AnxietyPOST-RCTNCT04070183
POST Facilitation for Community Dwelling Older Adults (POST-RCT)
A study testing POST Facilitation and Home Safety Evaluation in people with Anxiety and Depression, run by Indiana University at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Anxiety, Depression, Post Traumatic Stress Disorder
- What is being tested?
- POST Facilitation and Home Safety Evaluation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 389 participants
- Where
- 3 sitesUnited States
- Study dates
- 11 May 2020to 29 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Show all 16Show fewer
- 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.
Who cannot join
- 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 locations and contacts
3 sites in 1 country.
United States3 sites
Eskenazi Health
Indianapolis, Indiana, 46202
IU Health Methodist Hospital
Indianapolis, Indiana, 46202
IU Health University Hospital
Indianapolis, Indiana, 46202
About this study
Official title: POST Facilitation for Community Dwelling Older Adults With and Without Dementia
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.
Read the 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:
- 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).
- To test the effect of POLST Facilitation on intermediate outcomes including:
- The proportion of patients with a completed POLST form in the electronic medical record within 3 months of POLST Facilitation
- Decision quality regarding ACP as measured by the Decisional Conflict Scale, the advance care planning (ACP) Engagement Survey,and the POLST knowledge survey
- To test the effect of a POLST Facilitation on secondary outcomes of cost and end-of-life care including:
- Receipt of life-sustaining interventions or hospice within the 30 days prior to death, for patients who die during the year after POLST Facilitation
- The psychological well-being (anxiety, depression,and post traumatic stress) of surrogate decision makers after the patient's death
- The cost effectiveness of POLST Facilitation for the prevention of ICU admissions and hospitalizations
- Conditions
- Anxiety, Depression, Post Traumatic Stress Disorder, Satisfaction
- Being tested
- POST Facilitation, Home Safety Evaluation
- Keywords
- surrogate decision making, medical decision making, advance care planning, family communication
- Medical subject headings
- Anxiety Disorders, Depression, Stress Disorders, Post-Traumatic, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
POST FacilitationBehavioural
Also called Respecting Choices Advanced Steps
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.
Home Safety EvaluationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Attention Control (Home Safety Evaluation) | Other | 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. Receives: Behavioral: Home Safety Evaluation |
| Intervention (POST Facilitation) | Experimental | 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. Receives: Behavioral: POST Facilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Discordance between treatment preferences and treatment received 12 months after POST Facilitation
Chart review and comparative statistics will be used to determine discordance between patient/family preferences and care received at the end of life.
Measured: Assessed 12 months from the date that the patient receives POST facilitation or home safety evaluation
Secondary outcomes (8)
Proportion of patients who have a completed POST form 3 months after receiving POST Facilitation
Chart review and comparative statistics will be used to determine any correlations between intervention and completion of a POST form
Measured: Assessed 3 months from the date that the participant receives POST facilitation or a home safety evaluation
Decision conflict
Decisional Conflict Scale (DCS)
The DCS is used to assess decision conflict
Scores range from 0 (no decisional conflict) to 100 (high decisional conflict) 0= 'strongly agree'; 1= 'agree'; 2= 'neither agree nor disagree'; 3= 'disagree'; 4= 'strongly disagree'.
TOTAL SCORE 16 items are: a) summed; b) divided by 16; and c) multiplied by 25 Other papers may present scores ranging from 1 [low decisional conflict] to 5 [high decisional conflict].
Measured: Assessed 3 months from the date that the participant receives POST facilitation or a home safety evaluation
Decision quality- ACP engagement
Advance Care Planning (ACP) engagement survey
Measured: Assessed 3 months from the date that the participant receives POST facilitation or a home safety evaluation
Decision quality- POLST Knowledge
POLST Knowledge Survey
Measured: Assessed 3 months from the date that the participant receives POST facilitation or a home safety evaluation
Effect of the intervention on cost and end of life care (EOL) for patients who die within 12 months of the intervention
Will use comparative statistics to determine any correlations between intervention and EOL care (life sustaining treatments received and hospice enrollment within 30 days of death)
Measured: Assessed by chart review 12 months from the date that the participant receives POST facilitation or a home safety evaluation
Effect of the intervention on psychological well-being (anxiety)
Generalized Anxiety Disorder- 7 (GAD-7) (7 item inventory of anxiety)- assesses subject's self-reported anxiety for the last two weeks.
