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
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...
| Main Authors: | , , , , , , , , , , , , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
BMC
2023-12-01
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| Series: | Implementation Science |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s13012-023-01321-z |
| _version_ | 1827590436031561728 |
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| author | Ben Ainsworth Jeremy Horwood Scott R. Walter Sascha Miller Melanie Chalder Frank De Vocht James Denison-Day Martha M. C. Elwenspoek Helen J. Curtis Chris Bates Amir Mehrkar Seb Bacon Ben Goldacre The OpenSAFELY Collaborative Pippa Craggs Richard Amlôt Nick Francis Paul Little John Macleod Michael Moore Kate Morton Cathy Rice Jonathan Sterne Beth Stuart Lauren Towler Merlin L. Willcox Lucy Yardley |
| author_facet | Ben Ainsworth Jeremy Horwood Scott R. Walter Sascha Miller Melanie Chalder Frank De Vocht James Denison-Day Martha M. C. Elwenspoek Helen J. Curtis Chris Bates Amir Mehrkar Seb Bacon Ben Goldacre The OpenSAFELY Collaborative Pippa Craggs Richard Amlôt Nick Francis Paul Little John Macleod Michael Moore Kate Morton Cathy Rice Jonathan Sterne Beth Stuart Lauren Towler Merlin L. Willcox Lucy Yardley |
| author_sort | Ben Ainsworth |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-03-09T01:16:49Z |
| format | Article |
| id | doaj.art-b4cdb07d7a8548fa9e7d0eb16f55da29 |
| institution | Directory Open Access Journal |
| issn | 1748-5908 |
| language | English |
| last_indexed | 2024-03-09T01:16:49Z |
| publishDate | 2023-12-01 |
| publisher | BMC |
| record_format | Article |
| series | Implementation Science |
| spelling | doaj.art-b4cdb07d7a8548fa9e7d0eb16f55da292023-12-10T12:26:59ZengBMCImplementation Science1748-59082023-12-0118111310.1186/s13012-023-01321-zImplementing 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 platformBen Ainsworth0Jeremy Horwood1Scott R. Walter2Sascha Miller3Melanie Chalder4Frank De Vocht5James Denison-Day6Martha M. C. Elwenspoek7Helen J. Curtis8Chris Bates9Amir Mehrkar10Seb Bacon11Ben Goldacre12The OpenSAFELY CollaborativePippa Craggs13Richard Amlôt14Nick Francis15Paul Little16John Macleod17Michael Moore18Kate Morton19Cathy Rice20Jonathan Sterne21Beth Stuart22Lauren Towler23Merlin L. Willcox24Lucy Yardley25School of Psychology, University of SouthamptonNIHR Applied Research Collaboration West (NIHR ARC West), University Hospitals Bristol and Weston NHS Foundation TrustNIHR Applied Research Collaboration West (NIHR ARC West), University Hospitals Bristol and Weston NHS Foundation TrustSchool of Psychology, University of SouthamptonCentre for Academic Primary Care (CAPC), Bristol Medical School, Population Health Sciences, University of BristolNIHR Applied Research Collaboration West (NIHR ARC West), University Hospitals Bristol and Weston NHS Foundation TrustSchool of Psychology, University of SouthamptonNIHR Applied Research Collaboration West (NIHR ARC West), University Hospitals Bristol and Weston NHS Foundation TrustNuffield Department of Primary Care Health Sciences, The Bennett Institute for Applied Data Science, University of OxfordTPPNuffield Department of Primary Care Health Sciences, The Bennett Institute for Applied Data Science, University of OxfordNuffield Department of Primary Care Health Sciences, The Bennett Institute for Applied Data Science, University of OxfordNuffield Department of Primary Care Health Sciences, The Bennett Institute for Applied Data Science, University of OxfordNIHR Applied Research Collaboration West (NIHR ARC West), University Hospitals Bristol and Weston NHS Foundation TrustNIHR Applied Research Collaboration West (NIHR ARC West), University Hospitals Bristol and Weston NHS Foundation TrustFaculty of Medicine, University of SouthamptonFaculty of Medicine, University of SouthamptonNIHR Applied Research Collaboration West (NIHR ARC West), University Hospitals Bristol and Weston NHS Foundation TrustFaculty of Medicine, University of SouthamptonSchool of Psychology, University of SouthamptonPublic ContributorCentre for Academic Primary Care (CAPC), Bristol Medical School, Population Health Sciences, University of BristolFaculty of Medicine and Dentistry, Wolfson Institute of Population Health, Queen Mary University of LondonSchool of Psychology, University of SouthamptonFaculty of Medicine, University of SouthamptonSchool of Psychology, University of SouthamptonAbstract 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.https://doi.org/10.1186/s13012-023-01321-zRespiratory tract infectionsPrimary careCOVID-19Behaviour changeDigital medicineeHealth |
| spellingShingle | Ben Ainsworth Jeremy Horwood Scott R. Walter Sascha Miller Melanie Chalder Frank De Vocht James Denison-Day Martha M. C. Elwenspoek Helen J. Curtis Chris Bates Amir Mehrkar Seb Bacon Ben Goldacre The OpenSAFELY Collaborative Pippa Craggs Richard Amlôt Nick Francis Paul Little John Macleod Michael Moore Kate Morton Cathy Rice Jonathan Sterne Beth Stuart Lauren Towler Merlin L. Willcox Lucy Yardley 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 Respiratory tract infections Primary care COVID-19 Behaviour change Digital medicine eHealth |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | Respiratory tract infections Primary care COVID-19 Behaviour change Digital medicine eHealth |
| url | https://doi.org/10.1186/s13012-023-01321-z |
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