The Influence of Default Options in Advance Directives

NCT01346176 | Completed Results DMC

• 1 other identifier: 810894
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

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

Conditions

Advance Care Planning

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Patient Satisfaction With Advance Care Planning.

  Two months after AD completion

Study Arms (3)

Positive default

EXPERIMENTAL

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

Negative default

EXPERIMENTAL

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

Forced Choice

EXPERIMENTAL

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

Other: Advance Directive Forms

Interventions

Advance Directive Forms 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; Negative default; Positive default

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Pennsylvania: lead
• University of Pittsburgh: collaborator

Study Sites (1)

University of Pennsylvania School of Medicine

Philadelphia, Pennsylvania, 19104, United States

Location

Limitations and Caveats

1. This is a small sample from a single health system 2. Limited to patients with serious thoracic diseases 3. We did not randomly assign the ordering of options within the standard advance directive

Results Point of Contact

• Title: Scott D. Halpern
• Organization: University of Pennsylvania School of Medicine

elcooney@exchange.upenn.edu

215.573.9461

Study Officials

• Scott D. Halpern, MD, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: April 29, 2011
• First Posted: May 2, 2011
• Study Start: April 1, 2010
• Primary Completion: March 1, 2012
• Study Completion: August 1, 2012
• Last Updated: February 3, 2016
• Results First Posted: February 3, 2016

Record last verified: 2016-01

Locations

US (1)