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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: Completed NA study, sponsored by University of Pittsburgh.

NCT03537573 is a NA study that has completed, run by University of Pittsburgh. The registered enrollment target is 22,616 participants, above the 1,403-participant average among 58,714 other NA trials with a reported enrollment target (1512% higher). According to ClinicalTrials.gov, the official US trial registry.

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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

Primary Outcome

Initial opioid prescription (yes/no) (Primary) (Hypothesis 1a). Opioid prescription at qualifying clinic visit, measured via electronic health record (EHR).

Interventions

  • BEHAVIORAL Usual Care/Guideline
  • BEHAVIORAL Opioid Justification
  • BEHAVIORAL Provider Comparison

Trial Details

FieldValue
Enrollment Target 22,616 participants
Start Date 2018-09-23
Est. Completion 2021-02-28
Phase NA
University of Pittsburgh

1,238 total trials

What the finished NCT03537573 record still lists

NCT03537573 is an interventional study that assigns participants to a tested intervention. Its 22,616 participants enrollment target places it among the larger protocols in the corpus, above the 1,403-participant average among 58,714 other NA trials with a reported enrollment target (1512% higher).

The record links to 0 conditions, and to 3 interventions - of which Usual Care/Guideline is the first listed.

NCT03537573 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT03537573's enrollment target sits among peer trials

22,616 10th of 2000 higher than 1,991 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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Source: ClinicalTrials.gov NCT03537573, the US trial registry maintained by the National Library of Medicine. NCT03537573 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.