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Completed

NCT Number: NCT01386047

Evidence Based Decision Making: Integrating Clinical Prediction Rules

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).

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mount Sinai School of Medicine

New York, 10029, United States

About this study

Clinical prediction rules (CPRs) are frontline decision aids that help physicians make evidence-based, cost-effective decisions that benefit their patients. CPRs are proven tools that translate evidence into practice, increase quality while reducing costs, and can be used by physicians in a wide variety of clinical settings, such as primary care offices, emergency rooms, and hospitals. While many CPRs have been developed and validated over the years, health care providers have yet to incorporate them into everyday care.

CPRs aid providers in assessing the impact of individual components of a patient's history, physical examination, and basic lab results to estimate probability of disease or potential response to a treatment. Prediction rules use data that is readily available at the time of a patient encounter and often reduce unnecessary treatments and diagnostic testing. CPRs differ from reminder systems or alerts in that CPRs pull in aspects of the history and physical exam and in an evidence based fashion estimate probabilities, prognosis, or make treatment recommendations.

The goal of this study is to utilize patient electronic health records to incorporate CPRs into the face-to-face patient encounter. We propose to select certain clinical situations where well-validated CPRs are available and likely to be needed on a frequent basis. We will randomly assign an integrated CPR versus usual care into the point of care and evaluate the impact of this integration on doctor behavior and evidence-based decision making. Mount Sinai's Division of General Internal Medicine (DGIM) has significant experience with all aspects of CPRs, including derivation, validation, implementation, and systematic review. Furthermore, the Division has developed an interactive web library of CPRs for clinical use that is one of the most widely sites of its kind. We propose to collaborate with Epic, one of the nation's largest and most respected electronic medical record (EMR) companies, to integrate validated CPRs into EMRs and assess the impact on provider behavior and patient care.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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.

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.

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

    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.

Sponsors and collaborators

Lead sponsor

Northwell Health

Other

Collaborators

  • Agency for Healthcare Research and Quality (AHRQ)
  • Icahn School of Medicine at Mount Sinai

Registry information

Official study title

Evidence Based Decision Making: Integrating Clinical Prediction Rules Into Electronic Health Records

Acronym: iCPR and EHR

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Jun 30, 2011
Registry last updated
Oct 4, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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