The Influence of Default Options in Advance Directives

Not Applicable

Completed

• Conditions: Advance Care Planning
• Interventions: Other: Advance Directive Forms

• Registration Number: NCT01346176
• Lead Sponsor: University of Pennsylvania

Brief Summary

The investigators aim to assess the influence of default options in advance directives on older patients selections of life- extending therapies and to determine whether alerting patients to the spectrum of possible default options in advance directives influences their selections of life-extending therapies by manipulating the default options of advance directives given to patients in with severe respiratory disease

Detailed Description

The project is designed to document that default options influence terminally ill patients end-of-life decisions (in this case, adults with advance forms of lung disease) and that our team can recruit and retain patients in a study of advance care planning. In addition, because a larger-scale randomized clinical trial will require that the investigators alert participants to the range of possible default options, the investigators must also determine the effects that this alerting will have on their selections of life-extending therapies. Therefore, the investigators seek to achieve three aims: (1) assess the influence of default options in advance directives on patients selections of life-extending therapies; (2) determine whether alerting patients to the spectrum of possible default options in advance directives influences their selections of life extending therapies; and (3) document the feasibility of recruiting and retaining patients with advanced lung diseases from university-based clinical settings into a randomized trial of default options in advance directives.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2011-04-29
• Study First Submitted QC: 2011-04-29
• Study First Posted: 2011-05-02
• Primary Completion: 2012-03
• Study Completion: 2012-08
• Results First Submitted: 2012-12-21
• Status Verified: 2016-01
• Results First Submitted QC: 2016-01-04
• Last Update Submitted: 2016-01-04
• Results First Posted: 2016-02-03
• Last Update Posted: 2016-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 132

Inclusion Criteria

• Diagnosis of chronic obstructive pulmonary disease (COPD), idiopathic pulmonary fibrosis (IPF), non-small-cell lung cancer, or other interstitial or fibrotic lung disease
• Neither listed for nor considering solid organ transplantation
• Anticipated survival of less than 2 years
• Must be fluent and literate in English

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Exclusion Criteria

• Diagnosis of small-cell lung cancer or other respiratory diseases for which life extending medical therapies may be available

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Positive default	Advance Directive Forms	Patients in this arm will receive AD forms where specific life-extending interventions will be provided unless patients specifically opt-out from such selections
Negative default	Advance Directive Forms	Patients in this arm will receive AD forms where specific life-extending interventions will not be provided unless patients specifically opt-into such selections
Forced Choice	Advance Directive Forms	Patients in this arm will receive AD forms in which they must actively choose whether to receive each intervention.

Primary Outcome Measures

Name	Time	Method
Proportion of Subjects Who Select Palliative Care Options	6 months	The primary outcome variable will be the proportion of subjects that select palliative care options compared to the those who request aggressive treatment in each study arm. We will analyze the effects of manipulating default options and delays in alerting subjects to the presence of multiple default options on each selection in the ADs in order to see how default options influence decisions on general treatment goals and instructions for specific procedures.

Secondary Outcome Measures

Name	Time	Method
Patient Satisfaction With Advance Care Planning.	Two months after AD completion	Patients' satisfaction with their advance care planning was assessed two months after they completed their ADs. One of two authors blinded to patients' group assignments contacted patients by phone and administered a satisfaction survey based on the Canadian Healthcare Evaluation Project (CANHELP) questionnaire. This thirteen-item questionnaire has been validated for assessing satisfaction with end-of-life care planning. Patients were asked to indicate satisfaction with various parts of advance care planning (e.g. decisions about the use of life sustaining technologies including CPR or cardiopulmonary resuscitation, breathing machines, and dialysis) on a scale from 1 to 5, where 1 means not at all satisfied and 5 means completely satisfied. The overall average across the 13 item scale in each group is presented in the results below.

Trial Locations

Locations (1)

University of Pennsylvania School of Medicine; 🇺🇸 Philadelphia, Pennsylvania, United States