Comparative Effectiveness Trial of Communication Strategies in the Management of Chronic Pain
CompletedNot applicableNCT03301623
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Integrating the Patient Voice Into Comparative Effectiveness Trial of Communication Strategies in the Management of Chronic Pain
- Conditions
- Interventions
- Other: Clinical Decision Support
- Other: Patient Education and Activation Tools
- Sponsor
- Cedars-Sinai Medical Center
- Collaborators
- Patient-Centered Outcomes Research Institute
- Start date
- 2017-11-13
- Primary completion
- 2019-12-31
- Sex
- All
- Age range
- from 18 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: Within a 90-day period prior to the patient recruitment date: * ≥30 days of prescriptions for opioid medications; or * 2 or more opioid prescriptions; or * a total amount of ≥700 Morphine Milligram Equivalents (MME) in a single opioid prescription; and * Patients who have had 1 or more Cedars-Sinai Medical Group primary care physician in the year prior to the study start date; and * At least 1 visit during the follow-up year (the follow-up year will start after they consent to be in the study). Prescriptions in the inpatient setting will not make a patient eligible for this study. Exclusion Criteria: * Individuals less than 18 years of age; or * Individuals with any cancer treatment (chemotherapy or radiotherapy) administered 180 days or less prior to patient recruitment; or * Individuals with a cancer diagnosis in the Problem List 180 days or less prior to patient recruitment (patients with cancer surveillance only will be included in the study); or * Individuals with palliative care treatment administered 180 days or less prior to patient recruitment; or * Individuals with any end-of-life treatment (comfort care) prior to patient recruitment; or * Patients currently taking prescription medications (e.g. Suboxone, subutex, Buprenex, Butrans, Probuphine, Belbuca, buprenorphine/naloxone, Zubsolv, and Bunavail) for Opioid Use or other Substance Use Disorder treatment.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT03301623