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

NCT04070183 | Completed DMC

• 2 other identifiers: 1905850231R01AG056618
• Study Type: interventional
• Target: 389
• Locations: 1 country
• Sites: 3

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.

Conditions

Anxiety; Depression; Post Traumatic Stress Disorder; Satisfaction

Keywords

surrogate decision making; medical decision making; advance care planning; family communication

Outcome Measures

Primary Outcomes (1)

• 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.

  Assessed 12 months from the date that the patient receives POST facilitation or home safety evaluation

Secondary Outcomes (8)

• Proportion of patients who have a completed POST form 3 months after receiving POST Facilitation

  Assessed 3 months from the date that the participant receives POST facilitation or a home safety evaluation

• Decision conflict

  Assessed 3 months from the date that the participant receives POST facilitation or a home safety evaluation

• Decision quality- ACP engagement

  Assessed 3 months from the date that the participant receives POST facilitation or a home safety evaluation

• Decision quality- POLST Knowledge

  Assessed 3 months from the date that the participant receives POST facilitation or a home safety evaluation

• Effect of the intervention on cost and end of life care (EOL) for patients who die within 12 months of the intervention

  Assessed by chart review 12 months from the date that the participant receives POST facilitation or a home safety evaluation

Study Arms (2)

Attention Control (Home Safety Evaluation)

OTHER

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.

Behavioral: Home Safety Evaluation

Intervention (POST Facilitation)

EXPERIMENTAL

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.

Behavioral: POST Facilitation

Interventions

POST Facilitation BEHAVIORAL

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.

Also known as: Respecting Choices Advanced Steps

Intervention (POST Facilitation)

Home Safety Evaluation BEHAVIORAL

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.

Attention Control (Home Safety Evaluation)

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Patients:
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana University: lead
• National Institute on Aging (NIA): collaborator
• National Institutes of Health (NIH): collaborator
• Regenstrief Institute, Inc.: collaborator
• Indiana University Health: collaborator
• Eskenazi Health: collaborator
• Respecting Choices: collaborator

Study Sites (3)

Eskenazi Health

Indianapolis, Indiana, 46202, United States

Location

IU Health Methodist Hospital

Indianapolis, Indiana, 46202, United States

Location

IU Health University Hospital

Indianapolis, Indiana, 46202, United States

Location

Related Publications (1)

• Torke AM, Hickman S, Wocial L, Monahan PO, Burke ES, Slaven J, Ziemba K, Montgomery C, Koch S, Cavanaugh M, Fox Ludden E. Planning Ahead: protocol for a randomised trial of advance care planning for community dwelling older adults at increased mortality risk. BMJ Open. 2025 May 24;15(5):e102186. doi: 10.1136/bmjopen-2025-102186.

  PMID: 40413042 DERIVED

Related Links

• POLST Facilitation in Complex Care Management: A Feasibility Study

MeSH Terms

Conditions

Anxiety Disorders; Depression; Stress Disorders, Post-Traumatic; Personal Satisfaction

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Study Officials

• Alexia M Torke, MD, MS

  Regenstrief Institute, Indiana University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Model Details: Arm 1- Attention Control group Arm 2- Intervention group

Study Record Dates

• First Submitted: August 24, 2019
• First Posted: August 28, 2019
• Study Start: May 11, 2020
• Primary Completion: July 29, 2025
• Study Completion: July 29, 2025
• Last Updated: November 26, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: One year after publication of all prespecified study outcomes.
• Access Criteria: The PI will review requests based on a brief description of the request, provided by the requestor.

Locations

US (3)