Promoting Palliative Care for People With Heart Failure (P3HF)

July 14, 2026 updated by: Yale University

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

Recruiting

Conditions

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: Shelli Feder, PhD, Yale University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 2, 2026

Primary Completion (Estimated)

October 30, 2027

Study Completion (Estimated)

October 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)

July 16, 2026

Last Update Submitted That Met QC Criteria

July 14, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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