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| ID | Type | Description | Link |
|---|---|---|---|
| OCR40926 | Other Identifier | UF OnCore |
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Musculoskeletal trauma is one of the leading causes of disability in the United States and its negative quality of life impact extends beyond that of physical recovery. More than 50% of victims of musculoskeletal trauma suffer lasting mental health issues following their injury. These symptoms can develop across all spectrums of patients with a variety of injury severities. Previously, this research team developed a ten-step program with the aim of developing fostering coping mechanisms in trauma patients. We were unable to demonstrate a measurable benefit to their mental health or physical function. This has been mirrored in other studies as well; talk therapy and support groups are not a strong enough intervention for some patients.
We hypothesize that a subset of the trauma population would benefit from medical treatment for their depressive and anxious symptoms in the early recovery period. Given the limited resources of mental health systems, it would be ideal for their surgical providers to be able to manage safely their post-injury mental health issues during their surgical follow up. This is a pragmatic pilot study to develop an effective, acceptable, time-limited treatment strategy that could be safely implemented by non-mental health care providers for victims of musculoskeletal trauma.
Rationale
Over 50% of victims of musculoskeletal trauma suffer prolonged depressive and anxious symptomology following their initial injury. This is an independent risk factor for prolonged mental and physical disability. In previous research by the study team in orthopedic trauma patients without previous diagnosis of psychiatric illness, we have demonstrated 28% of these patients had depressive symptomology and 40% had anxiety symptomology 3 months following their traumatic injury. [1] Mental health resources are limited, placing the bulk of patient care on the orthopedic surgeons and primary care physicians. Support groups, self-help programs and talk therapy, while valuable, have not demonstrated measurable efficacy for this patient population. We hypothesize that a subset of the trauma population would benefit from medical treatment for their depressive and anxious symptoms in the early recovery period.
Specific Aims
Aim 1: Evaluate the efficacy of immediate Fluoxetine therapy versus standard of care Calcium treatment in improving mental health and wellbeing in the post-injury period for patients with musculoskeletal trauma.
Hypothesis: Patients randomized to Fluoxetine will have less severe depression, anxiety and post-traumatic stress symptoms than those treated with calcium.
Methodology: Patients >18 years of age admitted to UF Health with extremity fracture(s) resulting from high energy trauma (more than ground level fall) will be enrolled during their index hospitalization. Baseline mental well-being surveys will be obtained (Table 1) and patients will be randomized to calcium supplementation or Fluoxetine. The medications will be started during the hospitalization and prescribed upon discharge. The patient will be followed in the orthopedic clinic on a standard of care post-operative schedule (2 weeks, 3 months, 6 months, and 12 months). Serial mental well-being surveys will be administered at these time points. Post-operative complications such as infection, nonunion or any other reason for return to the operating room will be tracked.
Aim 2: Develop a safe Fluoxetine treatment protocol with a goal to be therapeutic by 6 weeks and taper completely off of treatment by 6-12 months.
Hypothesis: We will be able to develop a standardized, time-limited protocol that could feasibly be utilized by non-mental health providers.
Methodology: Dr. Barbosa De Faria will monitor symptoms and side effects of the Fluoxetine treatment study arm. Any evidence of escalation of depressive or suicidal ideology in either study population will result in immediate psychiatric treatment. Common side effects, medication adherence and appropriate discontinuation will be tracked. Patient reported pain scales will be obtained at each clinic visit as well as documentation of narcotic and cannabis pain treatment during recovery. Patients will be informed of the finite nature of the medical management. We will assess how many patients in the Fluoxetine arm report worsening of symptomology after the cessation of therapy at 9 months and how many seek continued management.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects randomized to get Fluoxetine therapy | Experimental | Subjects will be randomized to take Fluoxetine (10mg by mouth per day). The randomized drug will be prescribed by the orthopedic team on the day randomization so that the patient may be monitored for side effects during the remainder of their hospitalization. The patient will be prescribed the randomized medication on the day of discharge and a 90 day supply will be provided by the inpatient research pharmacy. |
|
| Subjects randomized to get Calcium Supplmentation | Active Comparator | Subjects will be randomized to take Calcium supplementation (1000mg by mouth per day). The randomized drug will be prescribed by the orthopedic team on the day randomization so that the patient may be monitored for side effects during the remainder of their hospitalization. The patient will be prescribed the randomized medication on the day of discharge and a 90 day supply will be provided by the inpatient research pharmacy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluoxetine | Drug | Subjects will be randomized to take Fluoxetine (10mg by mouth per day). The randomized drug will be prescribed by the orthopedic team on the day randomization so that the patient may be monitored for side effects during the remainder of their hospitalization. The patient will be prescribed the randomized medication on the day of discharge and a 90 day supply will be provided by the inpatient research pharmacy. |
| Measure | Description | Time Frame |
|---|---|---|
| BDI-II - Beck Depression Inventory-II | Score range 0-63. Higher scores indicate worse outcomes, reflecting greater severity of depressive symptoms. | Baseline, 2 weeks, 6 weeks,3 months, 6 months, 1 year |
| BAI - Beck Anxiety Inventory | Score range 0-63. Higher scores indicate worse outcomes, reflecting greater severity of anxiety symptoms. | Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 1 year |
| PSQI - Pittsburgh Sleep Quality Index | Score range 0-21. Higher scores indicate worse outcomes, representing poorer sleep quality. | 2 weeks, 6 weeks, 3 months |
| PSS-SR5 - PTSD Symptom Scale-Self-Report for DSM-5 | Score range 0-80. Higher scores indicate worse outcomes, representing greater PTSD symptom severity. | Baseline, 2 weeks, 6 weeks, 6 months, 1 year |
| PROMIS Social Isolation - Patient-Reported Outcomes Measurement Information System | Scores are typically reported as T-scores, which generally range from about 20-80 (population mean = 50, standard deviation = 10). Higher scores indicate worse outcomes, meaning greater perceived social isolation, a higher PROMIS Social Isolation score reflects feeling more isolated, excluded, or disconnected from others, while lower scores indicate better social connectedness and less isolation. | 6 weeks, 3 months,6 months, 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| PEG - Pain, Enjoyment of Life, and General Activity Scale | Score range 0-10. Higher scores indicate worse outcomes, representing greater pain intensity and interference with enjoyment of life and general activity. | Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer Hagen, MD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida | Gainesville | Florida | 32608 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35978446 | Derived | Lossada-Soto E, Pazik M, Horodyski MB, Vasilopoulos T, de Faria LB, Mathews C, Hagen J. Can fluoxetine mitigate mental health decline in musculoskeletal trauma patients: a pilot single-center randomized clinical trial. Pilot Feasibility Stud. 2022 Aug 17;8(1):184. doi: 10.1186/s40814-022-01119-8. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Subjects Randomized to Get Fluoxetine Therapy | Subjects will be randomized to take Fluoxetine (10mg by mouth per day). The randomized drug will be prescribed by the orthopedic team on the day randomization so that the patient may be monitored for side effects during the remainder of their hospitalization. The patient will be prescribed the randomized medication on the day of discharge and a 90 day supply will be provided by the inpatient research pharmacy. Fluoxetine: Subjects will be randomized to take Fluoxetine (10mg by mouth per day). The randomized drug will be prescribed by the orthopedic team on the day randomization so that the patient may be monitored for side effects during the remainder of their hospitalization. The patient will be prescribed the randomized medication on the day of discharge and a 90 day supply will be provided by the inpatient research pharmacy. |
