POST Facilitation for Post-Traumatic Stress Disorder

(POST-RCT Trial)

No longer recruiting at 2 trial locations

Overseen By Alexia M Torke, MD

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Indiana University

Disqualifiers: Hospice, Non-English speakers, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how POST Facilitation—guidance on completing a medical treatment form—can assist older adults with normal cognition or Alzheimer's and similar disorders. The researchers aim to determine if this process helps patients and their families better understand and prepare for medical care decisions. Participants will receive either a home visit for POST education or a home safety evaluation. Individuals 65 and older who are not in hospice care and can make decisions or have a decision-maker qualify for participation. As an unphased trial, this study offers participants the chance to contribute to research that may enhance decision-making processes for future patients.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that POST Facilitation is safe for older adults?

Research shows that POST Facilitation, the treatment under study, is generally considered safe as it is a type of psychological therapy. Studies have found that psychological therapies for conditions like PTSD (post-traumatic stress disorder) are effective and usually well-tolerated by patients. Although specific safety data for POST Facilitation is not yet available, similar therapies have proven effective and beneficial, suggesting it is likely safe for participants. Since this trial is marked "Not Applicable" for traditional phases, it likely involves a non-drug treatment, which typically carries a lower risk of side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about POST Facilitation for PTSD because it focuses on patient education and family involvement, which is a unique approach compared to traditional therapies like cognitive behavioral therapy and medication. Unlike these standard treatments, POST Facilitation involves trained nurses conducting home visits to educate patients and their families about the Physician Orders for Scope of Treatment (POST) form, promoting proactive planning and decision-making. This method aims to empower patients and their families, enhancing their understanding and management of PTSD in a more personalized and supportive environment.

What evidence suggests that POST Facilitation is effective for Post-Traumatic Stress Disorder?

Research has shown that psychological treatments can be very effective for PTSD (Post-Traumatic Stress Disorder). A review of several studies found strong evidence supporting these treatments. One study reported that 91% of participants experienced a significant reduction in PTSD symptoms after treatment. Another study found that 63.53% of participants improved with trauma-focused treatment for PTSD. In this trial, participants will receive either POST Facilitation or a Home Safety Evaluation. These findings suggest that methods like POST Facilitation, which participants in this trial may receive, could help reduce PTSD symptoms. ^{3 5 6 7 8}

Who Is on the Research Team?

Alexia M Torke, MD

Principal Investigator

Regenstrief Institute, Indiana University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am 65 years old or older.

Patients must be able to pass consent verification

Patients 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 not community-dwelling

Patients who are already enrolled in hospice

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive POST Facilitation or Home Safety Evaluation

1 visit

1 home visit

Follow-up

Participants are monitored for outcomes such as decision conflict, psychological well-being, and POST form completion

12 months

Outcome Assessment

Assessment of primary and secondary outcomes including discordance between treatment preferences and treatment received

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Home Safety Evaluation
• POST Facilitation

Trial Overview

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.

How Is the Trial Designed?

Group I: Intervention (POST Facilitation) Experimental Treatment 1 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 Treatment 1 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.

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Regenstrief Institute, Inc.

Collaborator

Trials

27

Recruited

98,500+

Indiana University Health

Collaborator

Trials

35

Recruited

18,500+

Eskenazi Health

Collaborator

Trials

14

Recruited

3,700+

Respecting Choices

Collaborator

Trials

2

Recruited

830+

Published Research Related to This Trial

A second victim support intervention was implemented in a 500-bed University Hospital in Granada, Spain, providing structured emotional support to healthcare workers involved in serious adverse events (SAEs) over two years, with 135 workers receiving second-level support.

The intervention led to increased notification rates of SAEs and high acceptance among professionals, enhancing the visibility of support actions and contributing to a stronger culture of patient safety within the hospital.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Second Victim Support at the Core of Severe Adverse Event Investigation. Cobos-Vargas, A., Pérez-Pérez, P., Núñez-Núñez, M., et al.[2023]

A systematic review of 66 trials involving 4190 patients with PTSD found that specific psychological interventions, such as cognitive behavioral therapy and exposure therapy, have large effect sizes, indicating they are effective in reducing PTSD symptoms.

No single psychological intervention was found to be consistently superior to others, but adherence to PTSD diagnostic criteria and trial quality were linked to larger effect sizes, suggesting that the effectiveness of these interventions can vary based on how well the trials are conducted.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrating fragmented evidence by network meta-analysis: relative effectiveness of psychological interventions for adults with post-traumatic stress disorder. Gerger, H., Munder, T., Gemperli, A., et al.[2014]

The study outlines a design for a web-based cognitive remediation training aimed at enhancing neurocognitive functions that may help prevent the development of PTSD in trauma survivors.

By focusing on early intervention shortly after trauma exposure, the study aims to address the challenges of administering targeted training to improve emotional reactivity and regulation, potentially reducing PTSD symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating web-based cognitive-affective remediation in recent trauma survivors: study rationale and protocol. Fine, NB., Achituv, M., Etkin, A., et al.[2020]

A systematic review of 126 randomized controlled trials found that certain factors, like having a comorbid diagnosis of depression and higher baseline PTSD severity, are linked to less effective treatment outcomes for PTSD.

Conversely, factors such as higher education, adherence to treatment homework, and experiencing a more recent trauma were associated with better treatment outcomes, highlighting the need for personalized approaches in PTSD therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of factors associated with outcome of psychological treatments for post-traumatic stress disorder. Barawi, KS., Lewis, C., Simon, N., et al.[2022]

The safety of psychological interventions is critical, as adverse events (AEs) can occur and must be carefully evaluated to ensure that these interventions do not cause harm before being deemed beneficial.

There is a pressing need for standardized protocols for assessing and reporting AEs in psychological interventions to improve transparency, consistency, and ultimately enhance clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Editorial: Primum non nocere - are adverse events accurately reported in studies on psychological interventions for children? Purgato, M., Cortese, S.[2023]

A significant 79% of pediatricians reported experiencing adverse events, with 'missing a diagnosis' being the most emotionally impactful and 'aggressive behavior' the most common, leading to higher rates of mental health issues compared to the general population.

Only 26.3% of pediatricians had access to a peer support protocol for emotional support after adverse events, highlighting the need for structured support systems and education on coping strategies to improve their mental well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Occupational well-being in pediatricians-a survey about work-related posttraumatic stress, depression, and anxiety. van Steijn, ME., Scheepstra, KWF., Yasar, G., et al.[2020]

Current clinical trials for behavioral health interventions often do not monitor adverse events as thoroughly as those for medications and medical devices, focusing mainly on serious incidents like suicide attempts and hospitalizations.

There is a need for expanded monitoring of adverse events in psychotherapy trials to better inform patients about potential risks, including temporary increases in anxiety, which are often overlooked but can impact treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The need for expanded monitoring of adverse events in behavioral health clinical trials. Peterson, AL., Roache, JD., Raj, J., et al.[2012]

Citations

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The CBT group (n = 12) had significantly greater reductions in PTSD symptoms than those in the usual care group (n = 19) from baseline to 12-month follow-up, as ...

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Posttraumatic Stress Disorder (PTSD)

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Participants who attended CISD were found to have lower anxiety and depression scores. A weak positive relationship was found between world assumptions and ...

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This investigation examined the complex interplay between PTSD, PTG, and resilience in relation to occupational safety behaviors among Turkish firefighters.