Clinical trial NCT05976347: Identifying and Treating Depression in the Orthopaedic Trauma Population
Official title: Identifying and Treating Depression in the Orthopaedic Trauma Population
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Depression
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2023-08-04
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Depressive Symptom Scores
timeFrame: Baseline
measure: Depressive Symptom Scores
timeFrame: Month 3
measure: Depressive Symptom Scores
timeFrame: Month 6
measure: Depressive Symptom Scores
timeFrame: Month 9
measure: Depressive Symptom Scores
timeFrame: Year 1
Secondary outcomes:
measure: Adherence to Treatment Percentage
timeFrame: Months 3, 6, and 12
measure: Utilization of non-pharmaceutical tools and resources Percentage
timeFrame: Months 3, 6, and 12
measure: Patient Reported Outcome Measures - PROMIS-29 Scores
timeFrame: Months 3, 6, and 12
measure: Patient Reported Outcome Measures - Work Productivity and Activity Impairment Questionnaire Scores
timeFrame: Months 3, 6, and 12
measure: Patient Reported Outcome Measures - Brief Pain Inventory Scores
timeFrame: Months 3, 6, and 12
measure: Healthcare Utilization - The number of hospitalizations and ED visits
timeFrame: Months 3, 6, and 12
measure: Patient Reported Outcome Measures: Patient Health Questionnaire 9 (PHQ-9)
timeFrame: Months 3, 6, and 12
measure: Patient Reported Outcome Measures - Veterans RAND 12 Item Health Survey (VR-12)
timeFrame: Months 3, 6, and 12
measure: Qualitative Interview Information
timeFrame: One time between 6-12 months
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Meghan K Wally, PhD
role: PRINCIPAL_INVESTIGATOR
References: