Clinical trial NCT02591472: An Integrated-Delivery-of-Care Approach to Improve Patient Outcomes, Safety, Well-Being After Orthopaedic Trauma
Official title: An Integrated-Delivery-of-Care Approach to Improve Patient Outcomes, Safety, Well-Being After Orthopaedic Trauma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Musculoskeletal Injury Trauma
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: National Athletic Trainers' Association Research & Education Foundation (NATA Foundation)
name: Foundation for Physical Medicine and Rehabilitation
First posted: 2015-10-29
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Change From Baseline, at Weeks 2, 6 and 12 on the Patient Reported Outcome Measurement Information System (PROMIS) - Physical Function Between the Groups.
timeFrame: Change from baseline at weeks 2, 6 and 12
Secondary outcomes:
measure: Change From Baseline at Weeks 6 and 12 on the Lower Extremity Gain Scale (LEGS) Between the Groups.
timeFrame: Change from baseline at weeks 6 and 12
measure: Change From Baseline at Weeks 2, 6 and 12 on the Tampa Scale of Kinesiophobia-11 (TSK-11) Between the Groups.
timeFrame: Change from baseline at weeks 2, 6 and 12
measure: Absolute Hand Grip Scores at Weeks 2, 6 and 12 on the Hand-held Hydraulic Dynamometer to Measure Handgrip Strength Between the Groups.
timeFrame: Absolute hand grip scores at weeks 2, 6 and 12
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: UF and Shands Orthopaedics and Sports Medicine Institute
state: Florida
Study officials:
affiliation: University of Florida Department of Orthopaedics
name: MaryBeth Horodyski, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Vincent 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.
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citation: Vranceanu 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.
citation: Holbrook 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.
citation: Calder 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.
citation: Ponzer 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.
citation: Zdziarski-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.