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The PAINFREE Initiative, a Stepped Wedge Cluster Randomized Trial (PAINFREE)

6 marzo 2019 aggiornato da: Suzanne Morin, McGill University Health Centre/Research Institute of the McGill University Health Centre

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:

  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

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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)

Tipo di studio

Interventistico

Iscrizione (Effettivo)

1375

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H3G 1A4
        • Department of Internal Medicine, Montreal General Hospital

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

75 anni e precedenti (Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Ricerca sui servizi sanitari
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione incrociata
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Nessun intervento: 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.
Sperimentale: 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.
Altro: 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
Nessun intervento: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Lasso di tempo
Time to achieve pain score documentation, and/or administration of an analgesic, within 2 hours of triage, in at least 80% of patients.
Lasso di tempo: Pre-implementation (baseline) and at 6 to 8 months (post-implementation)
Pre-implementation (baseline) and at 6 to 8 months (post-implementation)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Documentation of pain score
Lasso di tempo: Pre-implementation (baseline) and at 6 to 8 months (post-implementation)
Pre-implementation (baseline) and at 6 to 8 months (post-implementation)
Time to first pain score documentation
Lasso di tempo: Pre-implementation (baseline) and at 6 to 8 months (post-implementation)
Pre-implementation (baseline) and at 6 to 8 months (post-implementation)
Effectiveness of analgesia
Lasso di tempo: Pre-implementation (baseline) and at 6 to 8 months (post-implementation)
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)
Type of analgesia used
Lasso di tempo: Pre-implementation (baseline) and at 6 to 8 months (post-implementation)
Pre-implementation (baseline) and at 6 to 8 months (post-implementation)
Mean length of stay in Emergency Department
Lasso di tempo: Pre-implementation (baseline) and at 6 to 8 months (post-implementation)
Pre-implementation (baseline) and at 6 to 8 months (post-implementation)
Return to the Emergency Department within 7 days after the first Visit with an uncontrolled pain due to the fracture
Lasso di tempo: Pre-implementation (baseline) and at 6 to 8 months (post-implementation)
Pre-implementation (baseline) and at 6 to 8 months (post-implementation)
Evidence of worsening of Patients mental status while in Emergency Department
Lasso di tempo: Pre-implementation (baseline) and at 6 to 8 months (post-implementation)
Pre-implementation (baseline) and at 6 to 8 months (post-implementation)

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Predictors of successful implementation
Lasso di tempo: at 6 to 8 months after the implementation (post-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)
Change from immediate post-implementation time to analgesia administration at 2 months (end of post-implementation period)
Lasso di tempo: 2 months (end of post-implementation period)
2 months (end of post-implementation period)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

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

Collaboratori

Canadian Institutes of Health Research (CIHR)
Research Institute of the McGill University Health Center

Investigatori

  • Investigatore principale: Suzanne Morin, Dr, McGill University Hospital Center

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 marzo 2016

Completamento primario (Effettivo)

1 febbraio 2018

Completamento dello studio (Effettivo)

1 ottobre 2018

Date di iscrizione allo studio

Primo inviato

6 marzo 2017

Primo inviato che soddisfa i criteri di controllo qualità

10 marzo 2017

Primo Inserito (Effettivo)

17 marzo 2017

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

8 marzo 2019

Ultimo aggiornamento inviato che soddisfa i criteri QC

6 marzo 2019

Ultimo verificato

1 marzo 2019

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • MP-CUSM-13-054

Piano per i dati dei singoli partecipanti (IPD)

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Indeciso

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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