Identifying and Treating Depression in the Orthopaedic Trauma Population

Depression Clinical Trial

Official title:

Identifying and Treating Depression in the Orthopaedic Trauma Population

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05976347
• Other study ID #: IRB00096491
• Secondary ID: MSKRSH040123
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: July 2024
• Est. completion date: December 2025

Study information

• Verified date: April 2024
• Source: Wake Forest University Health Sciences
• Contact: Erica Grochowski, MPH
• Phone: 704-403-4980
• Email: Erica.Grochowski[@]atriumhealth.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Drug:
• Fluoxetine 20 MG
Fluoxetine 20 mg once daily
• Duloxetine 30 MG
Duloxetine 30 mg once daily

Other:
• Observation
Referral to behavioral health and resources for addressing depressive symptoms

Locations

Country	Name	City	State
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depressive Symptom Scores	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.	Baseline
Primary	Depressive Symptom Scores	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.	Month 3
Primary	Depressive Symptom Scores	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.	Month 6
Primary	Depressive Symptom Scores	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.	Month 9
Primary	Depressive Symptom Scores	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.	Year 1
Secondary	Adherence to Treatment Percentage	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).	Months 3, 6, and 12
Secondary	Utilization of non-pharmaceutical tools and resources Percentage	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).	Months 3, 6, and 12
Secondary	Patient Reported Outcome Measures - PROMIS-29 Scores	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.	Months 3, 6, and 12
Secondary	Patient Reported Outcome Measures - Work Productivity and Activity Impairment Questionnaire Scores	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.	Months 3, 6, and 12
Secondary	Patient Reported Outcome Measures - Brief Pain Inventory Scores	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.	Months 3, 6, and 12
Secondary	Healthcare Utilization - The number of hospitalizations and ED visits	The number of hospitalizations and ED visits	Months 3, 6, and 12
Secondary	Patient Reported Outcome Measures: Patient Health Questionnaire 9 (PHQ-9)	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.	Months 3, 6, and 12
Secondary	Patient Reported Outcome Measures - Veterans RAND 12 Item Health Survey (VR-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.	Months 3, 6, and 12
Secondary	Qualitative Interview Information	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.	One time between 6-12 months