Musculoskeletal Injury TraumaNCT02591472
An Integrated-Delivery-of-Care Approach to Improve Patient Outcomes, Safety, Well-Being After Orthopaedic Trauma
A study testing Integrated care (ICare), Patient-Reported Outcomes Measurement Information System and Lower Extremity Gain Scale (LEGS) in people with Musculoskeletal Injury Trauma, run by University of Florida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Musculoskeletal Injury Trauma
- What is being tested?
- Integrated care (ICare), Patient-Reported Outcomes Measurement Information System and Lower Extremity Gain Scale (LEGS)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jan 2016to 1 Jan 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
UF and Shands Orthopaedics and Sports Medicine Institute
Gainesville, Florida, 32611
About this study
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.
Read the 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.
- Conditions
- Musculoskeletal Injury Trauma
- Being tested
- Integrated care (ICare), Usual Care (UsCare), Patient-Reported Outcomes Measurement Information System, Lower Extremity Gain Scale (LEGS), Dynamometer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated care (ICare)Procedure or surgery
Also called 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)Procedure or surgery
Also called 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 SystemOther
Also called PROMIS
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)Other
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.
DynamometerOther
Also called Isometric handgrip strength
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)Other
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)Other
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-IIOther
Also called BDI-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)Other
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)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care (UsCare) | Active comparator | 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). Receives: 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) |
| Integrated Care (ICare) | Experimental | 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). Receives: Procedure: Integrated care (ICare); 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline at weeks 2, 6 and 12
Secondary outcomes (3)
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
Measured: Change from baseline at weeks 6 and 12
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
Measured: Change from baseline at weeks 2, 6 and 12
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).
Measured: Absolute hand grip scores at weeks 2, 6 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2015 (estimated)
- Study start11 Jan 2016
- Primary completion1 Jan 2023
- Study completion1 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Musculoskeletal Injury TraumaStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Athletic Trainers' Association Research & Education Foundation (NATA Foundation), Foundation for Physical Medicine and Rehabilitation
- Responsible party
- Sponsor
- Investigators
- MaryBeth Horodyski, Ph.D., Principal investigator, University of Florida Department of Orthopaedics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02591472
- Sponsor's protocol ID
- IRB201500753
- Status last verified
- Oct 2024
- First submitted
- 28 Oct 2015
- Last updated
- 28 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 23694884Vincent 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.
PubMed 25772720Becher 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.
PubMed 24736695Vranceanu 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.
PubMed 24500592Holbrook 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.
PubMed 10338392Calder 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.
PubMed 21091044Ponzer 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.
PubMed 10697086Zdziarski-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.
PubMed 29325583
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Integrated-Delivery-of-Care Approach to Improve Patient Outcomes, Safety, Well-Being After Orthopaedic Trauma
- ClinicalTrials.gov ID
- NCT02591472
- Acronym / sponsor ID
- IRB201500753
- Conditions
- Musculoskeletal Injury Trauma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- National Athletic Trainers' Association Research & Education Foundation (NATA Foundation), Foundation for Physical Medicine and Rehabilitation
- Study start
- 11 Jan 2016
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 29 Oct 2015 (estimated)
- Results
- Posted 28 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care (UsCare) | Active comparator | 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)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). |
| Integrated Care (ICare) | Experimental | Procedure: Integrated care (ICare), 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)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). |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Integrated care (ICare)Also: ICareThe 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. | Procedure or surgery | Integrated Care (ICare) |
| Usual Care (UsCare)Also: UsCareUsual 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. | Procedure or surgery | Usual Care (UsCare) |
| Patient-Reported Outcomes Measurement Information SystemAlso: PROMISQuestionnaires 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. | Other | Integrated Care (ICare), Usual Care (UsCare) |
| 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. | Other | Integrated Care (ICare), Usual Care (UsCare) |
| DynamometerAlso: Isometric handgrip strengthIsometric 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. | Other | Integrated Care (ICare), Usual Care (UsCare) |
| 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. | Other | Integrated Care (ICare), Usual Care (UsCare) |
| 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. | Other | Integrated Care (ICare), Usual Care (UsCare) |
| Beck Depression Inventory-IIAlso: BDI-IIThe 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. | Other | Integrated Care (ICare), Usual Care (UsCare) |
| 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. | Other | Integrated Care (ICare), Usual Care (UsCare) |
| 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 | Integrated Care (ICare), Usual Care (UsCare) |
Primary outcome
Change From Baseline, at Weeks 2, 6 and 12 on the Patient Reported Outcome Measurement Information System (PROMIS) - Physical Function Between the Groups.
Time frame: 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.
3 secondary outcomes
Change From Baseline at Weeks 6 and 12 on the Lower Extremity Gain Scale (LEGS) Between the Groups.
Time frame: Change from baseline at weeks 6 and 12
Change From Baseline at Weeks 2, 6 and 12 on the Tampa Scale of Kinesiophobia-11 (TSK-11) Between the Groups.
Time frame: Change from baseline at weeks 2, 6 and 12
Absolute Hand Grip Scores at Weeks 2, 6 and 12 on the Hand-held Hydraulic Dynamometer to Measure Handgrip Strength Between the Groups.
Time frame: Absolute hand grip scores at weeks 2, 6 and 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23694884Castillo 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.
- Background: PubMed 25772720Vincent 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.
- Background: PubMed 24736695Becher 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.
- Background: PubMed 24500592Vranceanu 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.
- Background: PubMed 10338392Holbrook 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.
- Background: PubMed 21091044Calder 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.
- Background: PubMed 10697086Ponzer 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.
- Derived from this study: PubMed 29325583Zdziarski-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.
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Individualised Cryoneurolysis to Treat Pain in the Context of Spasticity in the Upper and Lower Extremities
Centreal Neurological Condition, Acquired Brain Injury (Including Stroke)
RecruitingPhase 2
Extracorporeal Shockwave Therapy as an Additional Treatment for Spasticity Secondary to Spinal Cord Injury
Spinal Cord Injury, Spasticity
Recruiting
Wrist Injury Strengthening Exercise (WISE) Versus Usual Care Advice for Improving Pain and Function
Distal Radius Fracture, Colles Fracture
Not yet recruitingObservational study
From Blast Injury to Multicompartment Dysfunction:
Compartment Syndrome, Compartment Syndrome Nontraumatic Lower Extremity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MaryBeth Horodyski, Ph.D. principal investigator
University of Florida Department of Orthopaedics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrated care (ICare), Patient-Reported Outcomes Measurement Information System and Lower Extremity Gain Scale (LEGS) in people with Musculoskeletal Injury Trauma, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline, at Weeks 2, 6 and 12 on the Patient Reported Outcome Measurement Information System (PROMIS) - Physical Function Between the Groups. (time frame: Change from baseline at weeks 2, 6 and 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02591472, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2024.