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. (preprint)

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 the approval of NHS England, we implemented an efficient two-arm (1:1 ratio) cluster randomised controlled trial (RCT) to examine the effectiveness of randomising implementation of Germ Defence via GP practices across England, UK, compared with usual care. GP practices randomised to the intervention arm (n=3292) were emailed and asked to disseminate the Germ Defence intervention to all adult patients via mobile phone text, email or social media. GP practices randomised to the usual care arm (n=3287) maintained standard management for the 4-month trial period after 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, suspected COVID-19 diagnoses, COVID-19 symptoms, gastrointestinal infection diagnoses, antibiotic usage, hospital admissions.  The impact of the intervention on outcome rates was assessed using negative binomial regression modelling within the OpenSAFELY platform. The uptake of intervention by GP practice, and by patients were measured via website analytics. Results: Germ Defence was used 310,731 times. The average satisfaction score after using the website 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- 48% of a practice list. Practices with high levels of intervention uptake (>11%) had a lower proportion of minority ethnic groups. Conclusions:  We demonstrated that rapid large-scale implementation of a digital behavioural intervention 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.

Evaluation of standard and enhanced quality improvement methods to increase the uptake of magnesium sulphate in pre-term deliveries for the prevention of neurodisability (PReCePT Study): a cluster randomized controlled trial (preprint)

ABSTRACT Objective To investigate the impact of an enhanced QI support programme (ESP) in further improving the magnesium sulphate (MgSO 4 ) uptake compared to the National PReCePT Programme (NPP) model. Design An unblinded cluster randomised controlled trial. Setting NHS England and the AHSN network in 2018. Participants Maternity units with ≥10 pre-term deliveries annually and MgSO 4 uptake ≤70%. 40 maternity units (27 NPP, 13 ESP) were included. Randomisation was stratified by MgSO 4 uptake. Interventions MgSO 4 reduces the risk of cerebral palsy by 30%. NHS England commissioned the AHSN network in 2018 to deliver the NPP to increase MgSO 4 uptake in all maternity units in England. NPP units received PReCePT QI materials, regional support, and midwife backfill funding. ESP units received NPP plus backfill funding, unit-level QI coaching, and tablet computer Main outcome measures MgSO 4 uptake post-implementation was compared between trial groups. Implementation and lifetime costs, and quality-adjusted life-years were estimated. The implementation process, fidelity, and local adaptations were assessed through a qualitative process evaluation. Results Using routine data and multivariable linear regression, both ESP and NPP units increased uptake between pre- and post-implementation. Post-implementation uptake increase in ESP units was similar to NPP units (−0.84 percentage points difference, 95% Confidence Interval -5.03 to 3.35 percentage points). Decision tree and probabilistic analyses were used to estimate cost-effectiveness and the probability ESP cost-effective was < 30%. Midwives implementing the NPP allocated more than their funded hours. Implementers of the ESP had better overall understanding of and collective engagement in PReCePT QI and made more use of QI methods. Units varied in amount and kind of support required to successfully implement the intervention. Conclusion This trial did not find additional benefit from the ESP compared with the NPP. Units with low uptake of MgSO 4 were found to experience a range of local challenges and targeted enhanced support may improve performance and represent good value. Trial registration ISRCTN 40938673 ( https://www.isrctn.com/ISRCTN40938673 ) WHAT IS ALREADY KNOWN ON THIS TOPIC Since 2009 there has been strong evidence for the fetal neuroprotective benefits of antenatal MgSO 4 in women at risk of pre-term birth. This took a further 6 years to become a NICE recommended intervention. By 2017, only two-thirds of all eligible women in England were being given MgSO 4 , with wide regional variations. The PReCePT pilot study in 2015 demonstrated that uptake could be increased significantly using a Quality Improvement (QI) intervention to increase maternity staff awareness of MgSO 4 , and investment in staff time for training. In 2018, NHS England funded the National PReCePT Programme (NPP) in maternity units nationally, which provided a QI toolkit, backfill funding for a unit-level support for a midwife ‘champion’ and regional-level clinical champion. WHAT THIS STUDY ADDS The study has shown that national quality improvement programmes are effective in increasing MgSO 4 across maternity units in England. While overall uptake increased in both groups between baseline and follow-up, the study did not demonstrate additional benefit of the ESP compared to the NPP. Enhanced support can be delivered to units who are struggling or those with low improvement capability. Instead of delivering enhanced support to all units, a targeted intervention might be valuable for units who have low MgSO 4 implementation rates despite the national QI programme. Assessing individual organisations’ support needs based on factors including their readiness to change may help focus support to local needs.