End of Life CareBEACONNCT02100566
Behavioral Economics for Advance Care Options
A study testing Counseling (Care giver burden focus) and Counseling (patient autonomy focus) in people with End of Life Care, run by Ascension Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- End of Life Care
- What is being tested?
- Counseling (Care giver burden focus) and Counseling (patient autonomy focus)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patient referred to palliative care
- Patient has advance directive
- Patient has impaired decision making ability
- Patient previously enrolled in this study
Trial locations and contacts
1 site in 1 country.
United States1 site
Genesys Regional Medical Center
Grand Blanc, Michigan, 48439
About this study
Official title: Behavioral Economics for Advance Care OptioNs
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.
Read the 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.
- Conditions
- End of Life Care
- Being tested
- Counseling (Care giver burden focus), Counseling (patient autonomy focus)
- Keywords
- Advance Directive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Counseling (Care giver burden focus)Behavioural
Also called Focusing effect
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.
Counseling (patient autonomy focus)Behavioural
Also called Focusing effect
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.
| Study group | Role | What they receive |
|---|---|---|
| Behavioral Counseling | Experimental | Provide an advance directive document to patients along with counseling that either focuses on care giver burden or on patient autonomy. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Advance directive document completion
The number of advance directive documents completed within one month of enrollment.
Measured: 1 month
Secondary outcomes (1)
Advance Directive document completion
The number of advance directive documents completed within one year of enrollment.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionOct 2017
- Study completionOct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End of Life CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ascension Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Pennsylvania, Robert Wood Johnson Foundation
- Responsible party
- Principal investigator, Mark Vogel, PhD, Ascension Health
- Investigators
- Mark E Vogel, PhD, Principal investigator, Ascension HealthScott Halpern, MD, PhD, Principal investigator, University of PennsylvaniaKimberly R Barber, PhD, Study director, Genesys Regional Medical Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02100566
- Sponsor's protocol ID
- RWJ 71476
- Acronym
- BEACON
- Status last verified
- Jul 2021
- First submitted
- 27 Mar 2014
- Last updated
- 27 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Economics for Advance Care OptioNs
- ClinicalTrials.gov ID
- NCT02100566
- Acronym / sponsor ID
- BEACON / RWJ 71476
- Conditions
- End of Life Care
- Keywords
- Advance Directive
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Ascension HealthIndustry (pharma, biotech, devices)
- Collaborators
- University of Pennsylvania, Robert Wood Johnson Foundation
- Study start
- Apr 2014
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2019 (actual)
- First posted
- 1 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Behavioral Counseling | Experimental | Behavioral: Counseling (Care giver burden focus), Behavioral: Counseling (patient autonomy focus)Provide an advance directive document to patients along with counseling that either focuses on care giver burden or on patient autonomy. |
| Standard AD | No intervention | –The topic of advance directives (AD) is introduced but patient receives an AD document only upon request. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 50 years or older
- One or more of the following:
- Chronic obstructive pulmonary disease
- End stge renal disease
- Peripheral vascular disease
Key exclusion criteria (4 listed)
- Patient referred to palliative care
- Patient has advance directive
- Patient has impaired decision making ability
- Patient previously enrolled in this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Counseling (Care giver burden focus)Also: Focusing effectAn 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. | Behavioural | Behavioral Counseling |
| Counseling (patient autonomy focus)Also: Focusing effectAn 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. | Behavioural | Behavioral Counseling |
Primary outcome
Advance directive document completion
Time frame: 1 month
The number of advance directive documents completed within one month of enrollment.
1 secondary outcome
Advance Directive document completion
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark E Vogel, PhD principal investigator
Ascension Health
Scott Halpern, MD, PhD principal investigator
University of Pennsylvania
Kimberly R Barber, PhD study director
Genesys Regional Medical Director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Counseling (Care giver burden focus) and Counseling (patient autonomy focus) in people with End of Life Care, run by Ascension Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Advance directive document completion (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2021.