NCT05390125

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2020

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 30, 2020

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 28, 2021

Completed
12 months until next milestone

First Posted

Study publicly available on registry

May 25, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2022

Completed
Last Updated

May 25, 2022

Status Verified

May 1, 2022

Enrollment Period

1.8 years

First QC Date

May 28, 2021

Last Update Submit

May 23, 2022

Conditions

Outcome Measures

Primary Outcomes (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.

    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 .

    Retrospective chart review to be conducted from Feb to Aug 2022.

Secondary Outcomes (6)

  • Huddle Performance as scored on the metrics-based proficiency assessment developed as part of the training programme.

    To be conducted January -June 2022

  • Safety Culture as measured by the Safety Attitudes Questionnaire before and at 1 and 6 months after training.

    To be conducted July 21 to July 22

  • Economic impact as measured by the incremental cost effectiveness ratio (ICER) and budget impact analysis of the intervention.

    To be conducted May - September 22

  • Rates of reported incidents

    To be conducted April 2022 to August 2022

  • The prevalence of COVID-19 infections and COVID-19 ICU admissions in both hospitals

    July 2022

  • +1 more secondary outcomes

Study Arms (2)

4B ward staff

Multidisciplinary staff members from a surgical ward in Cork University Hospital.

Other: A team, proficiency based progression, simulation training programme

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.

Interventions

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.

4B ward staff

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Cork University Hospital

Cork, T12 DC4A, Ireland

RECRUITING

University Hospital Waterford

Waterford, X91 ER8E, Ireland

NOT YET RECRUITING

Related Publications (15)

  • Kitch BT, Cooper JB, Zapol WM, Marder JE, Karson A, Hutter M, Campbell EG. Handoffs causing patient harm: a survey of medical and surgical house staff. Jt Comm J Qual Patient Saf. 2008 Oct;34(10):563-70. doi: 10.1016/s1553-7250(08)34071-9.

    PMID: 18947116BACKGROUND
  • 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

    BACKGROUND
  • Weaver SJ, Dy SM, Rosen MA. Team-training in healthcare: a narrative synthesis of the literature. BMJ Qual Saf. 2014 May;23(5):359-72. doi: 10.1136/bmjqs-2013-001848. Epub 2014 Feb 5.

    PMID: 24501181BACKGROUND
  • Hughes AM, Gregory ME, Joseph DL, Sonesh SC, Marlow SL, Lacerenza CN, Benishek LE, King HB, Salas E. Saving lives: A meta-analysis of team training in healthcare. J Appl Psychol. 2016 Sep;101(9):1266-304. doi: 10.1037/apl0000120. Epub 2016 Jun 16.

    PMID: 27599089BACKGROUND
  • 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

    BACKGROUND
  • Gallagher AG, Satava RM, Shorten GD. Measuring surgical skill: a rapidly evolving scientific methodology. Surg Endosc. 2013 May;27(5):1451-5. doi: 10.1007/s00464-013-2786-x. Epub 2013 Feb 1. No abstract available.

    PMID: 23371021BACKGROUND
  • 7. Gallagher AG, O'Sullivan GC (2011). Fundamentals of surgical simulation; principles & practices: London: Springer Verlag.

    BACKGROUND
  • Breen D, O'Brien S, McCarthy N, Gallagher A, Walshe N. Effect of a proficiency-based progression simulation programme on clinical communication for the deteriorating patient: a randomised controlled trial. BMJ Open. 2019 Jul 9;9(7):e025992. doi: 10.1136/bmjopen-2018-025992.

    PMID: 31289064BACKGROUND
  • Kallidaikurichi Srinivasan K, Gallagher A, O'Brien N, Sudir V, Barrett N, O'Connor R, Holt F, Lee P, O'Donnell B, Shorten G. Proficiency-based progression training: an 'end to end' model for decreasing error applied to achievement of effective epidural analgesia during labour: a randomised control study. BMJ Open. 2018 Oct 15;8(10):e020099. doi: 10.1136/bmjopen-2017-020099.

    PMID: 30327396BACKGROUND
  • Angelo RL, Ryu RK, Pedowitz RA, Beach W, Burns J, Dodds J, Field L, Getelman M, Hobgood R, McIntyre L, Gallagher AG. A Proficiency-Based Progression Training Curriculum Coupled With a Model Simulator Results in the Acquisition of a Superior Arthroscopic Bankart Skill Set. Arthroscopy. 2015 Oct;31(10):1854-71. doi: 10.1016/j.arthro.2015.07.001. Epub 2015 Sep 2.

    PMID: 26341047BACKGROUND
  • Seymour NE, Gallagher AG, Roman SA, O'Brien MK, Bansal VK, Andersen DK, Satava RM. Virtual reality training improves operating room performance: results of a randomized, double-blinded study. Ann Surg. 2002 Oct;236(4):458-63; discussion 463-4. doi: 10.1097/00000658-200210000-00008.

    PMID: 12368674BACKGROUND
  • Ahlberg G, Enochsson L, Gallagher AG, Hedman L, Hogman C, McClusky DA 3rd, Ramel S, Smith CD, Arvidsson D. Proficiency-based virtual reality training significantly reduces the error rate for residents during their first 10 laparoscopic cholecystectomies. Am J Surg. 2007 Jun;193(6):797-804. doi: 10.1016/j.amjsurg.2006.06.050.

    PMID: 17512301BACKGROUND
  • 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

    BACKGROUND
  • 14. The Health Foundation. Measuring safety culture [Internet]. 2011. Available from: https://www.health.org.uk/sites/health/files/MeasuringSafetyCulture.pdf

    BACKGROUND
  • Sexton JB, Helmreich RL, Neilands TB, Rowan K, Vella K, Boyden J, Roberts PR, Thomas EJ. The Safety Attitudes Questionnaire: psychometric properties, benchmarking data, and emerging research. BMC Health Serv Res. 2006 Apr 3;6:44. doi: 10.1186/1472-6963-6-44.

    PMID: 16584553BACKGROUND

Study Officials

  • Dorothy Breen

    Cork University Hospital

    PRINCIPAL INVESTIGATOR
  • George Shorten

    University College Cork & Cork University Hospital

    PRINCIPAL INVESTIGATOR
  • Peter Neary

    University Hospital Waterford

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 28, 2021

First Posted

May 25, 2022

Study Start

September 30, 2020

Primary Completion

August 1, 2022

Study Completion

August 1, 2022

Last Updated

May 25, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations