- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06293794
Decision Support for Heart Failure Prescribing
February 27, 2024 updated by: University of Colorado, Denver
New Solutions to Support Evidence-based Prescribing for Heart Failure
Clinical decision support (CDS) tools can 'nudge' clinicians to make the best decisions easy.
Although required by "meaningful use" regulations, more than 40% of CDS lead to no change and the remaining lead to improvements that are modest at best.
This is because CDS tools often ignore contextual factors and present irrelevant information.
Although many tools have undergone patient-specific optimization, 'traditional CDS' are rarely clinician-specific.
For example, a traditional CDS tool for beta blockers and heart failure with reduced ejection fraction (HFrEF) addresses common prescribing misconceptions by stating asthma is not a contraindication and providing a safe threshold for blood pressure.
For clinicians without these misconceptions, these statements are irrelevant and distract from key information.
A 'personalized CDS' would evaluate clinician past prescribing patterns to determine whether prescribing misconceptions might exist and then conditionally present information to address those misconceptions.
The objective of this research is to create personalized clinician-specific CDS that overcome shortcomings of traditional CDS.
The central hypothesis is a personalized CDS that minimizes irrelevant information will lead to a higher rate of prescribing guideline-directed management and therapy (GDMT) for HFrEF compared to a traditional CDS.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
1075
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Katy Trinkley, PharmD, PhD
- Phone Number: (303) 724-3103
- Email: katy.trinkley@cuanschutz.edu
Study Contact Backup
- Name: Meagan Bean, MPH
- Email: meagan.bean@cuanschutz.edu
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- The study subjects are potential users of the CDS, specifically clinicians with prescribing privileges who practice at one of the health system's (UCHealth) outpatient cardiology or primary care clinics. Because we are observing their prescribing behaviors, we are also evaluating patient characteristics which could influence their prescribing decisions.
Exclusion Criteria:
- Clinicians who do not practice in cardiology or primary care clinics or do not practice within UCHealth system.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Traditional Clinical Decision Support (CDS)
|
The traditional CDS is the usual care intervention, which is patient-specific but are not clinician-specific.
|
Experimental: Personalized Clinical Decision Support (CDS)
|
The personalized CDS intervention evaluates clinician past prescribing patterns to determine whether prescribing misconceptions might exist and then conditionally present information to address those misconceptions.
This is done through a nudge in the electronic health record that addresses common prescribing misconceptions for heart failure.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of CDS alerts resulting in the prescription of a recommended medication
Time Frame: 6 months
|
The primary outcome is number of CDS alerts that resulted in the prescription of the medication recommended by the CDS alert.
Recommended medications include either evidence-based beta blockers, sacubitril/valsartan, mineralocorticoid receptor antagonists or sodium/glucose cotransport 2 inhibitors.
Prescriptions will be based on actual prescription orders instead of clinician-stated responses, given the latter may overestimate effectiveness.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of patients the CDS alerted for
Time Frame: 6 months
|
This outcome evaluates the reach of the CDS by counting the number of patients that the CDS alerted for.
|
6 months
|
Number of alerts that were not outright dismissed
Time Frame: 6 months
|
This outcome will help investigators understand if the CDS id being used or dismissed.
|
6 months
|
Number of prescription orders for guideline directed management and therapies (GDMT) for heart failure
Time Frame: 6 months
|
This outcome measures the number of prescriptions for each of the four categories of GDMT: evidence-based beta blockers, sacubitril/valsartan, mineralocorticoid receptor antagonists or sodium/glucose cotransport 2 inhibitors.
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
March 1, 2024
Primary Completion (Estimated)
September 1, 2024
Study Completion (Estimated)
September 1, 2025
Study Registration Dates
First Submitted
February 6, 2024
First Submitted That Met QC Criteria
February 27, 2024
First Posted (Estimated)
March 5, 2024
Study Record Updates
Last Update Posted (Estimated)
March 5, 2024
Last Update Submitted That Met QC Criteria
February 27, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 22-0991
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Heart Failure
-
Tufts Medical CenterMetro West Medical CenterCompletedCongestive Heart Failure | Diastolic Heart Failure | Systolic Heart FailureUnited States
-
Abbott Medical DevicesCompletedHeart Failure | Heart Failure, Diastolic | Heart Failure, Systolic | Heart Failure NYHA Class II | Heart Failure NYHA Class III | Heart Failure With Reduced Ejection Fraction | Heart Failure NYHA Class IV | Heart Failure With Normal Ejection Fraction | Heart Failure; With Decompensation | Heart Failure...United States, Canada
-
Manipal UniversityUnknownHeart Failure | Decompensated Heart Failure | Acute Heart Failure | Diastolic Heart Failure | Systolic Heart FailureIndia
-
University Hospital, MontpellierCompletedHeart Failure | Diastolic Heart Failure | Systolic Heart Failure Stage CFrance
-
VA Eastern Colorado Health Care SystemNational Institute on Aging (NIA)CompletedHeart Failure | Heart Failure, Diastolic | Heart Failure, Systolic | Heart Failure With Reduced Ejection Fraction | Heart Failure With Preserved Ejection Fraction | Heart Failure; With Decompensation | Heart Failure,Congestive | Heart Failure AcuteUnited States
-
Wake Forest UniversityCompletedHeart Failure, Congestive | Heart Failure With Preserved Ejection Fraction
-
Lancaster General HospitalLouise von Hess Medical Research InstituteEnrolling by invitationDiastolic Heart FailureUnited States
-
Giresun UniversityIstanbul University - Cerrahpasa (IUC)RecruitingHeart Failure | Diastolic Heart Failure | Systolic Heart FailureTurkey
-
Wake Forest UniversityNational Institute on Aging (NIA)CompletedHeart Failure, Congestive | Diastolic Heart FailureUnited States
-
US Department of Veterans AffairsCompleted
Clinical Trials on Traditional Clinical Decision Support (CDS)
-
American Academy of Family PhysiciansUniversity of Colorado, Denver; National Institute of Diabetes and Digestive... and other collaboratorsCompletedChronic Kidney Disease | Chronic Renal Insufficiency | Chronic Kidney Insufficiency | Chronic Renal Diseases | Kidney Insufficiency, ChronicUnited States
-
HealthPartners InstituteNational Heart, Lung, and Blood Institute (NHLBI)CompletedHypertension | Obesity | Pre HypertensionUnited States
-
Abdul Latif Jameel Poverty Action LabIcahn School of Medicine at Mount SinaiTerminatedCT and MR Image OrdersUnited States
-
Abdul Latif Jameel Poverty Action LabMassachusetts Institute of Technology; Aurora Health Care; Laura and John Arnold...CompletedCT, MR, NM, and PET Image OrdersUnited States
-
University of Massachusetts, WorcesterAgency for Healthcare Research and Quality (AHRQ); Baycrest Centre for Geriatric...WithdrawnAdverse Drug Events
-
Oregon Health and Science UniversityEnrolling by invitationAtrial FibrillationUnited States
-
University of Colorado, DenverATI Physical TherapyCompletedTotal Knee ReplacementUnited States
-
Northwestern UniversityUniversity of California, Los Angeles; National Institute on Aging (NIA); University... and other collaboratorsEnrolling by invitationPolypharmacyUnited States
-
Christopher HorvatBeckwith FoundationRecruitingBronchiolitisUnited States
-
University of Wisconsin, MadisonAgency for Healthcare Research and Quality (AHRQ)Recruiting