Promoting Clinical Guidelines for Opioid Prescribing

Opioid Use Clinical Trial

Official title: Promoting the Implementation of Clinical Guidelines for Opioid Prescribing in Primary Care Using Systems Consultation

Status Completed

Clinical Trial Summary

This study aims to understand the optimal sequencing and combination of implementation strategies that specific types of clinics and prescribers need to adopt clinical guidelines for opioid prescribing. The pragmatic goal is to give health systems a tool they can use to predict which clinics and prescribers will benefit most from which sequence and combination of implementation strategies.

Clinical Trial Description

The proposed study evaluates a sequence and combination of implementation strategies that is tailored to the needs of stakeholders at different levels (health system, clinic, and prescriber). We will deliver an adaptive version of systems consultation that progressively and adaptively drills down to offer more and more personalized levels of implementation support. The intervention starts with academic detailing, a systems-level strategy consisting of an expert-led training session plus distance-based follow up support. This strategy continues for the 21-month intervention for all clinics, but at 3 months, half of the clinics will be randomized to receive practice facilitation. Practice facilitation is a clinic-level strategy in which a highly-skilled external change agent helps clinics improve processes related to opioid prescribing. At 6 months, half of prescribers will be randomized to receive physician peer coaching. Physician peer coaching is a clinic-level strategy in which a physician expert gives one-on-one support to prescribers in managing their patients on long-term opioid therapy. These 3 discrete strategies will be delivered in a sequential, multiple-assignment randomized trial to 38 clinics from 2 Wisconsin health systems. The study has 3 specific aims:

1. Compare the effect over 21 months of (1). An adaptive systems consultation implementation strategy (intervention group) vs. (2). Academic detailing alone (control group) on average morphine milligram equivalent dose (the primary outcome).

2. Develop an assessment of contextual factors that influence the effectiveness of different implementation strategies. This aim will test 4 moderators and assess other factors that affect implementation. The goal is to develop a tool that decision-makers can use to predict which implementation strategies will be most effective in different settings.

3. Estimate the costs of delivering 4 different sequences and combinations of strategies, including the incremental cost effectiveness of adding facilitation and physician peer coaching. Results will help decision-makers weigh the costs and effects of using different implementation strategies. ;

Related Conditions & MeSH terms

• Opioid Use

• NCT number: NCT04044521
• Study type: Interventional
• Source: University of Wisconsin, Madison
• Status: Completed
• Phase: N/A
• Start date: January 31, 2020
• Completion date: September 1, 2022