An Integrated-Delivery-of-Care Approach to Improve Patient Outcomes, Safety, Well-Being After Orthopaedic Trauma

Study Overview
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Brief Summary
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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
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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.

Official Title
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An Integrated-Delivery-of-Care Approach to Improve Patient Outcomes, Safety, Well-Being After Orthopaedic Trauma

Conditions
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Musculoskeletal Injury Trauma

Intervention / Treatment
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* Procedure: Integrated care (ICare)
* Procedure: Usual Care (UsCare)
* Other: Patient-Reported Outcomes Measurement Information System
* Other: Lower Extremity Gain Scale (LEGS)
* Other: Dynamometer
* Other: Active Range of Motion (AROM)
* Other: Posttraumatic Stress Disorder (PTSD)
* Other: Beck Depression Inventory-II
* Other: State-Trait Anxiety Inventory (STAI)
* Other: Tampa Scale of Kinesiophobia-11 (TSK-11)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Usual Care (UsCare)<br>This group will receive UsCare for orthopedic trauma involves surgical intervention, acute care therapies, post-acute rehabilitation and follow-up clinic visits after discharge. Additionally, the following test will be performed: Lower Extremity Gain Scale (LEGS), dynamometer isometric handgrip strength, Active Range of Motion (AROM), Posttraumatic Stress Disorder (PTSD), Beck Depression Inventory-II, State-Trait Anxiety Inventory (STAI), Tampa Scale of Kinesiophobia-11 (TSK-11), and Patient-Reported Outcomes Measurement Information System (PROMIS). | Procedure: Usual Care (UsCare)<br>* 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.<br>* Other names: UsCare;Other: Patient-Reported Outcomes Measurement Information System<br>* 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.<br>* Other names: PROMIS;Other: Lower Extremity Gain Scale (LEGS)<br>* 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.<br>Other: Dynamometer<br>* 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.<br>* Other names: Isometric handgrip strength;Other: Active Range of Motion (AROM)<br>* 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.<br>Other: Posttraumatic Stress Disorder (PTSD)<br>* 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.<br>Other: Beck Depression Inventory-II<br>* 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.<br>* Other names: BDI-II;Other: State-Trait Anxiety Inventory (STAI)<br>* 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.<br>Other: Tampa Scale of Kinesiophobia-11 (TSK-11)<br>* 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.<br>|
| Experimental: Integrated Care (ICare)<br>This group will receive ICare for orthopedic trauma involves surgical intervention, acute care therapies, post-acute rehabilitation and follow-up clinic visits after discharge, plus simultaneous psychosocial support via the Transform-10 Program.. Additionally, the following test will be performed: Lower Extremity Gain Scale (LEGS), dynamometer isometric handgrip strength, Active Range of Motion (AROM), Posttraumatic Stress Disorder (PTSD), Beck Depression Inventory-II, State-Trait Anxiety Inventory (STAI), Tampa Scale of Kinesiophobia-11 (TSK-11), and Patient-Reported Outcomes Measurement Information System (PROMIS). | Procedure: Integrated care (ICare)<br>* 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.<br>* Other names: ICare;Other: Patient-Reported Outcomes Measurement Information System<br>* 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.<br>* Other names: PROMIS;Other: Lower Extremity Gain Scale (LEGS)<br>* 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.<br>Other: Dynamometer<br>* 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.<br>* Other names: Isometric handgrip strength;Other: Active Range of Motion (AROM)<br>* 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.<br>Other: Posttraumatic Stress Disorder (PTSD)<br>* 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.<br>Other: Beck Depression Inventory-II<br>* 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.<br>* Other names: BDI-II;Other: State-Trait Anxiety Inventory (STAI)<br>* 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.<br>Other: Tampa Scale of Kinesiophobia-11 (TSK-11)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 |