The PAINFREE Initiative, a Stepped Wedge Cluster Randomized Trial (PAINFREE)
Improving PAIN Control Following FRactures; Towards an Elder-friendly Emergency Department
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
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
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)
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Quebec
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Montreal, Quebec, Kanada, H3G 1A4
- Department of Internal Medicine, Montreal General Hospital
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Výzkum zdravotnických služeb
- Přidělení: Randomizované
- Intervenční model: Crossover Assignment
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Žádný zásah: 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. |
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Experimentální: 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. |
The PAINFREE Initiative is a Multifaceted intervention:
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Žádný zásah: 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.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Časové okno |
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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.
Časové okno: Pre-implementation (baseline) and at 6 to 8 months (post-implementation)
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Pre-implementation (baseline) and at 6 to 8 months (post-implementation)
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Documentation of pain score
Časové okno: Pre-implementation (baseline) and at 6 to 8 months (post-implementation)
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Pre-implementation (baseline) and at 6 to 8 months (post-implementation)
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Time to first pain score documentation
Časové okno: Pre-implementation (baseline) and at 6 to 8 months (post-implementation)
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Pre-implementation (baseline) and at 6 to 8 months (post-implementation)
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Effectiveness of analgesia
Časové okno: Pre-implementation (baseline) and at 6 to 8 months (post-implementation)
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Patients with pain score ≥7 who have pain score reduced by ≥ 3 points within 1 hour
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Pre-implementation (baseline) and at 6 to 8 months (post-implementation)
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Type of analgesia used
Časové okno: Pre-implementation (baseline) and at 6 to 8 months (post-implementation)
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Pre-implementation (baseline) and at 6 to 8 months (post-implementation)
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Mean length of stay in Emergency Department
Časové okno: Pre-implementation (baseline) and at 6 to 8 months (post-implementation)
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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
Časové okno: Pre-implementation (baseline) and at 6 to 8 months (post-implementation)
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Pre-implementation (baseline) and at 6 to 8 months (post-implementation)
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Evidence of worsening of Patients mental status while in Emergency Department
Časové okno: Pre-implementation (baseline) and at 6 to 8 months (post-implementation)
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Pre-implementation (baseline) and at 6 to 8 months (post-implementation)
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Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Predictors of successful implementation
Časové okno: at 6 to 8 months after the implementation (post-implementation)
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Qualitative Analysis: Nurses and physicians perceptions and behaviors toward pain management in older adults with fracture at Emergency Department
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at 6 to 8 months after the implementation (post-implementation)
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Change from immediate post-implementation time to analgesia administration at 2 months (end of post-implementation period)
Časové okno: 2 months (end of post-implementation period)
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2 months (end of post-implementation period)
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Spolupracovníci a vyšetřovatelé
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Suzanne Morin, Dr, McGill University Hospital Center
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- MP-CUSM-13-054
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
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