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

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ClinicalTrials.gov Identifier: NCT04070183
Recruitment Status : Recruiting
First Posted : August 28, 2019
Last Update Posted : July 10, 2020
Sponsor:
Collaborators:
National Institute on Aging (NIA)
National Institutes of Health (NIH)
Regenstrief Institute, Inc.
Indiana University Health
Eskenazi Health
Respecting Choices
Information provided by (Responsible Party):
Alexia M. Torke, Indiana University

Tracking Information
First Submitted Date  ICMJE August 24, 2019
First Posted Date  ICMJE August 28, 2019
Last Update Posted Date July 10, 2020
Actual Study Start Date  ICMJE May 11, 2020
Estimated Primary Completion Date October 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 11, 2020)
Discordance between treatment preferences and treatment received 12 months after POST Facilitation [ Time Frame: Assessed 12 months from the date that the patient receives POST facilitation or home safety evaluation ]
Chart review and comparative statistics will be used to determine discordance between patient/family preferences and care received at the end of life.
Original Primary Outcome Measures  ICMJE
 (submitted: August 24, 2019)
Discordance between treatment preferences and treatment received 12 months after POST Facilitation [ Time Frame: Assessed 12 months from the date that the patient receives POST facilitation or home safety evaluation ]
Decisional Conflict Scale
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 8, 2020)
  • Proportion of patients who have a completed POST form 3 months after receiving POST Facilitation [ Time Frame: Assessed 3 months from the date that the participant receives POST facilitation or a home safety evaluation ]
    Chart review and comparative statistics will be used to determine any correlations between intervention and completion of a POST form
  • Decision conflict [ Time Frame: Assessed 3 months from the date that the participant receives POST facilitation or a home safety evaluation ]
    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 [ Time Frame: Assessed 3 months from the date that the participant receives POST facilitation or a home safety evaluation ]
    Advance Care Planning (ACP) engagement survey
  • Decision quality [ Time Frame: Assessed 3 months from the date that the participant receives POST facilitation or a home safety evaluation ]
    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 [ Time Frame: Assessed by chart review 12 months from the date that the participant receives POST facilitation or a home safety evaluation ]
    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) [ Time Frame: Assessed 3 months from the date that the participant receives POST facilitation or a home safety evaluation ]
    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) [ Time Frame: Assessed 3 months from the date that the participant receives POST facilitation or a home safety evaluation ]
    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) [ Time Frame: Assessed 3 months from the date that the participant receives POST facilitation or a home safety evaluation ]
    (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).
Original Secondary Outcome Measures  ICMJE
 (submitted: August 24, 2019)
  • Proportion of patients who have a completed POST form 3 months after receiving POST Facilitation [ Time Frame: Assessed 3 months from the date that the participant receives POST facilitation or a home safety evaluation ]
    Chart review and comparative statistics will be used to determine any correlations between intervention and completion of a POST form
  • Decision quality/conflict [ Time Frame: Assessed 3 months from the date that the participant receives POST facilitation or a home safety evaluation ]
    Decision Conflict Scale (DCS) (a validated scale of decision conflict that is used to assess decision conflict when a person has made 1 or more major decisions for a patient in the hospital setting)
  • Decision quality [ Time Frame: Assessed 3 months from the date that the participant receives POST facilitation or a home safety evaluation ]
    Advance Care Planning (ACP) engagement survey
  • Decision quality [ Time Frame: Assessed 3 months from the date that the participant receives POST facilitation or a home safety evaluation ]
    POLST Knowledge Survey
  • Effect of the intervention on cost and end of life care for patients who die within 12 months of the intervention [ Time Frame: Assessed by chart review 12 months from the date that the participant receives POST facilitation or a home safety evaluation ]
    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) [ Time Frame: Assessed 3 months from the date that the participant receives POST facilitation or a home safety evaluation ]
    GAD-7 (7 item inventory of anxiety)
  • Effect of the intervention on psychological well-being (depression) [ Time Frame: Assessed 3 months from the date that the participant receives POST facilitation or a home safety evaluation ]
    PHQ-8 (8 item inventory of depression)
  • Effect of the intervention on psychological well-being (post traumatic stress) [ Time Frame: Assessed 3 months from the date that the participant receives POST facilitation or a home safety evaluation ]
    (IES-R (Impact of Events scale- inventory for PTSD)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE POST Facilitation for Community Dwelling Older Adults (POST-RCT)
Official Title  ICMJE POST Facilitation for Community Dwelling Older Adults With and Without Dementia
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:

  1. 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).

  2. To test the effect of POLST Facilitation on intermediate outcomes including:

    1. The proportion of patients with a completed POLST form in the electronic medical record within 3 months of POLST Facilitation
    2. Decision quality regarding ACP as measured by the Decisional Conflict Scale, the advance care planning (ACP) Engagement Survey,and the POLST knowledge survey
  3. To test the effect of a POLST Facilitation on secondary outcomes of cost and end-of-life care including:

    1. Receipt of life-sustaining interventions or hospice within the 30 days prior to death, for patients who die during the year after POLST Facilitation
    2. The psychological well-being (anxiety, depression,and post traumatic stress) of surrogate decision makers after the patient's death
    3. The cost effectiveness of POLST Facilitation for the prevention of ICU admissions and hospitalizations
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Arm 1- Attention Control group Arm 2- Intervention group
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Anxiety
  • Depression
  • Post Traumatic Stress Disorder
  • Satisfaction
Intervention  ICMJE
  • Behavioral: POST Facilitation
    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.
    Other Name: Respecting Choices Advanced Steps
  • Behavioral: Home Safety Evaluation
    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.
Study Arms  ICMJE
  • Attention Control (Home Safety Evaluation)
    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.
    Intervention: Behavioral: Home Safety Evaluation
  • Experimental: Intervention (POST Facilitation)
    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: Behavioral: POST Facilitation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 24, 2019)
876
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2024
Estimated Primary Completion Date October 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Community dwelling
  • Patient at a participating healthcare clinic
  • 65 or older
  • Gagne score of 47% or greater
  • endorsement of the surprise question by the patient's primary care provider (PCP) ("Would you be surprised if the patient died in the next 12 months)

Exclusion Criteria:

  • under 65
  • acute illness
  • deferred by PCP
  • Gagne score of 46% or less
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Emily S Burke, BA 317-274-9047 esburke@iupui.edu
Contact: Alexia M Torke, MD, MS atorke@iu.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04070183
Other Study ID Numbers  ICMJE 1905850231
R01AG056618 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Alexia M. Torke, Indiana University
Study Sponsor  ICMJE Indiana University
Collaborators  ICMJE
  • National Institute on Aging (NIA)
  • National Institutes of Health (NIH)
  • Regenstrief Institute, Inc.
  • Indiana University Health
  • Eskenazi Health
  • Respecting Choices
Investigators  ICMJE
Principal Investigator: Alexia M Torke, MD, MS Regenstrief Institute, Indiana University
PRS Account Indiana University
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP