The Role of SNRI's in the Prophylaxis of Depression in the First Year Following Lower Extremity Fragility Fractures in Geriatric Patients
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Geriatric Depression Scale (Short Form) Scores
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Geriatric (greater than or equal to 65 years old)
- •Lower extremity fragility fractures managed operatively
排除标准
- •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.)
研究组 & 干预措施
Duloxetine 30mg
Duloxetine 30mg daily 90 day supply and 3 refills
干预措施: Duloxetine 30 mg (Drug)
结局指标
主要结局
Geriatric Depression Scale (Short Form) Scores
时间窗: up to 1 year
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.
Geriatric Depression Scale (Short Form) Scores
时间窗: Baseline
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.
次要结局
- PROMIS-29 Subscale Scores - Depression(Month 3, Month 6, and Year 1)
- PROMIS-29 Subscale Scores - Physical Function(Month 3, Month 6, and Year 1)
- Number of patients who have side effects from the medication(Baseline, monthly up to 1 year)
- Number of participants who undergo re-operation(Baseline, monthly up to 1 year)
- Number of participants who are readmitted to the hospital(Baseline, monthly up to 1 year)
- Mortality Rate(Baseline, monthly up to 1 year)
- Number of participants who re-fracture the study injury(Baseline, monthly up to 1 year)