Clinical Decision Support Tool for Heart Failure

Overseen By Center for Health Information Partnerships

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Northwestern University

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

Compensation: Varies

Number of Visits: Unknown

5 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this pilot feasibility study is to test a pharmacist-facing clinical decision support tool designed to increase adherence to guideline-directed medical therapy and evaluate the tool using the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) evaluation framework.

Do I need to stop my current medications for this trial?

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

What data supports the effectiveness of the Clinical Decision Support Tool treatment for heart failure?

Patient-reported outcomes (PROs) are valuable in heart failure care because they help healthcare providers understand how patients feel and function, leading to more patient-centered care and improved quality of life. PROs have shown precision in evaluating disease status and are associated with better prognosis, suggesting that tools incorporating PROs could enhance heart failure management. ^{1 2 3 4 5}

Is the Clinical Decision Support Tool for Heart Failure safe for humans?

The Treatment Tool, part of a decision support framework for heart failure patients with left ventricular assist devices, includes features for predicting adverse events, which helps in assessing treatment safety. ^{6 7 8 9 10}

How does the Clinical Decision Support Tool for Heart Failure differ from other treatments?

The Clinical Decision Support Tool for Heart Failure is unique because it uses technology to help doctors make better treatment decisions by integrating expert advice and guidelines, optimizing medication doses, and predicting hospital readmissions. Unlike traditional treatments, it leverages electronic health records and telemonitoring to improve patient care and reduce hospital visits. ^{6 11 12 13 14}

Eligibility Criteria

This trial is for pharmacists working at Northwestern Medicine in the Medication Adjusted to Target (MAT) Clinic. There are no specific exclusion criteria, so all pharmacists in this setting are eligible to participate.

Inclusion Criteria

I am a pharmacist at Northwestern Medicine involved in the MAT Clinic.

Exclusion Criteria

N/A

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Pharmacists are exposed to a clinical decision support tool to facilitate monitoring adherence to GDMT for patients with heart failure with reduced ejection fraction

6 months

Ongoing monitoring through EHR

Implementation Evaluation

Qualitative interviews conducted to evaluate acceptability, appropriateness, and feasibility of the intervention

After the 6-month intervention period

Follow-up

Participants are monitored for adherence to GDMT and effectiveness of the intervention

4-8 weeks

Treatment Details

Interventions

• Clinical Decision Support Tool

Trial Overview The study is testing a new tool that helps pharmacists improve treatment adherence in heart failure patients by following medical guidelines more closely. The success of the tool will be measured using the RE-AIM framework.

Participant Groups

Group I: Active clinical decision support tool for pharmacists Experimental Treatment 1 Intervention

In this single arm, pilot feasibility study, pharmacists with be exposed to a clinical decision support tool to facilitate monitoring adherence to GDMT for patients with heart failure with reduced ejection fraction

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

Findings from Research

A systematic review identified 31 patient-reported outcome (PRO) instruments for heart failure, but only 2—the Minnesota Living with Heart Failure and Kansas City Cardiomyopathy questionnaires—met all evaluation criteria for psychometric properties and clinical utility.

Despite the existence of effective PRO instruments, there is a need for better education for healthcare providers on their value and a more streamlined implementation process in clinical settings to enhance patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utility of Patient-Reported Outcome Instruments in Heart Failure. Kelkar, AA., Spertus, J., Pang, P., et al.[2016]

Assessing patients' functional status in chronic heart failure is crucial for understanding the effectiveness of treatments in prolonging life while minimizing disability, bridging the gap between clinical assessments and patient-centered outcomes.

Systematic and unbiased collection of patient-reported outcomes is essential, as it provides a clearer picture of the benefits of medical interventions from the patients' perspective, rather than relying solely on healthcare providers' evaluations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcome assessment: functional status measures as therapeutic endpoints for heart failure. Rector, TS.[2019]

Patient-reported outcomes (PROs) are crucial in heart failure management as they provide insights into how patients feel and function, which can enhance patient-centered care.

The review emphasizes the need to advance PRO measurement and integrate these assessments into national databases and electronic health records to improve the quality of care for heart failure patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-reported outcomes in heart failure: existing measures and future uses. Thompson, LE., Bekelman, DB., Allen, LA., et al.[2022]

Patient-reported outcomes (PROs) are essential for understanding heart failure (HF) from the patient's perspective, as they capture the impact of the disease on daily life and can improve treatment adherence.

Despite their proven effectiveness in evaluating disease status and correlating with prognosis in clinical trials, the use of PROs in everyday clinical practice for heart failure remains limited, highlighting the need for strategies to integrate patient perspectives into care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of patient-reported outcomes in heart failure: from clinical trials to routine practice. Savarese, G., Lindenfeld, J., Stolfo, D., et al.[2023]

The Pediatric Quality of Life Inventory (PedsQL) showed strong responsiveness and predictive validity in a study of 4,637 pediatric patients, indicating it can effectively measure changes in health-related quality of life during hospital stays.

