Nonpharmacologic Pain Management in FQHC Primary Care Clinics

  • STATUS
    Recruiting
  • End date
    Mar 31, 2024
  • participants needed
    500
  • sponsor
    University of Utah
Updated on 7 November 2021
opioid
back pain
pain relieving

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.

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.

Details
Condition Lower Back Pain, Post-Surgical Pain, lumbago, Pain, Chronic Back Pain, Pain (Pediatric), chronic pains, Back Pain, Chronic Pain, Low Back Pain
Treatment Brief Pain Teleconsult, Telehealth Physical Therapy
Clinical Study IdentifierNCT04923334
SponsorUniversity of Utah
Last Modified on7 November 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Able to communicate in English or Spanish
Age between 18-70
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.)
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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