Utilising primary care electronic health records to deliver the ALABAMA randomised controlled trial of penicillin allergy assessment

• Published in: Current controlled trials in cardiovascular medicine 2024-10, Vol.25 (1), p.653-10, Article 653
• Main Authors: Ahmed, Shadia, Fielding, Joanne, Porter, Catherine E, Armitage, Kelsey F, Wanat, Marta, Bates, Chris, Engonidou, Lazarina, West, Robert M, Yu, Ly-Mee, Galal, Ushma, Howard, Philip, Butler, Christopher C, Savic, Sinisa, Boards, Jenny, Tonkin-Crine, Sarah, Parry, John, Pavitt, Sue A, Sandoe, Jonathan T
• Format: Article
• Language: English
• Subjects: Alabama; Allergic reaction; Allergy; Anti-Bacterial Agents - administration & dosage; Anti-Bacterial Agents - adverse effects; Anti-Bacterial Agents - therapeutic use; Antibiotics; Clinical trials; Co-design; Collaboration; Cost benefit analysis; Data collection; Data entry; Drug Hypersensitivity - diagnosis; Drug resistance in microorganisms; EHR; Electronic health record; Electronic Health Records; Electronic records; Health risk assessment; Humans; Information storage and retrieval; Medical care; Medical records; Meetings; Participation; Patients; Penicillin; Penicillin allergy; Penicillins - adverse effects; Primary care; Primary Health Care; Randomized Controlled Trials as Topic; Side effects; SystmOne; TPP; Utilization
• ISSN: 1745-6215; 1745-6215
• DOI: 10.1186/s13063-024-08506-x

Use of electronic health records (EHR) to provide real-world data for research is established, but using EHR to deliver randomised controlled trials (RCTs) more efficiently is less developed. The Allergy AntiBiotics And Microbial resistAnce (ALABAMA) RCT evaluated a penicillin allergy assessment pathway versus usual clinical care in a UK primary care setting. The aim of this paper is to describe how EHRs were used to facilitate efficient delivery of a large-scale randomised trial of a complex intervention embracing efficient participant identification, supporting minimising GP workload, providing accurate post-intervention EHR updates of allergy status, and facilitating participant follow up and outcome data collection. The generalisability of the EHR approach and health economic implications of EHR in clinical trials will be reported in the main ALABAMA trial cost-effectiveness analysis. A descriptive account of the adaptation of functionality within SystmOne used to deliver/facilitate multiple trial processes from participant identification to outcome data collection. An ALABAMA organisation group within SystmOne was established which allowed sharing of trial functions/materials developed centrally by the research team. The 'ALABAMA unit' within SystmOne was also created and provided a secure efficient environment to access participants' EHR data. Processes of referring consented participants, allocating them to a trial arm, and assigning specific functions to the intervention arm were developed by adapting tools such as templates, reports, and protocols which were already available in SystmOne as well as pathways to facilitate allergy de-labelling processes and data retrieval for trial outcome analysis. ALABAMA is one of the first RCTs to utilise SystmOne EHR functionality and data across the RCT delivery, demonstrating feasibility and applicability to other primary care RCTs. ClinicalTrials.gov: NCT04108637, registered 05/03/2019. ISRCTN: ISRCTN20579216.