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POST Facilitation for Post-Traumatic Stress Disorder (POST-RCT Trial)
N/A
Recruiting
Led By Alexia M Torke, MD, MS
Research Sponsored by Indiana University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
65 or older
Patients must be 65 or older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed 12 months from the date that the patient receives post facilitation or home safety evaluation
Awards & highlights
Summary
This trial will study the effects of a Physician Orders for Scope of Treatment (POST) Facilitation in a population of older adults who qualify for it, including those with normal cognition and those with Alzheimer's Disease and related disorders.
Who is the study for?
This trial is for community-dwelling older adults aged 65 or above with certain serious health conditions like metastatic cancer, heart failure, kidney disease, COPD, or advanced Alzheimer's. They must have a high risk of mortality within a year and either be able to make decisions themselves or have a surrogate decision maker. Those already in hospice care or with an existing POST form are excluded.
What is being tested?
The study is testing the effectiveness of Physician Orders for Scope of Treatment (POST) Facilitation compared to usual care in improving outcomes for older adults. It involves home safety evaluations and discussions about treatment preferences in case of severe illness.
What are the potential side effects?
Since this trial focuses on treatment planning rather than medical interventions, traditional side effects are not applicable. However, participants may experience emotional discomfort discussing end-of-life preferences.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 65 years old or older.
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I am 65 years old or older.
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My daily activities are limited due to my cancer.
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I can make my own health decisions or have someone who can.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ assessed 12 months from the date that the patient receives post facilitation or home safety evaluation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed 12 months from the date that the patient receives post facilitation or home safety evaluation
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Discordance between treatment preferences and treatment received 12 months after POST Facilitation
Secondary study objectives
Decision conflict
Decision quality- ACP engagement
Decision quality- POLST Knowledge
+5 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Intervention (POST Facilitation)Experimental Treatment1 Intervention
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 II: Attention Control (Home Safety Evaluation)Experimental Treatment1 Intervention
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.
Find a Location
Who is running the clinical trial?
National Institutes of Health (NIH)NIH
2,765 Previous Clinical Trials
8,132,733 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,733 Previous Clinical Trials
28,054,225 Total Patients Enrolled
Regenstrief Institute, Inc.OTHER
26 Previous Clinical Trials
97,739 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 65 years old or older.I am 65 years old or older.You have one of the following conditions or scores that indicate a higher risk of mortality:
- Gagne Mortality Index score of 7 or higher, which means a 30% risk of death
- Medicare Criteria for Hospice Admission: Functional Assessment Staging Tool (FAST) Index of 7c or higher, along with one or more other health conditions, for advanced Alzheimer's disease and related dementia
- Seattle Heart Failure Model score indicating a 30% or higher risk of death within one year for congestive heart failure
- Eastern Cooperative Oncology Group (ECOG) performance status indicating impaired performance for metastatic cancer
- Liu Comorbidity Index score of 10 or higher for End Stage Renal Disease
- BARC Index for chronic obstructive pulmonary disease (COPD) indicating a high-risk group based on blood results, age, respiratory variables, and comorbidities
- Model for End Stage Liver Disease (MELD) Index (specific to liver disease)My daily activities are limited due to my cancer.I can make my own health decisions or have someone who can.You have a high risk of dying based on a score called Gagne Mortality Index which is 7 or higher.I can make my own health decisions or have someone who can.You have end-stage renal disease.I do not have any current severe illnesses.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention (POST Facilitation)
- Group 2: Attention Control (Home Safety Evaluation)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Post-Traumatic Stress Disorder Patient Testimony for trial: Trial Name: NCT04070183 — N/A
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