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Comparative Effectiveness Trial of Communication Strategies in the Management of Chronic Pain

NCT03301623 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 983

Last updated 2021-10-13

Study results available
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Summary

Investigators will compare Clinical Decision Support (CDS) versus Patient Education and Activation Tools (PEATs) in patients prescribed long-term or multiple opioids to measure outcomes that are important to patients. Primary outcomes are pain interference, physical function, and satisfaction with patient-physician communication. Secondary outcomes are overall Health-Related Quality of Life and high-risk prescribing, including prescriptions over 90 morphine milligram equivalents per day and co-prescribing of benzodiazepines and opioids.

Patients in the PEAT arm will receive patient materials during the intervention, developed to engage patients in chronic pain treatment, prior to Primary Care Physician office visits. In the provider-facing CDS arm, PCPs will receive computerized reminders about appropriate opioid use during office visits for enrolled patients. Patients in both groups will receive questionnaires about pain interference, quality of life, and physician-patient communication through the patient portal one month after each visit to their Primary Care Physician (PCP). Investigators will use multi-level regression models to compare the effectiveness of these two communication strategies.

Conditions

Interventions

OTHER

Clinical Decision Support

The CDS intervention will test the use of existing guideline-based EHR alerts related to the prescription of opioids. CDS alerts employ computer algorithms that account for patient characteristics and diagnoses to deliver reminders of appropriate use when a provider enters an order for a medication.

OTHER

Patient Education and Activation Tools

The patient education materials selected for this study: "Pain Management: Which Treatment is Right for You," "Preparing for Your Health Care Visit," and a video from the American Chronic Pain Association (ACPA) named "A Car with Four Flat Tires," which helps to give patients a better understanding of how multi-modal treatment can be more effective than relying on one source of treatment (e.g., pain medication).

Sponsors & Collaborators

  • Patient-Centered Outcomes Research Institute

    collaborator OTHER

  • Cedars-Sinai Medical Center

    lead OTHER

Principal Investigators

  • Brennan Spiegel, MD, MSHS · Cedars-Sinai Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-13
Primary Completion
2019-12-31
Completion
2019-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03301623 on ClinicalTrials.gov