Improving Recovery After Orthopaedic Trauma: Cognitive-Behavioral Based Physical Therapy (CBPT)
Condition: Lower Extremity Injury
Study type: Interventional

Summary: 
      The goal of the CBPT study is to determine the efficacy of the CBPT program for improving
      outcomes in service members and civilians at-risk for poor outcomes following traumatic
      lower-extremity injury. Primary outcome is physical function measured through a
      patient-reported questionnaire and physical performance tests. Secondary outcomes include
      pain and general health. Tertiary outcome is return to work/duty.
    

Detailed description: 
      Following extremity injury, referral (and direct access) to physical therapy (PT) is
      considered standard of care. And, while PT strategies are commonly impairment focused,
      clinicians across multiple subspecialties of physical therapy recognize the importance of
      addressing pain and pain-related psychosocial factors as strong predictors of chronic pain as
      well as long-term physical and psychological disability.

      Cognitive-behavioral therapy (CBT) interventions have documented positive influence on
      psychosocial factors in patients with chronic pain. CBT-based self-management programs have
      also demonstrated improvement in patient outcomes and the adoption of a physically active
      lifestyle, as well as improvement in fear-avoidance beliefs and self-efficacy, in various
      populations with chronic conditions. These evidence-based CBT and self-management strategies
      provide the basis for the study intervention.

      The proposed project will conduct a multi-center, randomized controlled trial to determine
      the efficacy of the CBPT program in patients at-risk for poor outcomes following traumatic
      lower-extremity injury. Central hypothesis is that delivery of CBPT by physical therapists
      over the telephone will improve outcomes, through reductions in pain catastrophizing and fear
      of movement and improvement in pain self-efficacy. The investigators propose a large,
      rigorous evaluation of the CBPT program in patients with lower extremity trauma with the goal
      of engaging civilians and service members in their own care and improving pain and functional
      outcomes.

      Specific Aim 1 To determine the efficacy of the CBPT program for improving outcomes in
      service members and civilians at-risk for poor outcomes following traumatic lower-extremity
      injury. Primary outcome is physical function measured through a patient-reported
      questionnaire. Secondary outcomes include physical performance tests, pain and general
      health. Tertiary outcome is return to work/duty.

      Specific Aim 2 To determine whether changes in the intermediary outcomes of pain
      catastrophizing, fear of movement, and self-efficacy at 6 months are associated with
      improvement in outcomes 12 months after hospital discharge.

      Specific Aim 3 To determine whether subgroups of patients are more likely to benefit from the
      CBPT program.

      Specific Aim 4 To examine the value of CBPT relative to Education using Markov
      decision-analysis.
    

Intervention name(s): CBPT; Education Treatment
Intervention type(s): Other; Other
Intervention description(s): The CBPT program focuses on a patient-oriented cognitive-behavioral self-management approach to improve physical function and reduce pain, through reductions in pain catastrophizing and fear of movement and increases in self-efficacy.; Participants receiving the education control arm are receiving a placebo intervention to control for the attention of the interventionist. They will receive standardized educational material addressing recovery from orthopaedic trauma.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment