Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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12 December 2020 |
Main ID: |
NCT03082417 |
Date of registration:
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06/03/2017 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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The PAINFREE Initiative, a Stepped Wedge Cluster Randomized Trial
PAINFREE |
Scientific title:
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Improving PAIN Control Following FRactures; Towards an Elder-friendly Emergency Department |
Date of first enrolment:
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March 1, 2016 |
Target sample size:
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1375 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT03082417 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Health Services Research. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Canada
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Contacts
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Name:
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Suzanne Morin, Dr |
Address:
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Telephone:
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Email:
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Affiliation:
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McGill University Hospital Center |
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Key inclusion & exclusion criteria
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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
Age minimum:
75 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Older Adults
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Bone Fracture
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Pain, Acute
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Elderly
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Emergency Department
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Intervention(s)
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Other: Implementation
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Primary Outcome(s)
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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)]
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Secondary Outcome(s)
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Evidence of worsening of Patients mental status while in Emergency Department
[Time Frame: Pre-implementation (baseline) and at 6 to 8 months (post-implementation)]
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Effectiveness of analgesia
[Time Frame: Pre-implementation (baseline) and at 6 to 8 months (post-implementation)]
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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)]
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Time to first pain score documentation
[Time Frame: Pre-implementation (baseline) and at 6 to 8 months (post-implementation)]
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Type of analgesia used
[Time Frame: Pre-implementation (baseline) and at 6 to 8 months (post-implementation)]
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Documentation of pain score
[Time Frame: Pre-implementation (baseline) and at 6 to 8 months (post-implementation)]
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Mean length of stay in Emergency Department
[Time Frame: Pre-implementation (baseline) and at 6 to 8 months (post-implementation)]
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Secondary ID(s)
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MP-CUSM-13-054
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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