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

Primary Purpose

Elderly, Older Adults, Bone Fracture

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Implementation
Sponsored by
McGill University Health Centre/Research Institute of the McGill University Health Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Elderly focused on measuring Bone Fracture, 75 years old, Elderly, Older adults, Pain scale, Pain documentation, Analgesics, Acetaminophen, Opioid, Nonsteroidal anti-inflammatory drugs, Emergency Department

Eligibility Criteria

75 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Internal Medicine, Montreal General Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

No Intervention

Arm Label

Pre-Implementation

Implementation

Post-Implementation

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Time to achieve pain score documentation, and/or administration of an analgesic, within 2 hours of triage, in at least 80% of patients.

Secondary Outcome Measures

Documentation of pain score
Time to first pain score documentation
Effectiveness of analgesia
Patients with pain score ≥7 who have pain score reduced by ≥ 3 points within 1 hour
Type of analgesia used
Mean length of stay in Emergency Department
Return to the Emergency Department within 7 days after the first Visit with an uncontrolled pain due to the fracture
Evidence of worsening of Patients mental status while in Emergency Department

Full Information

First Posted
March 6, 2017
Last Updated
March 6, 2019
Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborators
Research Institute of the McGill University Health Center, Canadian Institutes of Health Research (CIHR)
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1. Study Identification

Unique Protocol Identification Number
NCT03082417
Brief Title
The PAINFREE Initiative, a Stepped Wedge Cluster Randomized Trial
Acronym
PAINFREE
Official Title
Improving PAIN Control Following FRactures; Towards an Elder-friendly Emergency Department
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
March 1, 2016 (Actual)
Primary Completion Date
February 1, 2018 (Actual)
Study Completion Date
October 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborators
Research Institute of the McGill University Health Center, Canadian Institutes of Health Research (CIHR)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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: 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
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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Pragmatic Stepped Wedge Cluster Randomized Trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1375 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pre-Implementation
Arm Type
No Intervention
Arm Description
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.
Arm Title
Implementation
Arm Type
Experimental
Arm Description
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.
Arm Title
Post-Implementation
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Implementation
Intervention Description
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
Primary Outcome Measure Information:
Title
Time to achieve pain score documentation, and/or administration of an analgesic, within 2 hours of triage, in at least 80% of patients.
Time Frame
Pre-implementation (baseline) and at 6 to 8 months (post-implementation)
Secondary Outcome Measure Information:
Title
Documentation of pain score
Time Frame
Pre-implementation (baseline) and at 6 to 8 months (post-implementation)
Title
Time to first pain score documentation
Time Frame
Pre-implementation (baseline) and at 6 to 8 months (post-implementation)
Title
Effectiveness of analgesia
Description
Patients with pain score ≥7 who have pain score reduced by ≥ 3 points within 1 hour
Time Frame
Pre-implementation (baseline) and at 6 to 8 months (post-implementation)
Title
Type of analgesia used
Time Frame
Pre-implementation (baseline) and at 6 to 8 months (post-implementation)
Title
Mean length of stay in Emergency Department
Time Frame
Pre-implementation (baseline) and at 6 to 8 months (post-implementation)
Title
Return to the Emergency Department within 7 days after the first Visit with an uncontrolled pain due to the fracture
Time Frame
Pre-implementation (baseline) and at 6 to 8 months (post-implementation)
Title
Evidence of worsening of Patients mental status while in Emergency Department
Time Frame
Pre-implementation (baseline) and at 6 to 8 months (post-implementation)
Other Pre-specified Outcome Measures:
Title
Predictors of successful implementation
Description
Qualitative Analysis: Nurses and physicians perceptions and behaviors toward pain management in older adults with fracture at Emergency Department
Time Frame
at 6 to 8 months after the implementation (post-implementation)
Title
Change from immediate post-implementation time to analgesia administration at 2 months (end of post-implementation period)
Time Frame
2 months (end of post-implementation period)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suzanne Morin, Dr
Organizational Affiliation
McGill University Hospital Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Internal Medicine, Montreal General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3G 1A4
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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The PAINFREE Initiative, a Stepped Wedge Cluster Randomized Trial

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