Integrated Clinical Prediction Rules: Bringing Evidence to Diverse Primary Care Settings
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Pneumonia |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | Any - 70 |
| Updated: | 10/27/2018 |
| Start Date: | March 2015 |
| End Date: | March 2019 |
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.
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.
As the nation continues its efforts to contain healthcare costs and improve quality,
healthcare information technology provides some of our most potent yet underutilized tools.
Clinical prediction rules are frontline decision aids that combine state-of-the-art evidence
with real-time patient history, physical examination, and laboratory data. While often
well-validated, clinical prediction rules have been underutilized in practice. Recently, our
team developed the integrated clinical prediction rule (iCPR) system, embedding CPRs within
the nation's largest commercial electronic health record (EHR) system. Using this novel
system, we demonstrated high rates of provider utilization and a significant reduction in
antibiotic prescribing and diagnostic test ordering among suspected cases of strep throat and
pneumonia at a single healthcare facility. The objective of the proposed project is to
generalize this platform across diverse settings and create a toolkit for further
dissemination. Building on the success of the original iCPR project, the specific aims of
this proposal are to (1) integrate our previously tested and refined iCPR tool into the same
commercial EHR in three different clinical settings, adapting the innovation to provider
preference, culture, and local workflow rather than imposing a rigidly standardized tool, (2)
identify and measure rate and variability of iCPR uptake across different settings, (3)
determine iCPR impact on antibiotic prescribing and diagnostic test-ordering patterns across
diverse clinical settings with a randomized controlled trial, and (4) use a well-established
theory-driven implementation framework to identify facilitators and barriers to integration
in each setting, and develop a toolkit for adapting and implementing the tool in diverse
settings. To achieve these aims, we propose a five-year study in which we first adapt,
integrate and usability-test the original iCPR at three new diverse sites. We will then
conduct a two-year randomized controlled trial with a one-year post-trial open-access
observation period to determine the persistence of: 1) the tool's utilization and 2) its
impact on antibiotic- and test-ordering in patients with suspected strep throat or pneumonia.
In the final year, study findings will be compiled into a toolkit so that any healthcare
facility using the Epic EHR can integrate iCPR into its ambulatory workflow. The study uses
several innovative and significant approaches, including: 1) adapting the nation's most
widespread commercial EHR system; 2) building the new tool with "off-the-shelf" technology
included in every Epic EHR package, so the innovation can be easily ported to all Epic EHR
users; 3) using highly specific, well-validated clinical prediction rules as its core
content; 4) guiding the integration process with highly generalizable usability testing
techniques; and 5) using a hybrid RE-AIM and normalization process theory implementation
evaluation framework. Together, these innovative approaches make iCPR uniquely suited to
overcome longstanding barriers and integrate and disseminate evidence-based tools into the
primary care workflow at the point of care in real time.
healthcare information technology provides some of our most potent yet underutilized tools.
Clinical prediction rules are frontline decision aids that combine state-of-the-art evidence
with real-time patient history, physical examination, and laboratory data. While often
well-validated, clinical prediction rules have been underutilized in practice. Recently, our
team developed the integrated clinical prediction rule (iCPR) system, embedding CPRs within
the nation's largest commercial electronic health record (EHR) system. Using this novel
system, we demonstrated high rates of provider utilization and a significant reduction in
antibiotic prescribing and diagnostic test ordering among suspected cases of strep throat and
pneumonia at a single healthcare facility. The objective of the proposed project is to
generalize this platform across diverse settings and create a toolkit for further
dissemination. Building on the success of the original iCPR project, the specific aims of
this proposal are to (1) integrate our previously tested and refined iCPR tool into the same
commercial EHR in three different clinical settings, adapting the innovation to provider
preference, culture, and local workflow rather than imposing a rigidly standardized tool, (2)
identify and measure rate and variability of iCPR uptake across different settings, (3)
determine iCPR impact on antibiotic prescribing and diagnostic test-ordering patterns across
diverse clinical settings with a randomized controlled trial, and (4) use a well-established
theory-driven implementation framework to identify facilitators and barriers to integration
in each setting, and develop a toolkit for adapting and implementing the tool in diverse
settings. To achieve these aims, we propose a five-year study in which we first adapt,
integrate and usability-test the original iCPR at three new diverse sites. We will then
conduct a two-year randomized controlled trial with a one-year post-trial open-access
observation period to determine the persistence of: 1) the tool's utilization and 2) its
impact on antibiotic- and test-ordering in patients with suspected strep throat or pneumonia.
In the final year, study findings will be compiled into a toolkit so that any healthcare
facility using the Epic EHR can integrate iCPR into its ambulatory workflow. The study uses
several innovative and significant approaches, including: 1) adapting the nation's most
widespread commercial EHR system; 2) building the new tool with "off-the-shelf" technology
included in every Epic EHR package, so the innovation can be easily ported to all Epic EHR
users; 3) using highly specific, well-validated clinical prediction rules as its core
content; 4) guiding the integration process with highly generalizable usability testing
techniques; and 5) using a hybrid RE-AIM and normalization process theory implementation
evaluation framework. Together, these innovative approaches make iCPR uniquely suited to
overcome longstanding barriers and integrate and disseminate evidence-based tools into the
primary care workflow at the point of care in real time.
Inclusion Criteria:
- seen for strep or pneumonia visit at participating site
Exclusion Criteria:
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New York University School of Medicine NYU School of Medicine has a proud history that...
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