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The PAINFREE Initiative, a Stepped Wedge Cluster Randomized Trial

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03082417
Acronym
PAINFREE
Enrollment
1375
Registered
2017-03-17
Start date
2016-03-01
Completion date
2018-10-01
Last updated
2019-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Bone Fracture, 75 years old, Elderly, Older adults, Pain scale, Pain documentation, Analgesics, Acetaminophen, Opioid, Nonsteroidal anti-inflammatory drugs, Emergency Department

Brief 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)

Interventions

OTHERImplementation

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

Sponsors

Research Institute of the McGill University Health Center
CollaboratorUNKNOWN
Canadian Institutes of Health Research (CIHR)
CollaboratorOTHER_GOV
McGill University Health Centre/Research Institute of the McGill University Health Centre
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

Pragmatic Stepped Wedge Cluster Randomized Trial

Eligibility

Sex/Gender
ALL
Age
75 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime 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

MeasureTime frameDescription
Evidence of worsening of Patients mental status while in Emergency DepartmentPre-implementation (baseline) and at 6 to 8 months (post-implementation)
Mean length of stay in Emergency DepartmentPre-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 fracturePre-implementation (baseline) and at 6 to 8 months (post-implementation)
Documentation of pain scorePre-implementation (baseline) and at 6 to 8 months (post-implementation)
Time to first pain score documentationPre-implementation (baseline) and at 6 to 8 months (post-implementation)
Effectiveness of analgesiaPre-implementation (baseline) and at 6 to 8 months (post-implementation)Patients with pain score ≥7 who have pain score reduced by ≥ 3 points within 1 hour
Type of analgesia usedPre-implementation (baseline) and at 6 to 8 months (post-implementation)

Other

MeasureTime frameDescription
Change from immediate post-implementation time to analgesia administration at 2 months (end of post-implementation period)2 months (end of post-implementation period)
Predictors of successful implementationat 6 to 8 months after the implementation (post-implementation)Qualitative Analysis: Nurses and physicians perceptions and behaviors toward pain management in older adults with fracture at Emergency Department

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026