telehealth Physical Therapy Participants randomized to Brief Pain Teleconsult plus Telehealth Physical Therapy will receive the brief teleconsult intervention in Phase 1 followed by the 10-week physical therapy intervention. No additional treatment is provided after the 12 week assessment. Brief Pain Teleconsult plus Telehealth Physical Therapy Brief Pain Teleconsult Participants randomized to Brief Pain Teleconsult plus Telehealth Physical Therapy will receive the brief teleconsult intervention in Phase 1 followed by the 10-week physical therapy intervention. No additional treatment is provided after the 12 week assessment.
- Primary Outcome Measures
Name Time Method PEG-3 12 weeks The PEG-3 measure includes 3 items evaluating 1) pain severity, and interference of pain with 2) enjoyment and 3) general activity. Item response options range from 0-10. The PEG-3 score is expressed as the mean of all item scores with higher scores indicating greater pain impact
- Secondary Outcome Measures
Name Time Method PEG-3 baseline, 26- and 52-weeks The PEG-3 measure includes 3 items evaluating 1) pain severity, and interference of pain with 2) enjoyment and 3) general activity. Item response options range from 0-10. The PEG-3 score is expressed as the mean of all item scores with higher scores indicating greater pain impact
Physical Function baseline, 12-, 26- and 52-weeks The PROMIS short form 6b for physical function uses fixed items from the PROMIS physical function item bank to provide a T-score with population mean = 50 (sd=10).
Sleep Disturbance baseline, 12-, 26- and 52-weeks The PROMIS short form 6a for sleep disturbance uses fixed items from the PROMIS sleep disturbance item bank to provide a T-score with population mean = 50 (sd=10).
opioid use across 52 week follow-up Prescription opioid use across the 52-week follow-up will be examined from EHR noting number of prescriptions and days of use.
Pain Catastrophizing baseline, 12-, 26- and 52-weeks The PSC-6 is a short-form questionnaire evaluating an individual's negative cognitive-affective response to anticipated or actual pain
Pain Self-Efficacy baseline, 12-, 26- and 52-weeks The PSEQ-4 is a short form questionnaire evaluating an individual's confidence in performing activities despite pain
Global Impression of Change baseline, 12-, 26- and 52-weeks The single-item PGIC assesses participants' of change following treatment based on the question: "Since my treatment, my pain is..." with Likert scale response options ranging from (0) "very much worse" to (6) "very much improved".
Trial Locations
- Locations (2)
Association of Utah Community Health
🇺🇸Salt Lake City, Utah, United States
The University of Utah Healthcare System
🇺🇸Salt Lake City, Utah, United States