Default Options in Advance Directives

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

270 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2016-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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This Study Will Focus on Advance Care Planning Among Patients With Life-limiting Illnesses

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Life-extension default advance directive

Intervention Type BEHAVIORAL

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.

Group Type EXPERIMENTAL

Comfort default advance directive

Intervention Type BEHAVIORAL

Standard advance directive

Subjects in the standard advance directive (AD) group will receive an AD that will have no options pre-selected.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Life-extension default advance directive

Intervention Type BEHAVIORAL

Comfort default advance directive

Intervention Type BEHAVIORAL

Eligibility Criteria

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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