The PAINFREE Initiative, a Stepped Wedge Cluster Randomized Trial

NCT ID: NCT03082417

Last Updated: 2019-03-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1375 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-01
• Study Completion Date: 2018-10-01

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)

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Implementation

Intervention Type: 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

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Implementation

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Research Institute of the McGill University Health Center

UNKNOWN

Sponsor Role: collaborator

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

McGill University Health Centre/Research Institute of the McGill University Health Centre

OTHER

Sponsor Role: lead

Responsible Party

Suzanne Morin

Associate Professor, Department of Medicine, McGill University Montreal General Hospital-McGill University Health Centre

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Suzanne Morin, Dr

Role: PRINCIPAL_INVESTIGATOR

McGill University Hospital Center

Locations

Department of Internal Medicine, Montreal General Hospital

Montreal, Quebec, Canada

Countries

Canada

Other Identifiers

MP-CUSM-13-054

Identifier Type: -

Identifier Source: org_study_id