An Integrated-Delivery-of-Care Approach to Improve Patient Outcomes, Safety, Well-Being After Orthopaedic Trauma
NCT ID: NCT02591472
Last Updated: 2024-10-28
Study Results
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View full resultsBasic Information
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COMPLETED
NA
88 participants
INTERVENTIONAL
2016-01-11
2023-01-01
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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 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).
Usual 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.
Patient-Reported Outcomes Measurement Information System
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.
Lower 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.
Dynamometer
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.
Active 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.
Posttraumatic 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.
Beck 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.
State-Trait Anxiety Inventory (STAI)
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.
Tampa 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.
Integrated Care (ICare)
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).
Integrated 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.
Patient-Reported Outcomes Measurement Information System
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.
Lower 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.
Dynamometer
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.
Active 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.
Posttraumatic 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.
Beck 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.
State-Trait Anxiety Inventory (STAI)
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.
Tampa 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.
Interventions
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Integrated 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.
Usual 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.
Patient-Reported Outcomes Measurement Information System
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.
Lower 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.
Dynamometer
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.
Active 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.
Posttraumatic 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.
Beck 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.
State-Trait Anxiety Inventory (STAI)
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.
Tampa 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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
85 Years
ALL
No
Sponsors
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National Athletic Trainers' Association Research & Education Foundation (NATA Foundation)
OTHER
Foundation for Physical Medicine and Rehabilitation
OTHER
University of Florida
OTHER
Responsible Party
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Principal Investigators
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MaryBeth Horodyski, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
University of Florida Department of Orthopaedics
Locations
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UF and Shands Orthopaedics and Sports Medicine Institute
Gainesville, Florida, United States
Countries
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References
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Castillo RC, Wegener ST, Newell MZ, Carlini AR, Bradford AN, Heins SE, Wysocki E, Pollak AN, Teter H, Mackenzie EJ. Improving outcomes at Level I trauma centers: an early evaluation of the Trauma Survivors Network. J Trauma Acute Care Surg. 2013 Jun;74(6):1534-40. doi: 10.1097/TA.0b013e3182921606.
Vincent HK, Horodyski M, Vincent KR, Brisbane ST, Sadasivan KK. Psychological Distress After Orthopedic Trauma: Prevalence in Patients and Implications for Rehabilitation. PM R. 2015 Sep;7(9):978-989. doi: 10.1016/j.pmrj.2015.03.007. Epub 2015 Mar 12.
Becher S, Smith M, Ziran B. Orthopaedic trauma patients and depression: a prospective cohort. J Orthop Trauma. 2014 Oct;28(10):e242-6. doi: 10.1097/BOT.0000000000000128.
Vranceanu AM, Bachoura A, Weening A, Vrahas M, Smith RM, Ring D. Psychological factors predict disability and pain intensity after skeletal trauma. J Bone Joint Surg Am. 2014 Feb 5;96(3):e20. doi: 10.2106/JBJS.L.00479.
Holbrook TL, Anderson JP, Sieber WJ, Browner D, Hoyt DB. Outcome after major trauma: 12-month and 18-month follow-up results from the Trauma Recovery Project. J Trauma. 1999 May;46(5):765-71; discussion 771-3. doi: 10.1097/00005373-199905000-00003.
Calder A, Badcoe A, Harms L. Broken bodies, healing spirits: road trauma survivor's perceptions of pastoral care during inpatient orthopaedic rehabilitation. Disabil Rehabil. 2011;33(15-16):1358-66. doi: 10.3109/09638288.2010.532280. Epub 2010 Nov 20.
Ponzer S, Molin U, Johansson SE, Bergman B, Tornkvist H. Psychosocial support in rehabilitation after orthopedic injuries. J Trauma. 2000 Feb;48(2):273-9. doi: 10.1097/00005373-200002000-00013.
Zdziarski-Horodyski L, Horodyski M, Sadasivan KK, Hagen J, Vasilopoulos T, Patrick M, Guenther R, Vincent HK. An integrated-delivery-of-care approach to improve patient reported physical function and mental wellbeing after orthopedic trauma: study protocol for a randomized controlled trial. Trials. 2018 Jan 11;19(1):32. doi: 10.1186/s13063-017-2430-5.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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IRB201500753
Identifier Type: -
Identifier Source: org_study_id
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