A Web-Based Intervention (Germ Defence) to Increase Handwashing During a Pandemic: Process Evaluations of a Randomized Controlled Trial and Public Dissemination.

BACKGROUND: Washing hands helps prevent transmission of seasonal and pandemic respiratory viruses. In a randomized controlled trial (RCT) during the swine flu outbreak, participants with access to a fully automated, digital intervention promoting handwashing reported washing their hands more often and experienced fewer respiratory tract infections than those without access to the intervention. Based on these findings, the intervention was adapted, renamed as "Germ Defence," and a study was designed to assess the preliminary dissemination of the intervention to the general public to help prevent the spread of seasonal colds and flu. OBJECTIVE: This study compares the process evaluations of the RCT and Germ Defence dissemination to examine (1) how web-based research enrollment procedures affected those who used the intervention, (2) intervention usage in the 2 contexts, and (3) whether increased intentions to wash hands are replicated once disseminated. METHODS: The RCT ran between 2010 and 2012 recruiting participants offline from general practices, with restricted access to the intervention (N=9155). Germ Defence was disseminated as an open access website for use by the general public from 2016 to 2019 (N=624). The process evaluation plan was developed using Medical Research Council guidance and the framework for Analyzing and Measuring Usage and Engagement Data. Both interventions contained a goal-setting section where users self-reported current and intended handwashing behavior across 7 situations. RESULTS: During web-based enrolment, 54.3% (17,511/32,250) of the RCT participants dropped out of the study compared to 36.5% (358/982) of Germ Defence users. Having reached the start of the intervention, 93.8% (8586/9155) of RCT users completed the core section, whereas 65.1% (406/624) of Germ Defence users reached the same point. Users across both studies selected to increase their handwashing in 5 out of 7 situations, including before eating snacks (RCT mean difference 1.040, 95% CI 1.016-1.063; Germ Defence mean difference 0.949, 95% CI 0.766-1.132) and after blowing their nose, sneezing, or coughing (RCT mean difference 0.995, 95% CI 0.972-1.019; Germ Defence mean difference 0.842, 95% CI 0.675-1.008). CONCLUSIONS: By comparing the preliminary dissemination of Germ Defence to the RCT, we were able to examine the potential effects of the research procedures on uptake and attrition such as the sizeable dropout during the RCT enrolment procedure that may have led to a more motivated sample. The Germ Defence study highlighted the points of attrition within the intervention. Despite sample bias in the trial context, the intervention replicated increases in intentions to handwash when used "in the wild." This preliminary dissemination study informed the adaptation of the intervention for the COVID-19 health emergency, and it has now been disseminated globally. TRIAL REGISTRATION: ISRCTN Registry ISRCTN75058295; https://www.isrctn.com/ISRCTN75058295.

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.

A Digital Intervention for Respiratory Tract Infections (Internet Dr): Process Evaluation to Understand How to Support Self-care for Minor Ailments.

BACKGROUND: Approximately 57 million physician appointments annually in the United Kingdom are for minor ailments. These illnesses could be self-cared for, which would potentially lower patients' anxiety, increase their confidence, and be more convenient. In a randomized controlled trial of the Internet Dr digital intervention, patients with access to the intervention had fewer consultations for respiratory tract infections (RTIs). Having established intervention efficacy, further examination of trial data is required to understand how the intervention works. OBJECTIVE: This paper reports a process evaluation of Internet Dr usage by the intervention group. The evaluation aims to demonstrate how meaningful usage metrics (ie, interactions that are specific and relevant to the intervention) can be derived from the theoretical principles underlying the intervention, then applied to examine whether these interactions are effective in supporting self-care for RTIs, for whom, and at what time. METHODS: The Internet Dr trial recorded patients' characteristics and usage data over 24 weeks. At follow-up, users reported whether their levels of enablement to cope with their illness changed over the trial period. The Medical Research Council process evaluation guidance and checklists from the framework for Analyzing and Measuring Usage and Engagement Data were applied to structure research questions examining associations between usage and enablement. RESULTS: Viewing pages containing advice on caring for RTIs were identified as a meaningful metric for measuring intervention usage. Almost half of the users (616/1491, 42.31%) viewed at least one advice page, with most people (478/616, 77.6%) accessing them when they initially enrolled in the study. Users who viewed an advice page reported increased enablement to cope with their illness as a result of having participated in the study compared with users who did not (mean 2.12, SD 2.92 vs mean 1.65, SD 3.10; mean difference 0.469, 95% CI 0.082-0.856). The target population was users who had visited their general practitioners for an RTI in the year before the trial, and analyses revealed that this group was more likely to access advice pages (odds ratio 1.35, 95% CI 1.159-1.571; P<.001). CONCLUSIONS: The process evaluation identifies viewing advice pages as associated with increased enablement to self-care, even when accessed in the absence of a RTI, meaning that dissemination activities need not be restricted to targeting users who are ill. The intervention was effective at reaching the target population of users who had previously consulted their general practitioners. However, attrition before reaching advice pages was high, highlighting the necessity of prioritizing access during the design phase. These findings provide guidance on how the intervention may be improved and disseminated and have wider implications for minor ailment interventions.

