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NCT03301623 · ClinicalTrials.gov registry record · NA
Comparative Effectiveness Trial of Communication Strategies in the Management of Chronic Pain
A NA study, sponsored by Cedars-Sinai Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 983
- Enrollment target
NCT03301623: Completed NA study, sponsored by Cedars-Sinai Medical Center.
NCT03301623 is a NA study that has completed, run by Cedars-Sinai Medical Center. The registered enrollment target is 983 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (30% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03301623, a NA study, has completed, sponsored by Cedars-Sinai Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 983 participants
- Enrollment target
Study 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.
Primary Outcome
PROMIS - Pain Interference instruments assess self-reported consequences of pain on relevant aspects of one's life. This includes the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities. The forms are universal rather than disease-specific. A higher PROMIS T-score represents more of the concept. For Pain Interference, a T-score of 60 is one SD higher pain than average. A t-score of 50 represents the mean pain interference reported by a
Interventions
- OTHER Clinical Decision Support
- OTHER Patient Education and Activation Tools
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 983 participants |
| Start Date | 2017-11-13 |
| Est. Completion | 2019-12-31 |
| Phase | NA |
What the finished NCT03301623 record still lists
NCT03301623 is an interventional study that assigns participants to a tested intervention. The registered 983 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (30% lower).
The record links to 0 conditions, and to 2 interventions - of which Clinical Decision Support is the first listed.
NCT03301623 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03301623 about?
NCT03301623 is a clinical study titled "Comparative Effectiveness Trial of Communication Strategies in the Management of Chronic Pain". 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 p...
What is the current status of trial NCT03301623?
This trial is currently completed. It is a NA study. The enrollment target is 983 participants. The study started on 2017-11-13. Estimated completion is 2019-12-31.
What interventions are being tested in trial NCT03301623?
The interventions under investigation include: Clinical Decision Support (OTHER), Patient Education and Activation Tools (OTHER).
Who is sponsoring clinical trial NCT03301623?
This trial is sponsored by Cedars-Sinai Medical Center, which has 339 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03301623's enrollment target sits among peer trials
983 122nd of 2000 higher than 1,879 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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