Behavioral Economics for Advance Care Options (BEACON)
Primary Purpose
End of Life Care
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Counseling (Care giver burden focus)
Counseling (patient autonomy focus)
Sponsored by
About this trial
This is an interventional health services research trial for End of Life Care focused on measuring Advance Directive
Eligibility 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
Sites / Locations
- Genesys Regional Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Behavioral Counseling
Standard AD
Arm Description
Provide an advance directive document to patients along with counseling that either focuses on care giver burden or on patient autonomy.
The topic of advance directives (AD) is introduced but patient receives an AD document only upon request.
Outcomes
Primary Outcome Measures
Advance directive document completion
The number of advance directive documents completed within one month of enrollment.
Secondary Outcome Measures
Advance Directive document completion
The number of advance directive documents completed within one year of enrollment.
Full Information
NCT ID
NCT02100566
First Posted
March 27, 2014
Last Updated
July 26, 2021
Sponsor
Ascension Genesys Hospital
Collaborators
University of Pennsylvania, Robert Wood Johnson Foundation
1. Study Identification
Unique Protocol Identification Number
NCT02100566
Brief Title
Behavioral Economics for Advance Care Options
Acronym
BEACON
Official Title
Behavioral Economics for Advance Care OptioNs
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
October 2017 (Actual)
Study Completion Date
October 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ascension Genesys Hospital
Collaborators
University of Pennsylvania, Robert Wood Johnson Foundation
4. Oversight
Data Monitoring Committee
No
5. 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.
Detailed Description
Primary research question: Does offering patients an Advance Directive (AD) document (by default), in combination with framing the rationale for AD completion (emphasizing either: A. patient control; or B. reduction in caregiver burden) improve AD completion as compared to a no-intervention control group?
Study Design: The project will conduct a 3-group randomized trial in which ADs are provided to hospitalized patients by default in the two treatment groups. When discussing the benefits of AD completion, intervention group A nurses will focus on ADs' potential to promote patients' control over the care they receive. In intervention group B, nurses will focus on the potential for AD completion to reduce caregiver burden. In the control group, patients will receive ADs only if they actively request them (as in standard practice). Specially trained nurses will be responsible for conducting the intervention. Training of RNs will consist of didactic and experiential learning on applying endowment and focusing effect scripts in a consistent manner that are true to the behavioral economic principles. Intervention will occur while in the hospital during which the patient will be presented with one of three options by the RN depending on their random assignment. Patients in both intervention groups will be given an AD by default. Patients who elect to complete an AD can have this completed with RN during the hospitalization or during a separate visit hospital worker who is trained in Advance Care Planning (ACP).
Methodology
Patient Eligibility:
The research RN will complete the "Selection of Patient Form" to determine eligibility for participation in the study (see subjects/sample below). Patients who are determined to be eligible for the study, will be asked if they are willing to participate in the study and asked to sign a consent form .
Intervention:
Patient is assigned into one of the three intervention groups and is provided one of three packets (packet includes script , copy of "Your Health, Your Choice: My Advance Directive", and self-addressed stamped envelope). The RN will provide the designated script regarding advance directives (see "Scripts for Intervention Groups"). Four possible outcomes can occur following this visit: A) patient indicates desire to complete AD while in the hospital; B) patient indicates desire to complete AD with ACP facilitator as separate visit; C) patient elects to complete AD on their own, or D) patient declines to complete AD. A).
Subjects/Sample: Hospitalized patients who reside in the County will be randomized to one of three groups. Eligibility will be determined before discharge. Inclusion criteria are adult patients, 50 years and older, who have a serious, life-limiting illness and require hospitalization (see below). Eligible patients will be identified and selected concurrently from new intakes to Genesys Regional Medical Center.
Inclusion Criteria:
A subject will be eligible for study participation if he/she meets the both 1 & 2 criteria:
1.1 Age 50 years and older 2.0 Subject must have one or more of the following serious life limiting illness that requires hospitalization (as determined from review of medical records and clinical judgment) 2.1. Chronic obstructive pulmonary disease (COPD) or any respiratory (pulmonary) disease that requires home oxygen use (e.g. interstitial lung disease, sleep-disordered breathing), 2.2. End Stage Renal Disease 2.3. Peripheral vascular disease (PVD) 2.4. NYHA Class III or IV Heart Failure (HF) Class III: Marked limitation in activity due to symptoms, even during less-than-ordinary activity, e.g. walking short distances (20-100 m). Comfortable only at rest.
Class IV: Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients.
2.5. Cancer as a discharge diagnosis (any type) Type: 2.6. Neuromuscular/movement disorders: Myasthenia gravis, ALS, Parkinson's, and Multiple sclerosis
Exclusion Criteria:
A subject will not be eligible for study participation if he/she meets any of the following criteria
3.1. Patient cannot sign legal documents such as consent or AD (Impaired decision-making capacity) 3.2. Previously specified written AD 3.3 Patient previously enrolled in this study.
Data Management and Statistical Analysis:
Sample Size- Calculated on the primary outcome of AD completion rate, the investigators used an estimated baseline completion of 10% for the control group. A two-tailed test for comparing completion rates between a default option and the standard, as well as, comparing the two framing interventions will require a total of 350 participants (125 in each intervention and 100 in the control). This achieves a minimum of 88% power to detect a 15% absolute difference between the groups at alpha of 0.05 and accounts for a 5% attrition rate. The hypothesis that AD completion rates differ by at least 15% between two groups within each arm (default option compared to control; autonomy framing compared to caregiver burden framing) will be analyzed using Chi-square analysis.
Expected Outcomes of the Study:
It is hypothesized that offering patients an AD document (by default), in combination with framing the rationale for AD completion (emphasizing either: A. patient control; or B. reduction in caregiver burden) will improve AD completion as compared to a no-intervention control group.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End of Life Care
Keywords
Advance Directive
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Behavioral Counseling
Arm Type
Experimental
Arm Description
Provide an advance directive document to patients along with counseling that either focuses on care giver burden or on patient autonomy.
Arm Title
Standard AD
Arm Type
No Intervention
Arm Description
The topic of advance directives (AD) is introduced but patient receives an AD document only upon request.
Intervention Type
Behavioral
Intervention Name(s)
Counseling (Care giver burden focus)
Other Intervention Name(s)
Focusing effect
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Counseling (patient autonomy focus)
Other Intervention Name(s)
Focusing effect
Intervention Description
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.
Primary Outcome Measure Information:
Title
Advance directive document completion
Description
The number of advance directive documents completed within one month of enrollment.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Advance Directive document completion
Description
The number of advance directive documents completed within one year of enrollment.
Time Frame
1 year
Other Pre-specified Outcome Measures:
Title
Advance directive communication
Description
The number of patients who discuss advance directives with their family or care giver within one year of enrollment.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark E Vogel, PhD
Organizational Affiliation
Ascension Genesys Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Scott Halpern, MD, PhD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kimberly R Barber, PhD
Organizational Affiliation
Genesys Regional Medical Director
Official's Role
Study Director
Facility Information:
Facility Name
Genesys Regional Medical Center
City
Grand Blanc
State/Province
Michigan
ZIP/Postal Code
48439
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Behavioral Economics for Advance Care Options
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