Purpose

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

Conditions

Eligibility

Eligible Ages
Over 65 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.)

Study Design

Phase
Phase 4
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Intervention 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
Primary Purpose
Prevention
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Duloxetine 30mg
Duloxetine 30mg daily 90 day supply and 3 refills
  • Drug: Duloxetine 30 mg
    Duloxetine 30mg daily prescribed at discharge
    Other names:
    • Common brands: Irenka, Cymbalta

Recruiting Locations

More Details

Status
Recruiting
Sponsor
Wake Forest University Health Sciences

Study Contact

Erica Grochowski, MPH
704-403-4980
Erica.Grochowski@atriumhealth.org

Detailed Description

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.