Behavioral Economics for Advance Care Options (BEACON)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2014 by Genesys Regional Medical Center
Sponsor:
Information provided by (Responsible Party):
Mark Vogel, PhD, Genesys Regional Medical Center
ClinicalTrials.gov Identifier:
NCT02100566
First received: March 27, 2014
Last updated: NA
Last verified: March 2014
History: No changes posted
  Purpose

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 home health care (HHC) patients with a serious, life limiting illness to test if the behavioral economics principles of endowment (possessing something) and focusing (featuring something important to you) can motivate AD completion. We will investigate 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.

We 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 Intervention
End of Life Care
Behavioral: Counseling (Care giver burden focus)
Behavioral: Counseling (patient autonomy focus)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Behavioral Economics for Advance Care OptioNs

Resource links provided by NLM:


Further study details as provided by Genesys Regional Medical Center:

Primary Outcome Measures:
  • Advance directive document completion [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    The number of advance directive documents completed within one month of enrollment.


Secondary Outcome Measures:
  • Advance Directive document completion [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    The number of advance directive documents completed within one year of enrollment.


Other Outcome Measures:
  • Advance directive communication [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    The number of patients who discuss advance directives with their family or care giver within one year of enrollment.


Estimated Enrollment: 350
Study Start Date: April 2014
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
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
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: NCT02100566

Contacts
Contact: Mark A Vogel, PhD 810-605-4616 mvogel@genesys.org
Contact: Kimberly R Barber, PhD 810-606-7724 kbarber@genesys.org

Locations
United States, Michigan
Reverence Home Health Care Not yet recruiting
Grand Blanc, Michigan, United States, 48439
Contact: Mark Vogel, PhD    810-605-4616    mvogel@genesys.org   
Contact: Kimberly Barber, PhD    810-606-7724    kbarber@genesys.org   
Principal Investigator: Mark Vogel, PhD         
Sponsors and Collaborators
Genesys Regional Medical Center
Investigators
Principal Investigator: Mark A Vogel, PhD Genesys Regional Medical Center
  More Information

No publications provided

Responsible Party: Mark Vogel, PhD, Behavioral Medicine Director, Genesys Regional Medical Center
ClinicalTrials.gov Identifier: NCT02100566     History of Changes
Other Study ID Numbers: RWJ 71476
Study First Received: March 27, 2014
Last Updated: March 27, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Genesys Regional Medical Center:
Advance Directive

ClinicalTrials.gov processed this record on August 01, 2014