Evidence Based Decision Making: Integrating Clinical Prediction Rules

NCT01386047 | Completed

• 2 other identifiers: GCO-09-03375R18HS018491
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 1

Brief Summary

Clinical prediction rules (CPRs) are frontline decision aids that help physicians make evidence-based, cost-effective decisions that benefit their patients. The aims of this project are to incorporate two well validated CPRs (Streptococcal Pharyngitis Prediction Rule and the Pneumonia Clinical Prediction Rule) into an outpatient Electronic Medical Record System (EMR) and to perform a randomized controlled trial of the effectiveness of integrated CPRs impact on doctor's behaviors (e.g. test ordering and medication prescribing).

Conditions

Strep Pharyngitis; Pneumonia

Keywords

Clinical Prediction Rules; Electronic Health Records; Walsh Clinical Prediction Rule; Heckerling Clinical Prediction Rule

Outcome Measures

Primary Outcomes (1)

• The primary outcome of this study will be focused on changes in doctor behavior and the comparison of the number of diagnostic tests ordered (chest x-rays) and antibiotics prescribed per patient encountered per diagnosis.

  The data for the intervention and control groups will be compared for each of the two diagnostic areas. For example, for all patients presenting with URI symptoms or sore throat, data will be collected from Epic on the number of prescriptions for antibiotics written by providers randomized to the iCPR compared to usual-care arms, respectively. Among patients presenting with suspicion of pneumonia, the number of chest x-rays ordered and antibiotics prescribed at the clinical encounter will be determined.

  Comparisons between case and control ordering will be measured after a year of using the EMR tool

Study Arms (2)

iCPR randomized providers

EXPERIMENTAL

The physician population for the proposed study will comprise primary care providers (physicians, internal medicine residents, or licensed nurse practitioners; practicing in the outpatient primary care clinics at Mount Sinai Medical Center. The iCPR tool will automatically trigger for providers randomized into the iCPR intervention arm when they initiated an encounter for a patient that meets the criteria for possible evaluation of Strep Pharyngitis or Pneumonia.

Other: Integrated Clinical Prediction Rule (iCPR)

Control providers

NO INTERVENTION

The physician population for the proposed study will comprise primary care providers (physicians, internal medicine residents, or licensed nurse practitioners; practicing in the outpatient primary care clinics at Mount Sinai Medical Center. These providers will conduct visits for Strep Pharyngitis and Pneumonia in their manner (usual care).

Interventions

Integrated Clinical Prediction Rule (iCPR) OTHER

Integrated clinical prediction rule for Strep Pharyngitis based on Walsh clinical prediction rule (CPR) criteria and rule for Pneumonia based on Hecklering CPR criteria.

iCPR randomized providers

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Providers who are part of Mount Sinai's Division of General Internal Medicine

You may not qualify if:

• Not a provider at Mount Sinai's Division of General Internal Medicine

Sponsors & Collaborators

• Northwell Health: lead
• Icahn School of Medicine at Mount Sinai: collaborator
• Agency for Healthcare Research and Quality (AHRQ): collaborator

Study Sites (1)

Mount Sinai School of Medicine

New York, New York, 10029, United States

Location

Related Publications (2)

• McGinn TG, McCullagh L, Kannry J, Knaus M, Sofianou A, Wisnivesky JP, Mann DM. Efficacy of an evidence-based clinical decision support in primary care practices: a randomized clinical trial. JAMA Intern Med. 2013 Sep 23;173(17):1584-91. doi: 10.1001/jamainternmed.2013.8980.

  PMID: 23896675 DERIVED

• Mann DM, Kannry JL, Edonyabo D, Li AC, Arciniega J, Stulman J, Romero L, Wisnivesky J, Adler R, McGinn TG. Rationale, design, and implementation protocol of an electronic health record integrated clinical prediction rule (iCPR) randomized trial in primary care. Implement Sci. 2011 Sep 19;6:109. doi: 10.1186/1748-5908-6-109.

  PMID: 21929769 DERIVED

MeSH Terms

Conditions

Pneumonia

Condition Hierarchy (Ancestors)

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

Study Officials

• Thomas M McGinn, MD, MPH

  Northwell Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair and Professor for the Hofstra North Shore-LIJ School of Medicine

Study Record Dates

• First Submitted: June 28, 2011
• First Posted: June 30, 2011
• Study Start: August 1, 2010
• Primary Completion: January 1, 2012
• Study Completion: July 1, 2012
• Last Updated: October 4, 2012

Record last verified: 2012-10

Locations

US (1)