The Influence of Default Options in Advance Directives

The Influence of Default Options in Advance Directives for Older Patients: A Pilot Study

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

Study Overview

• Status: Completed
• Conditions: Advance Care Planning
• Intervention / Treatment: Other: Advance Directive Forms

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.

• Study Type: Interventional
• Enrollment (Actual): 132
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Positive default; Patients in this arm will receive AD forms where specific life-extending interventions will be provided unless patients specifically opt-out from such selections	Other: Advance Directive Forms; Consenting subjects will be randomly assigned to one of 3 study arms. Subjects will receive a different AD form based on which arm they have been randomly assigned. Once a completed AD form is received, a debriefing session will be held to alert patients to exactly how the 3 ADs used in the study differ. Once patients are fully informed about the variations in the ADs, they will have an opportunity to change their AD selections prior to finalizing them as a part of their medical record. A final satisfaction interview will take place with a research associate who will contact patients via telephone to administer a satisfaction questionnaire.
Experimental: Negative default; Patients in this arm will receive AD forms where specific life-extending interventions will not be provided unless patients specifically opt-into such selections	Other: Advance Directive Forms; Consenting subjects will be randomly assigned to one of 3 study arms. Subjects will receive a different AD form based on which arm they have been randomly assigned. Once a completed AD form is received, a debriefing session will be held to alert patients to exactly how the 3 ADs used in the study differ. Once patients are fully informed about the variations in the ADs, they will have an opportunity to change their AD selections prior to finalizing them as a part of their medical record. A final satisfaction interview will take place with a research associate who will contact patients via telephone to administer a satisfaction questionnaire.
Experimental: Forced Choice; Patients in this arm will receive AD forms in which they must actively choose whether to receive each intervention.	Other: Advance Directive Forms; Consenting subjects will be randomly assigned to one of 3 study arms. Subjects will receive a different AD form based on which arm they have been randomly assigned. Once a completed AD form is received, a debriefing session will be held to alert patients to exactly how the 3 ADs used in the study differ. Once patients are fully informed about the variations in the ADs, they will have an opportunity to change their AD selections prior to finalizing them as a part of their medical record. A final satisfaction interview will take place with a research associate who will contact patients via telephone to administer a satisfaction questionnaire.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Subjects Who Select Palliative Care Options	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.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Satisfaction With Advance Care Planning.	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.	Two months after AD completion

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: University of Pittsburgh
• Investigators: Principal Investigator: Scott D. Halpern, MD, PhD, University of Pennsylvania

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (Actual): March 1, 2012
• Study Completion (Actual): August 1, 2012

Study Registration Dates

• First Submitted: April 29, 2011
• First Submitted That Met QC Criteria: April 29, 2011
• First Posted (Estimate): May 2, 2011

Study Record Updates

• Last Update Posted (Estimate): February 3, 2016
• Last Update Submitted That Met QC Criteria: January 4, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: 810894