Decision Support Systems, ClinicalNCT06847906
Evaluating the Reach of Clinical Decision Support for Patients With Heart Failure
A study testing Iteratively designed (new) clinical decision support tool for virtual visits and Traditional clinical decision support tool in people with Decision Support Systems, Clinical and Heart Failure, run by University of Colorado, Denver at 1 site in United States.
Trial summary
To work best, clinical decision support tools (CDS) must be timed to provide support when healthcare decisions are made, which includes virtual visits (phone or video). Unfortunately, most CDS tools are either missing from virtual visits or not designed for the unique context of virtual visits (e.g., availability of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Decision Support Systems, Clinical, Heart Failure
- What is being tested?
- Iteratively designed (new) clinical decision support tool for virtual visits and Traditional clinical decision support tool
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Feb 2025to 30 Jun 2026
- 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 years and older
- All sexes
- No healthy volunteers
- 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 clinics. Because we are observing their prescribing behaviors in a virtual care setting (phone or video), we are also evaluating patient characteristics which could influence their prescribing decisions.
Who cannot join
- Clinicians who do not practice in a UCHealth cardiology clinic.
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
To work best, clinical decision support tools (CDS) must be timed to provide support when healthcare decisions are made, which includes virtual visits (phone or video). Unfortunately, most CDS tools are either missing from virtual visits or not designed for the unique context of virtual visits (e.g., availability of physical assessments and labs, different workflows), which could generate new inequities for patients more likely to use virtual visits. The objective of this study is to test the reach, feasibility and acceptability of a new CDS tool for heart failure with reduced ejection fraction (HFrEF) during virtual visits. This new CDS tool was developed through an iterative design process, and will be compared to an existing HFrEF CDS tool in a randomized pilot study at outpatient cardiology clinics throughout the UCHealth system.
- Conditions
- Decision Support Systems, Clinical, Heart Failure
- Being tested
- Iteratively designed (new) clinical decision support tool for virtual visits, Traditional clinical decision support tool
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iteratively designed (new) clinical decision support tool for virtual visitsOther
The new, iteratively designed clinical decision support tool includes the traditional CDS along with links to supportive tipsheets, which include one for providers on how to add an order for patients to upload vitals in their electronic health record, and one that walks patients through how to upload vitals on their own.
Traditional clinical decision support toolOther
The traditional CDS tool is the usual care intervention, and does not include links to tipsheets to support virtual patient care.
| Study group | Role | What they receive |
|---|---|---|
| Iteratively designed (new) clinical decision support tool for virtual visits | Experimental | The new, iteratively designed clinical decision support tool includes the traditional CDS along with links to supportive tip-sheets, which include one for providers on how to add an order for patients to upload vitals in their electronic health record, and one that walks patients through how to upload vitals on their own. Receives: Other: Iteratively designed (new) clinical decision support tool for virtual visits |
| Traditional clinical decision support tool | Experimental | The traditional CDS tool is the usual care intervention, and does not include links to tip-sheets to support virtual patient care. Receives: Other: Traditional clinical decision support tool |
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 (5)
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 times a prescriber ordered at-home vitals
This outcome will count the number of times a prescriber orders patients to take their vitals at home after being exposed to the CDS tool.
Measured: 6 months
Number of patients who upload their vitals in the patient portal
This outcome will count the number of patients who upload their vitals into the electronic medical record.
Measured: 9 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 medical therapy (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 posted26 Feb 2025
- Study start25 Feb 2025
- Primary completion6 Aug 2025
- Study completion30 Jun 2026 (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 two different types of a virtual CDS tool in a randomized pilot study at one health system.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Sponsor
- Investigators
- Katy Trinkley, PharmD, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06847906
- Sponsor's protocol ID
- 22-1154
- Other IDs
- 23SCISA1144584
- Status last verified
- May 2026
- First submitted
- 21 Feb 2025
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- 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
- Evaluating the Reach of Clinical Decision Support for Patients With Heart Failure
- ClinicalTrials.gov ID
- NCT06847906
- Acronym / sponsor ID
- 22-1154
- Conditions
- Decision Support Systems, Clinical, Heart Failure
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- 25 Feb 2025 (actual)
- Primary completion
- 6 Aug 2025 (actual)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 26 Feb 2025 (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.
To work best, clinical decision support tools (CDS) must be timed to provide support when healthcare decisions are made, which includes virtual visits (phone or video). Unfortunately, most CDS tools are either missing from virtual visits or not designed for the unique context of virtual visits (e.g., availability of physical assessments and labs, different workflows), which could generate new inequities for patients more likely to use virtual visits. The objective of this study is to test the reach, feasibility and acceptability of a new CDS tool for heart failure with reduced ejection fraction (HFrEF) during virtual visits. This new CDS tool was developed through an iterative design process, and will be compared to an existing HFrEF CDS tool in a randomized pilot study at outpatient cardiology clinics throughout the UCHealth system.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Compare two different types of a virtual CDS tool in a randomized pilot study at one health system.
| Arm | Type | Receives |
|---|---|---|
| Iteratively designed (new) clinical decision support tool for virtual visits | Experimental | Other: Iteratively designed (new) clinical decision support tool for virtual visitsThe new, iteratively designed clinical decision support tool includes the traditional CDS along with links to supportive tip-sheets, which include one for providers on how to add an order for patients to upload vitals in their electronic health record, and one that walks patients through how to upload vitals on their own. |
| Traditional clinical decision support tool | Experimental | Other: Traditional clinical decision support toolThe traditional CDS tool is the usual care intervention, and does not include links to tip-sheets to support virtual patient care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not 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 clinics. Because we are observing their prescribing behaviors in a virtual care setting (phone or video), we are also evaluating patient characteristics which could influence their prescribing decisions.
Key exclusion criteria (1 listed)
- Clinicians who do not practice in a UCHealth cardiology clinic.
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 |
|---|---|---|
| Iteratively designed (new) clinical decision support tool for virtual visitsThe new, iteratively designed clinical decision support tool includes the traditional CDS along with links to supportive tipsheets, which include one for providers on how to add an order for patients to upload vitals in their electronic health record, and one that walks patients through how to upload vitals on their own. | Other | Iteratively designed (new) clinical decision support tool for virtual visits |
| Traditional clinical decision support toolThe traditional CDS tool is the usual care intervention, and does not include links to tipsheets to support virtual patient care. | Other | Traditional clinical decision support tool |
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.
5 secondary outcomes
Number of patients the CDS alerted for
Time frame: 6 months
Number of times a prescriber ordered at-home vitals
Time frame: 6 months
Number of patients who upload their vitals in the patient portal
Time frame: 9 months
Number of alerts that were not outright dismissed
Time frame: 6 months
Number of prescription orders for guideline directed medical therapy (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 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 Iteratively designed (new) clinical decision support tool for virtual visits and Traditional clinical decision support tool 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.