Designing Out Medical Error (DOME)

A number of studies from around the world suggest that approximately 10% of patients admitted to hospital suffer some kind of harm through errors in hospital procedures [1–3].Many of these are thought to be avoidable, and the Design for Patient Safety report [4] highlighted the problems in the use of design by the UK NHS.Modern healthcare is complex mix of equipment, environment, staff and processes. The ward, bay and bed space is home to a variety of equipment, often designed with little thought to the system in which it operates.The DOME project was set up to investigate how design of products, environments and systems could better support healthcare processes and reduce the instance of medical error on elective surgical wards.The collaborative team of designers, clinicians, psychologists and ergonomists carried out several hundred hours of initial observations in three hospitals in order to observe all activities that patients and staff participate in. The research team began by observing the surgical patient journey through the hospital and visualised this using mapping techniques.A comprehensive literature review of all published adverse events revealed that the surgical ward was as hazardous as the operating theatre, but the review did not identify the most important sources of error or explain why harm was occurring. Patients and staff participated in a risk assessment survey to determine which healthcare activities were most hazardous. The five most hazardous healthcare activities on surgical wards were identified and prioritised: hand hygiene, information hand-over, vital signs monitoring, isolation of infection and medication delivery. Detailed observations and in-depth interviews with patients and healthcare staff allowed these processes to be fully understood and mapped.They were then subjected to a Failure Mode and Effects Analysis (FMEA). Expert groups consisting of doctors, nurses, patients and researchers, all with experience of the subject matter, were organised by the DOME team to validate the healthcare process maps and then rate the risk associated with each step in the processes. This revealed where in each process the most risky points were.These points were then assessed using the framework for analysing risk and safety in clinical medicine. Subject experts were interviewed and asked to give reasons for each type of failure, within various categories (organisation/management, staff, patient factors etc).Concurrent with this research, the DOME project investigated how risk is managed and safety considered in other industries. Members of the team visited international sites in the mining, chemical, oil exploration, shipping and construction industries to draw lessons on ways to reduce systemic error. Task design, reminders, equipment and space were identified as generic components in any design-led approach to improving safety.This understanding of errors, their causes and methods to manage risk led to the creation of design briefs that resulted in a suite of prototypes. Two of these were developed further with a manufacturer, and one is now commercially available. This design, the ‘CareCentre™’ was subjected to a cluster-randomised crossover clinical trial [5].Four pairs of 6-bedded bays on surgical wards were randomised to receive CareCentres™ or standard conditions for 1 week. After 1 week, the pair of bays crossed over. Researchers observed each bay for 20 minutes per day in a randomised order, in line with the recommendations of the World Health Organisation (WHO) for hand hygiene observations. Measurements of the WHO's 5 moments for hand hygiene, donning and disposal of gloves and aprons at the bedside and use of writing surfaces were made. These were validated by a period of dual researcher observation. Repeated observation sessions were used (once a day for 5 days) in each study area, totalling 100 minutes observing the intervention and 100 minutes of control observations (200 minutes in total) for each study area. The intervention and control observations were carried out sequentially, the order of the observations was randomised for each session and the timing of both sessions was within the same hour of the day.The methodology resulted in five design interventions.The CareCentre™ is a unit placed at the end of the hospital bed, containing all the necessary equipment for common healthcare processes. It is intended to streamline staff workflow and improve access to equipment. It contains aprons and gloves, a medication locker, a flat surface for writing, a folder holder, alcohol hand gel, a clinical waste bin and cleaning wipes.A simple symbol to denote hand hygiene, taking cues from construction safety signage, replaces the often ignored and confusing plethora of signage currently surrounding the alcohol hand gel dispensers.A new handover environment features stowable seating, a fold away table, adjustable light levels and a ‘do not disturb’ sign. As space is at a premium, the design allows the room to be used as a staff room when handover is not in progress.The vital signs measuring trolley was redesigned to feature an improved cable management system (making it much easier to clean), and a touch screen to automatically record the patient's vital signs and display them on a chart.Finally, a new concept in blister pack design gives all the important information about the drug displayed in a clear, patient friendly way. The shape also helps with oral administration.In the clinical trial of the CareCentre™, 546 WHO hand hygiene opportunities were observed. With the CareCentre™, staff compliance with correct protocol was 54%, compared to 16% without (p < 0.001). 99 opportunities for the use of fresh gloves and disposal of used gloves at the bedside were observed. With the CareCentre™, 82% of staff adhered to correct protocol and 25% adhered without (p < 0.001). 26 opportunities for the use of fresh aprons and disposal of used aprons at the bedside were observed. Adherence was 67% with the CareCentre™ and 0% without (p < 0.032).The results of the methodology led to two sets of conclusions.Firstly, the subsequent designs were linked directly to the initial clinical research, and represent conclusions in themselves. The five designs have been displayed to clinical front line users and have formed a travelling exhibition at three venues across the UK. User feedback has been positive, and the project has won two international design awards (Core 77 Strategy and Research Pro Runner-up, International Design and Health Academy Award—Research category winner).Beyond the subjective validation of the designs, the clinical trial gave insight into the behavioral changes engendered by the newly designed CareCentre™. The results of this study showed that the design is associated with improved adherence to hand hygiene guidelines and correct use of gloves, aprons and documents. As a consequence, the implementation of the CareCentre™ will help reduce healthcare associated infections. These results show that the design has achieved what the brief intended. The other designs were not subject to the same levels of trial, but were produced using the same methodology.Secondly, the results are a validation of the design methodology. The collaboration at the heart of the DOME project was aimed at improving patient safety and quality through design, and the results show that the concepts have a tangible effect on user behavior.It was only by considering all the actions at the bedside simultaneously that the CareCentre™ was conceived. Whilst the initial brief concerned infection control precautions, the design has an impact on document review, medication and handover. This was the merit of considering multiple briefs (surrounding the five riskiest processes) concurrently, and viewing the problem of medical error from the different standpoints of different disciplines.The DOME methodology was intended to differ from the traditional method of medical design and development. This may be likened to a relay race of poorly connected team members. Clinicians pass the baton of research on to the designers, who in turn pass it on as a design concept to manufacturers. Each leg is run in isolation, and the result is that when the designs finally arrive back in the clinical environment, it is often not what was required.The DOME methodology can be likened to a rowing boat, where all team members are involved in every stage of the process. When the team is in the research phase, the clinical members lead and the others learn. In the design phase, the designers lead, but involve the clinical partners in the co-creation process, and so on.This methodology now has a sound evidence base proving that this approach can result in designs that reduce medical error.