Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05390125
Study type Observational
Source University College Cork
Contact Dorothy Breen
Phone 0872430373
Email dorothy.breen@hse.ie
Status Recruiting
Phase
Start date September 30, 2020
Completion date August 2022

See also
  Status Clinical Trial Phase
Completed NCT04012320 - Efficacy and Safety on the Use of Bisphosphonates in Paediatrics
Completed NCT02268331 - Comparison of Active vs. Passive Surveillance to Collect Adverse Events N/A
Completed NCT00244673 - Randomized Study of Not Giving Diphteria-tetanus-pertussis Vaccination With or After Measles Vaccination Phase 4
Recruiting NCT05038527 - ABM/P-15 Bone Graft vs Traditional Bone Graft in Adult Spinal Deformity Surgery N/A
Completed NCT01291667 - Study for HER2-Overexpressed MBC Patients Treated by Cipterbin® Plus vinorelbinE Phase 3
Completed NCT00681395 - Study to Compare the Bioavailability of ABT-335 and Rosuvastatin From ABT-143 Relative to That From the Co-administration of ABT-335 and Rosuvastatin Calcium Phase 1
Completed NCT05359666 - Retrospective Independent Safety Review of Closed Irrisept Study N/A
Recruiting NCT05311566 - PD-1 Antibody Plus Chemoradiotherapy for IB2-IIIB Cervical Cancer Phase 2
Recruiting NCT05310344 - Albumin-bound Paclitaxel and Bevacizumab for Platinum-resistant Recurrent Ovarian Cancer Phase 2
Recruiting NCT05311579 - Niraparib Plus Anlotinib for Recurrent Ovarian Cancer Phase 2
Completed NCT05815615 - Plasmapheresis: a Multi-modal Approach N/A
Completed NCT02130570 - Relative Patient Benefits of a Hospital-PCMH Collaboration Within an ACO to Improve Care Transitions N/A
Recruiting NCT05804188 - CRICKET: Critical Events in Anaesthetised Kids Undergoing Tracheal Intubation
Not yet recruiting NCT06117176 - Prospective Assessment Project of AirwaY Management-related Incidents in Adult Anaesthesia Care PAPAYA III
Recruiting NCT02725073 - Photodynamic Therapy in Locally Advanced Hilar Cholangiocarcinoma Phase 2
Completed NCT02928705 - Quality of Telemedically Guided Prehospital Analgesia N/A
Withdrawn NCT01128127 - Strategies for Improving Proton Pump Inhibitors (PPIs) Prescription Associated to Non-steroidal Anti-inflammatory Drugs (NSAIDs) N/A
Terminated NCT02011607 - Incidence of Adverse Airway Events in High Risk Patients Undergoing Upper GI Endoscopy Under Anesthesia
Completed NCT02310815 - ReSure Sealant Post Approval Study N/A
Recruiting NCT05709392 - Preterm DElayed Cord Clamping and Early Skin-to-Skin Contact: PreDECESS N/A