Patient-Centered Chronic Pain Care

Chronic Pain Clinical Trial

— IPRO  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05256394
• Other study ID #: IRB202101931
• Secondary ID: 1R18HS028584-01
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 15, 2024
• Est. completion date: August 31, 2024

Study information

• Verified date: March 2024
• Source: University of Florida
• Contact: Ramzi Salloum, Ph.D.
• Phone: 352-294-4997
• Email: rsalloum[@]ufl.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: August 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Musculoskeletal Pain
• Opioid Use

Intervention

Behavioral:
• Pain Manager + tailored implementation support
Individualized training, technical assistance, and workflow assessments.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	Agency for Healthcare Research and Quality (AHRQ)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adoption	Rate of qualifying patients seen for whom CDS use is documented	During the implementation trial (15 months total)
Secondary	Reach	Rate of clinic encounters where CDS is documented	During the implementation trial (15 months total)
Secondary	Shared decision making	SDM-Q-9 questionnaire: 9-item Shared Decision Making Questionnaire	Immediately after the intervention
Secondary	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
Secondary	Any opioid prescription	Binary measure of treatment choice that increases opioid-related risks	Baseline/pre-intervention, and at 1 and 3 months
Secondary	Opioid prescriptions =50 MME/day	Binary measure of treatment choice that increases opioid-related risks	Baseline/pre-intervention, and at 1 and 3 months
Secondary	Opioid prescriptions =90 MME/day	Binary measure of treatment choice that increases opioid-related risks	Baseline/pre-intervention, and at 1 and 3 months
Secondary	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
Secondary	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
Secondary	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
Secondary	Urine drug screen orders	Binary measure recommended by the CDC to decrease opioid-related risks	Baseline/pre-intervention, and at 1 and 3 months
Secondary	Naloxone prescriptions	Binary measure recommended by the CDC to decrease opioid-related risks	Baseline/pre-intervention, and at 1 and 3 months
Secondary	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