The PAINFREE Initiative, a Stepped Wedge Cluster Randomized Trial

McGill University

Status: Completed

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

Treatments: Other: Implementation

Study type: Interventional

Funder types: Other

Identifiers

NCT03082417

MP-CUSM-13-054

Details and patient eligibility

About

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

Full 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)

Enrollment: 1,375 patients

Sex: All

Ages: 75+ years old

Volunteers: No 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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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1,375 participants in 3 patient groups

Pre-Implementation

No Intervention group

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.

Implementation

Experimental group

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.

Treatment:

Other: Implementation

Post-Implementation

No Intervention group

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.