Completed

Impact of Default Options in Advance Directives on End-of-Life Care Choices for Veterans at High Risk for Critical Illness

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Study Aim

This study aims to evaluate how the setting of defaults in Advance Directives influences your choice towards comfort-oriented care plans, specifically for veterans at high risk for critical illness.

What is being tested

Comfort Default AD forms

+ Life Extension Default AD forms

+ Standard Default AD forms

Other
Who is being recruted

Cardiovascular Diseases+12

+ Chronic Disease

+ Heart Diseases

Over 18 Years
+16 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Services Research Study

Interventional
Study Start: March 2013
See protocol details

Summary

Principal SponsorCorporal Michael J. Crescenz VA Medical Center
Last updated: June 30, 2015
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2013

Actual date on which the first participant was enrolled.

This clinical trial focuses on understanding how 'default options' in Advance Directives (ADs) impact the end-of-life care choices of Veterans who are at high risk for critical illness. Advance Directives are legal documents that outline a person's preferences for medical care if they become unable to make decisions. The study aims to see how different default options in these documents can influence the choices made by these Veterans. The ultimate goal is to understand how these choices might affect the time Veterans spend in the hospital or ICU, and their overall satisfaction with end-of-life care planning. The trial is divided into three groups, each with different default options in their ADs. The main goal is to evaluate how many Veterans in each group choose a care plan that prioritizes comfort over life-extending treatments like mechanical ventilation and dialysis. This study doesn't involve any physical treatments or procedures, but instead, it's about understanding how the presentation of choices can impact decisions about care. The results of this study could potentially improve the way end-of-life care is planned and provided to Veterans.

NCT01817686
Principal SponsorCorporal Michael J. Crescenz VA Medical Center
Last updated: June 30, 2015
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

62 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Services Research Study

These studies look at how healthcare is delivered, managed, and organized. They aim to improve care quality, patient experience, and access to treatment.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Cardiovascular DiseasesChronic DiseaseHeart DiseasesLung DiseasesLung Diseases, ObstructivePathologic ProcessesPulmonary FibrosisRespiratory Tract DiseasesPathological Conditions, Signs and SymptomsLung Diseases, InterstitialDisease AttributesHeart FailureNeoplasmsPulmonary Disease, Chronic ObstructiveIdiopathic Pulmonary Fibrosis

Criteria

10 inclusion criteria required to participate
Age > 18 years
Any stage 3B or 4 solid tumor AND/OR
Chronic Obstructive Pulmonary Disease (COPD) with severe or very severe airflow obstruction on pulmonary function testing and or receiving or eligible to receive long-term oxygen therapy AND/OR
Congestive Heart Failure (CHF) either New York Heart Association NYHA) class IV or NYHA class III plus 1 hospitalization in the past year
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6 exclusion criteria prevent from participating
Cognitive impairment necessitating proxy consent
Diseases for which life-extending medical therapies may be available
Inability to speak and/or read English proficiently
New clinic patients meeting the clinic provider for the first time
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
ADs with pre-selected defaults that focus on providing comfort at end-of-life.

Group II

Experimental
ADs with pre-selected defaults that focus on extending life.

Group III

Experimental
ADs without pre-selected defaults.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Philadelphia Veterans Affairs Medical Center

Philadelphia, United StatesOpen Philadelphia Veterans Affairs Medical Center in Google Maps
CompletedOne Study Center