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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

Initial registration date is when the trial was registered.

It corresponds to when the registration was submitted to the Registry to be reviewed for publication.

First published
September 26, 2019, 11:53 AM EDT

First published corresponds to when the trial was first made public on the Registry after being reviewed.

Locations

Region

Primary Investigator

Affiliation
UC Berkeley

Other Primary Investigator(s)

PI Affiliation
UC Berkeley
PI Affiliation
Amazon Web Services
PI Affiliation
Providence St. Joseph Health

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.4212-2.0
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
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

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Post-Trial

Post Trial Information

Study Withdrawal

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Intervention

Is the intervention completed?
Yes
Intervention Completion Date
February 29, 2020, 12:00 +00:00
Data Collection Complete
Yes
Data Collection Completion Date
February 29, 2020, 12:00 +00:00
Final Sample Size: Number of Clusters (Unit of Randomization)
1200
Was attrition correlated with treatment status?
No
Final Sample Size: Total Number of Observations
1200
Final Sample Size (or Number of Clusters) by Treatment Arms
168 control; 207 electronic only; 210 electronic and paper letter; 212 electronic, paper letter, and traditional AD form; 202 electronic, paper letter, and short AD form; 201 electronic, paper letter, AD short form, and brochure
Data Publication

Data Publication

Is public data available?
No

Program Files

Program Files
No
Reports, Papers & Other Materials

Relevant Paper(s)

Reports & Other Materials

Description
Journal Article
Citation
Hong N, Root A, Handel B. The Role of Information and Nudges on Advance Directives and End-of-Life Planning: Evidence From a Randomized Trial. Medical Care Research and Review. 2023;80(3):283-292. doi:10.1177/10775587231157800