Clinical trial NCT05493072: RxConnect User Testing Study
Official title: Safety, Performance, and User Perceptions of RxConnect When Used to Provide Patient-specific, Indication Based Prescribing Support
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Behavior
Keywords: Medication safety
Prescribing practice
Prescribing behaviour
Lead sponsor: Imperial College London
Sponsor class: OTHER
Collaborators: name: National Institute for Health Research, United Kingdom
First posted: 2022-08-09
Enrollment: 24
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Background

Medication errors are the leading cause of preventable harm in healthcare settings worldwide. An estimated 237 million medication errors occur in England alone every year, with 66 million considered clinically significant. There is an estimated cost to the NHS from definitely avoidable adverse drug reactions as a result of these errors of £98.5 million per year, consuming 181,626 bed-days and causing to 712 deaths.

Medication related clinical decision support systems, often integrated with electronic prescribing systems, are rapidly increasing in number over the last few decades, ranging from drug-drug interaction alerts to allergy checks and formulary support. A recent systematic review summarised that these systems are still relatively immature, with limited use of patient-specific input or human factors research used to develop them. There is an opportunity to improve these systems significantly for the benefit of the user and for patient safety. The World Health Organization propose that interventions to reduce medication error should include the development of technologies that are well understood and designed for the systems and practice they are applied to.

Human factors and usability engineering is an integral part of developing medical devices, such as clinical decision support (CDS) systems, to ensure that such devices are easy to use and can be used safely as intended. User testing / usability testing, which may incorporate several methods, should be conductive throughout the development process (at formative, summative assessment, and during post-market surveillance). These methods are now becoming more common place in healthcare technology research and should continue to support the development of new technologies.

RxConnect

RxConnect, a newly registered UKCA marked medical device, is an on-demand clinical decision support tool that receives medication and patient inputs and uses them to filter an underlying formulary, such as the BNF, and perform dosing calculations, as needed, to return patient-specific dosing recommendations. RxConnect does not have a user interface and relies on an integration with third-party systems, such as electronic prescribing systems, to deliver CDS services to clinical end users. For this study a prototype user interface for RxConnect that emulates a typical electronic prescribing system will be used.

The study team hypothesise that use of RxConnect as a digital prescribing aid is quicker, easier, and as safe to use as currently available prescribing aids. This study aims to utilise user testing to prove or disprove the above hypothesis and to generate quantitative and qualitative outputs to support the continued development of RxConnect prior to clinical deployment.


Eligibility criteria: Inclusion Criteria:

* Willingness to consent and participate
* Medical doctor - Foundation year 1 and above OR registered non-medical prescriber (e.g. nurses or pharmacists)
* Regular (at least weekly) experience in prescribing medications as part of working role

Exclusion Criteria:

* Infrequent prescribing practice (less than once a week)
* Not willing to participate

Primary outcomes:
measure: Number of Prescribing Errors by Study Arm
timeFrame: 60 minutes
Secondary outcomes:
measure: Number of Medication Orders With a Large Magnitude Error (Greater Than 25% of the Recommended Dosing Range)
timeFrame: 60 minutes
measure: Time Taken to Prescribe Each Medication
timeFrame: 60 minutes
measure: Measurement of the Prescribers Perceived Mental Load Per Prescribing Scenario
timeFrame: 60 minutes
Other outcomes:
measure: Erroneous Medication Orders by Hierarchial Task Analysis (Identifying Vulnerable Steps in the Prescribing Workflow).
timeFrame: 60 minutes
measure: Number of Participants That Gave Qualitative Feedback
timeFrame: 60 minutes
Locations:
city: London
country: United Kingdom
facility: Imperial College NHS Healthcare Trust
Study officials:
References:
citation: Donaldson LJ, Kelley ET, Dhingra-Kumar N, Kieny MP, Sheikh A. Medication Without Harm: WHO's Third Global Patient Safety Challenge. Lancet. 2017 Apr 29;389(10080):1680-1681. doi: 10.1016/S0140-6736(17)31047-4. No abstract available.
citation: MHRA. Guidance on applying human factors and usability engineering of medical devices including drug-device combination products in Great Britain. 2021;(January):35. Available from: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/970563/Human-Factors_Medical-Devices_v2.0.pdf
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citation: Elliott RA, Camacho E, Jankovic D, Sculpher MJ, Faria R. Economic analysis of the prevalence and clinical and economic burden of medication error in England. BMJ Qual Saf. 2021 Feb;30(2):96-105. doi: 10.1136/bmjqs-2019-010206. Epub 2020 Jun 11.
citation: Tolley CL, Slight SP, Husband AK, Watson N, Bates DW. Improving medication-related clinical decision support. Am J Health Syst Pharm. 2018 Feb 15;75(4):239-246. doi: 10.2146/ajhp160830.
citation: Aufegger L, Serou N, Chen S, Franklin BD. Evaluating users' experiences of electronic prescribing systems in relation to patient safety: a mixed methods study. BMC Med Inform Decis Mak. 2020 Apr 3;20(1):62. doi: 10.1186/s12911-020-1080-9.