Clinical trial NCT03082417: The PAINFREE Initiative, a Stepped Wedge Cluster Randomized Trial
Official title: Improving PAIN Control Following FRactures; Towards an Elder-friendly Emergency Department
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Elderly
Older Adults
Bone Fracture
Emergency Department
Pain, Acute
Keywords: Bone Fracture
75 years old
Elderly
Older adults
Pain scale
Pain documentation
Analgesics
Acetaminophen
Opioid
Nonsteroidal anti-inflammatory drugs
Emergency Department
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
Collaborators: name: Research Institute of the McGill University Health Center
name: Canadian Institutes of Health Research (CIHR)
First posted: 2017-03-17
Enrollment: 1375
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Pragmatic Stepped Wedge Cluster Randomized Trial
Primary purpose: HEALTH_SERVICES_RESEARCH

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)

Eligibility criteria: 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

Primary outcomes:
measure: Time to achieve pain score documentation, and/or administration of an analgesic, within 2 hours of triage, in at least 80% of patients.
timeFrame: Pre-implementation (baseline) and at 6 to 8 months (post-implementation)
Secondary outcomes:
measure: Documentation of pain score
timeFrame: Pre-implementation (baseline) and at 6 to 8 months (post-implementation)
measure: Time to first pain score documentation
timeFrame: Pre-implementation (baseline) and at 6 to 8 months (post-implementation)
measure: Effectiveness of analgesia
timeFrame: Pre-implementation (baseline) and at 6 to 8 months (post-implementation)
measure: Type of analgesia used
timeFrame: Pre-implementation (baseline) and at 6 to 8 months (post-implementation)
measure: Mean length of stay in Emergency Department
timeFrame: Pre-implementation (baseline) and at 6 to 8 months (post-implementation)
measure: Return to the Emergency Department within 7 days after the first Visit with an uncontrolled pain due to the fracture
timeFrame: Pre-implementation (baseline) and at 6 to 8 months (post-implementation)
measure: Evidence of worsening of Patients mental status while in Emergency Department
timeFrame: Pre-implementation (baseline) and at 6 to 8 months (post-implementation)
Other outcomes:
measure: Predictors of successful implementation
timeFrame: at 6 to 8 months after the implementation (post-implementation)
measure: Change from immediate post-implementation time to analgesia administration at 2 months (end of post-implementation period)
timeFrame: 2 months (end of post-implementation period)
Locations:
city: Montreal
country: Canada
facility: Department of Internal Medicine, Montreal General Hospital
state: Quebec
Study officials:
affiliation: McGill University Hospital Center
name: Suzanne Morin, Dr
role: PRINCIPAL_INVESTIGATOR
References: