Deferring Agency at End-of-Life: The Role of Information and Advance Directives

Last registered on July 01, 2018
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Pre-Trial

Trial Information

General Information

Title
Deferring Agency at End-of-Life: The Role of Information and Advance Directives
RCT ID
AEARCTR-0003038
Initial registration date
June 29, 2018

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
July 01, 2018, 5:01 PM EDT

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

Locations

Country
United States of America
Region

Primary Investigator

Name
Allyson Root
Affiliation
UC Berkeley
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Other Primary Investigator(s)

PI Name
Callie Scott
PI Affiliation
Providence St. Joseph Health
Contact Investigator
PI Name
Ben Handel
PI Affiliation
UC Berkeley
Contact Investigator

Additional Trial Information

Status
On going
Start date
2018-06-27
End date
2018-10-31
Keywords
Health
Additional Keywords
Advance Directives
JEL code(s)
I12 Health Behavior
Secondary IDs
Abstract
We propose to pilot a randomized evaluation of strategies to facilitate advance directive completion in the 65+ patient population of our partner, Providence St. Joseph Health. Despite the significant economic and personal implications of end-of-life health care decisions, many people 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. Our trial will pilot two interventions with roughly 5,000 patients, with intention to scale the evaluation to include over 70,000 patients across 64 clinics. We will evaluate the effects of (i) an in-person drive to facilitate advance directive completion, (ii) an informational video on advance directives that will be electronically distributed to patients, and (iii) the interaction of these two interventions. 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, Allyson Root and Callie Scott. 2018. "Deferring Agency at End-of-Life: The Role of Information and Advance Directives." AEA RCT Registry. July 01. https://doi.org/10.1257/rct.3038-1.0
Former Citation
Handel, Ben, Allyson Root and Callie Scott. 2018. "Deferring Agency at End-of-Life: The Role of Information and Advance Directives." AEA RCT Registry. July 01. https://www.socialscienceregistry.org/trials/3038/history/31380
Sponsors & Partners

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Experimental Details

Interventions

Intervention(s)
After the survey completion date, we will proceed with the interventions: (1) a series of Advance Directive Drives at one of the two selected clinics (Clinic A) and (2) a distribution of a link to an ACP Decisions video via email to a randomly selected 50% of patients with an email on file who meet the inclusion criteria in the two selected clinics (Clinic A and Clinic B). All patients in the two clinics with an email on file will be contacted with an email message and patients without an email will be contacted by paper letter.
Intervention (Hidden)
AD Drive Intervention
Clinic A will host a series of three AD drives, where patients can ask questions about ACP, have a notary or appropriate witness validate the AD, and receive assistance in adding the AD to their EMR. The drives will be held in an open-house style (no appointment needed) on three different days. Patients at these clinics will receive an email message with information about the drives and a reminder to complete and upload an AD. Patients without an email on file will receive a mailed paper letter version of the message. The AD drive will be open to everyone going through the selected clinic, but only patients meeting study inclusion/exclusion criteria will receive the communication intervention. Patients at Clinic B will only receive a reminder to complete an AD.

Information Intervention
Patients at both clinics will be randomly assigned at the individual level to receive electronic access (via a link in an email message) to a video and two informational sheets from ACP Decisions with instructions for watching. The ACP Decisions (https://www.acpdecisions.org/) videos provide evidence-based explanations of key topics relevant to ACP and the completion of ADs, available in multiple languages (El-Jawahri et al. 2015). The video to be disseminated is titled “Advance Care Planning for Healthy Adults, All Chapters Reduced Length”, in addition to two informational sheets titled “A Guide to End of Life Choices” and “A Guide to Feeding Tubes”.
Intervention Start Date
2018-07-09
Intervention End Date
2018-07-20

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
This pilot experiment will seek to answer the following research question: What is the impact of electronic provision of information (video and brochures from ACP Decisions) about end-of-life decision making (Intervention B) on whether a patient aged 65+ completes and uploads an AD to their electronic medical record (EMR), for patients who do not have an uploaded, complete AD at the beginning of the study?

Randomization of the video intervention will be done at the individual patient level, stratified by clinic, but limited to patients who have a unique email address on file and do not have an AD already uploaded to the EMR. Participants will not know whether they are part of a study (waiver of consent). In addition to ITT, will use randomization as an instrument for watching the video (defined as clicking through the link).

Experimental Design Details
Randomization Method
Random number generator (Stata)
Randomization Unit
Individual
Was the treatment clustered?
No

Experiment Characteristics

Sample size: planned number of clusters
Approximately 5000 patients 65+ across the two clinics, 13% have ADs already uploaded and 30% do not have an email on file, so the video intervention will be randomized across 2968 patients, stratified by clinic.
Sample size: planned number of observations
Approximately 5000 patients 65+ across the two clinics, 13% have ADs already uploaded and 30% do not have an email on file, so the video intervention will be randomized across 2968 patients, stratified by clinic.
Sample size (or number of clusters) by treatment arms
Clinic A- No Video: 814, Video: 815
Clinic B- No Video: 669, Video: 670
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
2.5 percentage point increase in ADs uploaded in 4 weeks after intervention outreach
Supporting Documents and Materials
IRB

Institutional Review Boards (IRBs)

IRB Name
Providence Health and Services (Oregon)
IRB Approval Date
2018-06-01
IRB Approval Number
STUDY2018000241
Analysis Plan

Analysis Plan Documents

Pilot Pre-Analysis Plan

MD5: 6a302784723cbb1c742dd50ca98e5d7f

SHA1: 39ab5a5c3270274001ca83c6e74f0c60d85e6214

Uploaded At: June 29, 2018

Post-Trial

Post Trial Information

Study Withdrawal

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Intervention

Is the intervention completed?
No
Data Collection Complete
Data Publication

Data Publication

Is public data available?
No

Program Files

Program Files
Reports, Papers & Other Materials

Relevant Paper(s)

Reports & Other Materials