Nonpharmacologic Pain Management in FQHC Primary Care Clinics

Phase 3Active Not RecruitingNCT04923334

University of Utah500 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

500

Conditions

Low Back Pain Chronic Pain

Interventions

Brief Pain TeleconsultBEHAVIORAL

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.

Telehealth Physical TherapyBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.)

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

Outcomes

Primary Outcomes

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

Time frame: 12 weeks

Secondary Outcomes

Physical Function

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).