Decision Support Systems, ClinicalNCT06293794
Decision Support for Heart Failure Prescribing
A study testing Personalized Clinical Decision Support (CDS) and Traditional Clinical Decision Support (CDS) in people with Decision Support Systems, Clinical and Heart Failure, run by University of Colorado, Denver at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Decision Support Systems, Clinical, Heart Failure
- What is being tested?
- Personalized Clinical Decision Support (CDS) and Traditional Clinical Decision Support (CDS)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 764 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Feb 2025to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Clinicians who do not practice in cardiology or primary care clinics or do not practice within UCHealth system.
Trial locations and contacts
1 site in 1 country.
United States1 site
UCHealth Primary Care and Cardiology Outpatient Clinics
Aurora, Colorado, 80045
About this study
Official title: 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.
- Conditions
- Decision Support Systems, Clinical, Heart Failure
- Being tested
- Personalized Clinical Decision Support (CDS), Traditional Clinical Decision Support (CDS)
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized Clinical Decision Support (CDS)Other
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.
Traditional Clinical Decision Support (CDS)Other
The traditional CDS is the usual care intervention, which is patient-specific but are not clinician-specific.
| Study group | Role | What they receive |
|---|---|---|
| Traditional Clinical Decision Support (CDS) | Experimental | Clinicians will receive traditional CDS and perform usual care, which is patient-specific but not clinician-specific. Receives: Other: Traditional Clinical Decision Support (CDS) |
| Personalized Clinical Decision Support (CDS) | Experimental | Clinicians will receive a personalized CDS intervention that evaluates clinician past prescribing patterns to determine whether prescribing misconceptions might exist, and then conditionally present information to address those misconceptions through a nudge in the EHR. Receives: Other: Personalized Clinical Decision Support (CDS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of CDS alerts resulting in the prescription of a recommended medication
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.
Measured: 6 months
Secondary outcomes (3)
Number of patients the CDS alerted for
This outcome evaluates the reach of the CDS by counting the number of patients that the CDS alerted for.
Measured: 6 months
Number of alerts that were not outright dismissed
This outcome will help investigators understand if the CDS id being used or dismissed.
Measured: 6 months
Number of prescription orders for guideline directed management and therapies (GDMT) for heart failure
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2024
- Study start11 Feb 2025
- Primary completion1 Aug 2025
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Decision Support Systems, ClinicalStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- 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
- Model description
- Compare traditional and personalized CDS in a pragmatic randomized controlled trial at one health system.
- Masking
- None (open label)
- Enrolment
- 764 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Katy E Trinkley, PharmD, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06293794
- Sponsor's protocol ID
- 22-0991
- Status last verified
- May 2026
- First submitted
- 6 Feb 2024
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data obtained through this study may be provided to qualified researchers with academic interest in related areas of interest. Data shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (e.g., data use/sharing agreements) are prerequisites to the sharing of data with the requesting party. Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Solutions to Support Evidence-based Prescribing for Heart Failure
- ClinicalTrials.gov ID
- NCT06293794
- Acronym / sponsor ID
- 22-0991
- Conditions
- Decision Support Systems, Clinical, Heart Failure
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 764 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 11 Feb 2025 (actual)
- Primary completion
- 1 Aug 2025 (actual)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 5 Mar 2024 (actual)
- 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 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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Compare traditional and personalized CDS in a pragmatic randomized controlled trial at one health system.
| Arm | Type | Receives |
|---|---|---|
| Traditional Clinical Decision Support (CDS) | Experimental | Other: Traditional Clinical Decision Support (CDS)Clinicians will receive traditional CDS and perform usual care, which is patient-specific but not clinician-specific. |
| Personalized Clinical Decision Support (CDS) | Experimental | Other: Personalized Clinical Decision Support (CDS)Clinicians will receive a personalized CDS intervention that evaluates clinician past prescribing patterns to determine whether prescribing misconceptions might exist, and then conditionally present information to address those misconceptions through a nudge in the EHR. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Clinicians who do not practice in cardiology or primary care clinics or do not practice within UCHealth system.
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 |
|---|---|---|
| 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. | Other | Personalized Clinical Decision Support (CDS) |
| Traditional Clinical Decision Support (CDS)The traditional CDS is the usual care intervention, which is patient-specific but are not clinician-specific. | Other | Traditional Clinical Decision Support (CDS) |
Primary outcome
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.
3 secondary outcomes
Number of patients the CDS alerted for
Time frame: 6 months
Number of alerts that were not outright dismissed
Time frame: 6 months
Number of prescription orders for guideline directed management and therapies (GDMT) for heart failure
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Individual participant dataSharing planned: Yes. Data obtained through this study may be provided to qualified researchers with academic interest in related areas of interest. Data shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (e.g., data use/sharing agreements) are prerequisites to the sharing of data with the requesting party. Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement.
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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.
Katy E Trinkley, PharmD, PhD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized Clinical Decision Support (CDS) and Traditional Clinical Decision Support (CDS) in people with Decision Support Systems, Clinical and Heart Failure, run by University of Colorado, Denver 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: under way, not looking for participants, as of the sponsor's last update on 2 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Number of CDS alerts resulting in the prescription of a recommended medication (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Jun 2026.