Clinical Decision Support Tool for Heart Failure

Overseen By Katy Trinkley, PharmD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Katy E Trinkley

Disqualifiers: Non-UCHealth clinicians

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

500 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new tool that assists doctors in making better decisions during virtual visits for patients with heart failure with reduced ejection fraction (HFrEF). The goal is to evaluate the effectiveness of this tool compared to a traditional decision tool already in use. It focuses on enhancing virtual healthcare visits, as many existing tools are not suited for these appointments. The trial seeks clinicians who prescribe medications at UCHealth cardiology clinics and wish to improve their virtual care for heart failure patients. As an unphased trial, it offers patients the chance to contribute to innovative healthcare solutions that could enhance virtual care experiences.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that this clinical decision support tool is safe for virtual visits?

Research has shown that clinical decision support tools (CDS tools) are generally safe to use. These tools assist healthcare providers in making better decisions, particularly for patients with heart failure. One study examined a CDS tool used in emergency rooms and found no safety issues, indicating the tool did not harm patients.

Overall, CDS tools have improved care quality without introducing new risks. Since these tools offer advice rather than direct treatment, they are unlikely to cause side effects like medications might. The new CDS tool being tested in this trial was carefully designed to function effectively during virtual visits. Although specific safety data for this new tool is not yet available, existing evidence from similar tools is encouraging. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new clinical decision support tool specifically designed for virtual visits in managing heart failure. Unlike traditional tools, this new tool is iteratively designed, meaning it is continuously refined based on user feedback and evolving needs, potentially enhancing its accuracy and effectiveness. This approach aims to better support healthcare providers in making informed decisions during remote consultations, which could lead to improved patient outcomes and more personalized care for heart failure patients.

What evidence suggests that this clinical decision support tool is effective for heart failure?

Research has shown that tools designed to assist doctors in decision-making can significantly enhance the care of patients with heart failure. These tools enable doctors to adhere more closely to treatment guidelines, leading to improved patient outcomes. In this trial, one group of participants will use a new clinical decision support tool specifically designed for virtual visits, where physical exams and lab tests might not be as readily available. This design aims to ensure that patients relying on virtual visits receive the same quality of care. Another group will use a traditional clinical decision support tool. Although data collection on the effectiveness of this new tool is ongoing, similar tools have already succeeded in guiding heart failure treatment. ^{1 5 6 7 8}

Who Is on the Research Team?

Katy Trinkley, PharmD, PhD

Principal Investigator

University of Colorado, Denver

Are You a Good Fit for This Trial?

This trial is for clinicians with prescribing privileges at UCHealth's outpatient cardiology clinics. It observes their use of clinical decision support tools during virtual visits for heart failure patients, and also considers patient characteristics that might influence prescriptions.

Inclusion Criteria

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

I am being observed for how prescriptions are given to me in virtual appointments.

Exclusion Criteria

Clinicians who do not practice in a UCHealth cardiology clinic

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are exposed to either the new or traditional CDS tool during virtual visits to evaluate reach, feasibility, and acceptability

6 months

Virtual visits (phone or video)

Follow-up

Participants are monitored for the number of patients uploading vitals and other secondary outcomes

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Iteratively designed (new) clinical decision support tool for virtual visits

Trial Overview The study compares a new, iteratively designed clinical decision support tool tailored for virtual visits against a traditional one in managing heart failure. Clinicians are randomly chosen to use either the new or existing tool in a pilot study.

How Is the Trial Designed?

Group I: Traditional clinical decision support tool Experimental Treatment 1 Intervention

Group II: Iteratively designed (new) clinical decision support tool for virtual visits Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Katy E Trinkley

Lead Sponsor

Trials

1

Recruited

500+

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

American Heart Association (AHA)

Collaborator

Trials

2

Recruited

530+

Published Research Related to This Trial

Electronic health records (EHR) can significantly enhance the management of congestive heart failure (CHF) by standardizing care, promoting adherence to evidence-based guidelines, and improving workflow efficiency, as discussed in a review of various EHR tools.

The review highlights that EHR technologies, such as clinical decision support and telehealth, not only improve patient engagement and performance metrics but also contribute to quality improvement and clinical research in CHF management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Heart Failure Management Innovation Enabled by Electronic Health Records. Kao, DP., Trinkley, KE., Lin, CT.[2021]

A clinical decision support software (CDSS) for treating chronic heart failure was developed through a collaborative process and evaluated over six months, showing that 70% of participants found it more useful than traditional paper guidelines.

The evaluation revealed that general practitioners had lower computer literacy compared to junior doctors and medical students, which may hinder the CDSS's implementation; thus, improving computer skills and integrating the CDSS into clinical workflows could enhance its usage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical decision support software for management of chronic heart failure: development and evaluation. Leslie, SJ., Hartswood, M., Meurig, C., et al.[2022]

Clinical decision support software (CDSS) can enhance the treatment of chronic heart failure by providing evidence-based guidelines, but its effectiveness is limited by low computer skills among family physicians and the software's inability to address nonmedical patient needs.

To improve the implementation of CDSS in chronic heart failure management, strategies such as enhancing computer skills among healthcare providers and integrating CDSS into existing referral pathways are recommended.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical decision support software for chronic heart failure. Leslie, SJ., Denvir, MA.[2007]

A study analyzed the electronic health record (EHR) usage of 548 heart failure patients accessed by 5113 healthcare providers, revealing extensive collaboration among providers during hospital stays.

The findings showed that EHR access involved large groups of providers, with an average of 87.9 providers per collaboration module, highlighting the potential for improved care coordination through better understanding of these interactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Visualizing collaborative electronic health record usage for hospitalized patients with heart failure. Soulakis, ND., Carson, MB., Lee, YJ., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12535060/

Study protocol for the design, implementation, and evaluation ... For approximately what % of patients with acute heart failure did the clinician look up the STRATIFY CDS tool? For approximately what % of ...

2. withpower.com withpower.com/trial/phase-heart-failure-1-2025-77a3e

Clinical Decision Support Tool for Heart Failure What data supports the effectiveness of the treatment Iteratively designed (new) clinical decision support tool for virtual visits for heart failure?

3. jacc.org jacc.org/doi/10.1016/j.jacadv.2023.100354

Clinical Decision Support Tools for Optimizing Guideline ... Guideline-directed medical therapy (GDMT) for heart failure (HF) with a reduced ejection fraction confers a substantial benefit by reducing ...

4. anatoljcardiol.com anatoljcardiol.com/article/AJC-70337

Artificial Intelligence-Based Clinical Decision Support ... Machine learning can segment the heart chambers from cardiac MRIs and can be used to predict congestive heart failure (CHF) from its data and has likewise been ...

5. mayo.edu mayo.edu/research/clinical-trials/cls-20266927

A Study Evaluating a Decision Support Tool for Patients ... A Study Evaluating a Decision Support Tool for Patients and Caregivers Offered a Heart Assist Device for End Stage Heart Failure · Overview · Participation ...

6. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT06847906?draw=2&rank=1

Evaluating the Reach of Clinical Decision Support for ... 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) ...

7. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2812083

Clinical Decision Support to Treat Patients With Heart ... Clinical Decision Support Tool. We ... Cluster-randomized trial comparing ambulatory decision support tools to improve heart failure care.

8. sciencedirect.com sciencedirect.com/science/article/pii/S266666772400223X

Do clinical decision support tools improve quality of care ... Do clinical decision support tools improve quality of care outcomes in the primary prevention of cardiovascular disease: A systematic review and meta-analysis.