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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
TRIPLE
Enrollment
270
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, United States
The Perelman Center for Advance Medicine
Philadelphia, Pennsylvania, United States
Pennsylvania Hospital
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Hospital free days
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
Time frame: 6 months
Hospital and ICU admissions
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.
Time frame: up to 1 year
Costs of care
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
Time frame: up to 1 year
Hospice utilization
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.
Time frame: 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
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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.
Time frame: up to 1 year
Choices regarding post-hospitalization care, and the concordance of these choices with the care actually received
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.
Time frame: up to 1 year
Decision conflict
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.
Time frame: up to 1 year
Decision satisfaction
Satisfaction will also be measured with the CANHELP instrument's global satisfaction with end-of-life care question.
Time frame: up to 1 year
Quality of Life using the McGill Quality of Life (MQOL) instrument.
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.
Time frame: up to 1 year
Surrogates' Perception of the quality of death and dying
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.
Time frame: within 3 months of patient death
Post-traumatic stress in surrogates
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.
Time frame: within 3 months of patient death