Recruitment

Recruitment Status
Completed
Estimated Enrollment
350

Inclusion Criterias

50 years or older
Chronic obstructive pulmonary disease
One or more of the following:
...
50 years or older
Chronic obstructive pulmonary disease
One or more of the following:
Peripheral vascular disease
Neuromuscular / movement disorder
Cancer
NYHA class II or V heart failure
End stge renal disease

Exclusion Criterias

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

Summary

Conditions
End of Life Care
Type
Interventional
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Health Services Research

Participation Requirements

Age
Between 50 years and 125 years
Gender
Both males and females

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 ...

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.

Inclusion Criterias

50 years or older
Chronic obstructive pulmonary disease
One or more of the following:
...
50 years or older
Chronic obstructive pulmonary disease
One or more of the following:
Peripheral vascular disease
Neuromuscular / movement disorder
Cancer
NYHA class II or V heart failure
End stge renal disease

Exclusion Criterias

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

Locations

Grand Blanc, Michigan, 48439
Grand Blanc, Michigan, 48439

Tracking Information

NCT #
NCT02100566
Collaborators
  • University of Pennsylvania
  • Robert Wood Johnson Foundation
Investigators
  • Principal Investigator: Mark E Vogel, PhD Ascension Genesys Hospital Principal Investigator: Scott Halpern, MD, PhD University of Pennsylvania Study Director: Kimberly R Barber, PhD Genesys Regional Medical Director
  • Mark E Vogel, PhD Ascension Genesys Hospital Principal Investigator: Scott Halpern, MD, PhD University of Pennsylvania Study Director: Kimberly R Barber, PhD Genesys Regional Medical Director