- ICH GCP
- US-Register für klinische Studien
- Klinische Studie 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
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
-
-
Missouri
-
Kansas City, Missouri, Vereinigte Staaten, 64111
- Saint Luke's Hospital
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Unterstützende Pflege
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Sonstiges: 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.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Kansas City Cardiomyopathy Questionnaire (KCCQ)
Zeitfenster: 1 month
|
Heart failure-related quality of life
|
1 month
|
|
Decisional Conflict Scale
Zeitfenster: 1 month
|
Decision-making confidence/readiness
|
1 month
|
|
Peace, Equanimity, and Acceptance in Cancer Experience (PEACE) Scale
Zeitfenster: 1 month
|
Illness Acceptance
|
1 month
|
|
Kaldjian's Goals of Care at End of Life
Zeitfenster: 1 month
|
Patient-ranked importance for different goals of care
|
1 month
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Death
Zeitfenster: 6 months
|
Mortality
|
6 months
|
|
Code Status Change
Zeitfenster: 6 months
|
6 months
|
|
|
Advance Directive creation
Zeitfenster: 6 months
|
6 months
|
|
|
Durable Power of Attorney appointment
Zeitfenster: 6 months
|
6 months
|
|
|
Unscheduled Healthcare Encounter
Zeitfenster: 6 months
|
Composite of re-hospitalizations, emergency department visits, urgent care visits, and unscheduled outpatient heart failure clinic visits
|
6 months
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: John A Spertus, MD, MPH, Saint Luke's Hospital
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Voraussichtlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 14-192
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