Provider-Targeted Behavioral Interventions to Prevent Unsafe Opioid Prescribing for Acute Pain in Primary Care

Acute Pain Clinical Trial

Official title: Provider-Targeted Behavioral Interventions to Prevent Unsafe Opioid Prescribing for Acute Non-Cancer Pain in Primary Care

Status Active, not recruiting

Clinical Trial 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 primary outcome measures will be receipt of an initial opioid prescription and unsafe opioid prescribing. Secondary outcomes will be non-opioid pain management, and, in 514 patients, patient-reported pain and function.

Analytic Plan: The investigators will test for differences in the primary and secondary outcomes among the 4 intervention groups.

Once completed, the project will provide evidence that health systems and other stakeholders need to implement interventions to prevent unsafe opioid prescribing.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Acute Pain
• Headache
• Musculoskeletal Pain

• NCT number: NCT03537573
• Study type: Interventional
• Source: University of Pittsburgh
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 23, 2018
• Completion date: August 31, 2022