Clinical Trial Details
— Status: Withdrawn
Administrative data
| NCT number |
NCT02398617 |
| Other study ID # |
14-192 |
| Secondary ID |
|
| Status |
Withdrawn |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
December 2014 |
| Est. completion date |
December 2015 |
Study information
| Verified date |
October 2021 |
| Source |
Saint Luke's Health System |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
