Nonpharmacologic Pain Management in FQHC Primary Care Clinics (BeatPain Utah)

Utah System of Higher Education (USHE)

Status and phase: Enrolling; Phase 3

Conditions: Chronic Pain; Low Back Pain

Treatments: Behavioral: Telehealth Physical Therapy; Behavioral: Brief Pain Teleconsult

Study type: Interventional

Funder types: Other

Identifiers

NCT04923334

IRB_00143493

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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500 participants in 2 patient groups

Brief Pain Teleconsult

Experimental group

Description:

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.

Treatment:

Behavioral: Brief Pain Teleconsult

Behavioral: Telehealth Physical Therapy

Brief Pain Teleconsult plus Telehealth Physical Therapy

Experimental group

Description:

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.

Treatment:

Behavioral: Brief Pain Teleconsult

Behavioral: Telehealth Physical Therapy