Behavioral Economics for Advance Care Options

NCT02100566 | Completed

• 1 other identifier: RWJ 71476
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

End of Life Care

Keywords

Advance Directive

Outcome Measures

Primary Outcomes (1)

• Advance directive document completion

  The number of advance directive documents completed within one month of enrollment.

  1 month

Secondary Outcomes (1)

• Advance Directive document completion

  1 year

Other Outcomes (1)

• Advance directive communication

  1 year

Study Arms (2)

Behavioral Counseling

EXPERIMENTAL

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); Behavioral: Counseling (patient autonomy focus)

Standard AD

NO INTERVENTION

The topic of advance directives (AD) is introduced but patient receives an AD document only upon request.

Interventions

Counseling (Care giver burden focus) BEHAVIORAL

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.

Also known as: Focusing effect

Behavioral Counseling

Counseling (patient autonomy focus) BEHAVIORAL

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.

Also known as: Focusing effect

Behavioral Counseling

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Ascension Health: lead
• University of Pennsylvania: collaborator
• Robert Wood Johnson Foundation: collaborator

Study Sites (1)

Genesys Regional Medical Center

Grand Blanc, Michigan, 48439, United States

Location

MeSH Terms

Interventions

Counseling

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Mark E Vogel, PhD

  Ascension Health

  PRINCIPAL INVESTIGATOR

• Scott Halpern, MD, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

• Kimberly R Barber, PhD

  Genesys Regional Medical Director

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Behavioral Science and Psychology

Study Record Dates

• First Submitted: March 27, 2014
• First Posted: April 1, 2014
• Study Start: April 1, 2014
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2019
• Last Updated: July 27, 2021

Record last verified: 2021-07

Locations

US (1)