Clinical trial NCT04923334: Nonpharmacologic Pain Management in FQHC Primary Care Clinics
Official title: Nonpharmacologic Pain Management in FQHC Primary Care Clinics
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Low Back Pain
Chronic Pain
Keywords: Telehealth
Pain Management
Physical Therapy
Health Disparities
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: Duke University
First posted: 2021-06-11
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study design is a clinical trial testing adaptive interventions. All participants receive the Brief Pain Teleconsult in Phase I. We will randomly assign participants with 1:1 distribution to also receive 10-week Telehealth Physical Therapy during Phase I. All participants are re-assessed at 12 weeks and responder status is determined. For participants not receiving Telehealth Physical Therapy in Phase I, further treatment is based on responder status. Responders receive no further treatment. Non-responders receive the 10-week Telehealth Physical Therapy in Phase II. Participants randomized to Telehealth PT in Phase I receive no further treatment. Long-term assessments occur 26 and 52 weeks after randomization.
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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.)

Primary outcomes:
measure: PEG-3
timeFrame: 12 weeks
Secondary outcomes:
measure: Physical Function
timeFrame: baseline, 12-, 26- and 52-weeks
measure: Sleep Disturbance
timeFrame: baseline, 12-, 26- and 52-weeks
measure: Pain Catastrophizing
timeFrame: baseline, 12-, 26- and 52-weeks
measure: Pain Self-Efficacy
timeFrame: baseline, 12-, 26- and 52-weeks
measure: Global Impression of Change
timeFrame: baseline, 12-, 26- and 52-weeks
measure: opioid use
timeFrame: across 52 week follow-up
measure: PEG-3
timeFrame: baseline, 26- and 52-weeks
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Association of Utah Community Health
state: Utah
city: Salt Lake City
country: United States
facility: The University of Utah Healthcare System
state: Utah
Study officials:
References:
citation: Fritz JM, Del Fiol G, Gibson B, Wetter DW, Solis V, Bennett E, Thackeray A, Goode A, Lundberg K, Romero A, Ford I, Stevens L, Siaperas T, Morales J, Yack M, Greene T. BeatPain Utah: study protocol for a pragmatic randomised trial examining telehealth strategies to provide non-pharmacologic pain care for persons with chronic low back pain receiving care in federally qualified health centers. BMJ Open. 2022 Nov 9;12(11):e067732. doi: 10.1136/bmjopen-2022-067732.
citation: Fritz JM, Gibson B, Wetter DW, Del Fiol G, Solis V, Ford I, Lundberg K, Thackeray A. Use of implementation mapping in the planning of a hybrid type 1 pragmatic clinical trial: the BeatPain Utah study. Implement Sci Commun. 2024 Jan 5;5(1):3. doi: 10.1186/s43058-023-00542-z.
citation: Fritz JM, Ford I, George SZ, Vinci de Vanegas L, Cope T, Burke CA, Goode AP. Telehealth delivery of physical therapist-led interventions for persons with chronic low back pain in underserved communities: lessons from pragmatic clinical trials. Front Pain Res (Lausanne). 2024 Apr 19;5:1324096. doi: 10.3389/fpain.2024.1324096. eCollection 2024.