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



Status:Completed
Conditions:Hospital
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 85
Updated:10/27/2018
Start Date:January 11, 2016
End Date:February 14, 2018

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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.

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.

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.
We found this trial at
1
site
3450 Hull Road
Gainesville, Florida 32611
Principal Investigator: Heather K. Vincent, Ph.D.
Phone: 352-273-7372
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mi
from
Gainesville, FL
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