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NCT03454555 · ClinicalTrials.gov registry record · NA
Integrated Services for Pain: Interventions to Reduce Pain Effectively
A NA study, sponsored by RTI International.
- Completed
- Registry status
- NA
- Development phase
- 543
- Enrollment target
NCT03454555: Completed NA study, sponsored by RTI International.
NCT03454555 is a NA study that has completed, run by RTI International. The registered enrollment target is 543 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (61% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03454555, a NA study, has completed, sponsored by RTI International.
- COMPLETED
- Registry status
- NA
- Development phase
- 543 participants
- Enrollment target
Study Summary
Long-term pain -or pain that lasts for months or years-is one of the most common health problems in the United States. Clinicians often prescribe opioids which can help ease pain in the short term, but evidence does not support their effectiveness over the long term. For some people, long-term opioid use can lead to addiction and overdose. People need effective options and support to help maintain or improve their function and quality of life. This study compared two programs for helping people living with long-term pain who have been prescribed opioids for 3 or more months. This study was done at primary care and pain care clinics at 3 health systems in the Southeastern United States. The study team assigned people by chance to one of two study programs: (1) individual motivational interviewing plus group-based cognitive behavioral therapy (MI+CBT) or (2) patient-clinician shared decision making. In the MI+CBT program, the patient learned strategies to better cope with chronic pain. In the SDM program, the patient and clinician worked together through enhanced communication to make decisions that aligned with values and preferences of the patient. The study team compared the two programs by looking at changes in opioid dosage, physical functioning, and pain interference over time. They collected information about prescribed opioid dosage from electronic health records and patients completed surveys at the start of the study and 6 and 12 months later. The study team worked with an advisory group that included patients, advocates, clinicians, and pain experts. The advisory group met with the study team two to three times per year to provide input on the study.
Primary Outcome
The primary outcome was derived from electronic health records. Total morphine equivalents for each prescription was calculated by multiplying the quantity of each prescription by the strength of the prescription (milligrams of opioid per unit dispensed). The quantity-strength product was then multiplied by conversion factors to estimate the milligrams of morphine equivalent to the opioids dispensed in the prescription. The total average dose in morphine equivalents per day supplied was calculat
Interventions
- BEHAVIORAL Shared Decision Making
- BEHAVIORAL Motivational Interviewing and Cognitive Behavioral Therapy for Chronic Pain
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 543 participants |
| Start Date | 2019-06-26 |
| Est. Completion | 2023-09-30 |
| Phase | NA |
What the finished NCT03454555 record still lists
NCT03454555 is an interventional study that assigns participants to a tested intervention. The registered 543 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 (61% lower).
The record links to 0 conditions, and to 2 interventions - of which Shared Decision Making is the first listed.
NCT03454555 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03454555 about?
NCT03454555 is a clinical study titled "Integrated Services for Pain: Interventions to Reduce Pain Effectively". Long-term pain -or pain that lasts for months or years-is one of the most common health problems in the United States. Clinicians often prescribe opioids which can help ease pain in the short term, but evidence does not support their effectiveness over the long term. For some people, long-term opioi...
What is the current status of trial NCT03454555?
This trial is currently completed. It is a NA study. The enrollment target is 543 participants. The study started on 2019-06-26. Estimated completion is 2023-09-30.
What interventions are being tested in trial NCT03454555?
The interventions under investigation include: Shared Decision Making (BEHAVIORAL), Motivational Interviewing and Cognitive Behavioral Therapy for Chronic Pain (BEHAVIORAL).
Who is sponsoring clinical trial NCT03454555?
This trial is sponsored by RTI International, which has 45 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03454555's enrollment target sits among peer trials
543 186th of 2000 higher than 1,814 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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