Scores range from 0-21 0= 'Not at all'; 1= 'Several Days'; 2= 'More than half the days'; 3= 'Nearly every day' Scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively.
When used as a screening tool, further evaluation is recommended when the score is 10 or greater.
Using the threshold score of 10, the GAD-7 has a sensitivity of 89% and a specificity of 82% for GAD.
Measured: Assessed 3 months from the date that the participant receives POST facilitation or a home safety evaluation
Effect of the intervention on psychological well-being (depression)
Patient Health Questionnaire-8 (PHQ-8: item inventory of depression)
Scores range from 0-24 *note that this scale is adapted from the PHQ-9, to remove the question about suicidal ideation.
0= 'Not at all'; 1= 'Several Days'; 2= 'More than half the days'; 3= 'Nearly every day' Higher scores indicate higher severity of depressive symptoms.
Measured: Assessed 3 months from the date that the participant receives POST facilitation or a home safety evaluation
Effect of the intervention on psychological well-being (post traumatic stress)
(IES-R (Impact of Events Scale- Revised- inventory for PTSD) Scores range from 0-88 0= 'Not at all'; 1= 'A little bit'; 2= 'Moderately'; 3= 'Quite a bit'; 4= 'Extremely' The Impact of Event Scale-Revised (Weiss \& Marmar, 1997) is a 22-item scale which is rated on a 0 (not at all) to 4 (extremely) scale with respect to how distressing each item has been during the past week. Scale scores are formed for the three subscales, which reflect intrusion (8 items), avoidance (8 items), and hyperarousal (6 items).
Measured: Assessed 3 months from the date that the participant receives POST facilitation or a home safety evaluation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start11 May 2020
- Primary completion29 Jul 2025
- Study completion29 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Arm 1- Attention Control group Arm 2- Intervention group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 389 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA), National Institutes of Health (NIH), Regenstrief Institute, Inc., Indiana University Health, Eskenazi Health, Respecting Choices
- Responsible party
- Principal investigator, Alexia M. Torke, Indiana University
- Investigators
- Alexia M Torke, MD, MS, Principal investigator, Regenstrief Institute, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04070183
- Sponsor's protocol ID
- 1905850231
- Other IDs
- R01AG056618
- Acronym
- POST-RCT
- Status last verified
- Nov 2025
- First submitted
- 24 Aug 2019
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will construct a de-identified data set that could be available to other researchers. Survey data, technical appendix and statistical code will be preserved and shared via the NIH-supported National Archive of Computerized Data on Aging's (NACDA) Open Aging Repository (OAR).
Publications
Torke AM, Hickman S, Wocial L, Monahan PO, Burke ES, Slaven J, Ziemba K, Montgomery C, Koch S, Cavanaugh M, Fox Ludden E. Planning Ahead: protocol for a randomised trial of advance care planning for community dwelling older adults at increased mortality risk. BMJ Open. 2025 May 24;15(5):e102186. doi: 10.1136/bmjopen-2025-102186.
PubMed 40413042
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- POST Facilitation for Community Dwelling Older Adults With and Without Dementia
- ClinicalTrials.gov ID
- NCT04070183
- Acronym / sponsor ID
- POST-RCT / 1905850231
- Conditions
- Anxiety, Depression, Post Traumatic Stress Disorder, Satisfaction
- Keywords
- surrogate decision making, medical decision making, advance care planning, family communication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 389 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA), National Institutes of Health (NIH), Regenstrief Institute, Inc., Indiana University Health, Eskenazi Health, Respecting Choices
- Study start
- 11 May 2020 (actual)
- Primary completion
- 29 Jul 2025 (actual)
- Study completion
- 29 Jul 2025 (actual)
- First posted
- 28 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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).
