The PAINFREE Initiative, a Stepped Wedge Cluster Randomized Trial

Study Overview
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Brief Summary
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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: Montreal General Hospital Royal Victoria Hospital Ste Mary's Hospital Hôpital de Verdun Hôpital du Sacré-Coeur de Montréal Jewish General Hospital Lakeshore General Hospital

Detailed Description
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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)

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

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

Intervention / Treatment
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* Other: Implementation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Pragmatic Stepped Wedge Cluster Randomized Trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Pre-Implementation<br>Medical records of patients with a fracture visiting the Emergency departments will be reviewed. Data will be collected as a baseline prior to the intervention regarding how nurses and physicians working at Emergency Departments manage acute pain in targeted population. | |
| Experimental: Implementation<br>In this stepped-wedge trial design, the experimental arm refers to the time period during patients advertising and educational interventions. It consists in: Informing patients visiting Emergency department for fracture about Pain Management Nurses and physicians working at the Emergency Departments will receive an educational interventions focused on optimal acute pain management in older adults with fracture. | Other: Implementation<br>* The PAINFREE Initiative is a Multifaceted intervention: Educating and providing point-of-care tools to nurses working at Emergency Department to improve pain management in older adults with fractures Educating and providing point of care tools to Emergency Departments physicians working at Emergency Department to improve pain management in older adults with fractures Inform the patients and their family about how to better manage the pain after a fracture<br>|
| No Intervention: Post-Implementation<br>Data will be collected after the intervention regarding how the intervention impacted nurses' and physicians' work in the pain management in older adults with fracture visiting Emergency Departments manage acute pain in older adults. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to achieve pain score documentation, and/or administration of an analgesic, within 2 hours of triage, in at least 80% of patients. |  | Pre-implementation (baseline) and at 6 to 8 months (post-implementation) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Documentation of pain score |  | Pre-implementation (baseline) and at 6 to 8 months (post-implementation) | 
| Time to first pain score documentation |  | Pre-implementation (baseline) and at 6 to 8 months (post-implementation) | 
| Effectiveness of analgesia | Patients with pain score ≥7 who have pain score reduced by ≥ 3 points within 1 hour | Pre-implementation (baseline) and at 6 to 8 months (post-implementation) | 
| Type of analgesia used |  | Pre-implementation (baseline) and at 6 to 8 months (post-implementation) | 
| Mean length of stay in Emergency Department |  | Pre-implementation (baseline) and at 6 to 8 months (post-implementation) | 
| Return to the Emergency Department within 7 days after the first Visit with an uncontrolled pain due to the fracture |  | Pre-implementation (baseline) and at 6 to 8 months (post-implementation) | 
| Evidence of worsening of Patients mental status while in Emergency Department |  | Pre-implementation (baseline) and at 6 to 8 months (post-implementation) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bone Fracture, 75 years old, Elderly, Older adults, Pain scale, Pain documentation, Analgesics, Acetaminophen, Opioid, Nonsteroidal anti-inflammatory drugs, Emergency Department