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Default Options in Advance Directives

29 marzo 2019 aggiornato da: Scott Halpern, University of Pennsylvania
In a multicenter, randomized clinical trial of default options in advance directives among patients with incurable diseases, we will determine whether this simple and readily scalable intervention can improve patients quality of life and reduce resource utilization without reducing the number of days that patients are alive and living outside of an acute-care hospital.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Anticipato)

270

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • Pennsylvania
      • Philadelphia, Pennsylvania, Stati Uniti, 19104
        • Penn Presbyterian Medical Center
      • Philadelphia, Pennsylvania, Stati Uniti, 19107
        • Pennsylvania Hospital
      • Philadelphia, Pennsylvania, Stati Uniti, 19104
        • The Perelman Center for Advance Medicine
      • Pittsburgh, Pennsylvania, Stati Uniti, 15213
        • University of Pittsburgh Medical Center

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • Age 18 or older
  • Fluent in English
  • Has seen current physician at least once prior to current visit
  • Resident of Pennsylvania or New Jersey
  • One or more of the following diagnoses:
  • Amyotrophic lateral sclerosis
  • Stage IIIB or IV non-small cell lung cancer, pancreatic cancer, or cholangiocarcinoma
  • Stage IV breast, colon, esophageal, gastric, pancreatic, prostate, uterine, cervical, ovarian, or urothelial cancer; paraganglioma, or pheochromocytoma
  • Stage C or D hepatocellular carcinoma
  • Stage IV renal cell carcinoma
  • Stage IV or V chronic kidney disease
  • Mesothelioma or any malignancy metastatic to the pleura
  • Other incurable interstitial lung diseases with at least severe restriction on most recent pulmonary function tests or eligible for long-term oxygen therapy
  • Chronic obstructive pulmonary disease with at least severe airflow obstruction on most recent spirometry or eligible for long-term oxygen therapy
  • Congestive heart failure with NYHA Class IV status or Class III plus 1 heart failure related hospitalization in the past 12 months or ACC stage D or C classification with 1 heart failure related hospitalization in the past 12 months

Exclusion Criteria:

  • Currently listed for or being considered for solid organ transplant
  • Patients with a previously signed advance directive or living will.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Ricerca sui servizi sanitari
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Triplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Life-extension default
Subjects in this group will receive an advance directive form that defaults to an overall goal of care directed towards life extension (vs. comfort oriented care) unless the subject specifies otherwise. The form also states 4 specific life extending interventions (cardiopulmonary resuscitation, mechanical ventilation, hemodialysis, and feeding tube insertion) will be provided unless patients specifically opt-out from such selections. It also will state that upon discharge from the hospital, long-term care (vs. hospice care) will be provided unless the patient chooses otherwise.
Comportamentale: Life-extension default advance directive
Sperimentale: Comfort default
Subjects in this group will receive an advance directive form that defaults to an overall goal of care directed towards comfort and relief of pain and suffering (vs. life extension) unless the subject specifies otherwise. The form also states 4 specific life extending interventions (cardiopulmonary resuscitation, mechanical ventilation, hemodialysis, and feeding tube insertion) will be not provided unless patients specifically opts into such selections. It also will state that upon discharge from the hospital, hospice care (vs. long-term care) will be provided unless the patient chooses otherwise.
Comportamentale: Comfort default advance directive
Nessun intervento: Standard advance directive
Subjects in the standard advance directive (AD) group will receive an AD that will have no options pre-selected.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Hospital free days
Lasso di tempo: 6 months
The primary outcome is "Hospital-Free Days" (HFDs), a measure that PI Halpern has been developing in collaboration with Dr. Jeffrey Silber at Penn's Center for Outcomes Research. As the name describes, HFDs represent the number of days alive and not in an acute care facility. Although this is a simple concept, and provides an outcome measure of obvious importance to patients, the use of HFDs as a primary outcome in an RCT is highly innovative. To bolster confidence in the results, we will evaluate two key variations on the theme. First, we will explore "Healthcare Facility-Free Days," which represents the number of days alive where a patient is in neither an acute care facility, a chronic care facility, or a nursing home. We will also evaluate HFDs within a defined period of follow-up - 6 months in this case. This is analogous to the established outcome of ventilator-free days used commonly in RCTs among ICU patients
6 months

