Clinical trial NCT06933875: Promoting Palliative Care for People With Heart Failure
Official title: Promoting Palliative Care for People With Heart Failure: The P3HF Pilot Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Heart Failure
Palliative Care
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2025-04-18
Enrollment: 1485
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Providers who care for people hospitalized with heart failure at the two study sites will be recruited. Providers will be selected via retrospective chart review by study investigators. 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 providers, 700-1400 participants and 15 Level 2 providers (providers potentially impacted by the tool).
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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:

-

Primary outcomes:
measure: Mean System Usability Scale score
timeFrame: up to 15 months
measure: Mean Acceptability of Intervention Measure score
timeFrame: up to 15 months
measure: Mean Appropriateness of Intervention Measure score
timeFrame: up to 15 months
measure: Mean Feasibility of Intervention Measure score
timeFrame: up to 15 months
Secondary outcomes:
measure: Referral to Specialist Palliative Care
timeFrame: up to 15 months
measure: Consultation by Specialist Palliative Care
timeFrame: up to 15 months
measure: Advance Care Plan Documentation
timeFrame: up to 15 months
measure: Participants enrolled in hospice
timeFrame: up to 15 months
measure: Mean hospital length of stay
timeFrame: up to 15 months
measure: Participants readmitted to hospital
timeFrame: up to 15 months
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale New Haven Hospital Saint Raphael
state: Connecticut
city: New Haven
country: United States
facility: Yale New Haven Hospital York Street
state: Connecticut
Study officials:
affiliation: Yale University
name: Shelli Feder, PhD
role: PRINCIPAL_INVESTIGATOR
References: