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Identifying and Treating Depression in the Orthopaedic Trauma Population

Primary Purpose

Depression

Status
Not yet recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Fluoxetine 20 MG
Duloxetine 30 MG
Observation
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Wake Forest University Health Sciences

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Other

Arm Label

Selective serotonin reuptake inhibitors (SSRI)

serotonin and norepinephrine reuptake inhibitors (SNRI)

Observational

Arm Description

Fluoxetine, 20mg once daily

Duloxetine, 30mg once daily

Referral to behavioral health per standard practice and provision of resources for strategices to address depressive symptoms.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.

Secondary Outcome Measures

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).
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).
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.
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.
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.
Healthcare Utilization - The number of hospitalizations and ED visits
The number of hospitalizations and ED visits
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.
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.
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.

Full Information

First Posted
July 28, 2023
Last Updated
August 30, 2023
Sponsor
Wake Forest University Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05976347
Brief Title
Identifying and Treating Depression in the Orthopaedic Trauma Population
Official Title
Identifying and Treating Depression in the Orthopaedic Trauma Population
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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: 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). 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Selective serotonin reuptake inhibitors (SSRI)
Arm Type
Experimental
Arm Description
Fluoxetine, 20mg once daily
Arm Title
serotonin and norepinephrine reuptake inhibitors (SNRI)
Arm Type
Experimental
Arm Description
Duloxetine, 30mg once daily
Arm Title
Observational
Arm Type
Other
Arm Description
Referral to behavioral health per standard practice and provision of resources for strategices to address depressive symptoms.
Intervention Type
Drug
Intervention Name(s)
Fluoxetine 20 MG
Other Intervention Name(s)
Prozac Weekly, Sarafem, Prozac
Intervention Description
Fluoxetine 20 mg once daily
Intervention Type
Drug
Intervention Name(s)
Duloxetine 30 MG
Other Intervention Name(s)
Irenka and Cymbalta
Intervention Description
Duloxetine 30 mg once daily
Intervention Type
Other
Intervention Name(s)
Observation
Other Intervention Name(s)
Referral to behavioral health and resources
Intervention Description
Referral to behavioral health and resources for addressing depressive symptoms
Primary Outcome Measure Information:
Title
Depressive Symptom Scores
Description
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.
Time Frame
Baseline
Title
Depressive Symptom Scores
Description
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.
Time Frame
Month 3
Title
Depressive Symptom Scores
Description
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.
Time Frame
Month 6
Title
Depressive Symptom Scores
Description
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.
Time Frame
Month 9
Title
Depressive Symptom Scores
Description
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.
Time Frame
Year 1
Secondary Outcome Measure Information:
Title
Adherence to Treatment Percentage
Description
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).
Time Frame
Months 3, 6, and 12
Title
Utilization of non-pharmaceutical tools and resources Percentage
Description
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).
Time Frame
Months 3, 6, and 12
Title
Patient Reported Outcome Measures - PROMIS-29 Scores
Description
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.
Time Frame
Months 3, 6, and 12
Title
Patient Reported Outcome Measures - Work Productivity and Activity Impairment Questionnaire Scores
Description
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.
Time Frame
Months 3, 6, and 12
Title
Patient Reported Outcome Measures - Brief Pain Inventory Scores
Description
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.
Time Frame
Months 3, 6, and 12
Title
Healthcare Utilization - The number of hospitalizations and ED visits
Description
The number of hospitalizations and ED visits
Time Frame
Months 3, 6, and 12
Title
Patient Reported Outcome Measures: Patient Health Questionnaire 9 (PHQ-9)
Description
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.
Time Frame
Months 3, 6, and 12
Title
Patient Reported Outcome Measures - Veterans RAND 12 Item Health Survey (VR-12)
Description
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.
Time Frame
Months 3, 6, and 12
Title
Qualitative Interview Information
Description
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.
Time Frame
One time between 6-12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Erica Grochowski, MPH
Phone
704-403-4980
Email
Erica.Grochowski@atriumhealth.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Meghan K Wally, PhD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest University Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erica Grochowski, MPH
Phone
704-403-4980
Email
Erica.Grochowski@atriumhealth.org

12. IPD Sharing Statement

Plan to Share IPD
No

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Identifying and Treating Depression in the Orthopaedic Trauma Population

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