Evidence map›Paper›PMID 38049846›Full record

Trial reportImplementation science : IS2023

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.

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 and 17 more

Open access · goldAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Implementation science : IS, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
1.2field-weighted citation impact, top 19% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 6 citations in OpenAlex.

  1. Article
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

27 authors at 6 institutions in 1 country.

Ben Ainsworth *School of Psychology, University of Southampton, Southampton, UK.
Jeremy Horwood *NIHR Applied Research Collaboration West (NIHR ARC West), University Hospitals Bristol and Weston NHS Foundation Trust, Bristol, UK. j.horwood@bristol.ac.uk.ORCID 0000-0001-7092-4960
Scott R WalterNIHR Applied Research Collaboration West (NIHR ARC West), University Hospitals Bristol and Weston NHS Foundation Trust, Bristol, UK.
Sascha MillerSchool of Psychology, University of Southampton, Southampton, UK.
Melanie ChalderCentre for Academic Primary Care (CAPC), Bristol Medical School, Population Health Sciences, University of Bristol, Bristol, UK.
Frank De VochtNIHR Applied Research Collaboration West (NIHR ARC West), University Hospitals Bristol and Weston NHS Foundation Trust, Bristol, UK.
James Denison-DaySchool of Psychology, University of Southampton, Southampton, UK.
Martha M C ElwenspoekNIHR Applied Research Collaboration West (NIHR ARC West), University Hospitals Bristol and Weston NHS Foundation Trust, Bristol, UK.
Helen J CurtisNuffield Department of Primary Care Health Sciences, The Bennett Institute for Applied Data Science, University of Oxford, Oxford, UK.
Chris BatesTPP, Leeds, UK.
Amir MehrkarNuffield Department of Primary Care Health Sciences, The Bennett Institute for Applied Data Science, University of Oxford, Oxford, UK.
Seb BaconNuffield Department of Primary Care Health Sciences, The Bennett Institute for Applied Data Science, University of Oxford, Oxford, UK.
Ben GoldacreNuffield Department of Primary Care Health Sciences, The Bennett Institute for Applied Data Science, University of Oxford, Oxford, UK.
OpenSAFELY Collaborative
Pippa CraggsNIHR Applied Research Collaboration West (NIHR ARC West), University Hospitals Bristol and Weston NHS Foundation Trust, Bristol, UK.
Richard AmlôtNIHR Applied Research Collaboration West (NIHR ARC West), University Hospitals Bristol and Weston NHS Foundation Trust, Bristol, UK.
Nick FrancisFaculty of Medicine, University of Southampton, Southampton, UK.
Paul LittleFaculty of Medicine, University of Southampton, Southampton, UK.
John MacleodNIHR Applied Research Collaboration West (NIHR ARC West), University Hospitals Bristol and Weston NHS Foundation Trust, Bristol, UK.
Michael MooreFaculty of Medicine, University of Southampton, Southampton, UK.
Kate MortonSchool of Psychology, University of Southampton, Southampton, UK.
Cathy RicePublic Contributor, Southampton, UK.
Jonathan SterneCentre for Academic Primary Care (CAPC), Bristol Medical School, Population Health Sciences, University of Bristol, Bristol, UK.
Beth StuartFaculty of Medicine and Dentistry, Wolfson Institute of Population Health, Queen Mary University of London, London, UK.
Lauren TowlerSchool of Psychology, University of Southampton, Southampton, UK.
Merlin L WillcoxFaculty of Medicine, University of Southampton, Southampton, UK.
Lucy YardleySchool of Psychology, University of Southampton, Southampton, UK.
University of Bristol · GBUniversity Hospitals Bristol NHS Foundation Trust · GBUniversity of Southampton · GBUniversity of Oxford · GBQueen Mary University of London · GBWPP (United Kingdom) · GB

Funding

Medical Research Council MC_PC_19068Medical Research Council MC_PC-20059Medical Research Council MR/V015737/1Medical Research Council MR/W016729/1Wellcome TrustWellcome Trust 222097/Z/20/Z
6 · The paper itself

Abstract

backgroundGerm 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.

methodsWith 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.

resultsGerm 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.

conclusionsWhile 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 registrationThis trial was registered in the ISRCTN registry (14602359) on 12 August 2020.

Indexed as

COVID-19General PracticeRespiratory Tract InfectionsAdultEnglandHumansPrimary Health CareBehaviour changeCOVID-19Digital medicineEfficient trial designeHealthInfection controlPrimary careRCTRespiratory tract infections

Identifiers

PMID38049846
PMCPMC10694966
OpenAlexW4389300457

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.