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N/A N=88 Randomized Single-blind Treatment

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

Musculoskeletal Injury Trauma

Enrolled (actual)
88
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcome: Primary: Change From Baseline, at Weeks 2, 6 and 12 on the Patient Reported Outcome Measurement Information System (PROMIS) - Physical Function Between the Groups. — 18.65; 17.6; 25.8; 30.45 percentage of change from baseline

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Integrated care (ICare) (Procedure); Usual Care (UsCare) (Procedure); 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) (Other)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
University of Florida
Primary completion
Jan 2023

Outcome Measures

OutcomeResultp-value
PRIMARY
Change From Baseline, at Weeks 2, 6 and 12 on the Patient Reported Outcome Measurement Information System (PROMIS) - Physical Function Between the Groups.
18.65; 17.6; 25.8; 30.45; 47.65; 41.35
SECONDARY
Change From Baseline at Weeks 6 and 12 on the Lower Extremity Gain Scale (LEGS) Between the Groups.
34.55; 46.8; 87.6; 232.25
SECONDARY
Change From Baseline at Weeks 2, 6 and 12 on the Tampa Scale of Kinesiophobia-11 (TSK-11) Between the Groups.
26.1; 26.65; 24.5; 25; 23.15; 26
SECONDARY
Absolute Hand Grip Scores at Weeks 2, 6 and 12 on the Hand-held Hydraulic Dynamometer to Measure Handgrip Strength Between the Groups.
31.35; 30.1; 35.3; 30.9; 35.9; 33.95

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.

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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02591472). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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