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

Last registered on July 01, 2018

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
Last updated
July 01, 2018, 5:01 PM EDT

Locations

Region

Primary Investigator

Affiliation
UC Berkeley

Other Primary Investigator(s)

PI Affiliation
Providence St. Joseph Health
PI Affiliation
UC Berkeley

Additional Trial Information

Status
On going
Start date
2018-06-27
End date
2018-10-31
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
, , 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
, et al. 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 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
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