Heart FailureP3HFNCT06933875
Promoting Palliative Care for People With Heart Failure
A study testing Clinical Decision Support Tool in people with Heart Failure and Palliative Care, run by Yale University at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Palliative Care
- What is being tested?
- Clinical Decision Support Tool
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,260 participants
- Where
- 2 sitesUnited States
- Study dates
- 2 Jul 2026to 30 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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.
Who cannot join
- Pregnant at the time of admission.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Nathan Wright, MA contact
United States2 sites, 2 recruiting
- Recruiting
Yale New Haven Hospital Saint Raphael
New Haven, Connecticut, 06520
- Recruiting
Yale New Haven Hospital York Street
New Haven, Connecticut, 06520
About this study
Official title: 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.
Read the 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.
- Conditions
- Heart Failure, Palliative Care
- Being tested
- Clinical Decision Support Tool
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical Decision Support ToolBehavioural
Deliver prognostic information and evidence-based decision support at the point of care
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Clinical Decision Support Tool |
| Standard of Care | No intervention | Providers will provide usual standard of care for participants hospitalized with heart failure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean System Usability Scale score
System Usability Scale, 10-item Likert questionnaire. Total score range 0-100. Higher values indicate higher usability
Measured: 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.
Measured: 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.
Measured: 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.
Measured: up to 15 months
Secondary outcomes (7)
Referral to Specialist Palliative Care
Proportion of participants who are referred to Specialist Palliative Care
Measured: up to 15 months
Consultation by Specialist Palliative Care
Proportion of participants who have a completed consultation order by Specialist Palliative Care
Measured: up to 15 months
Advance Care Plan Documentation
Proportion of participants who have a documented Advance Care Plan
Measured: up to 15 months
Participants enrolled in hospice
Proportion of participants enrolled in hospice during hospitalization
Measured: up to 15 months
Mean hospital length of stay
Mean hospital length of stay in days
Measured: up to 15 months
Participants readmitted to hospital
Proportion of participants with 30-day hospital readmission
Measured: up to 15 months
Change in Code Status
Change in code status for comfort measures
Measured: up to 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2025
- Study start2 Jul 2026
- Primary completion30 Oct 2027 (estimated)
- Study completion30 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 2,260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Shelli Feder, PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06933875
- Sponsor's protocol ID
- 2000038269
- Other IDs
- 1R34HL174885-01
- Acronym
- P3HF
- Status last verified
- Jul 2026
- First submitted
- 11 Apr 2025
- Last updated
- 16 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Men Y, Wright N, O'Connor G, Han L, Kaur H, Suh E, Chen J, Kadhim B, Ahmad T, Beasley M, Segar N, Kim N, Quang J, Sharifi M, Feder S. Promoting palliative care for people with heart failure: the P3HF study protocol. BMC Palliat Care. 2026 Jul 11. doi: 10.1186/s12904-026-02206-w. Online ahead of print.
PubMed 42432643
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Palliative Care for People With Heart Failure: The P3HF Pilot Study
- ClinicalTrials.gov ID
- NCT06933875
- Acronym / sponsor ID
- P3HF / 2000038269
- Conditions
- Heart Failure, Palliative Care
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,260 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 2 Jul 2026 (actual)
- Primary completion
- 30 Oct 2027 (estimated)
- Study completion
- 30 Oct 2027 (estimated)
- First posted
- 18 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Clinical Decision Support (CDS) Tool | Experimental | Behavioral: Clinical Decision Support ToolPatients 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. |
| Standard of Care | No intervention | –Providers will provide usual standard of care for participants hospitalized with heart failure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (1 listed)
- Pregnant at the time of admission.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical Decision Support ToolDeliver prognostic information and evidence-based decision support at the point of care | Behavioural | Clinical Decision Support (CDS) Tool |
Primary outcome
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
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.
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.
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.
7 secondary outcomes
Referral to Specialist Palliative Care
Time frame: up to 15 months
Consultation by Specialist Palliative Care
Time frame: up to 15 months
Advance Care Plan Documentation
Time frame: up to 15 months
Participants enrolled in hospice
Time frame: up to 15 months
Mean hospital length of stay
Time frame: up to 15 months
Participants readmitted to hospital
Time frame: up to 15 months
Change in Code Status
Time frame: up to 15 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Derived from this study: PubMed 42432643Men Y, Wright N, O'Connor G, Han L, Kaur H, Suh E, Chen J, Kadhim B, Ahmad T, Beasley M, Segar N, Kim N, Quang J, Sharifi M, Feder S. Promoting palliative care for people with heart failure: the P3HF study protocol. BMC Palliat Care. 2026 Jul 11. doi: 10.1186/s12904-026-02206-w. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nathan Wright, MA contact
Shelli Feder, PhD principal investigator
Yale University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical Decision Support Tool in people with Heart Failure and Palliative Care, run by Yale University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shelli Feder, PhD (937-239-2801, shelli.feder@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean System Usability Scale score (time frame: up to 15 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06933875, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.