| FG001 | Subjects Randomized to Get Calcium Supplmentation | Subjects will be randomized to take Calcium supplementation (1000mg by mouth per day). The randomized drug will be prescribed by the orthopedic team on the day randomization so that the patient may be monitored for side effects during the remainder of their hospitalization. The patient will be prescribed the randomized medication on the day of discharge and a 90 day supply will be provided by the inpatient research pharmacy. Calcium: Subjects will be randomized to take Calcium supplementation (1000mg by mouth per day). The randomized drug will be prescribed by the orthopedic team on the day randomization so that the patient may be monitored for side effects during the remainder of their hospitalization. The patient will be prescribed the randomized medication on the day of discharge and a 90 day supply will be provided by the inpatient research pharmacy. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Subjects Randomized to Get Fluoxetine Therapy | Subjects will be randomized to take Fluoxetine (10mg by mouth per day). The randomized drug will be prescribed by the orthopedic team on the day randomization so that the patient may be monitored for side effects during the remainder of their hospitalization. The patient will be prescribed the randomized medication on the day of discharge and a 90 day supply will be provided by the inpatient research pharmacy. Fluoxetine: Subjects will be randomized to take Fluoxetine (10mg by mouth per day). The randomized drug will be prescribed by the orthopedic team on the day randomization so that the patient may be monitored for side effects during the remainder of their hospitalization. The patient will be prescribed the randomized medication on the day of discharge and a 90 day supply will be provided by the inpatient research pharmacy. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | BDI-II - Beck Depression Inventory-II | Score range 0-63. Higher scores indicate worse outcomes, reflecting greater severity of depressive symptoms. | subjects lost to follow up | Posted | Mean | Standard Deviation | units on a scale | Baseline, 2 weeks, 6 weeks,3 months, 6 months, 1 year |
|
From baseline thru 1 year post hospital discharge
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Subjects Randomized to Get Fluoxetine Therapy | Subjects will be randomized to take Fluoxetine (10mg by mouth per day). The randomized drug will be prescribed by the orthopedic team on the day randomization so that the patient may be monitored for side effects during the remainder of their hospitalization. The patient will be prescribed the randomized medication on the day of discharge and a 90 day supply will be provided by the inpatient research pharmacy. Fluoxetine: Subjects will be randomized to take Fluoxetine (10mg by mouth per day). The randomized drug will be prescribed by the orthopedic team on the day randomization so that the patient may be monitored for side effects during the remainder of their hospitalization. The patient will be prescribed the randomized medication on the day of discharge and a 90 day supply will be provided by the inpatient research pharmacy. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jennifer Hagen | University of Florida | (352) 273-7013 | hagenje@ortho.ufl.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 22, 2022 | Feb 19, 2026 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 15, 2022 | Feb 19, 2026 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D005473 | Fluoxetine |
| D002118 | Calcium |
| ID | Term |
|---|---|
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D008673 | Metals, Alkaline Earth |
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Researchers collecting survey data will be blinded to patients' intervention status.
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| Calcium | Drug | Subjects will be randomized to take Calcium supplementation (1000mg by mouth per day). The randomized drug will be prescribed by the orthopedic team on the day randomization so that the patient may be monitored for side effects during the remainder of their hospitalization. The patient will be prescribed the randomized medication on the day of discharge and a 90 day supply will be provided by the inpatient research pharmacy. |
|
| BG001 | Subjects Randomized to Get Calcium Supplmentation | Subjects will be randomized to take Calcium supplementation (1000mg by mouth per day). The randomized drug will be prescribed by the orthopedic team on the day randomization so that the patient may be monitored for side effects during the remainder of their hospitalization. The patient will be prescribed the randomized medication on the day of discharge and a 90 day supply will be provided by the inpatient research pharmacy. Calcium: Subjects will be randomized to take Calcium supplementation (1000mg by mouth per day). The randomized drug will be prescribed by the orthopedic team on the day randomization so that the patient may be monitored for side effects during the remainder of their hospitalization. The patient will be prescribed the randomized medication on the day of discharge and a 90 day supply will be provided by the inpatient research pharmacy. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| OG001 | Subjects Randomized to Get Calcium Supplmentation | Subjects will be randomized to take Calcium supplementation (1000mg by mouth per day). The randomized drug will be prescribed by the orthopedic team on the day randomization so that the patient may be monitored for side effects during the remainder of their hospitalization. The patient will be prescribed the randomized medication on the day of discharge and a 90 day supply will be provided by the inpatient research pharmacy. Calcium: Subjects will be randomized to take Calcium supplementation (1000mg by mouth per day). The randomized drug will be prescribed by the orthopedic team on the day randomization so that the patient may be monitored for side effects during the remainder of their hospitalization. The patient will be prescribed the randomized medication on the day of discharge and a 90 day supply will be provided by the inpatient research pharmacy. |
