The Influence of Default Options in Advance Directives - Full Text View

Purpose

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

Condition	Intervention
Advance Care Planning	Other: Advance Directive Forms

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Health Services Research
Official Title:	The Influence of Default Options in Advance Directives for Older Patients: A Pilot Study

Resource links provided by NLM:

MedlinePlus related topics: Advance Directives

U.S. FDA Resources

Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:

Proportion of subjects who select palliative care options compared to those who request aggressive treatment [ Time Frame: 6 months ] [ Designated as safety issue: No ]
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:

Patient satisfaction with advance care planning. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
To assess the relationship between AD completion itself and satisfaction, the a member of the research team will conduct similar interviews among an equally sized, random sample of control patients meeting our eligibility criteria but who were not enrolled due to time constraints. These control patients will be made aware of the study via telephone by a research associate. If they wish to participate, they will be administered a satisfaction questionnaire.

Estimated Enrollment:	220
Study Start Date:	April 2010
Estimated Study Completion Date:	August 2012
Primary Completion Date:	March 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

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.

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01346176

Contacts

Contact: Elizabeth Cooney, MPH	215-573-9461	elcooney@exchange.upenn.edu
Contact: Ashley Kraybill, BA		akray@mail.med.upenn.edu

Locations

United States, Pennsylvania
University of Pennsylvania School of Medicine	Recruiting
Philadelphia, Pennsylvania, United States, 19104
Principal Investigator: Scott D. Halpern, MD, PhD

Sponsors and Collaborators

University of Pennsylvania

University of Pittsburgh

Investigators

Principal Investigator:

Scott D. Halpern, MD, PhD

University of Pennsylvania

More Information

No publications provided

Responsible Party:	Scott Halpern, Assistant Professor of Medicine, University of Pennsylvania
ClinicalTrials.gov Identifier:	NCT01346176 History of Changes
Other Study ID Numbers:	810894
Study First Received:	April 29, 2011
Last Updated:	July 19, 2012
Health Authority:	United States: Institutional Review Board

ClinicalTrials.gov processed this record on May 16, 2013