Nonpharmacologic Pain Management in FQHC Primary Care Clinics

NCT04923334 | Recruiting Phase 3 DMC

• 1 other identifier: IRB_00143493
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 2

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.

Conditions

Low Back Pain; Chronic Pain

Keywords

Telehealth; Pain Management; Physical Therapy; Health Disparities

Outcome Measures

Primary Outcomes (1)

• PEG-3

  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

  12 weeks

Secondary Outcomes (7)

• Physical Function

  baseline, 12-, 26- and 52-weeks

• Sleep Disturbance

  baseline, 12-, 26- and 52-weeks

• Pain Catastrophizing

  baseline, 12-, 26- and 52-weeks

• Pain Self-Efficacy

  baseline, 12-, 26- and 52-weeks

• Global Impression of Change

  baseline, 12-, 26- and 52-weeks

Study Arms (2)

Brief Pain Teleconsult

EXPERIMENTAL

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.

Behavioral: Brief Pain Teleconsult; Behavioral: Telehealth Physical Therapy

Brief Pain Teleconsult plus Telehealth Physical Therapy

EXPERIMENTAL

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.

Behavioral: Brief Pain Teleconsult; Behavioral: Telehealth Physical Therapy

Interventions

Brief Pain Teleconsult BEHAVIORAL

The Brief Pain Teleconsult intervention includes 2 sessions provided by a licensed physical therapist over about 1 week. The sessions focus on pain education from a biopsychosocial perspective that is designed to address negative pain appraisals and catastrophizing thoughts, providing advice to be active and engage in exercise and physical activity, and reassurance that activity is beneficial and safe.

Brief Pain Teleconsult; Brief Pain Teleconsult plus Telehealth Physical Therapy

Telehealth Physical Therapy BEHAVIORAL

The Telehealth Physical Therapy intervention involves weekly telehealth sessions provided over 10 weeks. Telehealth Physical Therapy is provided by a licensed physical therapist. Key components of the intervention include reinforcing biopsychosocial education messages and developing an exercise and physical activity program using cognitive behavioral principles such as goal setting and positive reinforcement. Pain coping strategies including mindful breathing and progressive relaxation techniques will be included.

Brief Pain Teleconsult; Brief Pain Teleconsult plus Telehealth Physical Therapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.)

Sponsors & Collaborators

• University of Utah: lead
• Duke University: collaborator

Study Sites (2)

Association of Utah Community Health

Salt Lake City, Utah, 84106, United States

RECRUITING

The University of Utah Healthcare System

Salt Lake City, Utah, 84108, United States

RECRUITING

Related Publications (4)

• 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.

  PMID: 36351735 BACKGROUND

• 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.

  PMID: 38183154 BACKGROUND

• 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.

  PMID: 38706872 BACKGROUND

• Fritz JM, Gibson B, Wetter DW, Fiol GD, Solis VH, 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. Res Sq [Preprint]. 2023 Sep 11:rs.3.rs-3267087. doi: 10.21203/rs.3.rs-3267087/v1.

  PMID: 37790359 DERIVED

MeSH Terms

Conditions

Low Back Pain; Chronic Pain; Agnosia

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The study is outcome assessor and investigator blinded. Blinding will only be broken in emergency situations for reasons of participant safety such as a serious adverse event. If blinding is broken, either intentionally or unintentionally, the reason will be fully documented and entered on an electronic case report form. Every effort will be made to discuss the decision to break blinding with the Data Safety Monitoring Board in advance.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Distinguished Professor

Model Details: 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.

Study Record Dates

• First Submitted: June 1, 2021
• First Posted: June 11, 2021
• Study Start: November 4, 2021
• Primary Completion (Estimated): June 21, 2026
• Study Completion (Estimated): June 21, 2026
• Last Updated: August 7, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Following completion of the data collection

Locations

US (2)