The PAINFREE Initiative, a Stepped Wedge Cluster Randomized Trial

NCT03082417 | Completed DMC

• 1 other identifier: MP-CUSM-13-054
• Study Type: interventional
• Target: 1,375
• Locations: 1 country
• Sites: 1

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. 1.Montreal General Hospital
2. 2.Royal Victoria Hospital
3. 3.Ste Mary's Hospital
4. 4.Hôpital de Verdun
5. 5.Hôpital du Sacré-Coeur de Montréal
6. 6.Jewish General Hospital
7. 7.Lakeshore General Hospital

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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

  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)

Other Outcomes (2)

• Predictors of successful implementation

  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)

Study Arms (3)

Pre-Implementation

NO INTERVENTION

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.

Implementation

EXPERIMENTAL

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

Post-Implementation

NO INTERVENTION

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.

Interventions

Implementation OTHER

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

Implementation

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Age 75 years old or older
• Visiting Emergency Departments for a fracture

You may not qualify if:

• Having a skull fracture
• Having only fingers or toes fractures

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead
• Research Institute of the McGill University Health Center: collaborator
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

Department of Internal Medicine, Montreal General Hospital

Montreal, Quebec, H3G 1A4, Canada

Location

MeSH Terms

Conditions

Fractures, Bone; Emergencies; Acute Pain

Condition Hierarchy (Ancestors)

Wounds and Injuries; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Suzanne Morin, Dr

  McGill University Hospital Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Medicine, McGill University Montreal General Hospital-McGill University Health Centre

Model Details: Pragmatic Stepped Wedge Cluster Randomized Trial

Study Record Dates

• First Submitted: March 6, 2017
• First Posted: March 17, 2017
• Study Start: March 1, 2016
• Primary Completion: February 1, 2018
• Study Completion: October 1, 2018
• Last Updated: March 8, 2019

Record last verified: 2019-03

Locations

CA (1)