Musculoskeletal Injury Trauma Clinical Trial
Official title:
An Integrated-Delivery-of-Care Approach to Improve Patient Outcomes, Safety, Well-Being After Orthopaedic Trauma
| Verified date | July 2023 |
| Source | University of Florida |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 111 |
| Est. completion date | January 1, 2023 |
| Est. primary completion date | January 1, 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 85 Years |
| Eligibility | Inclusion Criteria: - Patients admitted with severe or multiple orthopedic trauma - Patients who have received or will receive =1 surgical procedure for their orthopedic injuries - Any major bone fractures that impairs mobility and/or participation in activities of daily living and self-care Exclusion Criteria: - Patients with a traumatic brain injury - Patients with the inability to communicate effectively (e.g., at a level where self-report measures could be answered completely; such as medicated state or mechanically ventilated) - Patients currently using psychotropic medications - Patients with psychotic, suicidal or homicidal ideations. |
| Country | Name | City | State |
|---|---|---|---|
| United States | UF and Shands Orthopaedics and Sports Medicine Institute | Gainesville | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| University of Florida | Foundation for Physical Medicine and Rehabilitation, National Athletic Trainers' Association Research & Education Foundation (NATA Foundation) |
United States,
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| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in baseline, at weeks 2, 6 and 12 and months 6 and 12 on the Patient Reported Outcome Measurement Information System (PROMIS) - Physical Function between the groups. | Survey questionnaire measures the perception of Physical Function. Physical Function Average: t score = 50±10 Min: 10 Max: 90 | Change in Baseline, at weeks 2, 6 and 12 and months 6 and 12 | |
| Primary | Change in baseline, at weeks 2, 6 and 12 and months 6 and 12 on the Patient Reported Outcome Measurement Information System (PROMIS) - Social Roles between the groups. | Survey questionnaire measures the perception of Social Roles. Social Roles Average: t score = 50±10 Min: 10 Max: 90 | Change in Baseline, at weeks 2, 6 and 12 and months 6 and 12 | |
| Primary | Change in baseline, at weeks 2, 6 and 12 and months 6 and 12 on the Patient Reported Outcome Measurement Information System (PROMIS) - - Psychosocial Illness Impact-positive between the groups. | Survey questionnaire measures the perception of Psychosocial Illness Impact. Psychosocial Average: t score = 50±10 Min: 13.8 Max: 68.7 | Change in Baseline, at weeks 2, 6 and 12 and months 6 and 12 | |
| Secondary | Change in baseline, at weeks 2, 6 and 12 and months 6 and 12 on The Beck Depression Inventory-II between the groups. | Survey questionnaire used to determine levels of depression.
Normal: 0-13 Min: 0 Max: 63 |
Change in Baseline, at weeks 2, 6 and 12 and months 6 and 12 | |
| Secondary | Change in baseline, at weeks 2, 6 and 12 and months 6 and 12 on The State-Trait Anxiety Inventory (STAI) between the groups. | Survey questionnaire used to determine levels of anxiety after traumatic injury.
Normal Range: 20-38 Min: 20 Max: 80 |
Change in Baseline, at weeks 2, 6 and 12 and months 6 and 12 | |
| Secondary | Change in baseline, at weeks 2, 6 and 12 and months 6 and 12 on the Lower Extremity Gain Scale (LEGS) between the groups. | LEGS consists combined score taken of a 3-meter walk, putting on a sock, putting on a shoe, rising from an armless chair, stepping up and down stairs, getting on and off the toilet, reaching from a sitting position to an object on the ground.
Best score 27 Minimum score 0 Normal scores not available |
Change in Baseline, at weeks 2, 6 and 12 and months 6 and 12 | |
| Secondary | Digital inclinometer measuring Change in baseline, at weeks 2, 6 and 12 and months 6 and 12 between the groups. | Digital inclinometer will be used to measure the Range of Motion in joints of interest. | Change in Baseline, at weeks 2, 6 and 12 and months 6 and 12 | |
| Secondary | Change in baseline, at weeks 2, 6 and 12 and months 6 and 12 on Posttraumatic Stress Disorder between the groups. | Survey questionnaire will be administered to measure posttraumatic stress levels.
Norm 30-35 Minimum 17 Maximum 85 |
Change in Baseline, at weeks 2, 6 and 12 and months 6 and 12 | |
| Secondary | Change in baseline, at weeks 2, 6 and 12 and months 6 and 12 on the Short-Form Patient Satisfaction Questionnaire (PSQ-18) between the groups. | The Short-Form Patient Satisfaction Questionnaire (PSQ-18) is a Likert scale instrument that asks about the level of patient agreement with specific questions pertaining to their medical care experiences.
Best Score: 90 Min: 18 Max: 90 |
Change in Baseline, at weeks 2, 6 and 12 and months 6 and 12 | |
| Secondary | Change in baseline, at weeks 2, 6 and 12 and months 6 and 12 on the Tampa Scale of Kinesiophobia-11 (TSK-11) between the groups. | Survey questionnaire given assess the pain-related fear of movement in orthopaedic trauma and the Tampa Scale of Kinesiophobia-11 (TSK-11) will be used. Best Score: 11 Min: 11 Max: 44 | Change in Baseline, at weeks 2, 6 and 12 and months 6 and 12 | |
| Secondary | Change in baseline, at weeks 2, 6 and 12 and months 6 and 12 on the Communication Assessment Questionnaire between the groups. | Survey asking the patient how the communication has been between the facilitator and the patient. Best Score: 75 Min: 0 Max: 75 | 12 month | |
| Secondary | Change in baseline, at weeks 2, 6 and 12 and months 6 and 12 on the Hand-held hydraulic dynamometer to measure Handgrip Strength between the groups. | Isometric handgrip strength is a valid predictor of mobility and will be measured using a hand-held hydraulic dynamometer.
Average: 39 kg Range: 33-45 kg |
Change in Baseline, at weeks 2, 6 and 12 and months 6 and 12 |