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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

389 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-11

Study Completion Date

2025-07-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Mobile App Psychological Interventions for Family Dementia Caregivers

NCT05253443

Family Caregivers

COMPLETED NA

Indiana University Dementia Screening Trial

NCT01699503

Dementia Alzheimer's Disease Mild Cognitive Impairment

COMPLETED NA

I-CARE 2: Mobile Telehealth to Reduce Alzheimer'S-related Symptoms

NCT05733520

Caregiver Burden Alzheimer Disease

RECRUITING NA

Five Session Unified Protocol for Older Adults With Emotional Distress and Reduced Mobility

NCT04837521

Emotional Distress Anxiety Depression

COMPLETED NA

Dyadic Tailored Home-Based Activity Program for Mild-to-Moderate Dementia Patients Post-Discharge

NCT07081750

Dementia

NOT_YET_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Anxiety Depression Post Traumatic Stress Disorder Satisfaction

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Arm 1- Attention Control group Arm 2- Intervention group

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type OTHER

Home Safety Evaluation

Intervention Type 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.

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.

Group Type EXPERIMENTAL

POST Facilitation

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Respecting Choices Advanced Steps

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No