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Behavioral Economics for Advance Care Options (BEACON)

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ClinicalTrials.gov Identifier: NCT02100566
Recruitment Status : Active, not recruiting
First Posted : April 1, 2014
Last Update Posted : October 11, 2016
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief Summary:

People with life-limiting illness often receive more aggressive healthcare than desired including costly procedures that provide little medical benefit. Advance Directives (AD) can reduce this effect but various factors limit their adoption.

A randomized trial will target hospitalized patients with a serious, life limiting illness to test if the behavioral economics principles of endowment (possessing something) and focusing (featuring something important to patients) can motivate AD completion. Investigators will examine if offering patients an AD by default, in combination with framing the rationale for AD completion (emphasizing patient control or caregiver burden) improves AD completion and family conversation compared to a no-intervention group. The study hypothesis is to determine if rates of AD completion and family conversations will be highest among patients receiving the intervention focused on reduced caregiver burden; and if the two intervention groups will have higher rates of both than the control group.

The investigators suspect that a small change in how patient information is framed (endowment and focusing used in tandem) will potentially leverage large increases in AD completion and that targeting HHC patients allows AD discussions early in the disease trajectory when they can participate in care decisions.


Condition or disease Intervention/treatment
End of Life Care Behavioral: Counseling (Care giver burden focus) Behavioral: Counseling (patient autonomy focus)

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Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Behavioral Economics for Advance Care OptioNs
Study Start Date : April 2014
Primary Completion Date : October 2016
Estimated Study Completion Date : October 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Behavioral Counseling
Provide an advance directive document to patients along with counseling that either focuses on care giver burden or on patient autonomy.
Behavioral: Counseling (Care giver burden focus)
An advance directive (AD) document is provided to the patient along with counseling that focuses on care giver burden as the reason for adoption of the AD.
Other Name: Focusing effect
Behavioral: Counseling (patient autonomy focus)
An advance directive (AD) document is provided to the patient along with counseling that focuses on patient autonomy (control) as the reason for adoption of the AD.
Other Name: Focusing effect
No Intervention: Standard AD
The topic of advance directives (AD) is introduced but patient receives an AD document only upon request.


Outcome Measures

Primary Outcome Measures :
  1. Advance directive document completion [ Time Frame: 1 month ]
    The number of advance directive documents completed within one month of enrollment.


Secondary Outcome Measures :
  1. Advance Directive document completion [ Time Frame: 1 year ]
    The number of advance directive documents completed within one year of enrollment.


Other Outcome Measures:
  1. Advance directive communication [ Time Frame: 1 year ]
    The number of patients who discuss advance directives with their family or care giver within one year of enrollment.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 50 years or older
  • One or more of the following:
  • Chronic obstructive pulmonary disease
  • End stge renal disease
  • Peripheral vascular disease
  • NYHA class II or V heart failure
  • Cancer
  • Neuromuscular / movement disorder

Exclusion Criteria:

  • Patient referred to palliative care
  • Patient has advance directive
  • Patient has impaired decision making ability
  • Patient previously enrolled in this study
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02100566


Locations
United States, Michigan
Genesys Regional Medical Center
Grand Blanc, Michigan, United States, 48439
Sponsors and Collaborators
Genesys Regional Medical Center
University of Pennsylvania
Robert Wood Johnson Foundation
Investigators
Principal Investigator: Mark E Vogel, PhD Genesys Regional Medical Center
Principal Investigator: Scott Halpern, MD, PhD University of Pennsylvania
Study Director: Kimberly R Barber, PhD Genesys Regional Medical Director
More Information

Responsible Party: Mark Vogel, PhD, Director of Behavioral Science and Psychology, Genesys Regional Medical Center
ClinicalTrials.gov Identifier: NCT02100566     History of Changes
Other Study ID Numbers: RWJ 71476
First Posted: April 1, 2014    Key Record Dates
Last Update Posted: October 11, 2016
Last Verified: October 2016

Keywords provided by Mark Vogel, PhD, Genesys Regional Medical Center:
Advance Directive