CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 983 enrolled
Drug / intervention
Clinical Decision Support +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03301623
NCT03301623N/ACompleted

Integrating the Patient Voice Into Comparative Effectiveness Trial of Communication Strategies in the Management of Chronic Pain

Cedars-Sinai Medical Center·interventional·Posted Oct 4, 2017·Updated Oct 13, 2021

In Brief

A clinical study evaluating Clinical Decision Support and Patient Education and Activation Tools for Chronic Pain. Completed, enrolled 983 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Pain
CountriesUnited States

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedOct 4, 2017
Enrollment StartNov 13, 2017
Primary CompletionDec 31, 2019
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 8.7 years ago

Interventions

Clinical Decision Supportother

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.

Patient Education and Activation Toolsother

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).