The Influence of Default Options in Advance Directives

NCT ID: NCT01346176

Last Updated: 2016-02-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 132 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2012-08-31

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.

Conditions

Advance Care Planning

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

Advance Directive Forms

Intervention Type: OTHER

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.

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

Group Type: EXPERIMENTAL

Advance Directive Forms

Intervention Type: OTHER

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.

Forced Choice

Patients in this arm will receive AD forms in which they must actively choose whether to receive each intervention.

Group Type: EXPERIMENTAL

Advance Directive Forms

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pittsburgh

OTHER

Sponsor Role: collaborator

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Scott Halpern

Assistant Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Scott D. Halpern, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

University of Pennsylvania School of Medicine

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

810894

Identifier Type: -

Identifier Source: org_study_id