Clinical trial NCT05851898: Serotonin-norepinephrine Reuptake Inhibitor in Prophylaxis of Depression Following Fragility Fractures
Official title: The Role of SNRI's in the Prophylaxis of Depression in the First Year Following Lower Extremity Fragility Fractures in Geriatric Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Depression in Old Age
Fragility Fracture
Keywords: Geriatrics
Serotonin-norepinephrine
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2023-05-10
Enrollment: 100
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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

Brief summary: 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: 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.

Eligibility criteria: 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.)

Primary outcomes:
measure: Geriatric Depression Scale (Short Form) Scores
timeFrame: Baseline
measure: Geriatric Depression Scale (Short Form) Scores
timeFrame: up to 1 year
Secondary outcomes:
measure: PROMIS-29 Subscale Scores - Depression
timeFrame: Month 3, Month 6, and Year 1
measure: PROMIS-29 Subscale Scores - Physical Function
timeFrame: Month 3, Month 6, and Year 1
measure: Number of patients who have side effects from the medication
timeFrame: Baseline, monthly up to 1 year
measure: Number of participants who undergo re-operation
timeFrame: Baseline, monthly up to 1 year
measure: Number of participants who are readmitted to the hospital
timeFrame: Baseline, monthly up to 1 year
measure: Mortality Rate
timeFrame: Baseline, monthly up to 1 year
measure: Number of participants who re-fracture the study injury
timeFrame: Baseline, monthly up to 1 year
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Rachel Seymour, PhD
role: PRINCIPAL_INVESTIGATOR
References: