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OpenTrials
Completed

NCT Number: NCT05256394

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.

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Key information

Conditions

Chronic Pain Muscular Diseases Musculoskeletal Diseases Musculoskeletal Pain Neurologic Manifestations Opioid Use Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UF Health Family Medicine - Commonwealth

Jacksonville, Florida, 32254, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pain Manager + tailored implementation support

Behavioral

Individualized training, technical assistance, and workflow assessments.

Primary outcomes

  1. Adoption

    Time frame: During the implementation trial (5 months total)

    Rate of qualifying patients seen for whom CDS use is documented

Secondary outcomes

  1. Reach

    Time frame: During the implementation trial (5 months total)

    Rate of clinic encounters where CDS is documented

  2. Shared decision making

    Time frame: Immediately after the intervention

    SDM-Q-9 questionnaire: 9-item Shared Decision Making Questionnaire

  3. Pain and function

    Time frame: 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

  4. Any opioid prescription

    Time frame: Baseline/pre-intervention, and at 1 and 3 months

    Binary measure of treatment choice that increases opioid-related risks

  5. Opioid prescriptions ≥50 MME/day

    Time frame: Baseline/pre-intervention, and at 1 and 3 months

    Binary measure of treatment choice that increases opioid-related risks

  6. Opioid prescriptions ≥90 MME/day

    Time frame: Baseline/pre-intervention, and at 1 and 3 months

    Binary measure of treatment choice that increases opioid-related risks

  7. Benzodiazepine prescription concurrent with opioid prescription

    Time frame: Baseline/pre-intervention, and at 1 and 3 months

    Binary measure of treatment choice that increases opioid-related risks

  8. Prescriptions for non-opioid pain medications

    Time frame: Baseline/pre-intervention, and at 1 and 3 months

    Binary measure recommended by the CDC to decrease opioid-related risks

  9. Prescriptions for non-pharmacologic pain treatments

    Time frame: Baseline/pre-intervention, and at 1 and 3 months

    Binary measure recommended by the CDC to decrease opioid-related risks

  10. Urine drug screen orders

    Time frame: Baseline/pre-intervention, and at 1 and 3 months

    Binary measure recommended by the CDC to decrease opioid-related risks

  11. Naloxone prescriptions

    Time frame: Baseline/pre-intervention, and at 1 and 3 months

    Binary measure recommended by the CDC to decrease opioid-related risks

  12. Prescription or referral for medication-assisted therapy (MAT)

    Time frame: Baseline/pre-intervention, and at 1 and 3 months

    Binary measure recommended by the CDC to decrease opioid-related risks

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • Agency for Healthcare Research and Quality (AHRQ)

Registry information

Official study title

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

Acronym: IPRO

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 25, 2022
Registry last updated
Nov 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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