RxConnect User Testing Study

NCT ID: NCT05493072

Last Updated: 2025-03-24

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-12

Study Completion Date

2023-03-30

Brief Summary

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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.

Detailed Description

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Conditions

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Behavior

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Control

Observation of control arm practice for 5 medication scenarios

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention

Observation of intervention practice for 5 medication scenarios

Group Type EXPERIMENTAL

RxConnect

Intervention Type OTHER

Participants use RxConnect, 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.

Interventions

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RxConnect

Participants use RxConnect, 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.

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute for Health Research, United Kingdom

OTHER_GOV

Sponsor Role collaborator

Imperial College London

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Imperial College NHS Healthcare Trust

London, , United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type BACKGROUND
PMID: 28463129 (View on PubMed)

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

Reference Type BACKGROUND

Holden RJ, Abebe E, Russ-Jara AL, Chui MA. Human factors and ergonomics methods for pharmacy research and clinical practice. Res Social Adm Pharm. 2021 Dec;17(12):2019-2027. doi: 10.1016/j.sapharm.2021.04.024. Epub 2021 May 2.

Reference Type BACKGROUND
PMID: 33985892 (View on PubMed)

Novak LL, Holden RJ, Anders SH, Hong JY, Karsh BT. Using a sociotechnical framework to understand adaptations in health IT implementation. Int J Med Inform. 2013 Dec;82(12):e331-44. doi: 10.1016/j.ijmedinf.2013.01.009. Epub 2013 Apr 3.

Reference Type BACKGROUND
PMID: 23562140 (View on PubMed)

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.

Reference Type RESULT
PMID: 32527980 (View on PubMed)

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.

Reference Type RESULT
PMID: 29436470 (View on PubMed)

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.

Reference Type RESULT
PMID: 32245467 (View on PubMed)

Feather C, Clarke J, Appelbaum N, Darzi A, Franklin BD. Comparing safety, performance and user perceptions of a patient-specific indication-based prescribing tool with current practice: a mixed methods randomised user testing study. BMJ Qual Saf. 2024 Nov 21:bmjqs-2024-017733. doi: 10.1136/bmjqs-2024-017733. Online ahead of print.

Reference Type DERIVED
PMID: 39577867 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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22CX7758

Identifier Type: -

Identifier Source: org_study_id

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