Serotonin-norepinephrine Reuptake Inhibitor in Prophylaxis of Depression Following Fragility Fractures

Study Overview
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Brief Summary
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The goal of this pilot study is to learn about the feasibility about prescribing anti-depressants at discharge in patients aged 50 years and older with a lower extremity fragility fracture. The main questions it aims to answer are: What are the obstacles to enrolling patients and prescribing anti-depressants among older adults? Is it possible to start prescribing SNRI medication upon discharge? What is the prevalence of depressive symptoms amongst patients with different types of injuries and weightbearing status? What is a transition of care plan for patients who have geriatric depression and require further care? Participants will: Undergo screening using the Geriatric Depression Scale Start on Duloxetine 30mg daily at time of discharge Report medication compliance and complete re-screening monthly Complete patient reported outcome measures and 3 months, 6 months, and 1 year Receive a referral to behavioral health, primary care, or psychiatrist for evaluation if they screen positive at any timepoint

Detailed Description
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As with many mental health diagnoses, there continues to be a stigma against receiving treatment and potentially even more so receiving prophylaxis16. Identifying these hurdles at the patient level will allow us to better educate patients and physicians about the benefits of this intervention. Secondly, this pilot study will help us determine if it is possible to start prescribing SNRI medication upon discharge. It will allow us to navigate the procurement of medications through Medicare, prescribing practices at discharge and address patient concerns regarding starting a new medication.

Official Title
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The Role of SNRI's in the Prophylaxis of Depression in the First Year Following Lower Extremity Fragility Fractures in Geriatric Patients

Conditions
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Depression in Old Age, Fragility Fracture

Intervention / Treatment
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* Drug: Duloxetine 30 mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Geriatric (greater than or equal to 65 years old) Lower extremity fragility fractures managed operatively Exclusion Criteria: Polytrauma Pathological fractures Patients on hospice Patients with previously diagnosed psychiatric disorders Patients with previously diagnosed dementia Patients already taking Selective serotonin reuptake inhibitors (SSRI)s and Serotonin- norepinephrine reuptake inhibitors (SNRI)s Patients already taking mood stabilizing medication Unable to provide informed consent (no use of a legal authorized representative) Patients with pre-existing life limiting diagnoses (cancer, etc.)

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: geriatric patients with operative lower extremity fragility fractures that will be started on Serotonin-norepinephrine reuptake inhibitor (SNRI) medication immediately after obtaining consent at index hospitalization or first post operative clinic appointment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Duloxetine 30mg<br>Duloxetine 30mg daily 90 day supply and 3 refills | Drug: Duloxetine 30 mg<br>* Duloxetine 30mg daily prescribed at discharge<br>* Other names: Common brands: Irenka, Cymbalta;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Geriatric Depression Scale (Short Form) Scores | This scale will be used as the primary outcome in this study as an indicator of patients who develop depression post-operatively. Scores range from 1-15. A score of 5 or greater indicates depression. | Baseline | 
| Geriatric Depression Scale (Short Form) Scores | This scale will be used as the primary outcome in this study as an indicator of patients who develop depression post-operatively. Scores range from 1-15. A score of 5 or greater indicates depression. | up to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PROMIS-29 Subscale Scores - Depression | The PROMIS-29 scales will be scored using a T-score metric method. A score of 50 points represents the population average for each scale, and 10 points represent one standard deviation. Higher scores means higher depression. | Month 3, Month 6, and Year 1 | 
| PROMIS-29 Subscale Scores - Physical Function | The PROMIS-29 scales will be scored using a T-score metric method. A score of 50 points represents the population average for each scale, and 10 points represent one standard deviation. Possible scores range from 0 to 100, with higher scores representing better health status | Month 3, Month 6, and Year 1 | 
| Number of patients who have side effects from the medication | Number of patients who have side effects from the medication | Baseline, monthly up to 1 year | 
| Number of participants who undergo re-operation | Number of participants who undergo re-operation | Baseline, monthly up to 1 year | 
| Number of participants who are readmitted to the hospital | Number of participants who are readmitted to the hospital | Baseline, monthly up to 1 year | 
| Mortality Rate | Mortality Rate | Baseline, monthly up to 1 year | 
| Number of participants who re-fracture the study injury | Number of participants who re-fracture | Baseline, monthly up to 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Geriatrics, Serotonin-norepinephrine