- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT02398617
End-Of-Life Decision Making and Preparedness Planning Among Heart Failure Patients Hospitalized for Advanced Disease
Facilitating End-Of-Life Decision Making and Preparedness Planning Among Heart Failure Patients Hospitalized for Advanced Disease
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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-
Missouri
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Kansas City, Missouri, Stany Zjednoczone, 64111
- Saint Luke's Hospital
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie podtrzymujące
- Przydział: Nie dotyczy
- Model interwencyjny: Zadanie dla jednej grupy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Inny: Decision Making Intervention
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.
|
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.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Kansas City Cardiomyopathy Questionnaire (KCCQ)
Ramy czasowe: 1 month
|
Heart failure-related quality of life
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1 month
|
|
Decisional Conflict Scale
Ramy czasowe: 1 month
|
Decision-making confidence/readiness
|
1 month
|
|
Peace, Equanimity, and Acceptance in Cancer Experience (PEACE) Scale
Ramy czasowe: 1 month
|
Illness Acceptance
|
1 month
|
|
Kaldjian's Goals of Care at End of Life
Ramy czasowe: 1 month
|
Patient-ranked importance for different goals of care
|
1 month
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Death
Ramy czasowe: 6 months
|
Mortality
|
6 months
|
|
Code Status Change
Ramy czasowe: 6 months
|
6 months
|
|
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Advance Directive creation
Ramy czasowe: 6 months
|
6 months
|
|
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Durable Power of Attorney appointment
Ramy czasowe: 6 months
|
6 months
|
|
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Unscheduled Healthcare Encounter
Ramy czasowe: 6 months
|
Composite of re-hospitalizations, emergency department visits, urgent care visits, and unscheduled outpatient heart failure clinic visits
|
6 months
|
Współpracownicy i badacze
Sponsor
Śledczy
- Główny śledczy: John A Spertus, MD, MPH, Saint Luke's Hospital
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Oczekiwany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Oszacować)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 14-192
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