Clinical trial NCT02398617: End-Of-Life Decision Making and Preparedness Planning Among Heart Failure Patients Hospitalized for Advanced Disease
Official title: Facilitating End-Of-Life Decision Making and Preparedness Planning Among Heart Failure Patients Hospitalized for Advanced Disease
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Heart Failure
Keywords: Heart Failure
End of Life Care
Decision Making
Lead sponsor: Saint Luke's Health System
Sponsor class: OTHER
First posted: 2015-03-25
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Heart failure is a chronic and frequently terminal illness associated with poor quality of life and high burden of morbidity, re-hospitalization, and cost. Accordingly, recent guideline updates have highlighted the need for improved focus on end-of-life and palliative care of advanced heart failure patients, in whom symptom burden can be high and treatment options are often limited. The aims of this study are to evaluate the feasibility of implementing a semi-structured, outpatient, nurse practitioner-led, educational supportive care intervention concerning multiple domains of end-of-life care not often included in regular, outpatient clinic visits.

Detailed description: This study will be a prospective pilot enrolling 10 patients with advanced disease admitted to the heart failure service at St. Luke's Mid America Heart Institute and who are not candidates for advanced therapies such as heart transplant or mechanical circulatory support (left ventricular assist device). Potential enrollees will be identified using a validated risk model that predicts death or poor quality of life in the six months after discharge from the hospital for heart failure exacerbation. Enrolled patients will complete validated questionnaires while still hospitalized, regarding health-related quality of life, illness acceptance, prioritization of different life goals, and confidence in decision-making regarding their terminal heart failure. Patients will then be given a paper exercise regarding delineation of an end-of-life plan and appointment of a surrogate medical decision-maker, to be completed after discharge. At their regularly scheduled admission follow-up visit with seven days of discharge, participants will be asked to bring their medical decision maker and participate in a semi-structured supplemental palliative care/education session facilitated by a heart failure nurse practitioner trained in palliative care discussions. Domains included in the intervention will include disease literacy and understanding, goals of care, legal issues for patients with terminal illness, symptom management, health-related quality of life, caregiver burden, patient autonomy, healthcare utilization, and establishment of end-of-life plans.

Outcomes to be measured after the intervention include repeated validated questionnaires and unstructured patient interviews at 1 month and, at 6 months, creation of a formalized end-of-life plan, change in code status, obtainment of an advanced directive, designation of a durable power of attorney, frequency of re-hospitalizations, emergency room visits and unscheduled clinic visits with providers, and death. These will be obtained at the time of regularly scheduled heart failure clinic follow-up visits or over the phone.

Eligibility criteria: Inclusion Criteria:

* advanced heart failure
* ineligible for advanced therapies
* 50% risk of death or continued poor heart failure-related health status at 6 months from hospital discharge, based on validated risk score

Exclusion Criteria:

* Hospice enrollment
* Previous heart transplant or left ventricular assist device placement

Primary outcomes:
measure: Kansas City Cardiomyopathy Questionnaire (KCCQ)
timeFrame: 1 month
measure: Decisional Conflict Scale
timeFrame: 1 month
measure: Peace, Equanimity, and Acceptance in Cancer Experience (PEACE) Scale
timeFrame: 1 month
measure: Kaldjian's Goals of Care at End of Life
timeFrame: 1 month
Secondary outcomes:
measure: Death
timeFrame: 6 months
measure: Code Status Change
timeFrame: 6 months
measure: Advance Directive creation
timeFrame: 6 months
measure: Durable Power of Attorney appointment
timeFrame: 6 months
measure: Unscheduled Healthcare Encounter
timeFrame: 6 months
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Saint Luke's Hospital
state: Missouri
Study officials:
affiliation: Saint Luke's Hospital
name: John A Spertus, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: