Patient-Centered Chronic Pain Care

Not Applicable

Recruiting

• Conditions: Chronic Pain; Musculoskeletal Pain; Opioid Use
• Interventions: Behavioral: Pain Manager + tailored implementation support

• Registration Number: NCT05256394
• Lead Sponsor: University of Florida

Brief Summary

This study will adapt and scale existing AHRQ-supported interoperable CDS for patient-centered chronic pain care. The objective of this project is to study the adaptation and implementation of an existing interoperable CDS tool for pain treatment shared decision making, with tailored implementation support, in primary care clinical settings. The central hypothesis is that tailored implementation support will increase CDS adoption and shared decision making.

Detailed Description

This study will adapt and scale the use of existing AHRQ-supported interoperable CDS that aids patient-centered chronic pain treatment decision making. The research will generate critical evidence on scalable strategies to implement and evaluate interoperable CDS in real-world settings across different types of EHRs. The pragmatic trial will enhance the reach of interoperable CDS to more diverse populations. Together, these efforts will lead to important new technology and evidence that patients, clinicians, and health systems can use to improve care for millions of Americans who suffer from pain and other chronic conditions.

Study Timeline

• Study First Submitted: 2022-01-28
• Study First Submitted QC: 2022-02-24
• Study First Posted: 2022-02-25
• Status Verified: 2025-01
• Study Start: 2025-01-13
• Last Update Submitted: 2025-01-21
• Last Update Posted: 2025-01-22
• Primary Completion: 2025-08-31
• Study Completion: 2025-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• Primary care patients receiving care at a participating clinic
• Patients with chronic non-cancer musculoskeletal pain and with a recent history of opioid use

Exclusion Criteria

• Due to the fact that the clinical decision support tool is currently available in English only, non-English speaking patients will not be eligible to participate

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Pain Manager + tailored implementation support Pain Manager	Pain Manager + tailored implementation support	Pain Manager is a decision support tool. All study clinics will begin the trial with Pain Manager integrated and available in their EHR. Consistent with the stepped-wedge design, intensive implementation support (e.g, administrative support, technical support)will be provided to two clinics at once by a multidisciplinary team.

Primary Outcome Measures

Name	Time	Method
Adoption	During the implementation trial (5 months total)	Rate of qualifying patients seen for whom CDS use is documented

Secondary Outcome Measures

Name	Time	Method
Reach	During the implementation trial (5 months total)	Rate of clinic encounters where CDS is documented
Shared decision making	Immediately after the intervention	SDM-Q-9 questionnaire: 9-item Shared Decision Making Questionnaire
Pain and function	Baseline/pre-intervention, and at 1 and 3 months	PEG-3: 3-item scale that measures pain on average, its interference with enjoyment of life, and with general activity
Any opioid prescription	Baseline/pre-intervention, and at 1 and 3 months	Binary measure of treatment choice that increases opioid-related risks
Opioid prescriptions ≥50 MME/day	Baseline/pre-intervention, and at 1 and 3 months	Binary measure of treatment choice that increases opioid-related risks
Opioid prescriptions ≥90 MME/day	Baseline/pre-intervention, and at 1 and 3 months	Binary measure of treatment choice that increases opioid-related risks
Benzodiazepine prescription concurrent with opioid prescription	Baseline/pre-intervention, and at 1 and 3 months	Binary measure of treatment choice that increases opioid-related risks
Prescriptions for non-opioid pain medications	Baseline/pre-intervention, and at 1 and 3 months	Binary measure recommended by the CDC to decrease opioid-related risks
Prescriptions for non-pharmacologic pain treatments	Baseline/pre-intervention, and at 1 and 3 months	Binary measure recommended by the CDC to decrease opioid-related risks
Urine drug screen orders	Baseline/pre-intervention, and at 1 and 3 months	Binary measure recommended by the CDC to decrease opioid-related risks
Naloxone prescriptions	Baseline/pre-intervention, and at 1 and 3 months	Binary measure recommended by the CDC to decrease opioid-related risks
Prescription or referral for medication-assisted therapy (MAT)	Baseline/pre-intervention, and at 1 and 3 months	Binary measure recommended by the CDC to decrease opioid-related risks

Trial Locations

Locations (1)

UF Health Family Medicine - Commonwealth; 🇺🇸 Jacksonville, Florida, United States