Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02100566 |
| Other study ID # |
RWJ 71476 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 2014 |
| Est. completion date |
October 2019 |
Study information
| Verified date |
July 2021 |
| Source |
Ascension Genesys Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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.
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.
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.
