Depression
Conditions
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.
Interventions
DRUGFluoxetine 20 MG
Fluoxetine 20 mg once daily
DRUGDuloxetine 30 MG
Duloxetine 30 mg once daily
OTHERObservation
Referral to behavioral health and resources for addressing depressive symptoms
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Patients will be randomized to receive either an Selective serotonin reuptake inhibitors (SSRI) or serotonin and norepinephrine reuptake inhibitors (SNRI), and patients who are not interested in taking medication for their symptoms will be enrolled in an observational arm.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* Currently taking medication to treat depression * Contraindication/allergy to one of the study medications * Bipolar disorder of psychotic disorder * Endorse suicidal ideation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Depressive Symptom Scores | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 - 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 - 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. |
| 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. |
| 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. |
| Healthcare Utilization - The number of hospitalizations and ED visits | Months 3, 6, and 12 | The number of hospitalizations and ED visits |
Countries
United States
Contacts
Primary ContactErica Grochowski, MPH
Outcome results
None listed