Clinical trial NCT02017548: Default Options in Advance Directives
Official title: Default Options in Advance Directives
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: This Study Will Focus on Advance Care Planning Among Patients With Life-limiting Illnesses
Keywords: advance directives, advance care planning
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: University of Pittsburgh
First posted: 2013-12-20
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.


Eligibility 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, 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.

Primary outcomes:
measure: Hospital free days
timeFrame: 6 months
Secondary outcomes:
measure: Hospital and ICU admissions
timeFrame: up to 1 year
measure: Costs of care
timeFrame: up to 1 year
measure: Hospice utilization
timeFrame: up to 1 year
measure: Choices to receive 4 potentially life-sustaining interventions, and the concordance of these choices with whether the interventions were actually received
timeFrame: up to 1 year
measure: Choices regarding post-hospitalization care, and the concordance of these choices with the care actually received
timeFrame: up to 1 year
measure: Decision conflict
timeFrame: up to 1 year
measure: Decision satisfaction
timeFrame: up to 1 year
measure: Quality of Life using the McGill Quality of Life (MQOL) instrument.
timeFrame: up to 1 year
measure: Surrogates' Perception of the quality of death and dying
timeFrame: within 3 months of patient death
measure: Post-traumatic stress in surrogates
timeFrame: within 3 months of patient death
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Penn Presbyterian Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: The Perelman Center for Advance Medicine
state: Pennsylvania
city: Philadelphia
country: United States
facility: Pennsylvania Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Scott D. Halpern, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Halpern SD, Small DS, Troxel AB, Cooney E, Bayes B, Chowdhury M, Tomko HE, Angus DC, Arnold RM, Loewenstein G, Volpp KG, White DB, Bryce CL. Effect of Default Options in Advance Directives on Hospital-Free Days and Care Choices Among Seriously Ill Patients: A Randomized Clinical Trial. JAMA Netw Open. 2020 Mar 2;3(3):e201742. doi: 10.1001/jamanetworkopen.2020.1742.
citation: Gabler NB, Cooney E, Small DS, Troxel AB, Arnold RM, White DB, Angus DC, Loewenstein G, Volpp KG, Bryce CL, Halpern SD. Default options in advance directives: study protocol for a randomised clinical trial. BMJ Open. 2016 Jun 6;6(6):e010628. doi: 10.1136/bmjopen-2015-010628.