- To test the effect of POLST Facilitation on intermediate outcomes including:
- The proportion of patients with a completed POLST form in the electronic medical record within 3 months of POLST Facilitation
- Decision quality regarding ACP as measured by the Decisional Conflict Scale, the advance care planning (ACP) Engagement Survey,and the POLST knowledge survey
- To test the effect of a POLST Facilitation on secondary outcomes of cost and end-of-life care including:
- Receipt of life-sustaining interventions or hospice within the 30 days prior to death, for patients who die during the year after POLST Facilitation
- The psychological well-being (anxiety, depression,and post traumatic stress) of surrogate decision makers after the patient's death
- The cost effectiveness of POLST Facilitation for the prevention of ICU admissions and hospitalizations
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Arm 1- Attention Control group Arm 2- Intervention group
| Arm | Type | Receives |
|---|---|---|
| Attention Control (Home Safety Evaluation) | Other | Behavioral: Home Safety EvaluationA 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. |
| Intervention (POST Facilitation) | Experimental | Behavioral: POST FacilitationA 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (16 listed)
- 65 or older
- have decision making capacity OR a qualified surrogate decision maker
- must meet one of the following index scores:
- must be able to pass consent verification
- must not be enrolled in hospice
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| POST FacilitationAlso: Respecting Choices Advanced StepsAdvanced 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. | Behavioural | Intervention (POST Facilitation) |
| Home Safety EvaluationNurse 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. | Behavioural | Attention Control (Home Safety Evaluation) |
Primary outcome
Discordance between treatment preferences and treatment received 12 months after POST Facilitation
Time frame: Assessed 12 months from the date that the patient receives POST facilitation or home safety evaluation
Chart review and comparative statistics will be used to determine discordance between patient/family preferences and care received at the end of life.
8 secondary outcomes
Proportion of patients who have a completed POST form 3 months after receiving POST Facilitation
Time frame: Assessed 3 months from the date that the participant receives POST facilitation or a home safety evaluation
Decision conflict
Time frame: Assessed 3 months from the date that the participant receives POST facilitation or a home safety evaluation
Decision quality- ACP engagement
Time frame: Assessed 3 months from the date that the participant receives POST facilitation or a home safety evaluation
Decision quality- POLST Knowledge
Time frame: Assessed 3 months from the date that the participant receives POST facilitation or a home safety evaluation
Effect of the intervention on cost and end of life care (EOL) for patients who die within 12 months of the intervention
Time frame: Assessed by chart review 12 months from the date that the participant receives POST facilitation or a home safety evaluation
Effect of the intervention on psychological well-being (anxiety)
Time frame: Assessed 3 months from the date that the participant receives POST facilitation or a home safety evaluation
Effect of the intervention on psychological well-being (depression)
Time frame: Assessed 3 months from the date that the participant receives POST facilitation or a home safety evaluation
Effect of the intervention on psychological well-being (post traumatic stress)
Time frame: Assessed 3 months from the date that the participant receives POST facilitation or a home safety evaluation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2025.
- Derived from this study: PubMed 40413042Torke AM, Hickman S, Wocial L, Monahan PO, Burke ES, Slaven J, Ziemba K, Montgomery C, Koch S, Cavanaugh M, Fox Ludden E. Planning Ahead: protocol for a randomised trial of advance care planning for community dwelling older adults at increased mortality risk. BMJ Open. 2025 May 24;15(5):e102186. doi: 10.1136/bmjopen-2025-102186.
- POLST Facilitation in Complex Care Management: A Feasibility StudyLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. We will construct a de-identified data set that could be available to other researchers. Survey data, technical appendix and statistical code will be preserved and shared via the NIH-supported National Archive of Computerized Data on Aging's (NACDA) Open Aging Repository (OAR).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexia M Torke, MD, MS principal investigator
Regenstrief Institute, Indiana University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing POST Facilitation and Home Safety Evaluation in people with Anxiety and Depression, run by Indiana University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Discordance between treatment preferences and treatment received 12 months after POST Facilitation (time frame: Assessed 12 months from the date that the patient receives POST facilitation or home safety evaluation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04070183, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2025.