Skip to main content
OpenTrials
Completed

NCT Number: NCT02209038

Choice Sets for Advance Directives

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

End Stage Renal Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lourdes-Camden, Camden, New Jersey, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Expanded AD Choice

Behavioral

Expanded Life-sustaining Therapy Choice

Behavioral

Primary outcomes

  1. advance directive

    Time frame: up to 4 weeks

    return of a completed and signed advance directive

Secondary outcomes

  1. Medical Outcomes Study Short Form-12v2

    Time frame: baseline and 3 months

    change from baseline in Short Form-12v2 score at 3 months

  2. McGill Quality of Life Questionnaire

    Time frame: baseline and 3 months

    change from baseline in McGill Quality of Life Questionnaire at 3 months

  3. Satisfaction with Decision Scale

    Time frame: baseline

    satisfaction with decision scale measured at baseline after decision to complete an advance directive is made

  4. Decisional Conflict Scale

    Time frame: up to 4 weeks

    Decisional Conflict Scale measured immediately after completion of an advance directive

  5. no life-sustaining therapy preference specified

    Time frame: 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

Other outcomes

  1. hospital admissions

    Time frame: up to 4 years

    number of hospital admissions from enrollment to study completion

  2. ICU admissions

    Time frame: up to 4 years

    number of ICU admissions from enrollment to study completion

  3. Hospice admission

    Time frame: up to 4 years

  4. death

    Time frame: up to 4 years

  5. demographics of patients (ineligible) whom already completed a living will

    Time frame: enrollment

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Aug 5, 2014
Registry last updated
Jan 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.