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

Phase 4RecruitingNCT05851898

Wake Forest University Health Sciences100 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

100

Eligibility

Sex: ALLMin age: 65 Years

Medical Language ↔ Plain English

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.)

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: up to 1 year

Secondary Outcomes

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.

Time frame: Month 3, Month 6, and Year 1

PROMIS-29 Subscale Scores - Physical Function

Time frame: Month 3, Month 6, and Year 1

Number of patients who have side effects from the medication