The SIxPeNCe Study
Research type
Research Study
Full title
STANDARD INFUSIONS IN PAEDIATRIC & NEONATAL CARE - NEXT STEPS (SIxPeNCe): A Prospective Qualitative Multi-centre Human Factors Study
IRAS ID
327717
Contact name
Adam B Sutherland
Contact email
Sponsor organisation
University of Bradford
Duration of Study in the UK
1 years, 0 months, 30 days
Research summary
Research Summary:
Currently doctors and nurse prescribe and administer infusions for children using weight based formulas. This approach has been linked to medication errors, delays in treatment and unexpected outcomes. The NHS wants to move to ready-to-use injectable medicines which in children's practice will mean changing to standard concentration infusions. This means changing a system of work that has existed for over fifty years and is embedded in practice. Some specialist centres have already made the change, and have used complex
devices like electronic prescribing and intelligent infusion pumps to support the roll out. However, these aren't universally available, or that useful in smaller hospitals where infusions for children and young people are rare.This research project wants to explore how changes in the way doctors and nurses prescribe and make up infusions might affect patient care, and develop some low-technology interventions to help support these new infusions in all parts of the NHS
Summary of Results:
Introduction Prescribing, preparing and administering intravenous medicines are high risk, complex processes that result in potentially severe patient harm in between 0.1 and 0.5% of administrations. A contributory factor to these harms in children is the persistence of bespoke weight-based infusion concentrations. The NHS wants to move to Standard Concentration Infusions (StdCs) to improve safety, efficiency and effectiveness of care. The evidence of StdCs comes from large tertiary children’s hospitals, but how these are rolled out in practice is unclear.
This study aimed to generate recommendations for implementation that could be used in childrens wards outside of big children hospital.Methods
We ran three projects.
Project 1 reviewed the literature on StdCs, how they were implemented, where and how they were measured.
Project 2 used interviews and observations to explore how doctors and nurses prescribed and prepared infusions. We compared rules and procedures with actual practice in both live and simulated infusions and spoke to doctors and nurses to find out why they were different and what their perceptions of the process was. We used a Human Factors method called FRAM to identify the parts of the process that had the most variation (that is, could be done in many different ways). All this information was then used to make a process model for how StdCs worked in terms of long term and short term outcomes, and we developed and a low-tech process to support safe IV infusion prescribing, preparation and administration.
In project 3 we used this process in a simulation to see how it affected the task.Results
In project 1 included 37 studies. Most papers were in paediatric or neonatal intensive care. 34/37 studies were set in America, Australia or Europe. 17 studies used special infusion pumps, and the rest used electronic patient records to prescribe them. 10 studies used nothing. There were no clinical trials and only 8 papers described HOW the StdCs were rolled out in practice. The rest just reported "We did this..." but with no information on how.
In project 2 we watched 13 infusions involving 44 doctors and nurses. We also spoke to 10 of these people (3 nurses, 5 consultants, 1 resident doctor and 1 pharmacist.) The process to prescribe, prepare and administer an infusion involved 25 different actions. 9 of these were "critical" - that is they HAD to be done, and were done very differently between people. We found that equipment wasn't defined as part of the task, so everyone measured volumes differently. Infusions were really rare in these hospitals, so noone was really familiar with what to do. They used a lot of guidelines and internet resources, but these are all in different places and said different things. We also saw that prescribing and preparation happened at the same time (when prescribing was supposed to happen before preparation.) This happened because doctors were unsure what they were doing, and needed nurses to help them, but nurses also had to make the infusion, so it was to save time and get them working together.
Doctors and nurses wanted a “simple” process that everyone could refer to. Therefore, we developed a paper intervention.
Project 3 used the data from project 2 to develop an picture of how the process ran, and we used this to develop a paper form that told people what to prescribe, what equipment to use and how to make it up. We tested this in a simulation with two doctors and two nurses. By having all the information in one place, people followed the instructions and did what they were told. This reduced the time of the process by 15%, but the individual tasks within the process were much quicker, with less stopping to ask questions. The people we studied liked the interactivity and clarity of the tool, and it brought all operators together. Some parts of the tool need revising though. In real life children often require several infusions, and it needs to capture that.Conclusion
The evidence supporting StdCs being used with pumps and electronic records isn't very clear, and might be used as a delay to rolling out. It is clear from previous research that they do make services more efficient and equitable. plemented safely is not well described. Our observations and intervies lead us to think that the issues around StdCs are around understanding and experience. Therefore, we need to give doctors and nurses clear guidelines on what to do, when and how.
Our simulation proved that the concept worked, improving the efficiency of the process, but further work is needed to develop a system that will work in real life. We also believe that our intervention identified the important safety critical aspects of the process, so can be used in emergency situations. More work is needed to develop this so that it can be introduced in practice.REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
24/YH/0105
Date of REC Opinion
25 Jun 2024
REC opinion
Further Information Favourable Opinion