The PAINFREE Initiative, a Stepped Wedge Cluster Randomized Trial (PAINFREE)

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

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

Study Overview

• Status: Completed
• Conditions: Pain, Acute; Elderly; Older Adults; Emergency Department; Bone Fracture
• Intervention / Treatment: Other: Implementation

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)

• Study Type: Interventional
• Enrollment (Actual): 1375
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H3G 1A4
      • Department of Internal Medicine, Montreal General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 75 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Pre-Implementation; 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; 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; 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
No Intervention: Post-Implementation; 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?

Primary Outcome Measures

Outcome Measure	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)

Other Outcome Measures

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

Collaborators and Investigators

• Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Collaborators: Canadian Institutes of Health Research (CIHR); Research Institute of the McGill University Health Center
• Investigators: Principal Investigator: Suzanne Morin, Dr, McGill University Hospital Center

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2016
• Primary Completion (Actual): February 1, 2018
• Study Completion (Actual): October 1, 2018

Study Registration Dates

• First Submitted: March 6, 2017
• First Submitted That Met QC Criteria: March 10, 2017
• First Posted (Actual): March 17, 2017

Study Record Updates

• Last Update Posted (Actual): March 8, 2019
• Last Update Submitted That Met QC Criteria: March 6, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Elderly; Emergency Department; Opioid; Older adults; Acetaminophen; Analgesics; Bone Fracture; 75 years old; Pain scale; Pain documentation; Nonsteroidal anti-inflammatory drugs
• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Wounds and Injuries; Disease Attributes; Emergencies; Fractures, Bone; Acute Pain
• Other Study ID Numbers: MP-CUSM-13-054

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided