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POST Facilitation for Community Dwelling Older Adults (POST-RCT) (POST-RCT)

Primary Purpose

Anxiety, Depression, Post Traumatic Stress Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
POST Facilitation
Home Safety Evaluation
Sponsored by
Indiana University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Anxiety focused on measuring surrogate decision making, medical decision making, advance care planning, family communication

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients:

  • 65 or older
  • have decision making capacity OR a qualified surrogate decision maker

  • must meet one of the following index scores:

    • Gagne Mortality Index score of 7 or greater (30% mortality risk)
    • Medicare Criteria for Hospice Admission: Functional Assessment Staging Tool (FAST) Index (Advanced Alzheimer's disease and related dementia) 7c or higher plus one or more comorbid conditions.
    • Seattle Heart Failure Model (congestive heart failure): score conferring a one-year mortality risk of 30% or greater
    • Eastern Cooperative Oncology Group (ECOG) performance status (metastatic cancer): Patients with an impaired performance score (greater than zero)
    • Liu Comorbidity Index (End Stage Renal Disease): Patients with a score of 10 or greater
    • blood results (B), age (A), respiratory variables (airflow obstruction, exacerbations, smoking) (R) and comorbidities (C) (BARC) Index for chronic obstructive pulmonary disease (COPD): high risk group
    • Model for End Stage Liver Disease (MELD) Index
  • must be able to pass consent verification
  • must not be enrolled in hospice
  • must not have an acute illness
  • must give patient's provider opportunity to review the "surprise question" (e.g. would you be surprised if the patient died in the next year) to confirm anticipated mortality within the next year (14 days to respond)
  • must not have a POST form on file.

Exclusion criteria:

  • lack of a patient or surrogate decision maker who can participate in POLST facilitation (for non-decisional patients a health care representative (HCR) or designated power of attorney for health care (DPOA-HC) must enroll with them)
  • patients who are already enrolled in hospice
  • patients or surrogates who cannot pass consent verification
  • patients or surrogates who do not speak English
  • patients with a POST form on file
  • patients who are not community-dwelling

Sites / Locations

  • Eskenazi HealthRecruiting
  • IU Health Methodist HospitalRecruiting
  • IU Health University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Attention Control (Home Safety Evaluation)

Intervention (POST Facilitation)

Arm Description

A nurse will complete a home visit with the patient and their surrogate decision maker or other family member (if they've designated one), in which he or she will provide suggestions on how to improve the safety of the patient's home.

A nurse will complete a home visit with the patient and their surrogate decision maker or other family (if they've designated one), in which he or she will provide education about the POST form. The POST facilitators will be nurses trained using the Respecting Choices Advanced Steps model.

Outcomes

Primary Outcome Measures

Discordance between treatment preferences and treatment received 12 months after POST Facilitation
Chart review and comparative statistics will be used to determine discordance between patient/family preferences and care received at the end of life.

Secondary Outcome Measures

Proportion of patients who have a completed POST form 3 months after receiving POST Facilitation
Chart review and comparative statistics will be used to determine any correlations between intervention and completion of a POST form
Decision conflict
Decisional Conflict Scale (DCS) The DCS is used to assess decision conflict Scores range from 0 (no decisional conflict) to 100 (high decisional conflict) 0= 'strongly agree'; 1= 'agree'; 2= 'neither agree nor disagree'; 3= 'disagree'; 4= 'strongly disagree'. TOTAL SCORE 16 items are: a) summed; b) divided by 16; and c) multiplied by 25 Other papers may present scores ranging from 1 [low decisional conflict] to 5 [high decisional conflict].
Decision quality- ACP engagement
Advance Care Planning (ACP) engagement survey
Decision quality- POLST Knowledge
POLST Knowledge Survey
Effect of the intervention on cost and end of life care (EOL) for patients who die within 12 months of the intervention
Will use comparative statistics to determine any correlations between intervention and EOL care (life sustaining treatments received and hospice enrollment within 30 days of death)
Effect of the intervention on psychological well-being (anxiety)
Generalized Anxiety Disorder- 7 (GAD-7) (7 item inventory of anxiety)- assesses subject's self-reported anxiety for the last two weeks. Scores range from 0-21 0= 'Not at all'; 1= 'Several Days'; 2= 'More than half the days'; 3= 'Nearly every day' Scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively. When used as a screening tool, further evaluation is recommended when the score is 10 or greater. Using the threshold score of 10, the GAD-7 has a sensitivity of 89% and a specificity of 82% for GAD.
Effect of the intervention on psychological well-being (depression)
Patient Health Questionnaire-8 (PHQ-8: item inventory of depression) Scores range from 0-24 *note that this scale is adapted from the PHQ-9, to remove the question about suicidal ideation. 0= 'Not at all'; 1= 'Several Days'; 2= 'More than half the days'; 3= 'Nearly every day' Higher scores indicate higher severity of depressive symptoms.
Effect of the intervention on psychological well-being (post traumatic stress)
(IES-R (Impact of Events Scale- Revised- inventory for PTSD) Scores range from 0-88 0= 'Not at all'; 1= 'A little bit'; 2= 'Moderately'; 3= 'Quite a bit'; 4= 'Extremely' The Impact of Event Scale-Revised (Weiss & Marmar, 1997) is a 22-item scale which is rated on a 0 (not at all) to 4 (extremely) scale with respect to how distressing each item has been during the past week. Scale scores are formed for the three subscales, which reflect intrusion (8 items), avoidance (8 items), and hyperarousal (6 items).

Full Information

First Posted
August 24, 2019
Last Updated
May 8, 2023
Sponsor
Indiana University
Collaborators
National Institute on Aging (NIA), National Institutes of Health (NIH), Regenstrief Institute, Inc., Indiana University Health, Eskenazi Health, Respecting Choices
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1. Study Identification

Unique Protocol Identification Number
NCT04070183
Brief Title
POST Facilitation for Community Dwelling Older Adults (POST-RCT)
Acronym
POST-RCT
Official Title
POST Facilitation for Community Dwelling Older Adults With and Without Dementia
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 11, 2020 (Actual)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
October 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University
Collaborators
National Institute on Aging (NIA), National Institutes of Health (NIH), Regenstrief Institute, Inc., Indiana University Health, Eskenazi Health, Respecting Choices

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
We propose to study the effects of Physician Orders for Scope of Treatment (POST) Facilitation in a randomized controlled trial in a population of community dwelling older adults who qualify for POLST facilitation, including those with normal cognition and those with Alzheimer's Disease and Related Disorders.
Detailed Description
The POLST paradigm, which stands for Physician Orders for Life Sustaining Treatment, was developed to address inconsistencies between care received and patient and family wishes for treatment, with an aim to increase concordant care. The POLST paradigm is nationally recognized and implemented in a number of states under different names. In Indiana, for example, it is called "Physician Orders for Scope of Treatment" (POST). Because of this, all patient facing materials will refer to POST, however, we use the terms POST and POLST interchangeably in this proposal. POLST affects delivery of medical interventions and improved concordance between patient preferences and care received. Our specific aims are: To test the effect of high quality POLST Facilitation delivered in the home compared to attention control on: a.discordance between preferences for treatment and treatments received in the subsequent 12 months (primary outcome). To test the effect of POLST Facilitation on intermediate outcomes including: The proportion of patients with a completed POLST form in the electronic medical record within 3 months of POLST Facilitation Decision quality regarding ACP as measured by the Decisional Conflict Scale, the advance care planning (ACP) Engagement Survey,and the POLST knowledge survey To test the effect of a POLST Facilitation on secondary outcomes of cost and end-of-life care including: Receipt of life-sustaining interventions or hospice within the 30 days prior to death, for patients who die during the year after POLST Facilitation The psychological well-being (anxiety, depression,and post traumatic stress) of surrogate decision makers after the patient's death The cost effectiveness of POLST Facilitation for the prevention of ICU admissions and hospitalizations

