Promoting Palliative Care for People With Heart Failure

NCT06933875 | Not Yet Recruiting

• 2 other identifiers: 20000382691R34HL174885-01
• Study Type: interventional
• Target: 2,260
• Locations: 1 country
• Sites: 2

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.

Conditions

Heart Failure; Palliative Care

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (7)

• Referral to Specialist Palliative Care

  up to 15 months

• Consultation by Specialist Palliative Care

  up to 15 months

• Advance Care Plan Documentation

  up to 15 months

• Participants enrolled in hospice

  up to 15 months

• Mean hospital length of stay

  up to 15 months

Study Arms (2)

Clinical Decision Support (CDS) Tool

EXPERIMENTAL

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

Standard of Care

NO INTERVENTION

Providers will provide usual standard of care for participants hospitalized with heart failure.

Interventions

Clinical Decision Support Tool BEHAVIORAL

Deliver prognostic information and evidence-based decision support at the point of care

Clinical Decision Support (CDS) Tool

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• Pregnant at the time of admission.

Sponsors & Collaborators

• Yale University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (2)

Yale New Haven Hospital Saint Raphael

New Haven, Connecticut, 06520, United States

Location

Yale New Haven Hospital York Street

New Haven, Connecticut, 06520, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Shelli Feder, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shelli Feder, PhD

CONTACT

937-239-2801; shelli.feder@yale.edu

Nathan Wright, MA

CONTACT

nathan.wright@yale.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Eligibility of patients will be assessed automatically by an existing Epic build and will not involve any human intervention. When a provider opens the order entry screen of the patient's medical record, this build will examine the record for all inclusion and exclusion criteria. Those who meet criteria will be automatically enrolled and placed into a randomization group based on the randomization status of their current provider at the time of enrollment. Target sample size is 70 Level 1 providers, 2260 participants and 15 Level 2 providers (providers potentially impacted by the tool).

Study Record Dates

• First Submitted: April 11, 2025
• First Posted: April 18, 2025
• Study Start (Estimated): May 22, 2026
• Primary Completion (Estimated): July 30, 2027
• Study Completion (Estimated): August 30, 2027
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)