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

Indiana University

Status: Completed

Conditions: Post Traumatic Stress Disorder; Satisfaction; Depression; Anxiety

Treatments: Behavioral: Home Safety Evaluation; Behavioral: POST Facilitation

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04070183

R01AG056618 (U.S. NIH Grant/Contract)

1905850231

Details and patient eligibility

About

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.

Full 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

Enrollment: 389 patients

Sex: All

Ages: 65+ years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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389 participants in 2 patient groups

Attention Control (Home Safety Evaluation)

Other group

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.

Treatment:

Behavioral: Home Safety Evaluation

Intervention (POST Facilitation)

Experimental group

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.

Treatment:

Behavioral: POST Facilitation