Establishing Covid-19 Research in UK Care Homes – Infrastructure Challenges for Trial Design

Abstract Background The Covid-19 pandemic brought into sharp relief the role that long-term care facilities play in health and social care of an aging population. It also cast a spotlight upon the need for high-quality research to assess the effectiveness of any care home interventions. The Prophylactic Therapies in Care Homes (PROTECT-CH) trial was one such study (funded by the UK National Institute for Health and Care Research). PROTECT-CH was designed to collect data in 200 care homes (approximately 6,400 residents), and whilst the changing epidemiology of Covid-19 in the UK (due to vaccination take-up) made this unfeasible other insights were gained about establishing large-scale research in care homes. Methods An iterative process evaluation of the set-up phase of a large, platform trial testing prophylactic measures in long-term care facilities. Including a documentary review of the PROTECT-CH working groups and an online survey of working group members. Results Documents were reviewed from 24 working groups, which in a hub and spoke model represented the PROTECT-CH trial infrastructure; representative of 20 of these groups completed an online survey about their organisation and working. Data demonstrated the number and organisation of individuals required to set up a large-scale care-home trial - 91 individuals representing a mix of academic, clinical, and methodological contributions from 25 organisations. Data demonstrated working groups specific to care home research, and activities designed to address the specific challenges of researching in care homes. PROTECT-CH produced dedicated training materials and reporting templates for care home research. PROTECT-CH established novel mechanisms for prescribing and clinical oversight in care home research. Conclusions PROTECT-CH has highlighted the complexity of establishing large, scale RCT research in long-term care facilities. It has produced resources which might be of use in subsequent care home research. Key messages • Infrastructure is required to support high quality research in long-term care facilities. • RCTs in long-term care facilities pose specific challenged to researchers.


Background:
The extent of the psychological impact of the pandemic is still unfolding. Despite existing literature, most studies lack rigor. We assessed the longitudinal rate of intra-individual change in maternal depression symptoms from before to after COVID-19 onset among US mothers enrolled in a home visiting program with robust adjustment for family contextual factors. We hypothesize that the rate of change in maternal depression symptoms increased after the pandemic onset. Methods: Eligibility included mothers with 1 depression assessment both prior to and after March 16, 2020; thresholds of 13 on the Edinburgh Postnatal Depression Scale and 10 on the Patient Health Questionnaire-9 identified probable depression. We used a generalized linear mixed effects longitudinal model with a random intercept and random slope for time (years) to analyze probable depression (event='Yes') pre-and post-COVID. Covariates for model estimation were based on the literature and theory. Results: Our cohort of 3,431 mothers included 43% non-Hispanic White, 21% non-Hispanic Black, and 31% Hispanic races/ ethnicities; 58% from rural/small towns, 18% Spanish-speaking, 63% with one child, median age of 29 and median 2 years follow-up. Households included: 82% low income, 24% low education, 10% insecure housing, 29% single parents, 21% mental illness, 10% substance abuse, and 8% domestic violence. Fourteen percent screened positive for depression pre-COVID, and 10% post-COVID. Depression was significantly higher pre-versus post-COVID, with no significant difference in the rate of change over time. Significant variables (p < 0.05) associated with depression included race/ethnicity, region of the country, number of home visits, mental illness, substance abuse, and domestic violence.

Conclusions:
After controlling for family contextual factors, we did not find a significant increase in maternal depression post-COVID-19. Additional research is needed to examine subgroups and the timing of events.

Key messages:
The extent of the psychological impact from the pandemic is still unfolding. It is difficult to fully articulate its effects without rigorous, longitudinal research designs.

In 2021, the European Union's (EU) 'Europe's Beating Cancer
Plan' set the goal to achieve a tobacco-free generation in Europe by 2040, which means that less than 5% of people will use tobacco. The EU proposed policies to address internationally relevant issues such as tobacco taxation, cross-border purchases, packaging, flavours, and online advertising. However, many tobacco control policies need to be adopted and implemented at the national or local level. It is therefore important to exchange research findings and insights on national tobacco control policies. In this workshop we present results mainly from the Netherlands. With a 21% smoking prevalence and scores 53 out of 100 points on the Tobacco Control Scale, it may therefore be considered an average European country in terms of its tobacco control. However, the Netherlands has progressed its tobacco control policies in recent years, in part due to the 2018 National Prevention Agreement. This Agreement included the same goal as the European tobacco-free generation goal. Achieving a tobaccofree generation requires the prevention of smoking initiation among young people, but also smoking cessation among those who already smoke. This is especially important among lower socioeconomic groups, as the smoking prevalence in these groups is higher both in adults and adolescents. Therefore, smoking and tobacco products need to be less visible and available in the environment, and easily accessible smoking cessation support needs to be provided. With this workshop, we cluster very recent evidence on the EU's tobacco-free generation goal. We will present evidence on four policy strategies for the smoke-free generation, in which their potential impact and challenges in implementation will be discussed. These presentations will be followed by a plenary discussion on the implications and the relevance of the four strategies taking into account differences between international settings. The presentations will focus on four policy areas: Policies to reduce smoke-exposure in and around sport clubs Policies to reduce availability of tobacco products in the retail environment Policies to reduce smoke-exposure in hospitality venues and homes Policies to increase access to smoking cessation The objectives of the workshop are: 1. Present evidence of four tobacco control policies strategies 2. Discussion of the international relevance and implications of the results Key messages: We present on multiple settings that can be further capitalised on to achieve a non-smoking norm, including sports clubs, retail outlets, hospitality venues, and the home environment.
The majority of European countries currently does not have strong tobacco control policies in the presented settings, and the potential of such policies throughout Europe will be discussed.

Background:
Although outdoor smoke-free policies (SFPs) at sports clubs represent an important new area of tobacco control, the majority of sports clubs are not smoke-free. This study aims to assess diffusion patterns of outdoor SFPs at sports clubs in the Netherlands, which may inform national strategies aimed at making all outdoor sports clubs smoke-free.

Methods:
Using a retrospective, registry-based design, an inventory was made of football, field hockey, tennis, and korfball clubs that became smoke-free between 2016-2020. We determined the type of sports, number of members, and proportion of youth members. The degree of urbanization and density of smokefree sports clubs were measured at the municipality level. The association between sports clubs' characteristics, degree of urbanization, and SFP adoption was analysed using multilevel regression analysis. Horizontal diffusion was tested by analysing the association between the density and annual incidence of smoke-free sports clubs.