COPE Trial – Cognitive Behavioural Therapy to Optimize Post-Operative Recovery
The presence of persistent post-surgical pain (PPSP) can have a major impact on patients’ quality of life, including their ability to return to work and their daily activities. Findings suggest that modifying patient beliefs and thought patterns through cognitive behavioural therapy (CBT) may be an effective strategy to improve outcomes among patients who have suffered trauma and require surgery.
This trial is a multi-center randomized controlled trial (RCT) of 1,000 participants with an open fracture of the appendicular skeleton or closed fracture of the lower extremity or pelvis treated with internal fixation. Eligible and consenting participants will be randomized to receive either CBT or usual care (control). Participants randomized to the CBT intervention will be offered the choice of the following two options: 1) a series of 6 telephone/video sessions with a dedicated therapist, or 2) online modules to be completed by the participant with supervision from a dedicated therapist (iCBT). Outcomes will be assessed at 3 months, 6 months, 9 months and 12 months’ post-fracture.
The primary objective of the COPE Trial is to determine if CBT, versus usual care, reduces the prevalence of moderate to severe PPSP over 12 months post-fracture in participants with extremity fractures treated with internal fixation.
This trial will be conducted at clinical sites in Canada and Europe that treat patients with acute extremity fractures. This study will be coordinated by McMaster University, Centre for Evidence-Based Orthopaedics (CEO) in collaboration with the Michael G. DeGroote National Pain Centre & the Michael G. DeGroote Institute for Pain Research and Care.
McMaster University invites qualified bidders to submit responses for the supply of centralized delivery of CBT through both telephone/video and a therapist-assisted, digital software application (iCBT) as a service (SaaS), infrastructure as a service (IaaS) and platform as a service (PaaS) to be provided in Canada, in accordance with the terms of this Request for Proposals.
Bidders must quote the entire bid. Partial bids will not be accepted.
