Clinical trial NCT05390125: Effectiveness of a Proficiency-based Progression Communication Training Programme
Official title: Safety Huddle Performance: The Effectiveness of an Interdisciplinary, Proficiency-based, Team Simulation Programme to Improve Communication and Reduce Patient Harm (PROTECT)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Adverse Events
Lead sponsor: University College Cork
Sponsor class: OTHER
Collaborators: name: Health Research Board, Ireland
name: Cork University Hospital
name: University Hospital Waterford
name: University of Ulster
name: Orsi Academy
name: International Society for Quality in Health care
name: Health Service Executive, Ireland
name: Irish Patients Association
First posted: 2022-05-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Detailed description: Effective communication in acute care settings is essential to the provision of safe and reliable patient care. The need for high quality communication skills has become urgent in Irish hospitals as organisations and medical therapies become more complex, specialisation increases, patients have a greater degree of comorbidity and working patterns move to a shift-based pattern (as a result of the European Working Time Directive). As many as 59% of hospital based medical trainees have encountered patient harm which they attribute to a substandard communication, with up to 12% reporting that this harm has been major. In a review undertaken by the National Confidential Enquiry into Patient Outcome and Death of patients who died within 4 days of admission in the UK, poor communication between and within clinical teams was identified as an important issue in 13.5% (267/1983) of the deaths.

A recent review of team training interventions showed that there was overall, moderate-to-high quality evidence suggesting team training can positively impact healthcare team processes and patient outcomes. A metanalysis of team training interventions supports the expanded use of team training and points toward recommendations for optimizing its effectiveness within the healthcare setting. Despite this evidence, communication training for healthcare workers is often either conducted within the boundaries of each discipline or not at all. As part of preparatory work for the National Clinical Guideline on Clinical Communication commissioned by the Department of Health in Ireland, a series of surveys, interviews and focus groups were undertaken across the acute hospital services in Ireland. Results of these surveys indicated that only 2 of 28 health professional training programmes for which information was available, had planned shared learning activities with other disciplines in relation to communication training. Furthermore, in focus groups and interviews undertaken across all disciplines, most participants reported that "they had not ever received formal training" in clinical communication.

Where communication programmes do exist, learner perceptions are frequently used as a marker of effectiveness rather than an objective assessment indicating a quantifiably improved skill set with a demonstrable patient impact.

Proficiency-based progression (PBP) training is an innovative form of outcomes-based training that involves training individuals to achieve a proficiency benchmark. Members of this research team have published extensively on this methodology which has been shown to improve both healthcare worker performance and patient outcomes.

The process involves a thorough task analysis of high performing individuals, teams or services to develop a set of clearly defined metrics. Education and simulation training programmes are then constructed to capture these metrics. In this way, training is honed on aspects that are strategic to high levels of performance to produce a more consistent skill set in the trainee. Practice is "deliberate" as a result of feedback on the metrics, rather than "repeated" which can allow for errors to go unchecked. Assessment consists of comparison against a "proficiency benchmark" which is set as the mean performance as scored on the metrics of real world clinicians who are genuinely good at the task in clinical practice. Results of studies undertaken with this approach on technical skill performance indicate that it is superior to standard simulation courses. The lead knowledge user (DB) and research co-applicant (AGG) have recently published the first randomised trial of its use in non-technical (communication) skills. The primary aim of the study was to determine if the addition of a proficiency-based progression simulation training programme to the national HSE, NEWS e-learning module results in better performance of clinical communication in the context of the deteriorating patient than either the e-learning module alone or in combination with standard simulation. Undergraduate medical and nursing participants were randomised to one of these three groups. Results showed that in a standardised simulated scenario, only 6.9% (2/29) of the e-learning group demonstrated proficiency compared to 13% (3/23) of the standard simulation group and 60% of the PBP group. These encouraging results were obtained despite the fact that the PBP training programme was constrained by the time allowed within the existing curriculum. Of note, work from a pilot for this study conducted the previous year, showed that trainee perceptions of the programme were not related to proficient performance.

The proposal presented here builds on this work and more importantly aims to use patient outcomes as well as healthcare worker performance as the ultimate marker of effectiveness. If this study is successful, the safety huddle training programme will represent an innovative and significant patient safety initiative, developed and designed within the Irish setting and deliverable on any ward/clinical area. It will have a tangible benefit to patients and families. The training programme will be multidisciplinary and represents a ward-based (clinical area), team intervention that will embed the safety huddle into daily practice.

This pragmatic approach by the PROTECT study will facilitate implementation as well as research. It is anticipated by embedding the training at team and ward level, "side to side "spread to other clinical areas in the two study institutions will occur in the months following the study. The study has senior organisational and clinical support at both hospital and regional level to accelerate further roll out to the wider region at the end of the study.

The published results will augment the invesigators' previous work in this area. It will build on this body of knowledge to expand high quality evidence for the Irish context in this domain. This evidence will inform future revisions of national clinical guidelines and training decisions made by training bodies, regulators and health care service providers to encourage a paradigm shift towards validated, team (rather than single discipline) training in the 1-2 years after completion of the study.

Eligibility 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.

Primary outcomes:
measure: 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.
timeFrame: Retrospective chart review to be conducted from Feb to Aug 2022.
Secondary outcomes:
measure: Huddle Performance as scored on the metrics-based proficiency assessment developed as part of the training programme.
timeFrame: To be conducted January -June 2022
measure: Safety Culture as measured by the Safety Attitudes Questionnaire before and at 1 and 6 months after training.
timeFrame: To be conducted July 21 to July 22
measure: Economic impact as measured by the incremental cost effectiveness ratio (ICER) and budget impact analysis of the intervention.
timeFrame: To be conducted May - September 22
measure: Rates of reported incidents
timeFrame: To be conducted April 2022 to August 2022
measure: The prevalence of COVID-19 infections and COVID-19 ICU admissions in both hospitals
timeFrame: July 2022
measure: The effect of the safety huddle on creating awareness amongst staff of which patients have been identified as watchers
timeFrame: July 2021 and July 2022
Other outcomes:
Locations:
city: Cork
country: Ireland
facility: Cork University Hospital
city: Waterford
country: Ireland
facility: University Hospital Waterford
Study officials:
affiliation: Cork University Hospital
name: Dorothy Breen
role: PRINCIPAL_INVESTIGATOR
affiliation: University College Cork & Cork University Hospital
name: George Shorten
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Waterford
name: Peter Neary
role: PRINCIPAL_INVESTIGATOR
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