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Completed

NCT Number: NCT02591472

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

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.

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Key information

Conditions

Musculoskeletal Injury Trauma

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UF and Shands Orthopaedics and Sports Medicine Institute

Gainesville, Florida, 32611, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Integrated care (ICare)

Procedure

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.

Other names: ICare

Usual Care (UsCare)

Procedure

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.

Other names: UsCare

Patient-Reported Outcomes Measurement Information System

Other

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.

Other names: PROMIS

Lower Extremity Gain Scale (LEGS)

Other

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.

Dynamometer

Other

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.

Other names: Isometric handgrip strength

Active Range of Motion (AROM)

Other

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.

Posttraumatic Stress Disorder (PTSD)

Other

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.

Beck Depression Inventory-II

Other

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.

Other names: BDI-II

State-Trait Anxiety Inventory (STAI)

Other

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)

Other

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.

Primary outcomes

  1. Change From Baseline, at Weeks 2, 6 and 12 on the Patient Reported Outcome Measurement Information System (PROMIS) - Physical Function Between the Groups.

    Time frame: Change from baseline at weeks 2, 6 and 12

    Survey questionnaire measures the perception of Physical Function. Physical Function Average: t score = 50±10 Min: 10 Max: 90 A higher PROMIS T-score represents more of the concept being measured. For positively-worded concepts like Physical Functional T-score of 60 is one SD better than average. By comparison, a Physical Function T-score of 40 is one SD worse than average.

Secondary outcomes

  1. Change From Baseline at Weeks 6 and 12 on the Lower Extremity Gain Scale (LEGS) Between the Groups.

    Time frame: Change from baseline at weeks 6 and 12

    LEGS consists combined score taken 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.

    Best score 27 Minimum score 0 Normal scores not available

  2. Change From Baseline at Weeks 2, 6 and 12 on the Tampa Scale of Kinesiophobia-11 (TSK-11) Between the Groups.

    Time frame: Change from baseline at weeks 2, 6 and 12

    Survey questionnaire given assess the pain-related fear of movement in orthopaedic trauma and the Tampa Scale of Kinesiophobia-11 (TSK-11) will be used. Best Score: 11 Min: 11 Max: 44

  3. Absolute Hand Grip Scores at Weeks 2, 6 and 12 on the Hand-held Hydraulic Dynamometer to Measure Handgrip Strength Between the Groups.

    Time frame: Absolute hand grip scores at weeks 2, 6 and 12

    Isometric handgrip strength is a valid predictor of mobility and will be measured using a hand-held hydraulic dynamometer.

    Average: 39 kg Range: 33-45 kg This is an estimated range for normal healthy subject. However, some of the patients in this study did not fall within this estimated range.

    The Unit of Measure is kilograms (kg). Subsequently all values presented are in kilograms (kg).

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • Foundation for Physical Medicine and Rehabilitation
  • National Athletic Trainers' Association Research & Education Foundation (NATA Foundation)

Registry information

Important dates

Study start
2016
Primary completion
2023
Study completion
2023
First posted
Oct 29, 2015
Registry last updated
Oct 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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