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NCT03537573 · ClinicalTrials.gov registry record · NA
Provider-Targeted Behavioral Interventions to Prevent Unsafe Opioid Prescribing for Acute Pain in Primary Care
A NA study, sponsored by University of Pittsburgh.
- Completed
- Registry status
- NA
- Development phase
- 22,616
- Enrollment target
NCT03537573 is a NA study that has completed, run by University of Pittsburgh. The registered enrollment target is 22,616 participants.
The verdict
NCT03537573, a NA study, has completed, sponsored by University of Pittsburgh.
- COMPLETED
- Registry status
- NA
- Development phase
- 22,616 participants
- Enrollment target
Study Summary
The investigators will assess whether behavioral science-based interventions can "nudge" providers towards more evidence-based care for patients with acute non-cancer pain. Aim 1) Among opioid naïve primary care patients with acute non-cancer pain, compare the effect of the provider-targeted behavioral interventions (opioid justification and provider comparison), individually and in combination, on initial opioid prescription, initial use of non-opioid management, and patient-reported pain and function. Aim 2) Compare the effect of the 2 provider-targeted behavioral interventions, individually and in combination, on unsafe opioid prescribing and transition to chronic opioid therapy. Aim 3) Assess provider satisfaction and experience with the provider-targeted behavioral interventions. Hypotheses: Aim 1, H1a: Compared with the guideline (usual care) alone, the addition of the opioid justification and provider comparison behavioral interventions will be associated with a decreased proportion of opioid prescription and increased proportion of non-opioid management at the initial outpatient visit for acute non-cancer pain. Aim 1, H1b: Compared with usual care (guideline) alone, the addition of the opioid justification and provider comparison behavioral interventions will be associated with no difference in patient-reported pain, function, and satisfaction at 1, 6, and 12 months. Aim 2, H2: Compared with the usual care (guideline), the addition of opioid justification and provider comparison behavioral interventions will be associated with a decreased proportion of patients receiving unsafe opioid therapy and a decreased proportion of patients transitioning to chronic opioid therapy. Study Design: Pragmatic, cluster-randomized clinical trial in 48 primary care clinics. Study Population: The patient population will be 19,855 opioid naïve adults who present to clinic with acute uncomplicated musculoskeletal pain or headache. Primary and Secondary Outcomes: The pr
Interventions
- BEHAVIORAL Usual Care/Guideline
- BEHAVIORAL Opioid Justification
- BEHAVIORAL Provider Comparison
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22,616 participants |
| Start Date | 2018-09-23 |
| Est. Completion | 2021-02-28 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03537573
The ClinicalTrials.gov registry entry for NCT03537573 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 22,616 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Pittsburgh, which has 1,238 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Usual Care/Guideline is the first listed.
NCT03537573 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03537573 about?
NCT03537573 is a clinical study titled "Provider-Targeted Behavioral Interventions to Prevent Unsafe Opioid Prescribing for Acute Pain in Primary Care". The investigators will assess whether behavioral science-based interventions can "nudge" providers towards more evidence-based care for patients with acute non-cancer pain. Aim 1) Among opioid naïve primary care patients with acute non-cancer pain, compare the effect of the provider-targeted behavi...
What is the current status of trial NCT03537573?
This trial is currently completed. It is a NA study. The enrollment target is 22,616 participants. The study started on 2018-09-23. Estimated completion is 2021-02-28.
What interventions are being tested in trial NCT03537573?
The interventions under investigation include: Usual Care/Guideline (BEHAVIORAL), Opioid Justification (BEHAVIORAL), Provider Comparison (BEHAVIORAL).
Who is sponsoring clinical trial NCT03537573?
This trial is sponsored by University of Pittsburgh, which has 1,238 total clinical trials registered on ClinicalTrials.gov.
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