Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

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

6 mars 2019 uppdaterad av: 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

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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)

Studietyp

Interventionell

Inskrivning (Faktisk)

1375

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

75 år och äldre (Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Hälsovårdsforskning
  • Tilldelning: Randomiserad
  • Interventionsmodell: Crossover tilldelning
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Inget ingripande: 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.
Experimentell: 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.
Övrig: 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
Inget ingripande: 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.

Vad mäter studien?

Primära resultatmått

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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Documentation of pain score
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: Pre-implementation (baseline) and at 6 to 8 months (post-implementation)
Pre-implementation (baseline) and at 6 to 8 months (post-implementation)

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Predictors of successful implementation
Tidsram: 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)
Tidsram: 2 months (end of post-implementation period)
2 months (end of post-implementation period)

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

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

Samarbetspartners

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

Utredare

  • Huvudutredare: Suzanne Morin, Dr, McGill University Hospital Center

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 mars 2016

Primärt slutförande (Faktisk)

1 februari 2018

Avslutad studie (Faktisk)

1 oktober 2018

Studieregistreringsdatum

Först inskickad

6 mars 2017

Först inskickad som uppfyllde QC-kriterierna

10 mars 2017

Första postat (Faktisk)

17 mars 2017

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

8 mars 2019

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

6 mars 2019

Senast verifierad

1 mars 2019

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • MP-CUSM-13-054

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

Obeslutsam

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Kliniska prövningar på Smärta, Akut

Kliniska prövningar på Implementation

Sök liknande försök

Sponsorer och medarbetare

Medicinska tillstånd

Läkemedelsinterventioner

CROs by country

CROs in Burkina Faso

Betingelser

Sällsynta sjukdomar

Läkemedelsinterventioner

Kosttillskott

Sponsor / medarbetare

Platser

3
Prenumerera