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| Primary | BAI - Beck Anxiety Inventory | Score range 0-63. Higher scores indicate worse outcomes, reflecting greater severity of anxiety symptoms. | subjects lost to follow up | Posted | Mean | Standard Deviation | units on a scale | Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 1 year |
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| Primary | PSQI - Pittsburgh Sleep Quality Index | Score range 0-21. Higher scores indicate worse outcomes, representing poorer sleep quality. | subjects lost to follow up | Posted | Mean | Standard Deviation | units on a scale | 2 weeks, 6 weeks, 3 months |
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| Primary | PSS-SR5 - PTSD Symptom Scale-Self-Report for DSM-5 | Score range 0-80. Higher scores indicate worse outcomes, representing greater PTSD symptom severity. | subjects lost to follow up | Posted | Mean | Standard Deviation | units on a scale | Baseline, 2 weeks, 6 weeks, 6 months, 1 year |
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| Primary | PROMIS Social Isolation - Patient-Reported Outcomes Measurement Information System | Scores are typically reported as T-scores, which generally range from about 20-80 (population mean = 50, standard deviation = 10). Higher scores indicate worse outcomes, meaning greater perceived social isolation, a higher PROMIS Social Isolation score reflects feeling more isolated, excluded, or disconnected from others, while lower scores indicate better social connectedness and less isolation. | subjects lost to follow up | Posted | Mean | Standard Deviation | units on a scale | 6 weeks, 3 months,6 months, 1 year |
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| Secondary | PEG - Pain, Enjoyment of Life, and General Activity Scale | Score range 0-10. Higher scores indicate worse outcomes, representing greater pain intensity and interference with enjoyment of life and general activity. | subjects lost to follow up | Posted | Mean | Standard Deviation | units on a scale | Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 1 year |
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| 0 |
| 22 |
| 0 |
| 22 |
| 0 |
| 22 |
| EG001 | Subjects Randomized to Get Calcium Supplmentation | Subjects will be randomized to take Calcium supplementation (1000mg by mouth per day). The randomized drug will be prescribed by the orthopedic team on the day randomization so that the patient may be monitored for side effects during the remainder of their hospitalization. The patient will be prescribed the randomized medication on the day of discharge and a 90 day supply will be provided by the inpatient research pharmacy. Calcium: Subjects will be randomized to take Calcium supplementation (1000mg by mouth per day). The randomized drug will be prescribed by the orthopedic team on the day randomization so that the patient may be monitored for side effects during the remainder of their hospitalization. The patient will be prescribed the randomized medication on the day of discharge and a 90 day supply will be provided by the inpatient research pharmacy. | 0 | 33 | 0 | 33 | 0 | 33 |
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| D004602 |
| Elements |
| D007287 | Inorganic Chemicals |
| D008670 | Metals |
| D001779 | Blood Coagulation Factors |
| D001685 | Biological Factors |
| 2 weeks |
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| 6 weeks |
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| 3 months |
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| 6 months |
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| 1 year |
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| 6 weeks |
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| 3 months |
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| 2 weeks |
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| 6 weeks |
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| 6 months |
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| 1 year |
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| 3 months |
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| 6 months |
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| 1 year |
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| 2 weeks |
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| 6 weeks |
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| 3 months |
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| 6 months |
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| 1 year |
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