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

  • STATUS
    Recruiting
  • End date
    Oct 2, 2024
  • participants needed
    876
  • sponsor
    Indiana University
Updated on 2 May 2022
cancer

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.

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:
  4. Receipt of life-sustaining interventions or hospice within the 30 days prior to death, for patients who die during the year after POLST Facilitation
  5. The psychological well-being (anxiety, depression,and post traumatic stress) of surrogate decision makers after the patient's death
  6. The cost effectiveness of POLST Facilitation for the prevention of ICU admissions and hospitalizations

Details
Condition Anxiety, Depression, Post Traumatic Stress Disorder, Satisfaction
Treatment POST Facilitation, Home Safety Evaluation
Clinical Study IdentifierNCT04070183
SponsorIndiana University
Last Modified on2 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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)
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
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