Identifying and Treating Depression in the Orthopaedic Trauma Population
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
- Depressive Symptom Scores
研究概览
简要总结
The goal of this trial is to pilot a way for orthopaedic surgeons to safely screen for depression and provide treatment for depression with medication. The main questions it aims to answer are:
- What are the outcomes of patients who screen positive for depressive symptoms and are prescribed either an Selective serotonin reuptake inhibitors (SSRI) or serotonin and norepinephrine reuptake inhibitors (SNRI).
- What are the outcomes of patients who screen positive for depressive symptoms and choose not to pursue treatment with medication?
详细描述
Depression is common among orthopaedic trauma patients and associated with worsened outcomes including pain, opioid consumption, patient-reported outcomes ,complications, and length of stay. Addressing depression, therefore, should lead to improved outcomes. Orthopaedic surgeons may believe treating depression is outside their scope or that they lack tools to address depressive symptoms. In fact, only 45% of surgeons report they are likely to screen patients, and only 27% are likely to refer patients for psychological treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients presenting to an Orthopaedic trauma clinic for the first time following operative extremity fracture or any pelvis fracture
- •A score of greater than or equal to 5 on the Patient Health Questionnaire-9 (PHQ-9) at first post- operative visit
- •Age 18 or older
- •Speak English or Spanish
排除标准
- •Currently taking medication to treat depression
- •Contraindication/allergy to one of the study medications
- •Bipolar disorder of psychotic disorder
- •Endorse suicidal ideation
研究组 & 干预措施
Observational
Referral to behavioral health per standard practice and provision of resources for strategices to address depressive symptoms.
干预措施: Observation (Other)
serotonin and norepinephrine reuptake inhibitors (SNRI)
Duloxetine, 30mg once daily
干预措施: Duloxetine 30 MG (Drug)
Selective serotonin reuptake inhibitors (SSRI)
Fluoxetine, 20mg once daily
干预措施: Fluoxetine 20 MG (Drug)
结局指标
主要结局
Depressive Symptom Scores
时间窗: Year 1
Improvement in depressive symptoms, indication by either remission (PHQ-9 score \<5) or a 50% reduction in PHQ-9 score. The Patient Health Questionnaire (PHQ-9) is a self-report tool that incorporates DSM-IV depression diagnostic criteria with other leading major depressive symptoms. The too rates the frequency of the symptoms which factors into the scoring severity index. PHQ-9 scores of 5, 10, 15, and 20 represent mild, moderate, moderately severe and severe depression.
Depressive Symptom Scores
时间窗: Baseline
Improvement in depressive symptoms, indication by either remission (PHQ-9 score \<5) or a 50% reduction in PHQ-9 score. The Patient Health Questionnaire (PHQ-9) is a self-report tool that incorporates DSM-IV depression diagnostic criteria with other leading major depressive symptoms. The too rates the frequency of the symptoms which factors into the scoring severity index. PHQ-9 scores of 5, 10, 15, and 20 represent mild, moderate, moderately severe and severe depression.
Depressive Symptom Scores
时间窗: Month 3
Improvement in depressive symptoms, indication by either remission (PHQ-9 score \<5) or a 50% reduction in PHQ-9 score. The Patient Health Questionnaire (PHQ-9) is a self-report tool that incorporates DSM-IV depression diagnostic criteria with other leading major depressive symptoms. The too rates the frequency of the symptoms which factors into the scoring severity index. PHQ-9 scores of 5, 10, 15, and 20 represent mild, moderate, moderately severe and severe depression.
Depressive Symptom Scores
时间窗: Month 6
Improvement in depressive symptoms, indication by either remission (PHQ-9 score \<5) or a 50% reduction in PHQ-9 score. The Patient Health Questionnaire (PHQ-9) is a self-report tool that incorporates DSM-IV depression diagnostic criteria with other leading major depressive symptoms. The too rates the frequency of the symptoms which factors into the scoring severity index. PHQ-9 scores of 5, 10, 15, and 20 represent mild, moderate, moderately severe and severe depression.
Depressive Symptom Scores
时间窗: Month 9
Improvement in depressive symptoms, indication by either remission (PHQ-9 score \<5) or a 50% reduction in PHQ-9 score. The Patient Health Questionnaire (PHQ-9) is a self-report tool that incorporates DSM-IV depression diagnostic criteria with other leading major depressive symptoms. The too rates the frequency of the symptoms which factors into the scoring severity index. PHQ-9 scores of 5, 10, 15, and 20 represent mild, moderate, moderately severe and severe depression.
次要结局
- Adherence to Treatment Percentage(Months 3, 6, and 12)
- Patient Reported Outcome Measures: Patient Health Questionnaire 9 (PHQ-9)(Months 3, 6, and 12)
- Patient Reported Outcome Measures - Veterans RAND 12 Item Health Survey (VR-12)(Months 3, 6, and 12)
- Qualitative Interview Information(One time between 6-12 months)
- Patient Reported Outcome Measures - PROMIS-29 Scores(Months 3, 6, and 12)
- Patient Reported Outcome Measures - Brief Pain Inventory Scores(Months 3, 6, and 12)
- Healthcare Utilization - The number of hospitalizations and ED visits(Months 3, 6, and 12)
- Utilization of non-pharmaceutical tools and resources Percentage(Months 3, 6, and 12)
- Patient Reported Outcome Measures - Work Productivity and Activity Impairment Questionnaire Scores(Months 3, 6, and 12)