Patient-Centered Chronic Pain Care (IPRO)

Scaling Interoperable Clinical Decision Support for Patient-Centered Chronic Pain Care

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.

Study Overview

• Status: Completed
• Conditions: Musculoskeletal Pain; Chronic Pain; Opioid Use
• Intervention / Treatment: Behavioral: Pain Manager + tailored implementation support

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 Type: Interventional
• Enrollment (Actual): 39
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32254
      • UF Health Family Medicine - Commonwealth

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Pain Manager + tailored implementation support Pain Manager; 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.	Behavioral: Pain Manager + tailored implementation support; Individualized training, technical assistance, and workflow assessments.
No Intervention: Pain Manager implementation in EHR; Pain Manager is a decision support tool. All study clinics will begin the trial with Pain Manager integrated and available in their EHR. The other 6 clinics will have no additional tailor support.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adoption	Rate of qualifying patients seen for whom CDS use is documented	During the implementation trial (5 months total)

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Florida
• Collaborators: Agency for Healthcare Research and Quality (AHRQ)
• Investigators: Principal Investigator: Christopher Harle, Ph.D., University of Florida

Publications and helpful links

General Publications

• Salloum RG, Bilello L, Bian J, Diiulio J, Paz LG, Gurka MJ, Gutierrez M, Hurley RW, Jones RE, Martinez-Wittinghan F, Marcial L, Masri G, McDonnell C, Militello LG, Modave F, Nguyen K, Rhodes B, Siler K, Willis D, Harle CA. Study protocol for a type III hybrid effectiveness-implementation trial to evaluate scaling interoperable clinical decision support for patient-centered chronic pain management in primary care. Implement Sci. 2022 Jul 15;17(1):44. doi: 10.1186/s13012-022-01217-4.

Study record dates

Study Major Dates

• Study Start (Actual): January 13, 2025
• Primary Completion (Actual): August 31, 2025
• Study Completion (Actual): August 31, 2025

Study Registration Dates

• First Submitted: January 28, 2022
• First Submitted That Met QC Criteria: February 24, 2022
• First Posted (Actual): February 25, 2022

Study Record Updates

• Last Update Posted (Estimated): November 4, 2025
• Last Update Submitted That Met QC Criteria: October 31, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Musculoskeletal Pain; Chronic Pain
• Other Study ID Numbers: IRB202101931; 1R18HS028584-01 (U.S. AHRQ Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No