Primary Palliative Care in Heart Failure: A Pilot Trial

Heart Failure Clinical Trial

Official title:

Primary Palliative Care in Heart Failure: A Pilot Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03170466
• Other study ID #: PRO16090248
• Secondary ID: K01HL133466-01
• Status: Completed
• Phase: N/A
• Start date: October 23, 2017
• Est. completion date: August 1, 2020

Study information

• Verified date: September 2020
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Patients with advanced heart failure (HF) typically experience significant burdens that negatively impact their quality of life. Although palliative care has been shown to improve patient outcomes in other serious illnesses, insufficient data exist to support its use in HF. Furthermore, the demand for palliative care in serious illness outstrips the available supply of certified palliative care clinicians. This pilot trial will assess the feasibility and acceptability of training cardiology nurses in basic palliative care skills and their ability to deliver this care alongside usual HF management.

Description:

Patients with advanced heart failure (HF) suffer from significant pain, fatigue, difficulty breathing, anxiety, and depression. Palliative Care (PC) is a medical specialty designed to focus on relieving patient suffering by providing an extra layer of support on top of usual care. To date, there has been little research on the impact of PC in HF. We will conduct a randomized clinical trial to assess the feasibility, acceptability, and perceived effectiveness of training cardiology nurses in PC and administering PC to their patients. Patients will be randomized into either the usual care group or the intervention group. Usual care participants will receive their care with no alterations, and intervention participants will receive the PC intervention from their nurse on top of their usual care. Both groups will complete health-related surveys on tablet computers, via email, and/or via telephone. In the intervention group, these answers will be used to tailor the intervention to the specific patient's needs. Caregivers will also be recruited into the study, and will complete surveys similar to the patients via the aforementioned methods.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 1, 2020
• Est. primary completion date: May 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• New York Heart Association Class III or IV Heart Failure

• 2 or more hospitalizations in the past year due to Heart Failure

Exclusion Criteria:

• Less than 40 years old

• Currently awaiting a transplant

• Received outpatient palliative care within the past 12 months

• Pregnant or intends to be within the next 12 months

• No regular phone access

• Not fluent in English

• Failed the Callahan 6-item Screener

• Does not intent to regularly attend clinic for the next 12 months

Related Conditions & MeSH terms

• Heart Failure

Intervention

Behavioral:
• Primary Palliative Care
The intervention will span 4 domains: symptom management (e.g., dyspnea), psychosocial support (e.g., anxiety), advance care planning (e.g., understanding prognosis and electing a proxy) and care coordination (e.g., communication across providers).

Locations

Country	Name	City	State
United States	UPMC Heart Vascular Institute	White Oak	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of enrolling 30 patients via attempting to enroll 30 patients	We will assess the feasibility of enrolling 30 patients by attempting to enroll 30 patients.	One year
Secondary	Intervention Acceptability	We will evaluate acceptability of the intervention through interviews with patients, caregivers, and healthcare providers.	Two years
Secondary	Intervention Fidelity via the Intervention Fidelity Monitoring Report	We will assess intervention fidelity by audio-recording the interventions and having independent reviewers listen to them and complete our Intervention Fidelity Monitoring Report.	Two years