NDLI: 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

Content Provider	Springer Nature : BioMed Central
Author	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 Mehrkar, Amir Bacon, Seb Goldacre, Ben Craggs, Pippa Amlôt, Richard Francis, Nick Little, Paul Macleod, John Moore, Michael Morton, Kate Rice, Cathy Sterne, Jonathan Stuart, Beth Towler, Lauren Willcox, Merlin L. Yardley, Lucy
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. Trial registration This trial was registered in the ISRCTN registry (14602359) on 12 August 2020.
Related Links	https://implementationscience.biomedcentral.com/counter/pdf/10.1186/s13012-023-01321-z.pdf
Ending Page	13
Page Count	13
Starting Page	1
File Format	HTM / HTML
ISSN	17485908
DOI	10.1186/s13012-023-01321-z
Journal	Implementation Science
Issue Number	1
Volume Number	18
Language	English
Publisher	BioMed Central
Publisher Date	2023-12-04
Access Restriction	Open
Subject Keyword	Health Services Research Public Health Health Informatics Health Policy Health Administration Health Promotion and Disease Prevention Respiratory tract infections Primary care COVID-19 Behaviour change Digital medicine eHealth Infection control RCT Efficient trial design
Content Type	Text
Resource Type	Article
Subject	Health Policy Public Health, Environmental and Occupational Health Health Informatics
Journal Impact Factor	8.8/2023
5-Year Journal Impact Factor	9.2/2023

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1	Ministry of Education (GoI), Department of Higher Education	Sanctioning Authority	https://www.education.gov.in/ict-initiatives
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