Clinical trial NCT04070183: POST Facilitation for Community Dwelling Older Adults (POST-RCT)
Official title: POST Facilitation for Community Dwelling Older Adults With and Without Dementia
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Anxiety
Depression
Post Traumatic Stress Disorder
Satisfaction
Keywords: surrogate decision making
medical decision making
advance care planning
family communication
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
name: National Institutes of Health (NIH)
name: Regenstrief Institute, Inc.
name: Indiana University Health
name: Eskenazi Health
name: Respecting Choices
First posted: 2019-08-28
Enrollment: 778
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Arm 1- Attention Control group Arm 2- Intervention group
Primary purpose: SUPPORTIVE_CARE

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

Eligibility criteria: 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

Primary outcomes:
measure: Discordance between treatment preferences and treatment received 12 months after POST Facilitation
timeFrame: Assessed 12 months from the date that the patient receives POST facilitation or home safety evaluation
Secondary outcomes:
measure: Proportion of patients who have a completed POST form 3 months after receiving POST Facilitation
timeFrame: Assessed 3 months from the date that the participant receives POST facilitation or a home safety evaluation
measure: Decision conflict
timeFrame: Assessed 3 months from the date that the participant receives POST facilitation or a home safety evaluation
measure: Decision quality- ACP engagement
timeFrame: Assessed 3 months from the date that the participant receives POST facilitation or a home safety evaluation
measure: Decision quality- POLST Knowledge
timeFrame: Assessed 3 months from the date that the participant receives POST facilitation or a home safety evaluation
measure: Effect of the intervention on cost and end of life care (EOL) for patients who die within 12 months of the intervention
timeFrame: Assessed by chart review 12 months from the date that the participant receives POST facilitation or a home safety evaluation
measure: Effect of the intervention on psychological well-being (anxiety)
timeFrame: Assessed 3 months from the date that the participant receives POST facilitation or a home safety evaluation
measure: Effect of the intervention on psychological well-being (depression)
timeFrame: Assessed 3 months from the date that the participant receives POST facilitation or a home safety evaluation
measure: Effect of the intervention on psychological well-being (post traumatic stress)
timeFrame: Assessed 3 months from the date that the participant receives POST facilitation or a home safety evaluation
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Eskenazi Health
state: Indiana
city: Indianapolis
country: United States
facility: IU Health Methodist Hospital
state: Indiana
city: Indianapolis
country: United States
facility: IU Health University Hospital
state: Indiana
Study officials:
affiliation: Regenstrief Institute, Indiana University
name: Alexia M Torke, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: