Musculoskeletal Injury Trauma
Conditions
Brief 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.
Detailed description
The research study will determine whether the Usual Care or Integrated Care (which is Usual Care plus emotional support, and education/information during the hospital stay) helps patients feel better about their physical function and emotional well-being. Participants with serious musculoskeletal injury, being treated at to the University of Florida's (UF) Orthopaedic Trauma service at UF Health at Shands Hospital, will be randomized (like tossing a coin) between the two groups. Usual Care will follow all the highest standards for injury treatment. Integrated Care will include medical care and emotional support. Study Staff are trained to provide emotional support and teach patients the skills for goal setting, taking ownership of journey, establishing lifelines, mobilizing resources and reducing stressors. In addition, questionnaires and simple functional tests will be collected at the hospital and at normal follow-up visits at weeks 2, 6 and 12 and months 6 and 12.
Interventions
PROCEDUREIntegrated care (ICare)
The Integrated Care approach provides Usual Care processes plus simultaneous psychosocial support via the Transform-10 Program. The Transform-10 Program will include information regarding emotional well-being, social support, and provides opportunity for the patient to openly discuss their thoughts and concerns regarding their recovery. The patient's normal clinical care usually includes a hospital stay, a 2 week follow up, 6 week follow up, 12 week follow up, 6 month, and 1 year follow up visit.
PROCEDUREUsual Care (UsCare)
Usual Care includes radiographic imaging and administration of pain medication and antibiotics, skin care and range of motion of the injured area. The patient's normal clinical care usually includes a hospital stay, a 2 week follow up, 6 week follow up, 12 week follow up, 6 month, and 1 year follow up visit. At the end of the study all of the materials that make up the Transform-10 Program will be provided.
Questionnaires of Physical Functional quality of life and Emotional Well-being will be performed during the hospital stay, a 2 week follow up, 6 week follow up, 12 week follow up, 6 month, and 1 year follow up visit.
OTHERLower Extremity Gain Scale (LEGS)
LEGS consists 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. In people with traumatic fractures, LEGS has high internal consistency and the content, concurrent and construct validity are high. This assessment will be performed during the hospital stay, at the 2 week follow up, 6 week follow up, 12 week follow up, 6 month, and 1 year follow up visit.
OTHERDynamometer
Isometric handgrip strength will be measured using a hand-held hydraulic dynamometer. Handgrip strength is clinically important as it strongly predicts long-term function capability after orthopedic trauma. This assessment will be performed during the hospital stay, at the 2 week follow up, 6 week follow up, 12 week follow up, 6 month, and 1 year follow up visit.
OTHERActive Range of Motion (AROM)
The use of goniometer and a digital inclinometer will be used to assess AROM. This assessment will be performed during the hospital stay, at the 2 week follow up, 6 week follow up, 12 week follow up, 6 month, and 1 year follow up visit.
OTHERPosttraumatic Stress Disorder (PTSD)
The Posttraumatic Stress Disorder (PTSD) Checklist will be administered to measure posttraumatic stress levels. This assessment will be performed during the hospital stay, at the 2 week follow up, 6 week follow up, 12 week follow up, 6 month, and 1 year follow up visit.
OTHERBeck Depression Inventory-II
The Beck Depression Inventory-II is a broadly-applicable, clinically relevant psychometric instrument with high reliability and consistency which notes depression. This assessment will be performed during the hospital stay, at the 2 week follow up, 6 week follow up, 12 week follow up, 6 month, and 1 year follow up visit.
The State-Trait Anxiety Inventory (STAI) will be used to measure state anxiety (anxiety about an event) and trait anxiety (anxiety level as a personal characteristic). This assessment will be performed during the hospital stay, at the 2 week follow up, 6 week follow up, 12 week follow up, 6 month, and 1 year follow up visit.
OTHERTampa Scale of Kinesiophobia-11 (TSK-11)
Tampa Scale of Kinesiophobia-11 (TSK-11) will be used to assess pain-related fear in orthopaedic trauma. This assessment will be performed during the hospital stay, at the 2 week follow up, 6 week follow up, 12 week follow up, 6 month, and 1 year follow up visit.
