Adverse Events Clinical Trial
— PROTECTOfficial title:
Safety Huddle Performance: The Effectiveness of an Interdisciplinary, Proficiency-based, Team Simulation Programme to Improve Communication and Reduce Patient Harm (PROTECT)
NCT number | NCT05390125 |
Other study ID # | PROTECT |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | September 30, 2020 |
Est. completion date | August 2022 |
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.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | August 2022 |
Est. primary completion date | August 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Ireland | Cork University Hospital | Cork | |
Ireland | University Hospital Waterford | Waterford |
Lead Sponsor | Collaborator |
---|---|
Dorothy Breen | Cork University Hospital, Health Research Board, Ireland, Health Service Executive, Ireland, International Society for Quality in Health care, Irish Patients Association, Orsi Academy, University Hospital Waterford, University of Ulster |
Ireland,
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* Note: There are 15 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Huddle Performance as scored on the metrics-based proficiency assessment developed as part of the training programme. | 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) | To be conducted January -June 2022 | |
Secondary | Safety Culture as measured by the Safety Attitudes Questionnaire before and at 1 and 6 months after training. | 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. |
To be conducted July 21 to July 22 | |
Secondary | Economic impact as measured by the incremental cost effectiveness ratio (ICER) and budget impact analysis of the intervention. | 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. |
To be conducted May - September 22 | |
Secondary | Rates of reported incidents | Number and type of incidents reported on the Irish National Incident Monitoring system for 5 years preceding June 22 | To be conducted April 2022 to August 2022 | |
Secondary | The prevalence of COVID-19 infections and COVID-19 ICU admissions in both hospitals | 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. | July 2022 | |
Secondary | The effect of the safety huddle on creating awareness amongst staff of which patients have been identified as watchers | 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. | July 2021 and July 2022 |
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