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Effectiveness of a Proficiency-based Progression Communication Training Programme (PROTECT)

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ClinicalTrials.gov Identifier: NCT05390125
Recruitment Status : Recruiting
First Posted : May 25, 2022
Last Update Posted : May 25, 2022
Sponsor:
Collaborators:
Health Research Board, Ireland
Cork University Hospital
University Hospital Waterford
University of Ulster
Orsi Academy
International Society for Quality in Health care
Health Service Executive, Ireland
Irish Patients Association
Information provided by (Responsible Party):
Dorothy Breen, University College Cork

Brief Summary:
Breakdown in communication between healthcare workers leads to significant patient harm on a daily basis, worldwide. The "safety huddle" is being introduced internationally as a means of overcoming this problem. The "safety huddle" is where healthcare workers of all types gather for a 15-minute meeting to voice and address safety concerns for their patients. The safety of the patients depends on how well people communicate with each other at the "safety huddle". As communication skills vary, the research team plans to devise a team training course for healthcare workers of all types that ensures a standard is reached which is as good as teams we know perform well. The research team plans to introduce this training programme to one ward in two different hospitals with the aim of reducing patient harm. The team will compare rates of harm using a method that has been used around the world and involves looking back through some patients' notes for certain clues. The team will do this by choosing notes at random for a 6-month period before the training and again for a 6 month period after the training. The researchers will then see if levels of harm have improved or not with the team training. The researchers will also measure how well the teams conduct the "safety huddle" and if they felt that in general there was more safety awareness on the ward.

Condition or disease Intervention/treatment
Adverse Events Other: A team, proficiency based progression, simulation training programme

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Safety Huddle Performance: The Effectiveness of an Interdisciplinary, Proficiency-based, Team Simulation Programme to Improve Communication and Reduce Patient Harm (PROTECT)
Actual Study Start Date : September 30, 2020
Estimated Primary Completion Date : August 2022
Estimated Study Completion Date : August 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Patient Safety

Group/Cohort Intervention/treatment
4B ward staff
Multidisciplinary staff members from a surgical ward in Cork University Hospital.
Other: A team, proficiency based progression, simulation training programme
The training programme will consist of two components (i) a short online training course including video examples of high performing teams and also poor practice (ii) a ward-based team huddle simulation training and assessment programme. The design and shape of the training and assessment will be based on the development of robust metrics. The design of the metrics and programme will centre around use in the acute hospital setting but will be readily adaptable to the obstetric, paediatric setting. The process of validating the metrics and building the online and simulation course involves the review of videotapes of safety huddle performance.

Cedar ward staff
Multidisciplinary staff members from the Cedar ward in University Hospital Waterford with a similar case mix of patients to ward 4B in CUH.



Primary Outcome Measures :
  1. The primary outcome will be the incidence of adverse events on each ward for a 6 month period before and after the team training intervention. [ Time Frame: Retrospective chart review to be conducted from Feb to Aug 2022. ]
    Adverse events will be documented from random chart review using Institute of Healthcare Improvement Trigger tool methodology including the surgical module before and after the intervention .


Secondary Outcome Measures :
  1. Huddle Performance as scored on the metrics-based proficiency assessment developed as part of the training programme. [ Time Frame: To be conducted January -June 2022 ]
    The number of huddle metrics achieved and benchmark assessment by direct observation (at least once/week) and independent videotape review (once/month x 6 months post training)

  2. Safety Culture as measured by the Safety Attitudes Questionnaire before and at 1 and 6 months after training. [ Time Frame: To be conducted July 21 to July 22 ]

    The Safety Attitudes Questionnaire will be conducted on both wards before training commencing in July 2021 - Dec 2021 before the intervention and repeated in March/ April 2022 immediately after the training intervention and again in July 2022.

    Most of the survey items use 5-point agreement scales ("Strongly disagree" to "Strongly agree") or frequency scales ("Never" to "Always") and also include a "Does not apply or Don't know" response option. The survey has a section at the end for open-ended comments.


  3. Economic impact as measured by the incremental cost effectiveness ratio (ICER) and budget impact analysis of the intervention. [ Time Frame: To be conducted May - September 22 ]

    The cost effectiveness of the intervention will be assessed by comparing incremental costs and effects of the intervention compared to without the intervention. All direct costs associated with the intervention will be identified, measured and valued. In the baseline analysis a cost utility analysis will be performed; wherein effects are estimated in Quality Adjusted Life years. To examine robustness a cost effectiveness analysis will also be performed, whereby effects are measured by reduction in adverse events to determine if additional costs yield additional benefits.

    A probabilistic sensitivity analysis will be performed to examine uncertainty around the parameters and outputs. Also, a budget impact analysis will be performed.


  4. Rates of reported incidents [ Time Frame: To be conducted April 2022 to August 2022 ]
    Number and type of incidents reported on the Irish National Incident Monitoring system for 5 years preceding June 22

  5. The prevalence of COVID-19 infections and COVID-19 ICU admissions in both hospitals [ Time Frame: July 2022 ]
    Measuring the prevalence of COIVD-19 infections and COVID-19 ICU admissions in both hospitals over the duration of the research project, from September 2020 - September 2022.

  6. The effect of the safety huddle on creating awareness amongst staff of which patients have been identified as watchers [ Time Frame: July 2021 and July 2022 ]
    Examine the effect of the safety huddle in creating awareness of the patients who've been identified as "watchers" on the ward in those staff members who did not participate in the huddle. This will be assessed in one study ward by asking 5 nursing staff members not present at the huddle who the "watchers" reported for that day are. This will be done at two different time points, once in July 2021 and again in July 2022 to compare data before and after the training course.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Members of the multidisciplinary team include nurses, doctors, physios, occupational therapists, pharmacists, dieticians, and occupational therapists etc. The two wards chosen have a similar case mix of patient cohorts to each other. Staff members who are frequently working on either ward 4B or the Cedar ward are to be included in the study population.
Criteria

Inclusion Criteria:

  • Multidisciplinary staff member primarily based on ward 4B, Cork University Hospital
  • Multidisciplinary staff member primarily based on the Cedar ward, University Hospital Waterford

Exclusion Criteria:

  • Lack of consent.
  • Rotating staff who undertake occasional work in the designated wards.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05390125


Contacts
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Contact: Dorothy Breen 0872430373 dorothy.breen@hse.ie
Contact: Amy Stone 0857075459 amy.stone@ucc.ie

Locations
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Ireland
Cork University Hospital Recruiting
Cork, Ireland, T12 DC4A
Contact: Dorothy Breen    0872430373    dorothy.breen@hse.ie   
Contact: Amy Stone    0857075459    amy.stone@ucc.ie   
University Hospital Waterford Not yet recruiting
Waterford, Ireland, X91 ER8E
Contact: Dorothy Breen    0872430373    dorothy.breen@hse.ie   
Contact: Amy Stone    0857075459    amy.stone@ucc.ie   
Principal Investigator: Peter Neary         
Sponsors and Collaborators
Dorothy Breen
Health Research Board, Ireland
Cork University Hospital
University Hospital Waterford
University of Ulster
Orsi Academy
International Society for Quality in Health care
Health Service Executive, Ireland
Irish Patients Association
Investigators
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Principal Investigator: Dorothy Breen Cork University Hospital
Principal Investigator: George Shorten University College Cork & Cork University Hospital
Principal Investigator: Peter Neary University Hospital Waterford
Publications:
2. National Confidential Enquiry into Patient Outcome and Death. Caring to the end? A review of the care of patients who died in hospital within four days of admission. NCEPOD, 2009. www.ncepod.org.uk/2009report2/Downloads/DAH_report.pdf
5. National Clinical Effectiveness Committee. Communication (Clinical Handover) in Acute and Children's Hospital Services, National Clinical Guideline No. 11. http://health.gov.ie/wp-content/uploads/2015/12/NCG-No-11-Clinical-Handover-Acute-andChildrens-Hospital-Services-Full-Report.pdf
7. Gallagher AG, O'Sullivan GC (2011). Fundamentals of surgical simulation; principles & practices: London: Springer Verlag.
13. Griffin FA, Resar RK. IHI Global Trigger Tool for Measuring Adverse Events (Second Edition). IHI Innovation Series white paper. Cambridge, MA: Institute for Healthcare Improvement; 2009. (Available on www.IHI.org
14. The Health Foundation. Measuring safety culture [Internet]. 2011. Available from: https://www.health.org.uk/sites/health/files/MeasuringSafetyCulture.pdf

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Responsible Party: Dorothy Breen, Principal Investigator, University College Cork
ClinicalTrials.gov Identifier: NCT05390125    
Other Study ID Numbers: PROTECT
First Posted: May 25, 2022    Key Record Dates
Last Update Posted: May 25, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No