Choice Sets for Advance Directives

End Stage Renal Disease Clinical Trial

Official title:

A Randomized Trial of Expanded Choice Sets to Increase Completion of Advance Directives

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02209038
• Other study ID #: 820002
• Status: Completed
• Phase: N/A
• First received: July 16, 2014
• Last updated: January 5, 2016
• Start date: July 2014
• Est. completion date: October 2015

Study information

• Verified date: January 2016
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 321
• Est. completion date: October 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age 18 or older

• Proficient in English

• Chronic hemodialysis for minimum 90 days

• Does not currently have a living will

Exclusion Criteria:

• Blindness

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Diseases
• Kidney Failure, Chronic

Intervention

Behavioral:
• Expanded AD Choice

• Expanded Life-sustaining Therapy Choice

Locations

Country	Name	City	State
United States	Lourdes-Camden	Camden	New Jersey
United States	Callowhill DaVita	Philadelphia	Pennsylvania
United States	City Line DaVita	Philadelphia	Pennsylvania
United States	Cottman DaVita	Philadelphia	Pennsylvania
United States	Franklin DaVita	Philadelphia	Pennsylvania
United States	Market Street DaVita	Philadelphia	Pennsylvania
United States	PDI Walnut Tower DaVita	Philadelphia	Pennsylvania
United States	Philadelphia 42nd Street DaVita	Philadelphia	Pennsylvania
United States	Philadelphia PMC-Lombard DaVita	Philadelphia	Pennsylvania
United States	South Broad Street	Philadelphia	Pennsylvania
United States	South Philadelphia DaVita	Philadelphia	Pennsylvania
United States	University City DaVita	Philadelphia	Pennsylvania
United States	Radnor DaVita	Radnor	Pennsylvania
United States	Abington DaVita	Willow Grove	Pennsylvania
United States	Willow Grove DaVita	Willow Grove	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	hospital admissions	number of hospital admissions from enrollment to study completion	up to 4 years	No
Other	ICU admissions	number of ICU admissions from enrollment to study completion	up to 4 years	No
Other	Hospice admission		up to 4 years	No
Other	death		up to 4 years	No
Other	demographics of patients (ineligible) whom already completed a living will		enrollment	No
Primary	advance directive	return of a completed and signed advance directive	up to 4 weeks	No
Secondary	Medical Outcomes Study Short Form-12v2	change from baseline in Short Form-12v2 score at 3 months	baseline and 3 months	No
Secondary	McGill Quality of Life Questionnaire	change from baseline in McGill Quality of Life Questionnaire at 3 months	baseline and 3 months	No
Secondary	Satisfaction with Decision Scale	satisfaction with decision scale measured at baseline after decision to complete an advance directive is made	baseline	No
Secondary	Decisional Conflict Scale	Decisional Conflict Scale measured immediately after completion of an advance directive	up to 4 weeks	No
Secondary	no life-sustaining therapy preference specified	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	up to 4 weeks	No