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Hospital and ICU admissions
Lasso di tempo: up to 1 year
The numbers of admissions will be analyzed as count data. From the dates of hospital and ICU admissions, we will calculate the proportion of each patient's total survival time during study follow-up that was spent in the hospital or ICU.
up to 1 year
Costs of care
Lasso di tempo: up to 1 year
We will combine all costs of inpatient and outpatient hospice, hospital stays, and life-sustaining procedures. The perspective will be that of all potential payers. Costs will be inflated to the date on which analyses are performed using the U.S. gross domestic product deflator
up to 1 year
Hospice utilization
Lasso di tempo: up to 1 year
We will analyze hospice utilization in 2 ways: (a) time from advance directive completion to hospice enrollment; and (b) duration of hospice utilization prior to death.
up to 1 year
Choices to receive 4 potentially life-sustaining interventions, and the concordance of these choices with whether the interventions were actually received
Lasso di tempo: up to 1 year
We will record selections that patients made on their advance directives about 4 specific life-sustaining interventions. Utilizing data from the Pennsylvania Healthcare Cost Containment Consortium and the New Jersey Department of Health and Senior Services, we will be able to determine which patients received each intervention. Thus, we will be able to reliably evaluate the proportions of patients who received unwanted interventions. Because we cannot determine the denominator of patients with indications for these interventions, we will not evaluate the proportions of patients who went without desired services.
up to 1 year
Choices regarding post-hospitalization care, and the concordance of these choices with the care actually received
Lasso di tempo: up to 1 year
Patients will indicate on their advance directives forms their selections for post-hospitalization care. We will utilize data from the Pennsylvania Health Care Cost Containment Consortium and New Jersey Department of Health and Senior Services to asses if the care patient indicate is the care they receive.
up to 1 year
Decision conflict
Lasso di tempo: up to 1 year
The decision conflict scale is a well-validated instrument used to assess patients' certainty in making healthcare decisions. The DCS will be sent home with consenting patients to complete and return along with their advance directive forms and an instruction sheet explaining to patients that they should complete their advance directive forms first, followed by the DCS, and both should be mailed to the research team in the provided stamped envelope.
up to 1 year
Decision satisfaction
Lasso di tempo: up to 1 year
Satisfaction will also be measured with the CANHELP instrument's global satisfaction with end-of-life care question.
up to 1 year
Quality of Life using the McGill Quality of Life (MQOL) instrument.
Lasso di tempo: up to 1 year
The MQOL is a well-Validated and widely used scale designed specifically for patients with serious illnesses. The MQOL can be completed by family members on behalf of patients who have lost the capacity to complete it themselves. Thus, we will have surrogates (the individuals identified on patients' advance directive forms as their appointed healthcare agents) complete the MQOL for incapacitated patients to minimize missing data.
up to 1 year
Surrogates' Perception of the quality of death and dying
Lasso di tempo: within 3 months of patient death
Because we are recruiting patients with serious life-limiting illnesses, we anticipate that some patients will die over the course of this study period. We will speak with surrogates of deceased patients to assess their perceived quality of death and dying using Prigerson's Quality of Death measure.
within 3 months of patient death
Post-traumatic stress in surrogates
Lasso di tempo: within 3 months of patient death
The risk of post-traumatic stress disorder in surrogates among deceased patients will be assessed using the Impact of Events Scale. The IES is a valid and reliable scale that has been used frequently to assess PTSD risk among family members of critically ill patients.
within 3 months of patient death

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of Pennsylvania

Collaboratori

University of Pittsburgh

Investigatori

  • Investigatore principale: Scott D. Halpern, MD, PhD, University of Pennsylvania

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 gennaio 2014

Completamento primario (Effettivo)

1 novembre 2016

Completamento dello studio (Effettivo)

1 novembre 2016

Date di iscrizione allo studio

Primo inviato

16 dicembre 2013

Primo inviato che soddisfa i criteri di controllo qualità

16 dicembre 2013

Primo Inserito (Stima)

20 dicembre 2013

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

1 aprile 2019

Ultimo aggiornamento inviato che soddisfa i criteri QC

29 marzo 2019

Ultimo verificato

1 marzo 2019

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Altri numeri di identificazione dello studio

  • UPenn 819325

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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