NCT02209038

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
321

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2014

Geographic Reach
1 country

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

July 16, 2014

Completed
20 days until next milestone

First Posted

Study publicly available on registry

August 5, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

January 7, 2016

Status Verified

January 1, 2016

Enrollment Period

1 year

First QC Date

July 16, 2014

Last Update Submit

January 5, 2016

Conditions

Keywords

end stage renal diseasehemodialysisdialysis

Outcome Measures

Primary Outcomes (1)

  • advance directive

    return of a completed and signed advance directive

    up to 4 weeks

Secondary Outcomes (5)

  • Medical Outcomes Study Short Form-12v2

    baseline and 3 months

  • McGill Quality of Life Questionnaire

    baseline and 3 months

  • Satisfaction with Decision Scale

    baseline

  • Decisional Conflict Scale

    up to 4 weeks

  • no life-sustaining therapy preference specified

    up to 4 weeks

Other Outcomes (5)

  • hospital admissions

    up to 4 years

  • ICU admissions

    up to 4 years

  • Hospice admission

    up to 4 years

  • +2 more other outcomes

Study Arms (4)

Expanded AD Choice

EXPERIMENTAL

"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.

Behavioral: Expanded AD Choice

Standard AD Choice

NO INTERVENTION

"Would you like to complete an advance directive with the assistance of any person(s) you choose?" 2 answer choices: * Yes, I would like to complete an AD. * No, I do not wish to complete an advance directive.

Expanded Life-sustaining therapy Choice

EXPERIMENTAL

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.

Behavioral: Expanded Life-sustaining Therapy Choice

Standard Life-sustaining Therapy Choice

NO INTERVENTION

For each hypothetical illness state described in the living will: 3 answer choices: * No, I would not want life support. * Yes, I would want life support. * I do not wish to specify a preference at this time.

Interventions

Expanded AD Choice
Expanded Life-sustaining therapy Choice

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Lourdes-Camden

Camden, New Jersey, 08103, United States

Location

Market Street DaVita

Philadelphia, Pennsylvania, 19104, United States

Location

Philadelphia 42nd Street DaVita

Philadelphia, Pennsylvania, 19104, United States

Location

Philadelphia PMC-Lombard DaVita

Philadelphia, Pennsylvania, 19104, United States

Location

University City DaVita

Philadelphia, Pennsylvania, 19104, United States

Location

Franklin DaVita

Philadelphia, Pennsylvania, 19106, United States

Location

PDI Walnut Tower DaVita

Philadelphia, Pennsylvania, 19107, United States

Location

Callowhill DaVita

Philadelphia, Pennsylvania, 19123, United States

Location

City Line DaVita

Philadelphia, Pennsylvania, 19131, United States

Location

South Broad Street

Philadelphia, Pennsylvania, 19146, United States

Location

Cottman DaVita

Philadelphia, Pennsylvania, 19149, United States

Location

South Philadelphia DaVita

Philadelphia, Pennsylvania, United States

Location

Radnor DaVita

Radnor, Pennsylvania, 19087, United States

Location

Abington DaVita

Willow Grove, Pennsylvania, 19090, United States

Location

Willow Grove DaVita

Willow Grove, Pennsylvania, 19090, United States

Location

Related Publications (1)

  • Courtright KR, Madden V, Gabler NB, Cooney E, Kim J, Herbst N, Burgoon L, Whealdon J, Dember LM, Halpern SD. A Randomized Trial of Expanding Choice Sets to Motivate Advance Directive Completion. Med Decis Making. 2017 Jul;37(5):544-554. doi: 10.1177/0272989X16663709. Epub 2016 Aug 10.

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Scott D Halpern, MD, PhD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR
  • Katherine R Courtright, MD

    University of Pennsylvania

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 16, 2014

First Posted

August 5, 2014

Study Start

July 1, 2014

Primary Completion

July 1, 2015

Study Completion

October 1, 2015

Last Updated

January 7, 2016

Record last verified: 2016-01

Locations