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Default Options in Advance Directives

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University of Pennsylvania
Sponsor:
Collaborator:
University of Pittsburgh
Information provided by (Responsible Party):
Scott Halpern, University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT02017548
First received: December 16, 2013
Last updated: May 29, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
This Study Will Focus on Advance Care Planning Among Patients With Life-limiting Illnesses
Behavioral: Life-extension default advance directive
Behavioral: Comfort default advance directive

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Default Options in Advance Directives

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Hospital free days [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Hospital and ICU admissions [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]
    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.

  • Costs of care [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]
    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

  • Hospice utilization [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]
    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.

  • Choices to receive 4 potentially life-sustaining interventions, and the concordance of these choices with whether the interventions were actually received [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]
    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.

  • Choices regarding post-hospitalization care, and the concordance of these choices with the care actually received [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]
    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.

  • Decision regret [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]
    Decision regret will be measured using Dr. Jamie Brehaut's 5-item Decision Regret Scale that has previously been shown to have good internal consistency and strong inverse associations with decision satisfaction.

  • Decision satisfaction [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]
    Satisfaction will also be measured with the CANHELP instrument's global satisfaction with end-of-life care question.

  • Quality of Life using the McGill Quality of Life (MQOL) instrument. [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]
    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.

  • Surrogates' Perception of the quality of death and dying [ Time Frame: within 3 months of patient death ] [ Designated as safety issue: Yes ]
    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 the quality of dying and death (QODD) instrument

  • Post-traumatic stress in surrogates [ Time Frame: within 3 months of patient death ] [ Designated as safety issue: No ]
    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.

  • Complicated grief among surrogates [ Time Frame: within 3 months of patient death ] [ Designated as safety issue: No ]
    Complicated grief will be assessed using Prigerson's Inventory of Complicated Grief to distinguish pathologic grieving from normal bereavement.


Estimated Enrollment: 270
Study Start Date: January 2014
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Behavioral: Life-extension default advance directive
Experimental: 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.
Behavioral: Comfort default advance directive
No Intervention: Standard advance directive
Subjects in the standard advance directive (AD) group will receive an AD that will have no options pre-selected.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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, 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02017548

Contacts
Contact: Elizabeth Cooney, MPH 215.573.9461 elcooney@exchange.upenn.edu
Contact: Cary J. Hilbert 215.573.6116 chilbert@mail.med.upenn.edu

Locations
United States, Pennsylvania
The Perelman Center for Advance Medicine Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Cooney    215-573-9461      
Penn Presbyterian Medical Center Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Cooney    215-573-9461      
Pennsylvania Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Cooney    215-573-9461      
University of Pittsburgh Medical Center Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Principal Investigator: Cindy L. Bryce, PhD         
Sponsors and Collaborators
University of Pennsylvania
University of Pittsburgh
Investigators
Principal Investigator: Scott D. Halpern, MD, PhD University of Pennsylvania
  More Information

No publications provided

Responsible Party: Scott Halpern, Assistant Professor of Medicine, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02017548     History of Changes
Other Study ID Numbers: UPenn 819325
Study First Received: December 16, 2013
Last Updated: May 29, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pennsylvania:
advance directives, advance care planning

ClinicalTrials.gov processed this record on July 24, 2014