Strep PharyngitisiCPR and EHRNCT01386047
Evidence Based Decision Making: Integrating Clinical Prediction Rules
A study testing Integrated Clinical Prediction Rule (iCPR) in people with Strep Pharyngitis and Pneumonia, run by Northwell Health at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Strep Pharyngitis, Pneumonia
- What is being tested?
- Integrated Clinical Prediction Rule (iCPR)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to Jul 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Providers who are part of Mount Sinai's Division of General Internal Medicine
Who cannot join
- Not a provider at Mount Sinai's Division of General Internal Medicine
Trial locations and contacts
1 site in 1 country.
United States1 site
Mount Sinai School of Medicine
New York, New York, 10029
About this study
Official title: Evidence Based Decision Making: Integrating Clinical Prediction Rules Into Electronic Health Records
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).
Read the detailed description
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.
- Conditions
- Strep Pharyngitis, Pneumonia
- Being tested
- Integrated Clinical Prediction Rule (iCPR)
- Keywords
- Clinical Prediction Rules, Electronic Health Records, Walsh Clinical Prediction Rule, Heckerling Clinical Prediction Rule
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Comparisons between case and control ordering will be measured after a year of using the EMR tool
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2011 (estimated)
- Study startAug 2010
- Primary completionJan 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Strep PharyngitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Collaborators
- Icahn School of Medicine at Mount Sinai, Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Principal investigator, Thomas McGinn, Northwell Health
- Investigators
- Thomas M McGinn, MD, MPH, Principal investigator, Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01386047
- Sponsor's protocol ID
- GCO-09-0337
- Other IDs
- 5R18HS018491
- Acronym
- iCPR and EHR
- Status last verified
- Oct 2012
- First submitted
- 28 Jun 2011
- Last updated
- 4 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23896675Mann 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.
PubMed 21929769
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evidence Based Decision Making: Integrating Clinical Prediction Rules Into Electronic Health Records
- ClinicalTrials.gov ID
- NCT01386047
- Acronym / sponsor ID
- iCPR and EHR / GCO-09-0337
- Conditions
- Strep Pharyngitis, Pneumonia
- Keywords
- Clinical Prediction Rules, Electronic Health Records, Walsh Clinical Prediction Rule, Heckerling Clinical Prediction Rule
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Collaborators
- Icahn School of Medicine at Mount Sinai, Agency for Healthcare Research and Quality (AHRQ)
- Study start
- Aug 2010
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 30 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| iCPR randomized providers | Experimental | Other: Integrated Clinical Prediction Rule (iCPR)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. |
| 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). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Providers who are part of Mount Sinai's Division of General Internal Medicine
Key exclusion criteria (1 listed)
- Not a provider at Mount Sinai's Division of General Internal Medicine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Integrated Clinical Prediction Rule (iCPR)Integrated clinical prediction rule for Strep Pharyngitis based on Walsh clinical prediction rule (CPR) criteria and rule for Pneumonia based on Hecklering CPR criteria. | Other | iCPR randomized providers |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2012.
- Derived from this study: PubMed 23896675McGinn 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.
- Derived from this study: PubMed 21929769Mann 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas M McGinn, MD, MPH principal investigator
Northwell Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrated Clinical Prediction Rule (iCPR) in people with Strep Pharyngitis and Pneumonia, run by Northwell Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01386047, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2012.