Default Options in Advance Directives

University of Pennsylvania

Status: Completed

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

Treatments: Behavioral: Comfort default advance directive; Behavioral: Life-extension default advance directive

Study type: Interventional

Funder types: Other

Identifiers

NCT02017548

UPenn 819325

Details and patient eligibility

About

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.

Enrollment: 270 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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270 participants in 3 patient groups

Life-extension default

Experimental group

Description:

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.

Treatment:

Behavioral: Life-extension default advance directive

Comfort default

Experimental group

Description:

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.

Treatment:

Behavioral: Comfort default advance directive

Standard advance directive

No Intervention group

Description:

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