| Study name |
An integrated‐delivery‐of‐care approach to improve patient outcomes, safety, well‐being after orthopaedic trauma. |
| Methods |
Randomised trial, USA |
| Participants |
111 participants with serious musculoskeletal injury, being treated at to the University of Florida's (UF) Orthopaedic Trauma service at UF Health at Shands Hospital, randomised between the two groups (intervention and usual care). |
| Interventions |
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 randomised (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. |
| Outcomes |
Primary outcome 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
Primary outcome 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
Primary outcome 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 |
| Starting date |
January 2016 |
| Contact information |
Heather K Vincent, Ph.D. University of Florida Department of Orthopaedics. |
| Notes |
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