The Influence of Default Options in Advance Directives

This study has been completed.
Sponsor:
Collaborator:
University of Pittsburgh
Information provided by (Responsible Party):
Scott Halpern, University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01346176
First received: April 29, 2011
Last updated: January 4, 2016
Last verified: January 2016
  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:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Proportion of Subjects Who Select Palliative Care Options [ 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: Two months after AD completion ] [ Designated as safety issue: No ]
    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.


Enrollment: 132
Study Start Date: April 2010
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Pennsylvania
University of Pennsylvania School of Medicine
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
University of Pittsburgh
Investigators
Principal Investigator: Scott D. Halpern, MD, PhD University of Pennsylvania
  More Information

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
Results First Received: December 21, 2012
Last Updated: January 4, 2016
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on May 26, 2016