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

NCT02534987 | Completed

• 2 other identifiers: 16-012405R01AI108680-01
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Strep Throat; Pneumonia

Outcome Measures

Primary Outcomes (1)

• overall rate of antibiotic prescribing

  overall rate of antibiotic prescribing for strep and pneumonia

  2 years

Study Arms (2)

iCPR2 intervention

EXPERIMENTAL

EMR integrated clinical prediction rule system guiding antibiotic prescription choices for strep and pneumonia

Other: iCPR2

iCPR2 control

NO INTERVENTION

Standard education/academic detailing on appropriate treatment of strep and pneumonia

Interventions

iCPR2 OTHER

clinical decision support guiding clinician through clinical prediction rule and associated evidence based orders for strep and pneumonia

iCPR2 intervention

Eligibility Criteria

• Age: Up to 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• seen for strep or pneumonia visit at participating site

You may not qualify if:

• none

Sponsors & Collaborators

• NYU Langone Health: lead
• University of Utah: collaborator
• University of Wisconsin, Madison: collaborator
• North Shore University Hospital: collaborator
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

Related Publications (3)

• Mann D, Hess R, McGinn T, Richardson S, Jones S, Palmisano J, Chokshi SK, Mishuris R, McCullagh L, Park L, Dinh-Le C, Smith P, Feldstein D. Impact of Clinical Decision Support on Antibiotic Prescribing for Acute Respiratory Infections: a Cluster Randomized Implementation Trial. J Gen Intern Med. 2020 Nov;35(Suppl 2):788-795. doi: 10.1007/s11606-020-06096-3. Epub 2020 Sep 1.

  PMID: 32875505 DERIVED

• Mishuris RG, Palmisano J, McCullagh L, Hess R, Feldstein DA, Smith PD, McGinn T, Mann DM. Using normalisation process theory to understand workflow implications of decision support implementation across diverse primary care settings. BMJ Health Care Inform. 2019 Oct;26(1):e100088. doi: 10.1136/bmjhci-2019-100088.

  PMID: 31630113 DERIVED

• Feldstein DA, Hess R, McGinn T, Mishuris RG, McCullagh L, Smith PD, Flynn M, Palmisano J, Doros G, Mann D. Design and implementation of electronic health record integrated clinical prediction rules (iCPR): a randomized trial in diverse primary care settings. Implement Sci. 2017 Mar 14;12(1):37. doi: 10.1186/s13012-017-0567-y.

  PMID: 28292304 DERIVED

MeSH Terms

Conditions

Pneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Devin Mann, MD, MPH

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2015
• First Posted: August 28, 2015
• Study Start: March 1, 2015
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: May 21, 2020

Record last verified: 2020-05

Locations

US (1)