Promoting Palliative Care for People With Heart Failure (P3HF)

Promoting Palliative Care for People With Heart Failure: The P3HF Pilot Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Heart Failure; Palliative Care
• Intervention / Treatment: Behavioral: Clinical Decision Support Tool

Detailed Description

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

• Study Type: Interventional
• Enrollment (Estimated): 2260
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shelli Feder, PhD; Phone Number: 937-239-2801; Email: shelli.feder@yale.edu
• Study Contact Backup: Name: Nathan Wright, MA; Email: nathan.wright@yale.edu

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Yale New Haven Hospital Saint Raphael
    • New Haven, Connecticut, United States, 06520
      • Yale New Haven Hospital York Street

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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:

• Age 18 years of age or older
• N-terminal pro-B-type natriuretic peptide values of >500 pg/ml
• Received intravenous diuretics within 24 hours of admission.

Exclusion Criteria:

• Pregnant at the time of admission.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard of Care; Providers will provide usual standard of care for participants hospitalized with heart failure.
Experimental: Clinical Decision Support (CDS) Tool; Patients will be randomized to have the CDS tool to deliver prognostic information and evidence-based decision support at the point of care for timely referral to palliative care for participants hospitalized with heart failure.	Behavioral: Clinical Decision Support Tool; Deliver prognostic information and evidence-based decision support at the point of care

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Referral to Specialist Palliative Care	Proportion of participants who are referred to Specialist Palliative Care	up to 15 months
Consultation by Specialist Palliative Care	Proportion of participants who have a completed consultation order by Specialist Palliative Care	up to 15 months
Advance Care Plan Documentation	Proportion of participants who have a documented Advance Care Plan	up to 15 months
Participants enrolled in hospice	Proportion of participants enrolled in hospice during hospitalization	up to 15 months
Mean hospital length of stay	Mean hospital length of stay in days	up to 15 months
Participants readmitted to hospital	Proportion of participants with 30-day hospital readmission	up to 15 months
Change in Code Status	Change in code status for comfort measures	up to 15 months

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Shelli Feder, PhD, Yale University

Study record dates

Study Major Dates

• Study Start (Estimated): May 22, 2026
• Primary Completion (Estimated): July 30, 2027
• Study Completion (Estimated): August 30, 2027

Study Registration Dates

• First Submitted: April 11, 2025
• First Submitted That Met QC Criteria: April 11, 2025
• First Posted (Actual): April 18, 2025

Study Record Updates

• Last Update Posted (Actual): April 30, 2026
• Last Update Submitted That Met QC Criteria: April 24, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure
• Other Study ID Numbers: 2000038269; 1R34HL174885-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No