Infection control in the home: a qualitative study exploring perceptions and experiences of adhering to protective behaviours in the home during the COVID-19 pandemic.

OBJECTIVES: We sought to explore people's experiences and perceptions of implementing infection control behaviours in the home during the COVID-19 pandemic, guided by an online behavioural intervention. DESIGN: Inductive qualitative study. SETTING: UK public during the COVID-19 pandemic. PARTICIPANTS: Thirteen people took part in telephone interviews, and 124 completed a qualitative open-text survey. All were recruited from the public. Most survey participants were aged over 60 years, while interview participants were more distributed in age. Most reported being at increased risk from COVID-19, and were white British. INTERVENTION: Online behavioural intervention to support infection control behaviours in the home during the COVID-19 pandemic. DATA COLLECTION: Telephone think-aloud interviews and qualitative survey data. DATA ANALYSIS: The think-aloud interview data and qualitative survey data were analysed independently using inductive thematic analysis. The findings were subsequently triangulated. RESULTS: Thematic analysis of the telephone interviews generated seven themes: perceived risk; belief in the effectiveness of protective behaviours; acceptability of distancing and isolation; having capacity to perform the behaviours; habit forming reduces effort; having the confidence to perform the behaviours; and social norms affect motivation to engage in the behaviours. The themes identified from the survey data mapped well onto the interview analysis. Isolating and social distancing at home were less acceptable than cleaning and handwashing, influenced by the need for intimacy with household members. This was especially true in the absence of symptoms and when perceived risk was low. People felt more empowered when they understood that even small changes, such as spending some time apart, were worthwhile to reduce exposure and lessen viral load. CONCLUSIONS: The current study provided valuable insight into the acceptability and feasibility of protective behaviours, and how public health guidance could be incorporated into a behaviour change intervention for the public during a pandemic.

Adapting Behavioral Interventions for a Changing Public Health Context: A Worked Example of Implementing a Digital Intervention During a Global Pandemic Using Rapid Optimisation Methods.

Background: A rigorous approach is needed to inform rapid adaptation and optimisation of behavioral interventions in evolving public health contexts, such as the Covid-19 pandemic. This helps ensure that interventions are relevant, persuasive, and feasible while remaining evidence-based. This paper provides a set of iterative methods to rapidly adapt and optimize an intervention during implementation. These methods are demonstrated through the example of optimizing an effective online handwashing intervention called Germ Defense. Methods: Three revised versions of the intervention were rapidly optimized and launched within short timeframes of 1-2 months. Optimisations were informed by: regular stakeholder engagement; emerging scientific evidence, and changing government guidance; rapid qualitative research (telephone think-aloud interviews and open-text surveys), and analyses of usage data. All feedback was rapidly collated, using the Table of Changes method from the Person-Based Approach to prioritize potential optimisations in terms of their likely impact on behavior change. Written feedback from stakeholders on each new iteration of the intervention also informed specific optimisations of the content. Results: Working closely with clinical stakeholders ensured that the intervention was clinically accurate, for example, confirming that information about transmission and exposure was consistent with evidence. Patient and Public Involvement (PPI) contributors identified important clarifications to intervention content, such as whether Covid-19 can be transmitted via air as well as surfaces, and ensured that information about difficult behaviors (such as self-isolation) was supportive and feasible. Iterative updates were made in line with emerging evidence, including changes to the information about face-coverings and opening windows. Qualitative research provided insights into barriers to engaging with the intervention and target behaviors, with open-text surveys providing a useful supplement to detailed think-aloud interviews. Usage data helped identify common points of disengagement, which guided decisions about optimisations. The Table of Changes was modified to facilitate rapid collation and prioritization of multiple sources of feedback to inform optimisations. Engagement with PPI informed the optimisation process. Conclusions: Rapid optimisation methods of this kind may in future be used to help improve the speed and efficiency of adaptation, optimization, and implementation of interventions, in line with calls for more rapid, pragmatic health research methods.