Health informatics (HI) innovations in randomised trials and clinical cohorts - Identification, screening, stratified care and data collection during primary care consultations

Wathall, Simon; Foster, Nadine; Hill, Jonathan; Konstantinou, Kika; Lawton, Sarah; Muller, Sara

Abstract

Introduction: Recruitment and retention of participants remain the main challenges for clinical research, particularly for primary care studies undertaken at point-of-care where consultation time is pressured. The Health Informatics (HI) team at Keele Clinical Trials Unit (CTU) has developed tools which are embedded into GP clinical IT systems, to facilitate the conduct of trials and cohort studies in real-time GP consultations.

Methods: HI clinical system protocols were developed to efficiently utilise patients’ electronic primary care medical record to automate processes such as patient identification and eligibility screening whilst remaining as unobtrusive as possible for the clinician end-user. Protocols and templates are developed to embed stratified care tools into the consultation to guide treatment decision-making, and automate coding of patient eligibility, consent and outcome/trial data into patients’ primary care records.

Results: Automated coding facilitates efficient and accurate data recording for a number of clinical research studies. Regular audits allow
the level of GP engagement and efficiency with recruitment and the
study intervention to be assessed. Three exemplar studies will be
presented, all of which had bespoke point-of-care HI templates that
have facilitated research delivery in busy GP consultations. Arthritis Research UK funded PMR Cohort Study (Polymyalgia Rheumatica – a low incidence condition): 386 GP practices, suitable for invitation n=739 NIHR HTA funded SCOPiC Trial (SCiatica Outcomes in Primary Care): 42 GP practices, HI protocol fires n=19,375, eligible n=3,963, suitable for invitation n=2,677 NIHR PGfAR funded STarT MSK Pilot trial: 8 GP practices, HI protocol fires n=3,063, eligible n=1,653, suitable for invitation n=1255.

Discussion: Utilising GP clinical IT systems to embed HI research templates has resulted in efficient recruitment to randomised trials and cohort studies. Consideration needs to be given to clinical coding,
training of clinical end-users, consultation styles and auditing system
usage behaviour to ensure these HI solutions are successful.

Citation

Wathall, S., Foster, N., Hill, J., Konstantinou, K., Lawton, S., & Muller, S. (2019, October). Health informatics (HI) innovations in randomised trials and clinical cohorts - Identification, screening, stratified care and data collection during primary care consultations. Paper presented at 5th International Clinical Trials Methodology Conference (ICTMC 2019), Brighton, England, UK

• Presentation Conference Type: Conference Paper (unpublished)
• Conference Name: 5th International Clinical Trials Methodology Conference (ICTMC 2019)
• Conference Location: Brighton, England, UK
• Start Date: Oct 6, 2019
• End Date: Oct 9, 2019
• Deposit Date: Jun 23, 2023
• Publisher URL: https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-019-3688-6