The PAINFREE Initiative, a Stepped Wedge Cluster Randomized Trial

Using a stepped-wedge cluster randomized trial design, we will implement PAINFREE sequentially in 7 Emergency Departments (EDs) in the greater Montreal area where as each ED site acts as its own control and provides data in both pre- and post-implementation periods. Mixed methods analysis will be used to link quantitative (pain management indicators pre- and post-implementation) to qualitative (feasibility, fidelity and acceptability of implementation) data sets to facilitate data triangulation to evaluate the effects of PAINFREE in real world settings.

PAINFREE Initiative at each site includes 3 phases: pre-implementation, implementation, and post-implementation. The approach is patient-centered and is composed of three complementary components: a patient component, a physician component, and a nursing component.

Each program phases include the following steps:

• Pre-implementation (2 months):

• In all study sites, distribution and analysis of a web-based survey for nurses to document factors that can impact PAINFREE implementation in their environment
• Review of medical records of the target population for extraction of selected variables
• PAINFREE implementation (6 months):

• Awareness campaigns will be organized throughout the institution of each study site (posters, brochures, billboards, lanyards)
• Profession-specific educational presentations (1 hour) for physicians and nurses, accredited as part of continued professional development programs
• Distribution of standardized point-of-care tools to improve pain assessment and documentation (pocket cards, use of validated pain scales), treatment (standardized prescription) and re-assessment
• Distribution of educational material and tools targeting pain care literacy (pain scale interpretation, pamphlet) for patients and their families
• Post-implementation (4 months):

• Review of medical records of target population for extraction of selected variables
• Distribution of report cards comparing each ED's post- and pre-intervention performance on pain management indicators and comparing their performance to that of other sites
• Phone call interviews with patients
• Focus group interviews (physicians and nurses)

Inclusion criteria

• Age 75 years old or older
• Visiting Emergency Departments for a fracture

Exclusion criteria

• Having a skull fracture
• Having only fingers or toes fractures