Sponsors
National Athletic Trainers' Association Research & Education Foundation (NATA Foundation)
Foundation for Physical Medicine and Rehabilitation
University of Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline, at Weeks 2, 6 and 12 on the Patient Reported Outcome Measurement Information System (PROMIS) - Physical Function Between the Groups. | Change from baseline at weeks 2, 6 and 12 | Survey questionnaire measures the perception of Physical Function. Physical Function Average: t score = 50±10 Min: 10 Max: 90 A higher PROMIS T-score represents more of the concept being measured. For positively-worded concepts like Physical Functional T-score of 60 is one SD better than average. By comparison, a Physical Function T-score of 40 is one SD worse than average. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline at Weeks 6 and 12 on the Lower Extremity Gain Scale (LEGS) Between the Groups. | Change from baseline at weeks 6 and 12 | 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 From Baseline at Weeks 2, 6 and 12 on the Tampa Scale of Kinesiophobia-11 (TSK-11) Between the Groups. | Change from baseline at weeks 2, 6 and 12 | 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 |
| Absolute Hand Grip Scores at Weeks 2, 6 and 12 on the Hand-held Hydraulic Dynamometer to Measure Handgrip Strength Between the Groups. | Absolute hand grip scores at weeks 2, 6 and 12 | 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 This is an estimated range for normal healthy subject. However, some of the patients in this study did not fall within this estimated range. The Unit of Measure is kilograms (kg). Subsequently all values presented are in kilograms (kg). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Usual Care (UsCare) This group will receive UsCare for orthopedic trauma involves surgical intervention, acute care therapies, post-acute rehabilitation and follow-up clinic visits.
Usual Care (UsCare) includes radiographic imaging and administration of pain medication and antibiotics, skin care and range of motion of the injured area. Normal clinical care usually includes a hospital stay, a 2 week, 6 week, and 12 week follow up visits. At the end of the study the materials for the Transform-10 Program will be provided. Additionally, the following tests will be performed:
Patient-Reported Outcomes Measurement Information System: Questionnaires of Physical Functional quality of life and Emotional Well-being will be done during the 2 week, 6 week,12 week follow up visits.
Lower Extremity Gain Scale (LEGS) consists of a 3-meter walk, putting on sock, putting on shoe, rising from a chair, stepping up/ down stairs, getting on/off the toilet, reaching from a sitting position to an object on the ground. This will be performed at the 6 week and 12 week follow up visits.
Dynamometer: Isometric handgrip strength will be measured with a hand-held hydraulic dynamometer. This test will be performed at the 2 week, 6 week and 12 week follow up visits.
Tampa Scale of Kinesiophobia-11 (TSK-11) will be used to assess pain-related fear in orthopaedic trauma. This will be performed at the 2 week, 6 week and 12 week follow up visits. | 50 |
| Integrated Care (ICare) This group will receive ICare for orthopedic trauma involves surgical intervention, acute therapies, post-acute rehabilitation and follow-up clinic visits and simultaneous psychosocial support via the Transform-10 Program.
Integrated care (ICare):This approach provides Usual Care plus the Transform-10 Program that includes information for emotional well-being, social support and opportunity for the patient to discuss thoughts and concerns with recovery. Patient's normal clinical care usually includes a hospital stay, a 2 week, 6 week, and 12 week follow up visits.
Additionally, the following test will be performed:
Patient-Reported Outcomes Measurement Information System: Questionnaires of Physical Functional quality of life and Emotional Well-being will be done during the 2 week, 6 week,12 week follow up visits.
Lower Extremity Gain Scale (LEGS) consists of a 3-meter walk, putting on sock, putting on shoe, rising from a chair, stepping up/ down stairs, getting on/off the toilet, reaching from a sitting position to an object on the ground. This will be performed at the 6 week and 12 week follow up visits.
Dynamometer: Isometric handgrip strength will be measured with a hand-held hydraulic dynamometer. This test will be performed at the 2 week, 6 week and 12 week follow up visits.
Tampa Scale of Kinesiophobia-11 (TSK-11) will be used to assess pain-related fear in orthopaedic trauma. This will be performed at the 2 week, 6 week and 12 week follow up visits. | 38 |
| Total | 88 |
Baseline characteristics
| Characteristic | Integrated Care (ICare) | Total | Usual Care (UsCare) |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 5 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 35 Participants | 83 Participants | 48 Participants |
| Age, Continuous | 41.25 years STANDARD_DEVIATION 18.1 | 42.23 years STANDARD_DEVIATION 16.4 | 43.2 years STANDARD_DEVIATION 15.3 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 14 Participants | 9 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 8 Participants | 8 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 32 Participants | 63 Participants | 31 Participants |
| Region of Enrollment United States | 38 participants | 88 participants | 50 participants |
| Sex: Female, Male Female | 17 Participants | 34 Participants | 17 Participants |
| Sex: Female, Male Male | 21 Participants | 54 Participants | 33 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 50 | 0 / 38 |
| other Total, other adverse events | 0 / 50 | 0 / 38 |
| serious Total, serious adverse events | 0 / 50 | 0 / 38 |
Outcome results
Primary
Change From Baseline, at Weeks 2, 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 A higher PROMIS T-score represents more of the concept being measured. For positively-worded concepts like Physical Functional T-score of 60 is one SD better than average. By comparison, a Physical Function T-score of 40 is one SD worse than average.
Time frame: Change from baseline at weeks 2, 6 and 12
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Care (UsCare) | Change From Baseline, at Weeks 2, 6 and 12 on the Patient Reported Outcome Measurement Information System (PROMIS) - Physical Function Between the Groups. | 2 weeks | 18.65 percentage of change from baseline | Standard Deviation 26 |
| Usual Care (UsCare) | Change From Baseline, at Weeks 2, 6 and 12 on the Patient Reported Outcome Measurement Information System (PROMIS) - Physical Function Between the Groups. | 6 weeks | 25.8 percentage of change from baseline | Standard Deviation 28.3 |
| Usual Care (UsCare) | Change From Baseline, at Weeks 2, 6 and 12 on the Patient Reported Outcome Measurement Information System (PROMIS) - Physical Function Between the Groups. | 12 weeks | 47.65 percentage of change from baseline | Standard Deviation 37.9 |
| Integrated Care (ICare) | Change From Baseline, at Weeks 2, 6 and 12 on the Patient Reported Outcome Measurement Information System (PROMIS) - Physical Function Between the Groups. | 2 weeks | 17.6 percentage of change from baseline | Standard Deviation 31.9 |
| Integrated Care (ICare) | Change From Baseline, at Weeks 2, 6 and 12 on the Patient Reported Outcome Measurement Information System (PROMIS) - Physical Function Between the Groups. | 6 weeks | 30.45 percentage of change from baseline | Standard Deviation 33.05 |
| Integrated Care (ICare) | Change From Baseline, at Weeks 2, 6 and 12 on the Patient Reported Outcome Measurement Information System (PROMIS) - Physical Function Between the Groups. | 12 weeks | 41.35 percentage of change from baseline | Standard Deviation 31.1 |
Secondary
Absolute Hand Grip Scores at Weeks 2, 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 This is an estimated range for normal healthy subject. However, some of the patients in this study did not fall within this estimated range. The Unit of Measure is kilograms (kg). Subsequently all values presented are in kilograms (kg).
Time frame: Absolute hand grip scores at weeks 2, 6 and 12
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Care (UsCare) | Absolute Hand Grip Scores at Weeks 2, 6 and 12 on the Hand-held Hydraulic Dynamometer to Measure Handgrip Strength Between the Groups. | 2 weeks | 31.35 kilograms | Standard Deviation 16.6 |
| Usual Care (UsCare) | Absolute Hand Grip Scores at Weeks 2, 6 and 12 on the Hand-held Hydraulic Dynamometer to Measure Handgrip Strength Between the Groups. | 6 weeks | 35.3 kilograms | Standard Deviation 15.8 |
| Usual Care (UsCare) | Absolute Hand Grip Scores at Weeks 2, 6 and 12 on the Hand-held Hydraulic Dynamometer to Measure Handgrip Strength Between the Groups. | 12 weeks | 35.9 kilograms | Standard Deviation 15.45 |
| Integrated Care (ICare) | Absolute Hand Grip Scores at Weeks 2, 6 and 12 on the Hand-held Hydraulic Dynamometer to Measure Handgrip Strength Between the Groups. | 2 weeks | 30.1 kilograms | Standard Deviation 19.15 |
| Integrated Care (ICare) | Absolute Hand Grip Scores at Weeks 2, 6 and 12 on the Hand-held Hydraulic Dynamometer to Measure Handgrip Strength Between the Groups. | 6 weeks | 30.9 kilograms | Standard Deviation 13.1 |
| Integrated Care (ICare) | Absolute Hand Grip Scores at Weeks 2, 6 and 12 on the Hand-held Hydraulic Dynamometer to Measure Handgrip Strength Between the Groups. | 12 weeks | 33.95 kilograms | Standard Deviation 12.8 |
Secondary
Change From Baseline at Weeks 2, 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
Time frame: Change from baseline at weeks 2, 6 and 12
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Care (UsCare) | Change From Baseline at Weeks 2, 6 and 12 on the Tampa Scale of Kinesiophobia-11 (TSK-11) Between the Groups. | week 6 | 24.5 score on a scale | Standard Deviation 6.69 |
| Usual Care (UsCare) | Change From Baseline at Weeks 2, 6 and 12 on the Tampa Scale of Kinesiophobia-11 (TSK-11) Between the Groups. | week 2 | 26.1 score on a scale | Standard Deviation 7.45 |
| Usual Care (UsCare) | Change From Baseline at Weeks 2, 6 and 12 on the Tampa Scale of Kinesiophobia-11 (TSK-11) Between the Groups. | week 12 | 23.15 score on a scale | Standard Deviation 6.19 |
| Integrated Care (ICare) | Change From Baseline at Weeks 2, 6 and 12 on the Tampa Scale of Kinesiophobia-11 (TSK-11) Between the Groups. | week 2 | 26.65 score on a scale | Standard Deviation 5.37 |
| Integrated Care (ICare) | Change From Baseline at Weeks 2, 6 and 12 on the Tampa Scale of Kinesiophobia-11 (TSK-11) Between the Groups. | week 6 | 25 score on a scale | Standard Deviation 6.48 |
| Integrated Care (ICare) | Change From Baseline at Weeks 2, 6 and 12 on the Tampa Scale of Kinesiophobia-11 (TSK-11) Between the Groups. | week 12 | 26 score on a scale | Standard Deviation 7.45 |
Secondary
Change From Baseline at Weeks 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
Time frame: Change from baseline at weeks 6 and 12
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Care (UsCare) | Change From Baseline at Weeks 6 and 12 on the Lower Extremity Gain Scale (LEGS) Between the Groups. | week 6 | 34.55 percentage of change in LEGS score | Standard Deviation 35.55 |
| Usual Care (UsCare) | Change From Baseline at Weeks 6 and 12 on the Lower Extremity Gain Scale (LEGS) Between the Groups. | week 12 | 87.6 percentage of change in LEGS score | Standard Deviation 66.45 |
| Integrated Care (ICare) | Change From Baseline at Weeks 6 and 12 on the Lower Extremity Gain Scale (LEGS) Between the Groups. | week 6 | 46.8 percentage of change in LEGS score | Standard Deviation 54.15 |
| Integrated Care (ICare) | Change From Baseline at Weeks 6 and 12 on the Lower Extremity Gain Scale (LEGS) Between the Groups. | week 12 | 232.25 percentage of change in LEGS score | Standard Deviation 267.35 |