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NCT02591472 · ClinicalTrials.gov registry record · NA
An Integrated-Delivery-of-Care Approach to Improve Patient Outcomes, Safety, Well-Being After Orthopaedic Trauma
A NA study of Musculoskeletal Injury Trauma, sponsored by University of Florida.
- Completed
- Registry status
- NA
- Development phase
- 88
- Enrollment target
- 1
- Study location
NCT02591472 is a NA study of Musculoskeletal Injury Trauma that has completed, run by University of Florida. The registered enrollment target is 88 participants. The trial reports 1 study location across 1 state.
The verdict
NCT02591472, a NA study of Musculoskeletal Injury Trauma, has completed, sponsored by University of Florida.
- COMPLETED
- Registry status
- NA
- Development phase
- 88 participants
- Enrollment target
- 1
- Study location
Study Summary
Orthopedic trauma is an unforeseen life-changing event. Nearly 2.8 million Americans sustain traumatic orthopedic injuries such as major fractures or amputation each year. Injury is treated in the hospital by physicians who medically stabilize and reconstruct the patient. Upon completion of their hospital stay, patients are discharged to begin their reintegration back into home and community activities. Despite high surgical success and survivorship rates, these injuries often result in poor quality of life (QOL)-related outcomes in otherwise healthy people. Fifty to ninety percent of patients develop severe psychological distress such as post-traumatic stress syndrome, depression or anxiety. Patients are often not provided the comprehensive support care and resources that are necessary to cope successfully with psychological stress and reintegrate into purposeful living. This is a major problem because high distress levels predict poor physical function, use of pain medications and low QOL. Survivors often cannot return to work, have persistent pain and experience social isolation. Distress worsens the self-perceptions of functional gain and efficacy and decreases personal fulfillment. Lingering psychological distress contributes to the development of other health problems and rebuilding of life is negatively impacted. The lack of psychosocial support contributes to injury re-occurrence, injury recidivism, re-hospitalizations and longer hospitalization stays, and higher personal and societal health care costs. There is currently a lack of comparative efficacy research to determine which delivery approach produces greater improvements in the outcomes that are most desired by patients, specifically, functional QOL and emotional well-being. The proposed research will directly compare these delivery-of-care approaches and measure the patient-reported outcomes that are considered important to patients.
Conditions Studied
Interventions
- OTHER Patient-Reported Outcomes Measurement Information System
- PROCEDURE Integrated care (ICare)
- PROCEDURE Usual Care (UsCare)
- OTHER Lower Extremity Gain Scale (LEGS)
- OTHER Dynamometer
Study Locations (1)
Florida
- UF and Shands Orthopaedics and Sports Medicine Institute - Gainesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 88 participants |
| Start Date | 2016-01-11 |
| Est. Completion | 2023-01-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02591472
The ClinicalTrials.gov registry entry for NCT02591472 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 88 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Florida, which has 1,106 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Musculoskeletal Injury Trauma appearing as the primary indexed condition, and to 5 interventions - of which Patient-Reported Outcomes Measurement Information System is the first listed.
NCT02591472 reports 1 study location spanning 1 distinct geographic area - top geographies include Florida.
Frequently Asked Questions
What is clinical trial NCT02591472 about?
NCT02591472 is a clinical study titled "An Integrated-Delivery-of-Care Approach to Improve Patient Outcomes, Safety, Well-Being After Orthopaedic Trauma". Orthopedic trauma is an unforeseen life-changing event. Nearly 2.8 million Americans sustain traumatic orthopedic injuries such as major fractures or amputation each year. Injury is treated in the hospital by physicians who medically stabilize and reconstruct the patient. Upon completion of their ho...
What is the current status of trial NCT02591472?
This trial is currently completed. It is a NA study. The enrollment target is 88 participants. The study started on 2016-01-11. Estimated completion is 2023-01-01.
What conditions does trial NCT02591472 study?
This clinical trial studies the following conditions: Musculoskeletal Injury Trauma.
What interventions are being tested in trial NCT02591472?
The interventions under investigation include: Patient-Reported Outcomes Measurement Information System (OTHER), Integrated care (ICare) (PROCEDURE), Usual Care (UsCare) (PROCEDURE), Lower Extremity Gain Scale (LEGS) (OTHER), Dynamometer (OTHER).
Who is sponsoring clinical trial NCT02591472?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02591472 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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