Patients with medically complex conditions had lower improvement scores on the PedsQL compared to those without chronic conditions, and lower admission scores were linked to higher risks of prolonged hospital stays and readmissions, highlighting its potential as a tool for assessing patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validity and responsiveness of the pediatric quality of life inventory (PedsQL) 4.0 generic core scales in the pediatric inpatient setting. Desai, AD., Zhou, C., Stanford, S., et al.[2022]

The Treatment Tool, part of the SensorART platform, aids specialists in managing heart failure patients with left ventricular assist devices (LVADs) by providing decision support for treatment strategies and patient assessments.

This web-based tool calculates risk scores and predicts adverse events, enhancing the ability of healthcare providers to make informed decisions regarding LVAD management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse event prediction in patients with left ventricular assist devices. Tsipouras, MG., Karvounis, EC., Tzallas, AT., et al.[2020]

In a study of 261 heart failure patients, common adverse drug events (ADEs) included dizziness (26%) and dry mouth (24%), with nearly half of the patients perceiving these ADEs as serious and significantly impacting their daily lives.

Patients expressed a strong belief in healthcare providers' ability to manage ADEs, but many felt that these issues were chronic and caused emotional distress, highlighting the need for better communication between patients and providers regarding ADE management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perceived adverse drug events in heart failure: patients' perception and related factors. De Smedt, RH., Haaijer-Ruskamp, FM., Groenier, KH., et al.[2011]

The study analyzed serious and fatal adverse drug reactions (ADRs) for 137 commonly-prescribed medicines, revealing significant differences in ADR rates across various therapeutic classes, which highlights the importance of monitoring drug safety.

This research demonstrates the feasibility of creating comparative safety charts by mapping ADR reports to prescription data, which could aid healthcare professionals in making informed decisions about medication safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Comparative Safety Analysis of Medicines Based on the UK Pharmacovigilance and General Practice Prescribing Data in England. Mokbel, K., Daniels, R., Weedon, MN., et al.[2022]

In a study of 754 heart failure patients, 50% reported experiencing dizziness and 44% reported a dry cough, with these adverse effects leading to a 38% increased likelihood of medication changes.

Among the reported adverse effects, a dry cough was associated with the highest risk of medication change (1.83 times more likely), while patients reporting gout had a fourfold increase in the likelihood of starting or intensifying alleviating medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of perceived adverse effects on medication changes in heart failure patients. De Smedt, RH., Jaarsma, T., Haaijer-Ruskamp, FM., et al.[2013]

A new tool for clinicians in inpatient oncology units has been developed to prevent adverse events and enhance patient safety, focusing specifically on cancer patients.

The tool includes a catalog of adverse events and a risk map, which helps healthcare providers implement best practices in their daily activities to improve clinical safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving patient safety in the inpatient setting through risk assessment and mitigation. Reche Navarro, MN.[2016]

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]

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]

The development of clinical decision support (CDS) tools for predicting hospital readmissions in heart failure patients can be enhanced by combining interdisciplinary expertise, ensuring the tools are evidence-based and user-friendly.

Involving clinicians throughout the development process helps tailor the CDS tools to meet end-user needs, facilitating better integration into clinical workflows.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interdisciplinary Human-Centered AI for Hospital Readmission Prediction of Heart Failure Patients. Soliman, A., Nair, M., Petersson, M., et al.[2023]

The use of a clinical decision support system in telemonitoring heart failure patients allows for real-time medication adjustments based on vital signs, potentially improving patient outcomes and reducing unnecessary hospital visits.

This study evaluates the effectiveness of the decision support system within the INTENSE-HF trial, highlighting its adherence to European Society of Cardiology guidelines while also identifying areas for improvement in telehealth practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telemonitoring in heart failure patients with clinical decision support to optimize medication doses based on guidelines. Kropf, M., Modre-Osprian, R., Hayn, D., et al.[2020]

References

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

Utility of Patient-Reported Outcome Instruments in Heart Failure. [2016]

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

Outcome assessment: functional status measures as therapeutic endpoints for heart failure. [2019]

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

Patient-reported outcomes in heart failure: existing measures and future uses. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Use of patient-reported outcomes in heart failure: from clinical trials to routine practice. [2023]

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

Validity and responsiveness of the pediatric quality of life inventory (PedsQL) 4.0 generic core scales in the pediatric inpatient setting. [2022]

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

Adverse event prediction in patients with left ventricular assist devices. [2020]

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

Perceived adverse drug events in heart failure: patients' perception and related factors. [2011]

8. Greece pubmed.ncbi.nlm.nih.gov

A Comparative Safety Analysis of Medicines Based on the UK Pharmacovigilance and General Practice Prescribing Data in England. [2022]

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

The impact of perceived adverse effects on medication changes in heart failure patients. [2013]

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

Improving patient safety in the inpatient setting through risk assessment and mitigation. [2016]

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

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

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

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

13. Netherlands pubmed.ncbi.nlm.nih.gov

Interdisciplinary Human-Centered AI for Hospital Readmission Prediction of Heart Failure Patients. [2023]

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

Telemonitoring in heart failure patients with clinical decision support to optimize medication doses based on guidelines. [2020]