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Depression, Post Traumatic Stress Disorder, Satisfaction
Keywords
surrogate decision making, medical decision making, advance care planning, family communication

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Arm 1- Attention Control group Arm 2- Intervention group
Masking
None (Open Label)
Allocation
Randomized
Enrollment
876 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Attention Control (Home Safety Evaluation)
Arm Type
Other
Arm Description
A nurse will complete a home visit with the patient and their surrogate decision maker or other family member (if they've designated one), in which he or she will provide suggestions on how to improve the safety of the patient's home.
Arm Title
Intervention (POST Facilitation)
Arm Type
Experimental
Arm Description
A nurse will complete a home visit with the patient and their surrogate decision maker or other family (if they've designated one), in which he or she will provide education about the POST form. The POST facilitators will be nurses trained using the Respecting Choices Advanced Steps model.
Intervention Type
Behavioral
Intervention Name(s)
POST Facilitation
Other Intervention Name(s)
Respecting Choices Advanced Steps
Intervention Description
Advanced steps is initiated as a component of quality end-of-life care for frail elders and those whose death in the next 12 months would not be unexpected. The AS planning conversation is focused on goals of care to make timely, proactive, and specific end-of-life decisions. Ideally, these decisions are converted into medical orders that can be followed throughout the continuum of care. The Physician Orders for Life-Sustaining Treatment (POLST) program is the nationally recognized model for this stage of planning.
Intervention Type
Behavioral
Intervention Name(s)
Home Safety Evaluation
Intervention Description
Nurse evaluation and education on how to improve safety at home for community dwelling older adults (examples of education and evaluation includes fall risks, fire and carbon monoxide (CO) detectors, transferring safety (e.g. in and out of the tub, bed, etc.) and others.
Primary Outcome Measure Information:
Title
Discordance between treatment preferences and treatment received 12 months after POST Facilitation
Description
Chart review and comparative statistics will be used to determine discordance between patient/family preferences and care received at the end of life.
Time Frame
Assessed 12 months from the date that the patient receives POST facilitation or home safety evaluation
Secondary Outcome Measure Information:
Title
Proportion of patients who have a completed POST form 3 months after receiving POST Facilitation
Description
Chart review and comparative statistics will be used to determine any correlations between intervention and completion of a POST form
Time Frame
Assessed 3 months from the date that the participant receives POST facilitation or a home safety evaluation
Title
Decision conflict
Description
Decisional Conflict Scale (DCS) The DCS is used to assess decision conflict Scores range from 0 (no decisional conflict) to 100 (high decisional conflict) 0= 'strongly agree'; 1= 'agree'; 2= 'neither agree nor disagree'; 3= 'disagree'; 4= 'strongly disagree'. TOTAL SCORE 16 items are: a) summed; b) divided by 16; and c) multiplied by 25 Other papers may present scores ranging from 1 [low decisional conflict] to 5 [high decisional conflict].
Time Frame
Assessed 3 months from the date that the participant receives POST facilitation or a home safety evaluation
Title
Decision quality- ACP engagement
Description
Advance Care Planning (ACP) engagement survey
Time Frame
Assessed 3 months from the date that the participant receives POST facilitation or a home safety evaluation
Title
Decision quality- POLST Knowledge
Description
POLST Knowledge Survey
Time Frame
Assessed 3 months from the date that the participant receives POST facilitation or a home safety evaluation
Title
Effect of the intervention on cost and end of life care (EOL) for patients who die within 12 months of the intervention
Description
Will use comparative statistics to determine any correlations between intervention and EOL care (life sustaining treatments received and hospice enrollment within 30 days of death)
Time Frame
Assessed by chart review 12 months from the date that the participant receives POST facilitation or a home safety evaluation
Title
Effect of the intervention on psychological well-being (anxiety)
Description
