Choice Sets for Advance Directives

Not Applicable

Completed

• Conditions: End Stage Renal Disease
• Interventions: Behavioral: Expanded AD Choice; Behavioral: Expanded Life-sustaining Therapy Choice

• Registration Number: NCT02209038
• Lead Sponsor: University of Pennsylvania

Brief Summary

There is a large gap between the care seriously ill patients want and the care they receive. Advance directives (ADs) offer an opportunity for patients to express specific end-of-life preferences to avoid unwanted care. As promising as ADs may be for improving the quality of care near the end of life, rates of AD completion remain low and previous efforts to encourage their completion have had limited success. Principles of behavioral economics, such as the effects of defaults and other framing effects, may offer a novel approach to bridge the gap in end-of-life care. The goal of this study is to test whether the framing effect of expanding choice sets can increase the completion of and specification of choices within advance directives.

Detailed Description

This study has been designed as two sequential randomized trials to test two separate expanded choice set interventions, with the second randomization enrollment being contingent on results from the first. All enrolled subjects will be asked if they would like to complete an advance directive and will have been randomized to receive either an expanded answer choice set or a standard answer choice, as described in detail elsewhere. Only those subjects who express a desire to complete an advance directive from both arms will then be randomized again in a stratified fashion to receive either a standard advance directive or one with an expanded choice set for the decisions regarding life-sustaining therapy, as described in detail elsewhere.

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-07-16
• Study First Submitted QC: 2014-08-04
• Study First Posted: 2014-08-05
• Primary Completion: 2015-07
• Study Completion: 2015-10
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-05
• Last Update Posted: 2016-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 321

Inclusion Criteria

• Age 18 or older
• Proficient in English
• Chronic hemodialysis for minimum 90 days
• Does not currently have a living will

Read More

Exclusion Criteria

• Blindness
• Cognitive impairment that prohibits subject's provision of informed consent

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Expanded AD Choice	Expanded AD Choice	"Would you like to complete an advance directive with the assistance of any person(s) you choose?" 4 answer choices: * Yes, I would like to complete a comprehensive version of an advance directive. * Yes, I would like to complete an expanded version of an advance directive. * Yes, I would like to complete a brief version of an advance directive. * No, I do not wish to complete an advance directive.
Expanded Life-sustaining therapy Choice	Expanded Life-sustaining Therapy Choice	For each hypothetical illness state described in the living will: 4 answer choices: * No, I would not want life support. * Yes, I would want life support. * I would want life support if my doctor believes it could help, but I want to stop receiving life support if at any time my doctor believes it is only delaying the moment of my death. * I do not wish to specify a preference at this time.

Primary Outcome Measures

Name	Time	Method
advance directive	up to 4 weeks	return of a completed and signed advance directive

Secondary Outcome Measures

Name	Time	Method
Medical Outcomes Study Short Form-12v2	baseline and 3 months	change from baseline in Short Form-12v2 score at 3 months
no life-sustaining therapy preference specified	up to 4 weeks	among all patients who complete an AD, the proportion of subjects who choose not to specify a preference for life-sustaining therapy on at least 1 clinical scenario within the AD
McGill Quality of Life Questionnaire	baseline and 3 months	change from baseline in McGill Quality of Life Questionnaire at 3 months
Satisfaction with Decision Scale	baseline	satisfaction with decision scale measured at baseline after decision to complete an advance directive is made
Decisional Conflict Scale	up to 4 weeks	Decisional Conflict Scale measured immediately after completion of an advance directive

Trial Locations

Locations (15)

Willow Grove DaVita; 🇺🇸 Willow Grove, Pennsylvania, United States

PDI Walnut Tower DaVita; 🇺🇸 Philadelphia, Pennsylvania, United States

Abington DaVita; 🇺🇸 Willow Grove, Pennsylvania, United States

South Broad Street; 🇺🇸 Philadelphia, Pennsylvania, United States

Cottman DaVita; 🇺🇸 Philadelphia, Pennsylvania, United States

South Philadelphia DaVita; 🇺🇸 Philadelphia, Pennsylvania, United States

Lourdes-Camden; 🇺🇸 Camden, New Jersey, United States

City Line DaVita; 🇺🇸 Philadelphia, Pennsylvania, United States

Radnor DaVita; 🇺🇸 Radnor, Pennsylvania, United States

Market Street DaVita; 🇺🇸 Philadelphia, Pennsylvania, United States

Philadelphia PMC-Lombard DaVita; 🇺🇸 Philadelphia, Pennsylvania, United States

Philadelphia 42nd Street DaVita; 🇺🇸 Philadelphia, Pennsylvania, United States

Franklin DaVita; 🇺🇸 Philadelphia, Pennsylvania, United States

Callowhill DaVita; 🇺🇸 Philadelphia, Pennsylvania, United States

University City DaVita; 🇺🇸 Philadelphia, Pennsylvania, United States