NCT03082417

The PAINFREE Initiative, a Stepped Wedge Cluster Randomized Trial

Improving PAIN Control Following FRactures; Towards an Elder-friendly Emergency Department

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,375 (actual)
• Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre · Academic / Other
• Sex: All
• Age: 75 Years
• Healthy volunteers: Not accepted

Summary

The PAINFREE (Improving PAIN control following FRactures; towards an Elder-friendly Emergency department) Initiative is a patient-centered multifaceted intervention which aims to improve pain management in patients 75 years and older presenting with a fracture at 7 Emergency Department of participating Montreal hospitals: 1. Montreal General Hospital 2. Royal Victoria Hospital 3. Ste Mary's Hospital 4. Hôpital de Verdun 5. Hôpital du Sacré-Coeur de Montréal 6. Jewish General Hospital 7. Lakeshore General Hospital

Detailed description

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: 1. Pre-implementation (2 months): 1. 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 2. Review of medical records of the target population for extraction of selected variables 2. PAINFREE implementation (6 months): 1. Awareness campaigns will be organized throughout the institution of each study site (posters, brochures, billboards, lanyards) 2. Profession-specific educational presentations (1 hour) for physicians and nurses, accredited as part of continued professional development programs 3. 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 4. Distribution of educational material and tools targeting pain care literacy (pain scale interpretation, pamphlet) for patients and their families 3. Post-implementation (4 months): 1. Review of medical records of target population for extraction of selected variables 2. 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 3. Phone call interviews with patients 4. Focus group interviews (physicians and nurses)

Conditions

• Elderly
• Older Adults
• Bone Fracture
• Emergency Department
• Pain, Acute

Interventions

Type	Name	Description
OTHER	Implementation	The PAINFREE Initiative is a Multifaceted intervention: 1. Educating and providing point-of-care tools to nurses working at Emergency Department to improve pain management in older adults with fractures 2. Educating and providing point of care tools to Emergency Departments physicians working at Emergency Department to improve pain management in older adults with fractures 3. Inform the patients and their family about how to better manage the pain after a fracture

Timeline

• Start date: 2016-03-01
• Primary completion: 2018-02-01
• Completion: 2018-10-01
• First posted: 2017-03-17
• Last updated: 2019-03-08

Locations

1 site across 1 country: Canada