Deferring Agency at End-of-Life: The Role of Information and Advance Directives
Last registered on September 26, 2019

Pre-Trial

Trial Information
General Information
Title
Deferring Agency at End-of-Life: The Role of Information and Advance Directives
RCT ID
AEARCTR-0004212
Initial registration date
September 25, 2019
Last updated
September 26, 2019 11:53 AM EDT
Location(s)

This section is unavailable to the public. Use the button below to request access to this information.

Request Information
Primary Investigator
Affiliation
UC Berkeley
Other Primary Investigator(s)
PI Affiliation
Providence St. Joseph Health
PI Affiliation
UC Berkeley
PI Affiliation
Amazon Web Services
Additional Trial Information
Status
In development
Start date
2019-05-01
End date
2021-04-30
Secondary IDs
Abstract
We propose a pilot randomized evaluation of strategies to facilitate advance directive completion in the aged 55+ patient population of our partner, Providence St. Joseph Health (PSJH). Despite the significant economic and personal implications of end-of-life health care decisions, many fail to document their wishes or to select a representative who can make medical decisions on their behalf. Descriptive evidence suggests that this results in sub-optimal outcomes including dissatisfaction and potentially unnecessary medical spending. However, it is not well understood why patients fail to engage in this apparently high-value planning. We propose a pilot randomized trial to study the effect of a targeted informational outreach to promote advance directive completion among 3,000 patients in 5 PSJH primary care clinics. This study is a follow-up and refinement of a JPAL-funded pilot study conducted during summer 2018 in two clinics at PSJH. Key outcomes will include advance directive completion rates, decisions made on advance directive forms, and eventually observed care decisions. We will also leverage surveys and granular data on patient health to better understand barriers to advance care planning and relate to underlying economic theory that explains behavior.
External Link(s)
Registration Citation
Citation
Handel, Ben et al. 2019. "Deferring Agency at End-of-Life: The Role of Information and Advance Directives." AEA RCT Registry. September 26. https://doi.org/10.1257/rct.4212-1.0.
Experimental Details
Interventions
Intervention(s)
Intervention Start Date
2019-11-01
Intervention End Date
2020-01-31
Primary Outcomes
Primary Outcomes (end points)
Uploads Advance Directive to EMR; Fraction Total Patients Uploaded Advance Directive to EMR (clinic level); Fraction Total Patients Completing healthcare proxy selection field (clinic level)
Primary Outcomes (explanation)
Secondary Outcomes
Secondary Outcomes (end points)
Completes Surrogate Selection on AD; Completes Care Preferences on AD; Preference/Dis-preference for Life Support on AD (clinic and individual level); Preference/Dis-preference for Tube Feeding (clinic and individual level)
Secondary Outcomes (explanation)
Experimental Design
Experimental Design
Individual patients in five clinics with upcoming appointments who do not have AD on file will be randomized into one of six treatment arms. These treatment arms are: (1) Pure Control, No Outreach; (2) Electronic Reminder Only; (3) Electronic Reminder + Paper Letter; (4) Electronic Reminder + Paper Letter + Traditional AD Form; (5) Electronic Reminder + Paper Letter + Simple AD Form; and (6) Electronic Reminder + Paper Letter + Simple AD Form + Info. The total number of patients aged 55+ having an appointment over a period of two months is, with no AD on file, is around 600 per clinic. This brings the total sample size to roughly 3,000.
Experimental Design Details
Not available
Randomization Method
Random number generator (Stata)
Randomization Unit
Randomization will be done at the individual level
Was the treatment clustered?
No
Experiment Characteristics
Sample size: planned number of clusters
5 PSJH primary care clinics; 6 separate arms of intervention of 500 individuals each
Sample size: planned number of observations
3,000 individuals across 5 clinics and 6 separate arms
Sample size (or number of clusters) by treatment arms
500 individuals per arm; 6 separate arms for a total of 3,000 individuals
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
IRB
INSTITUTIONAL REVIEW BOARDS (IRBs)
IRB Name
Providence Health and Services (Oregon)
IRB Approval Date
2019-09-24
IRB Approval Number
STUDY2019000377
Analysis Plan

There are documents in this trial unavailable to the public. Use the button below to request access to this information.

Request Information