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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

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
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
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.
Behaviour change, COVID-19, Digital medicine, Efficient trial design, Infection control, Primary care, RCT, Respiratory tract infections, eHealth
1748-5908
67
Ainsworth, Ben
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Horwood, Jeremy
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Walter, Scott R.
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Miller, Sascha
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Chalder, Melanie
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De Vocht, Frank
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Denison-Day, James
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Elwenspoek, Martha M.C.
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Curtis, Helen J.
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Bates, Chris
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Mehrkar, Amir
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Bacon, Seb
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Goldacre, Ben
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Amlôt, Richard
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Francis, Nick
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Little, Paul
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Moore, Michael
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Morton, Kate
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Rice, Cathy
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Sterne, Jonathan
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Stuart, Beth
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Towler, Lauren
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Willcox, Merlin L.
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Yardley, Lucy
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The OpenSAFELY Collaborative
Ainsworth, Ben
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Horwood, Jeremy
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Walter, Scott R.
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Miller, Sascha
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Chalder, Melanie
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De Vocht, Frank
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Denison-Day, James
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Elwenspoek, Martha M.C.
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Curtis, Helen J.
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Bates, Chris
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Mehrkar, Amir
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Bacon, Seb
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Goldacre, Ben
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Amlôt, Richard
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Francis, Nick
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Little, Paul
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Moore, Michael
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Morton, Kate
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Rice, Cathy
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Sterne, Jonathan
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Stuart, Beth
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Towler, Lauren
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Willcox, Merlin L.
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Yardley, Lucy
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Curtis, Helen J., Amlôt, Richard, Rice, Cathy and Sterne, Jonathan , The OpenSAFELY Collaborative (2023) 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. Implementation Science, 18 (1), 67, [67]. (doi:10.1186/s13012-023-01321-z).

Record type: Article

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.

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Accepted/In Press date: 15 November 2023
Published date: 4 December 2023
Additional Information: Publisher Copyright: © 2023. The Author(s).
Keywords: Behaviour change, COVID-19, Digital medicine, Efficient trial design, Infection control, Primary care, RCT, Respiratory tract infections, eHealth

Identifiers

Local EPrints ID: 485553
URI: http://eprints.soton.ac.uk/id/eprint/485553
ISSN: 1748-5908
PURE UUID: bd900835-3a12-4d94-b695-4cc7a82358df
ORCID for Ben Ainsworth: ORCID iD orcid.org/0000-0002-5098-1092
ORCID for Sascha Miller: ORCID iD orcid.org/0000-0002-1949-5774
ORCID for James Denison-Day: ORCID iD orcid.org/0000-0003-0223-0005
ORCID for Nick Francis: ORCID iD orcid.org/0000-0001-8939-7312
ORCID for Paul Little: ORCID iD orcid.org/0000-0003-3664-1873
ORCID for Michael Moore: ORCID iD orcid.org/0000-0002-5127-4509
ORCID for Kate Morton: ORCID iD orcid.org/0000-0002-6674-0314
ORCID for Beth Stuart: ORCID iD orcid.org/0000-0001-5432-7437
ORCID for Lauren Towler: ORCID iD orcid.org/0000-0002-6597-0927
ORCID for Merlin L. Willcox: ORCID iD orcid.org/0000-0002-5227-3444
ORCID for Lucy Yardley: ORCID iD orcid.org/0000-0002-3853-883X

Catalogue record

Date deposited: 08 Dec 2023 17:57
Last modified: 30 Nov 2024 03:03

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Contributors

Author: Ben Ainsworth ORCID iD
Author: Jeremy Horwood
Author: Scott R. Walter
Author: Sascha Miller ORCID iD
Author: Melanie Chalder
Author: Frank De Vocht
Author: Martha M.C. Elwenspoek
Author: Helen J. Curtis
Author: Chris Bates
Author: Amir Mehrkar
Author: Seb Bacon
Author: Ben Goldacre
Author: Richard Amlôt
Author: Nick Francis ORCID iD
Author: Paul Little ORCID iD
Author: Michael Moore ORCID iD
Author: Kate Morton ORCID iD
Author: Cathy Rice
Author: Jonathan Sterne
Author: Beth Stuart ORCID iD
Author: Lauren Towler ORCID iD
Author: Lucy Yardley ORCID iD
Corporate Author: The OpenSAFELY Collaborative

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