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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Iteratively designed (new) clinical decision support tool for virtual visits for heart failure?

Research on similar tools, like a web-based symptom monitoring tool for heart failure, shows that patients and clinicians found it helpful for tracking symptoms and communicating with doctors. Additionally, telemedicine support has been shown to potentially improve patient outcomes in heart failure management. ^{1 2 3 4 5}

How is the new clinical decision support tool for heart failure different from other treatments?

This new clinical decision support tool is unique because it is designed for virtual visits, leveraging electronic health records (EHR) to standardize care, improve efficiency, and enhance patient engagement, unlike traditional treatments that may not utilize such technology. ^{4 6 7 8 9}

Research Team

Katy Trinkley, PharmD, PhD

Principal Investigator

University of Colorado, Denver

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Design and Evaluation of a Web-Based Symptom Monitoring Tool for Heart Failure. [2017]

2. England pubmed.ncbi.nlm.nih.gov

Visualizing collaborative electronic health record usage for hospitalized patients with heart failure. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Telemedicine Support for Primary Care Providers versus Usual Care in Patients with Heart Failure: Protocol of a Pragmatic Cluster Randomised Trial within the Brazilian Heart Insufficiency with Telemedicine (BRAHIT) Study. [2023]

4. Canada pubmed.ncbi.nlm.nih.gov

Using an Electronic App to Promote Home-Based Self-Care in Older Patients With Heart Failure: Qualitative Study on Patient and Informal Caregiver Challenges. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Information Needs of Skilled Nursing Facility Staff to Support Heart Failure Disease Management. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Heart Failure Management Innovation Enabled by Electronic Health Records. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Clinical decision support software for management of chronic heart failure: development and evaluation. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Evaluation of a web-based interactive heart failure patient simulation: a pilot study. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Clinical decision support software for chronic heart failure. [2007]