Promoting Palliative Care for People With Heart Failure

Not Applicable

Not yet recruiting

• Conditions: Heart Failure; Palliative Care

• Registration Number: NCT06933875
• Lead Sponsor: Yale University

Brief Summary

This project will develop and test a novel clinical decision support tool (CDS) that encourages timely referral to palliative care for people hospitalized with heart failure. This intervention will incorporate an existing, validated 1-year mortality risk model into a CDS to deliver prognostic information and evidence-based decision support at the point of care. Thus, this research may lead to improved care-concordant and goal-directed care for people with heart failure.

Detailed Description

Healthcare providers will encounter the tool during the routine care of their hospitalized patients. Providers randomized to the intervention arm will receive training on the use of the tool and complete one post-trial survey. Providers randomized to the intervention arm will also have the opportunity to participate in 1 post-trial interview. Level 2 providers will participate in one interview.

Study Timeline

• Study First Submitted: 2025-04-11
• Study First Submitted QC: 2025-04-11
• Study First Posted: 2025-04-18
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-05
• Last Update Posted: 2025-05-09
• Study Start: 2026-02
• Primary Completion: 2027-04-30
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1485

Inclusion Criteria

Healthcare providers must meet the following criteria:

• Are an attending physician, fellow, or resident, advanced practice nurse, or physician associate
• Has ordering privileges
• Are members of one of the hospitals' admitting teams (e.g., hospitalist service, cardiology service)
• Anticipate employment at one of the two study sites for the 15-month trial period.

Or

• Palliative care team member
• Hospital administrator/quality and safety personnel

Patients of providers enrolled in the study must meet the following criteria for heart failure during hospitalization:

• N-terminal pro-B-type natriuretic peptide values of >500 pg/ml
• Not pregnant at the time of admission.
• Received intravenous diuretics within 24 hours of admission.

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Mean System Usability Scale score	up to 15 months	System Usability Scale, 10-item Likert questionnaire. Total score range 0-100. Higher values indicate higher usability
Mean Acceptability of Intervention Measure score	up to 15 months	Acceptability of Intervention Measure, 4-item questionnaire. Total score range 1-4. Higher values indicate higher acceptability.
Mean Appropriateness of Intervention Measure score	up to 15 months	Appropriateness of Intervention Measure, 4-item questionnaire. Total score range 1-4. Higher values indicate higher appropriateness.
Mean Feasibility of Intervention Measure score	up to 15 months	Feasibility of Intervention Measure, 4-item questionnaire. Total score range 1-4. Higher values indicate higher feasibility.

Secondary Outcome Measures

Name	Time	Method
Referral to Specialist Palliative Care	up to 15 months	Proportion of participants who are referred to Specialist Palliative Care
Consultation by Specialist Palliative Care	up to 15 months	Proportion of participants who have a completed consultation order by Specialist Palliative Care
Advance Care Plan Documentation	up to 15 months	Proportion of participants who have a documented Advance Care Plan
Participants enrolled in hospice	up to 15 months	Proportion of participants enrolled in hospice during hospitalization
Mean hospital length of stay	up to 15 months	Mean hospital length of stay in days
Participants readmitted to hospital	up to 15 months	Proportion of participants with 30-day hospital readmission

Trial Locations

Locations (2)

Yale New Haven Hospital Saint Raphael; 🇺🇸 New Haven, Connecticut, United States

Yale New Haven Hospital York Street; 🇺🇸 New Haven, Connecticut, United States