Generalized Anxiety Disorder- 7 (GAD-7) (7 item inventory of anxiety)- assesses subject's self-reported anxiety for the last two weeks. Scores range from 0-21 0= 'Not at all'; 1= 'Several Days'; 2= 'More than half the days'; 3= 'Nearly every day' Scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively. When used as a screening tool, further evaluation is recommended when the score is 10 or greater. Using the threshold score of 10, the GAD-7 has a sensitivity of 89% and a specificity of 82% for GAD.
Time Frame
Assessed 3 months from the date that the participant receives POST facilitation or a home safety evaluation
Title
Effect of the intervention on psychological well-being (depression)
Description
Patient Health Questionnaire-8 (PHQ-8: item inventory of depression) Scores range from 0-24 *note that this scale is adapted from the PHQ-9, to remove the question about suicidal ideation. 0= 'Not at all'; 1= 'Several Days'; 2= 'More than half the days'; 3= 'Nearly every day' Higher scores indicate higher severity of depressive symptoms.
Time Frame
Assessed 3 months from the date that the participant receives POST facilitation or a home safety evaluation
Title
Effect of the intervention on psychological well-being (post traumatic stress)
Description
(IES-R (Impact of Events Scale- Revised- inventory for PTSD) Scores range from 0-88 0= 'Not at all'; 1= 'A little bit'; 2= 'Moderately'; 3= 'Quite a bit'; 4= 'Extremely' The Impact of Event Scale-Revised (Weiss & Marmar, 1997) is a 22-item scale which is rated on a 0 (not at all) to 4 (extremely) scale with respect to how distressing each item has been during the past week. Scale scores are formed for the three subscales, which reflect intrusion (8 items), avoidance (8 items), and hyperarousal (6 items).
Time Frame
Assessed 3 months from the date that the participant receives POST facilitation or a home safety evaluation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients: 65 or older have decision making capacity OR a qualified surrogate decision maker must meet one of the following index scores: Gagne Mortality Index score of 7 or greater (30% mortality risk) Medicare Criteria for Hospice Admission: Functional Assessment Staging Tool (FAST) Index (Advanced Alzheimer's disease and related dementia) 7c or higher plus one or more comorbid conditions. Seattle Heart Failure Model (congestive heart failure): score conferring a one-year mortality risk of 30% or greater Eastern Cooperative Oncology Group (ECOG) performance status (metastatic cancer): Patients with an impaired performance score (greater than zero) Liu Comorbidity Index (End Stage Renal Disease): Patients with a score of 10 or greater blood results (B), age (A), respiratory variables (airflow obstruction, exacerbations, smoking) (R) and comorbidities (C) (BARC) Index for chronic obstructive pulmonary disease (COPD): high risk group Model for End Stage Liver Disease (MELD) Index must be able to pass consent verification must not be enrolled in hospice must not have an acute illness must give patient's provider opportunity to review the "surprise question" (e.g. would you be surprised if the patient died in the next year) to confirm anticipated mortality within the next year (14 days to respond) must not have a POST form on file. Exclusion criteria: lack of a patient or surrogate decision maker who can participate in POLST facilitation (for non-decisional patients a health care representative (HCR) or designated power of attorney for health care (DPOA-HC) must enroll with them) patients who are already enrolled in hospice patients or surrogates who cannot pass consent verification patients or surrogates who do not speak English patients with a POST form on file patients who are not community-dwelling
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emily S Burke, BA
Phone
317-274-9047
Email
esburke@iupui.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Alexia M Torke, MD, MS
Email
atorke@iu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexia M Torke, MD, MS
Organizational Affiliation
Regenstrief Institute, Indiana University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eskenazi Health
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patti Noblet
First Name & Middle Initial & Last Name & Degree
Alexia M Torke, MD
Facility Name
IU Health Methodist Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emily S Burke, BA
First Name & Middle Initial & Last Name & Degree
Alexia M Torke, MD, MS
Facility Name
IU Health University Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emily S Burke, BA
First Name & Middle Initial & Last Name & Degree
Alexia M Torke, MD, MS

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://pubmed.ncbi.nlm.nih.gov/30153739/
Description
POLST Facilitation in Complex Care Management: A Feasibility Study

Learn more about this trial

POST Facilitation for Community Dwelling Older Adults (POST-RCT)

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