An Integrated-Delivery-of-Care Approach to Improve Patient Outcomes, Safety, Well-Being After Orthopaedic Trauma
Condition: Musculoskeletal Injury Trauma
MeSH terms: Wounds and Injuries
Study type: Interventional

Summary: 
      Orthopedic trauma is an unforeseen life-changing event. Nearly 2.8 million Americans sustain
      traumatic orthopedic injuries such as major fractures or amputation each year. Injury is
      treated in the hospital by physicians who medically stabilize and reconstruct the patient.
      Upon completion of their hospital stay, patients are discharged to begin their reintegration
      back into home and community activities. Despite high surgical success and survivorship
      rates, these injuries often result in poor quality of life (QOL)-related outcomes in
      otherwise healthy people. Fifty to ninety percent of patients develop severe psychological
      distress such as post-traumatic stress syndrome, depression or anxiety. Patients are often
      not provided the comprehensive support care and resources that are necessary to cope
      successfully with psychological stress and reintegrate into purposeful living. This is a
      major problem because high distress levels predict poor physical function, use of pain
      medications and low QOL. Survivors often cannot return to work, have persistent pain and
      experience social isolation. Distress worsens the self-perceptions of functional gain and
      efficacy and decreases personal fulfillment. Lingering psychological distress contributes to
      the development of other health problems and rebuilding of life is negatively impacted. The
      lack of psychosocial support contributes to injury re-occurrence, injury recidivism,
      re-hospitalizations and longer hospitalization stays, and higher personal and societal health
      care costs.

      There is currently a lack of comparative efficacy research to determine which delivery
      approach produces greater improvements in the outcomes that are most desired by patients,
      specifically, functional QOL and emotional well-being. The proposed research will directly
      compare these delivery-of-care approaches and measure the patient-reported outcomes that are
      considered important to patients.
    

Detailed description: 
      The research study will determine whether the Usual Care or Integrated Care (which is Usual
      Care plus emotional support, and education/information during the hospital stay) helps
      patients feel better about their physical function and emotional well-being.

      Participants with serious musculoskeletal injury, being treated at to the University of
      Florida's (UF) Orthopaedic Trauma service at UF Health at Shands Hospital, will be randomized
      (like tossing a coin) between the two groups.

      Usual Care will follow all the highest standards for injury treatment.

      Integrated Care will include medical care and emotional support. Study Staff are trained to
      provide emotional support and teach patients the skills for goal setting, taking ownership of
      journey, establishing lifelines, mobilizing resources and reducing stressors.

      In addition, questionnaires and simple functional tests will be collected at the hospital and
      at normal follow-up visits at weeks 2, 6 and 12 and months 6 and 12.
    

Intervention name(s): Integrated care (ICare); Usual Care (UsCare); Patient-Reported Outcomes Measurement Information System; Lower Extremity Gain Scale (LEGS); Dynamometer; 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)
Intervention type(s): Procedure; Procedure; Other; Other; Other; Other; Other; Other; Other; Other
Intervention description(s): 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 includes radiographic imaging and administration of pain medication and antibiotics, skin care and range of motion of the injured area. The patient's normal clinical care usually includes a hospital stay, a 2 week follow up, 6 week follow up, 12 week follow up, 6 month, and 1 year follow up visit. At the end of the study all of the materials that make up the Transform-10 Program will be provided.; Questionnaires of Physical Functional quality of life and Emotional Well-being will be performed during the hospital stay, a 2 week follow up, 6 week follow up, 12 week follow up, 6 month, and 1 year follow up visit.; 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.; 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.; 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.; 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.; The Beck Depression Inventory-II is a broadly-applicable, clinically relevant psychometric instrument with high reliability and consistency which notes depression. This assessment will be performed during the hospital stay, at the 2 week follow up, 6 week follow up, 12 week follow up, 6 month, and 1 year follow up visit.; The State-Trait Anxiety Inventory (STAI) will be used to measure state anxiety (anxiety about an event) and trait anxiety (anxiety level as a personal characteristic). This assessment will be performed during the hospital stay, at the 2 week follow up, 6 week follow up, 12 week follow up, 6 month, and 1 year follow up visit.; 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 name(s): ICare; UsCare; PROMIS; Isometric handgrip strength; BDI-II
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment