Идёт набор NCT05976347

Identifying and Treating Depression in the Orthopaedic Trauma Population

Фаза IV С лечением Depression

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Fluoxetine 20 MG, Duloxetine 30 MG, Observation.
Кому может быть актуально: Состояния в реестре: Depression. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

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: 1. 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). 2. What are the outcomes of patients who screen positive for depressive symptoms and choose not to pursue treatment with medication?

Подробное описание

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.

Вмешательства

Препарат Fluoxetine 20 MG
Fluoxetine 20 mg once daily
Препарат Duloxetine 30 MG
Duloxetine 30 mg once daily
Другое Observation
Referral to behavioral health and resources for addressing depressive symptoms

Первичные конечные точки

Depressive Symptom Scores [Срок оценки: Baseline]
Depressive Symptom Scores [Срок оценки: Month 3]
Depressive Symptom Scores [Срок оценки: Month 6]
Depressive Symptom Scores [Срок оценки: Month 9]
Depressive Symptom Scores [Срок оценки: Year 1]

Вторичные конечные точки (9)

Adherence to Treatment Percentage [Срок оценки: Months 3, 6, and 12]
Utilization of non-pharmaceutical tools and resources Percentage [Срок оценки: Months 3, 6, and 12]
Patient Reported Outcome Measures - PROMIS-29 Scores [Срок оценки: Months 3, 6, and 12]
Patient Reported Outcome Measures - Work Productivity and Activity Impairment Questionnaire Scores [Срок оценки: Months 3, 6, and 12]
Patient Reported Outcome Measures - Brief Pain Inventory Scores [Срок оценки: Months 3, 6, and 12]
Healthcare Utilization - The number of hospitalizations and ED visits [Срок оценки: Months 3, 6, and 12]
Patient Reported Outcome Measures: Patient Health Questionnaire 9 (PHQ-9) [Срок оценки: Months 3, 6, and 12]
Patient Reported Outcome Measures - Veterans RAND 12 Item Health Survey (VR-12) [Срок оценки: Months 3, 6, and 12]
Qualitative Interview Information [Срок оценки: One time between 6-12 months]

Критерии участия

Критерии включения

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