Utilising primary care electronic health records to deliver the ALABAMA randomised controlled trial of penicillin allergy assessment
Background: 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 as...
| Main Authors: | , , , , , , , , , , , , , , , , , |
|---|---|
| Format: | Journal article |
| Language: | English |
| Published: |
BioMed Central
2024
|
| _version_ | 1826314726526681088 |
|---|---|
| author | Ahmed, S Fielding, J Porter, CE Armitage, KF Wanat, M Bates, C Engonidou, L West, RM Yu, L Galal, U Howard, P Butler, CC Savic, S Boards, J Tonkin-Crine, S Parry, J Pavitt, SA Sandoe, JT |
| author_facet | Ahmed, S Fielding, J Porter, CE Armitage, KF Wanat, M Bates, C Engonidou, L West, RM Yu, L Galal, U Howard, P Butler, CC Savic, S Boards, J Tonkin-Crine, S Parry, J Pavitt, SA Sandoe, JT |
| author_sort | Ahmed, S |
| collection | OXFORD |
| description | Background: 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. Methods: A descriptive account of the adaptation of functionality within SystmOne used to deliver/facilitate multiple trial processes from participant identification to outcome data collection. Results: 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. Conclusions: 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. Trial registration: ClinicalTrials.gov: NCT04108637, registered 05/03/2019. ISRCTN: ISRCTN20579216. |
| first_indexed | 2024-12-09T03:09:54Z |
| format | Journal article |
| id | oxford-uuid:8f9e2000-ae91-4c0d-9501-3c234a908e52 |
| institution | University of Oxford |
| language | English |
| last_indexed | 2024-12-09T03:09:54Z |
| publishDate | 2024 |
| publisher | BioMed Central |
| record_format | dspace |
| spelling | oxford-uuid:8f9e2000-ae91-4c0d-9501-3c234a908e522024-10-03T20:07:49ZUtilising primary care electronic health records to deliver the ALABAMA randomised controlled trial of penicillin allergy assessmentJournal articlehttp://purl.org/coar/resource_type/c_dcae04bcuuid:8f9e2000-ae91-4c0d-9501-3c234a908e52EnglishJisc Publications RouterBioMed Central2024Ahmed, SFielding, JPorter, CEArmitage, KFWanat, MBates, CEngonidou, LWest, RMYu, LGalal, UHoward, PButler, CCSavic, SBoards, JTonkin-Crine, SParry, JPavitt, SASandoe, JTBackground: 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. Methods: A descriptive account of the adaptation of functionality within SystmOne used to deliver/facilitate multiple trial processes from participant identification to outcome data collection. Results: 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. Conclusions: 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. Trial registration: ClinicalTrials.gov: NCT04108637, registered 05/03/2019. ISRCTN: ISRCTN20579216. |
| spellingShingle | Ahmed, S Fielding, J Porter, CE Armitage, KF Wanat, M Bates, C Engonidou, L West, RM Yu, L Galal, U Howard, P Butler, CC Savic, S Boards, J Tonkin-Crine, S Parry, J Pavitt, SA Sandoe, JT Utilising primary care electronic health records to deliver the ALABAMA randomised controlled trial of penicillin allergy assessment |
| title | Utilising primary care electronic health records to deliver the ALABAMA randomised controlled trial of penicillin allergy assessment |
| title_full | Utilising primary care electronic health records to deliver the ALABAMA randomised controlled trial of penicillin allergy assessment |
| title_fullStr | Utilising primary care electronic health records to deliver the ALABAMA randomised controlled trial of penicillin allergy assessment |
| title_full_unstemmed | Utilising primary care electronic health records to deliver the ALABAMA randomised controlled trial of penicillin allergy assessment |
| title_short | Utilising primary care electronic health records to deliver the ALABAMA randomised controlled trial of penicillin allergy assessment |
| title_sort | utilising primary care electronic health records to deliver the alabama randomised controlled trial of penicillin allergy assessment |
| work_keys_str_mv | AT ahmeds utilisingprimarycareelectronichealthrecordstodeliverthealabamarandomisedcontrolledtrialofpenicillinallergyassessment AT fieldingj utilisingprimarycareelectronichealthrecordstodeliverthealabamarandomisedcontrolledtrialofpenicillinallergyassessment AT porterce utilisingprimarycareelectronichealthrecordstodeliverthealabamarandomisedcontrolledtrialofpenicillinallergyassessment AT armitagekf utilisingprimarycareelectronichealthrecordstodeliverthealabamarandomisedcontrolledtrialofpenicillinallergyassessment AT wanatm utilisingprimarycareelectronichealthrecordstodeliverthealabamarandomisedcontrolledtrialofpenicillinallergyassessment AT batesc utilisingprimarycareelectronichealthrecordstodeliverthealabamarandomisedcontrolledtrialofpenicillinallergyassessment AT engonidoul utilisingprimarycareelectronichealthrecordstodeliverthealabamarandomisedcontrolledtrialofpenicillinallergyassessment AT westrm utilisingprimarycareelectronichealthrecordstodeliverthealabamarandomisedcontrolledtrialofpenicillinallergyassessment AT yul utilisingprimarycareelectronichealthrecordstodeliverthealabamarandomisedcontrolledtrialofpenicillinallergyassessment AT galalu utilisingprimarycareelectronichealthrecordstodeliverthealabamarandomisedcontrolledtrialofpenicillinallergyassessment AT howardp utilisingprimarycareelectronichealthrecordstodeliverthealabamarandomisedcontrolledtrialofpenicillinallergyassessment AT butlercc utilisingprimarycareelectronichealthrecordstodeliverthealabamarandomisedcontrolledtrialofpenicillinallergyassessment AT savics utilisingprimarycareelectronichealthrecordstodeliverthealabamarandomisedcontrolledtrialofpenicillinallergyassessment AT boardsj utilisingprimarycareelectronichealthrecordstodeliverthealabamarandomisedcontrolledtrialofpenicillinallergyassessment AT tonkincrines utilisingprimarycareelectronichealthrecordstodeliverthealabamarandomisedcontrolledtrialofpenicillinallergyassessment AT parryj utilisingprimarycareelectronichealthrecordstodeliverthealabamarandomisedcontrolledtrialofpenicillinallergyassessment AT pavittsa utilisingprimarycareelectronichealthrecordstodeliverthealabamarandomisedcontrolledtrialofpenicillinallergyassessment AT sandoejt utilisingprimarycareelectronichealthrecordstodeliverthealabamarandomisedcontrolledtrialofpenicillinallergyassessment |