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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02591472
Recruitment Status : Completed
First Posted : October 29, 2015
Last Update Posted : October 3, 2019
Sponsor:
Collaborators:
National Athletic Trainers' Association Research & Education Foundation (NATA Foundation)
Foundation for Physical Medicine and Rehabilitation
Information provided by (Responsible Party):
University of Florida

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.


Condition or disease Intervention/treatment Phase
Musculoskeletal Injury Trauma 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) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 111 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: An Integrated-Delivery-of-Care Approach to Improve Patient Outcomes, Safety, Well-Being After Orthopaedic Trauma
Study Start Date : January 11, 2016
Actual Primary Completion Date : February 14, 2018
Actual Study Completion Date : February 14, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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).
Procedure: 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.
Other Name: UsCare

Other: 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.
Other Name: PROMIS

Other: 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: 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.
Other Name: Isometric handgrip strength

Other: 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: 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: 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.
Other Name: BDI-II

Other: 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: 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.

Experimental: 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).
Procedure: 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.
Other Name: ICare

Other: 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.
Other Name: PROMIS

Other: 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: 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.
Other Name: Isometric handgrip strength

Other: 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: 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: 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.
Other Name: BDI-II

Other: 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: 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.




Primary Outcome Measures :
  1. 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. [ Time Frame: Change in Baseline, at weeks 2, 6 and 12 and months 6 and 12 ]
    Survey questionnaire measures the perception of Physical Function. Physical Function Average: t score = 50±10 Min: 10 Max: 90

  2. 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. [ Time Frame: Change in Baseline, at weeks 2, 6 and 12 and months 6 and 12 ]
    Survey questionnaire measures the perception of Social Roles. Social Roles Average: t score = 50±10 Min: 10 Max: 90

  3. 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. [ Time Frame: Change in Baseline, at weeks 2, 6 and 12 and months 6 and 12 ]
    Survey questionnaire measures the perception of Psychosocial Illness Impact. Psychosocial Average: t score = 50±10 Min: 13.8 Max: 68.7


Secondary Outcome Measures :
  1. Change in baseline, at weeks 2, 6 and 12 and months 6 and 12 on The Beck Depression Inventory-II between the groups. [ Time Frame: Change in Baseline, at weeks 2, 6 and 12 and months 6 and 12 ]

    Survey questionnaire used to determine levels of depression.

    Normal: 0-13 Min: 0 Max: 63


  2. Change in baseline, at weeks 2, 6 and 12 and months 6 and 12 on The State-Trait Anxiety Inventory (STAI) between the groups. [ Time Frame: Change in Baseline, at weeks 2, 6 and 12 and months 6 and 12 ]

    Survey questionnaire used to determine levels of anxiety after traumatic injury.

    Normal Range: 20-38 Min: 20 Max: 80


  3. Change in baseline, at weeks 2, 6 and 12 and months 6 and 12 on the Lower Extremity Gain Scale (LEGS) between the groups. [ Time Frame: Change in Baseline, at weeks 2, 6 and 12 and months 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


  4. Digital inclinometer measuring Change in baseline, at weeks 2, 6 and 12 and months 6 and 12 between the groups. [ Time Frame: Change in Baseline, at weeks 2, 6 and 12 and months 6 and 12 ]
    Digital inclinometer will be used to measure the Range of Motion in joints of interest.

  5. Change in baseline, at weeks 2, 6 and 12 and months 6 and 12 on Posttraumatic Stress Disorder between the groups. [ Time Frame: Change in Baseline, at weeks 2, 6 and 12 and months 6 and 12 ]

    Survey questionnaire will be administered to measure posttraumatic stress levels.

    Norm 30-35 Minimum 17 Maximum 85


  6. 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. [ Time Frame: Change in Baseline, at weeks 2, 6 and 12 and months 6 and 12 ]

    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


  7. 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. [ Time Frame: Change in Baseline, at weeks 2, 6 and 12 and months 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

  8. Change in baseline, at weeks 2, 6 and 12 and months 6 and 12 on the Communication Assessment Questionnaire between the groups. [ Time Frame: 12 month ]
    Survey asking the patient how the communication has been between the facilitator and the patient. Best Score: 75 Min: 0 Max: 75

  9. 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. [ Time Frame: Change in Baseline, at weeks 2, 6 and 12 and months 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




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02591472


Locations
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United States, Florida
UF and Shands Orthopaedics and Sports Medicine Institute
Gainesville, Florida, United States, 32611
Sponsors and Collaborators
University of Florida
National Athletic Trainers' Association Research & Education Foundation (NATA Foundation)
Foundation for Physical Medicine and Rehabilitation
Investigators
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Principal Investigator: Heather K Vincent, Ph.D. University of Florida Department of Orthopaedics
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT02591472    
Other Study ID Numbers: IRB201500753
First Posted: October 29, 2015    Key Record Dates
Last Update Posted: October 3, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Wounds and Injuries