Identifying and Treating Depression in the Orthopaedic Trauma Population
- Conditions
- Depression
- Interventions
- Registration Number
- NCT05976347
- Lead Sponsor
- Wake Forest University Health Sciences
- Brief Summary
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?
- Detailed Description
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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 100
- 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
- Currently taking medication to treat depression
- Contraindication/allergy to one of the study medications
- Bipolar disorder of psychotic disorder
- Endorse suicidal ideation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Observational Observation Referral to behavioral health per standard practice and provision of resources for strategices to address depressive symptoms. serotonin and norepinephrine reuptake inhibitors (SNRI) Duloxetine 30 MG Duloxetine, 30mg once daily Selective serotonin reuptake inhibitors (SSRI) Fluoxetine 20 MG Fluoxetine, 20mg once daily
- Primary Outcome Measures
Name Time Method Depressive Symptom Scores 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.
- Secondary Outcome Measures
Name Time Method Adherence to Treatment Percentage Months 3, 6, and 12 Adherence to treatment and side effects or adverse events associated with the medications will be collected using patient logs, study visit questionnaires, and the medical record (i.e., number of prescriptions filled).
Patient Reported Outcome Measures: Patient Health Questionnaire 9 (PHQ-9) Months 3, 6, and 12 A PHQ-9 score total of 0-4 points equals "normal" or minimal depression. Scoring between 5-9 points indicates mild depression, 10-14 points indicates moderate depression, 15-19 points indicates moderately severe depression, and 20 or more points indicates severe depression. The higher the score, the more symptoms of depression experienced, and the more severe the depression is.
Patient Reported Outcome Measures - Veterans RAND 12 Item Health Survey (VR-12) Months 3, 6, and 12 Measures health related quality of life across 7 domains. The answers are summarized into two scores - a Physical Component Score and a Mental Component Score.
Qualitative Interview Information One time between 6-12 months Patients in the observational arm will participate in semi-structured interviews. Interviews will be recorded and transcribed verbatim within one week. Field notes will be written within one week of each interview, and the interview guide will be revised as appropriate.
Patient Reported Outcome Measures - PROMIS-29 Scores Months 3, 6, and 12 The PROMIS-29 scales will be scored using a T-score metric method. A score of 50 points represents the population average for each scale, and 10 points represent one standard deviation. Higher scores mean a higher level of disability.
Patient Reported Outcome Measures - Brief Pain Inventory Scores Months 3, 6, and 12 Assesses the severity of pain and the impact of pain on daily functions. Assesses the severity of and impact of pain on daily function. Patients are asked to rate their current symptoms, average experiences of pain, and the minimum and maximum intensities of their symptoms on scales that range from 1-10. A total pain severity score can be found by averaging these items or a single items can be treated as the primary outcome. Higher scores indicate greater severity and more interference.
Healthcare Utilization - The number of hospitalizations and ED visits Months 3, 6, and 12 The number of hospitalizations and ED visits
Utilization of non-pharmaceutical tools and resources Percentage Months 3, 6, and 12 Engagement with behavioral health resources will be collected using patient logs, study visit questionnaires, and the medical record (i.e., number of visits with Behavioral Health).
Patient Reported Outcome Measures - Work Productivity and Activity Impairment Questionnaire Scores Months 3, 6, and 12 The Work Productivity and Activity Impairment questionnaire measures how work productivity and activities are impaired by a specific health condition or disease. Scores are expressed as a percentage of impairment/productivity loss, a high score indicates greater impairment.
Trial Locations
- Locations (1)
Wake Forest University Health Sciences
🇺🇸Winston-Salem, North Carolina, United States