The PAINFREE Initiative, a Stepped Wedge Cluster Randomized Trial

Pain, Acute Clinical Trial

— PAINFREE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03082417
• Other study ID #: MP-CUSM-13-054
• Status: Completed
• Phase: N/A
• Start date: March 1, 2016
• Est. completion date: October 1, 2018

Study information

• Verified date: March 2019
• Source: McGill University Health Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1375
• Est. completion date: October 1, 2018
• Est. primary completion date: February 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 75 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Bone Fracture
• Elderly
• Emergencies
• Emergency Department
• Fractures, Bone
• Older Adults
• Pain, Acute

Intervention

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

Locations

Country	Name	City	State
Canada	Department of Internal Medicine, Montreal General Hospital	Montreal	Quebec

Sponsors (3)

Lead Sponsor	Collaborator
McGill University Health Center	Canadian Institutes of Health Research (CIHR), Research Institute of the McGill University Health Center

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Other	Change from immediate post-implementation time to analgesia administration at 2 months (end of post-implementation period)		2 months (end of post-implementation period)
Primary	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	Documentation of pain score		Pre-implementation (baseline) and at 6 to 8 months (post-implementation)
Secondary	Time to first pain score documentation		Pre-implementation (baseline) and at 6 to 8 months (post-implementation)
Secondary	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)
Secondary	Type of analgesia used		Pre-implementation (baseline) and at 6 to 8 months (post-implementation)
Secondary	Mean length of stay in Emergency Department		Pre-implementation (baseline) and at 6 to 8 months (post-implementation)
Secondary	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)
Secondary	Evidence of worsening of Patients mental status while in Emergency Department		Pre-implementation (baseline) and at 6 to 8 months (post-implementation)