Integrated Clinical Prediction Rules: Bringing Evidence to Diverse Primary Care Settings

Completed · Not applicable

Conditions studied: Strep Throat, Pneumonia

In brief

The study is a randomized controlled trial, with an Intervention Group and a Control Group at the University of Utah (U of U) and University of Wisconsin (UW). BU serves as the primary award and coordinating institution. The unit of randomization will be at the clinic level at each institution. UW will recruit all General Internal Medicine (GIM) Clinics and Department of Family Medicine (DFM) Clinics in Dane County as well as their East and West Urgent Care Clinics. U of U will recruit all affiliated primary care practices. The unit of randomization will be the clinic. The study biostatistician will receive a list of clinic sites that have agreed to participate in the study from the site PIs. Clinics will be randomized to either Intervention group or to a Control group stratified by clinic size. Both groups will receive a single 45 minute academic detailing session describing evidenced-based diagnosis and treatment for strep throat and pneumonia. The Intervention Group will also receive a demonstration of the iCPR tool during their academic detailing session. Providers and clinic staff will be invited to the academic detailing session. Any provider or staff that is unable to attend the session will receive written and electronic copies of the material. Individual providers will not be specifically recruited for participation and they will participate or not based on personal preferences as they would for any clinic quality improvement project. The iCPR tool will be "turned on" for providers in the Intervention group. This means that the best practice alerts will trigger for appropriate patients with suspected strep throat or pneumonia. We will collect and analyze data about the use of each element of the iCPR tool during patient visits, including which elements of the tool were used and how often. We will also collect data from the site EHRs about antibiotic and diagnostic test orders for strep throat and pneumonia from all clinics participating in the trial, both Intervention and Control groups. After one year of study implementation, we will run an Interim Primary Outcome Report comparing the antibiotic and diagnostic test orders between the Intervention and Control group clinics. This report will be in the aggregate and will not contain any personally-identifiable information. If there is a significant difference between the groups that meets our predetermined stopping end points, we will stop the randomized controlled trial.

Key facts

Study ID
NCT02534987
Run by
NYU Langone Health
People needed
33
Starts
2015-03-01
Expected to finish
2018-06-01
Last updated by the study team
2020-05-21

Who can join

Age: any, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

You may not qualify if…

Where it is running

Full record on ClinicalTrials.gov

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