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Implementing Germ Defence digital behaviour change intervention via all primary care practices in England to reduce respiratory infections during the COVID-19 pandemic: an efficient cluster randomised controlled trial using the OpenSAFELY platform
Ainsworth, Ben Horwood, Jeremy Walter, Scott R Miller, Sascha Chalder, Melanie De Vocht, Frank Denison-Day, James Elwenspoek, Martha M C Curtis, Helen J Bates, Chris
Ainsworth, Ben
Horwood, Jeremy
Walter, Scott R
Miller, Sascha
Chalder, Melanie
De Vocht, Frank
Denison-Day, James
Elwenspoek, Martha M C
Curtis, Helen J
Bates, Chris
Abstract
Background: Germ Defence ( www.germdefence.org ) is an evidence-based interactive website that promotes behaviour change for infection control within households. To maximise the potential of Germ Defence to effectively reduce the spread of COVID-19, the intervention needed to be implemented at scale rapidly.
Methods: With NHS England approval, we conducted an efficient two-arm (1:1 ratio) cluster randomised controlled trial (RCT) to examine the effectiveness of randomising implementation of Germ Defence via general practitioner (GP) practices across England, UK, compared with usual care to disseminate Germ Defence to patients. GP practices randomised to the intervention arm (n = 3292) were emailed and asked to disseminate Germ Defence to all adult patients via mobile phone text, email or social media. Usual care arm GP practices (n = 3287) maintained standard management for the 4-month trial period and then asked to share Germ Defence with their adult patients. The primary outcome was the rate of GP presentations for respiratory tract infections (RTI) per patient. Secondary outcomes comprised rates of acute RTIs, confirmed COVID-19 diagnoses and suspected COVID-19 diagnoses, COVID-19 symptoms, gastrointestinal infection diagnoses, antibiotic usage and hospital admissions. The impact of the intervention on outcome rates was assessed using negative binomial regression modelling within the OpenSAFELY platform. The uptake of the intervention by GP practice and by patients was measured via website analytics.
Results: Germ Defence was used 310,731 times. The average website satisfaction score was 7.52 (0-10 not at all to very satisfied, N = 9933). There was no evidence of a difference in the rate of RTIs between intervention and control practices (rate ratio (RR) 1.01, 95% CI 0.96, 1.06, p = 0.70). This was similar to all other eight health outcomes. Patient engagement within intervention arm practices ranged from 0 to 48% of a practice list.
Conclusions: While the RCT did not demonstrate a difference in health outcomes, we demonstrated that rapid large-scale implementation of a digital behavioural intervention is possible and can be evaluated with a novel efficient prospective RCT methodology analysing routinely collected patient data entirely within a trusted research environment.
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Date
2023-12
Type
Article
Subject
Behaviour change, COVID-19, Digital medicine, Efficient trial design, Infection control, Primary care, RCT, Respiratory tract infections, eHealth
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Citation
Ainsworth B, Horwood J, Walter SR, Miller S, Chalder M, De Vocht F, Denison-Day J, Elwenspoek MMC, Curtis HJ, Bates C, Mehrkar A, Bacon S, Goldacre B; OpenSAFELY Collaborative; Craggs P, Amlôt R, Francis N, Little P, Macleod J, Moore M, Morton K, Rice C, Sterne J, Stuart B, Towler L, Willcox ML, Yardley L. Implementing Germ Defence digital behaviour change intervention via all primary care practices in England to reduce respiratory infections during the COVID-19 pandemic: an efficient cluster randomised controlled trial using the OpenSAFELY platform. Implement Sci. 2023 Dec 4;18(1):67. doi: 10.1186/s13012-023-01321-z. PMID: 38049846; PMCID: PMC10694966.
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This article relates to a research study that included patients or members of the workforce as study participants from GP practices in Nottingham and Nottinghamshire.
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