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Protocol for the process evaluation of an intervention to improve antenatal smoking cessation support (MOHMQuit) in maternity services in New South Wales, Australia

Por: Longman · J. · Paul · C. · Cashmore · A. · Twyman · L. · Barnes · L. A. J. · Adams · C. · Bonevski · B. · Milat · A. · Passey · M. E.
Introduction

Smoking cessation in pregnancy remains a public health priority. Our team used the Behaviour Change Wheel to develop the Midwives and Obstetricians Helping Mothers to Quit smoking (MOHMQuit) intervention with health system, leader (including managers and educators) and clinician components. MOHMQuit addresses a critical evidence to practice gap in the provision of smoking cessation support in antenatal care. It involves nine maternity services in New South Wales in a cluster randomised stepped-wedge controlled trial of effectiveness. This paper describes the design and rationale for the process evaluation of MOHMQuit. The process evaluation aims to assess to what extent and how MOHMQuit is being implemented (acceptability; adoption/uptake; appropriateness; feasibility; fidelity; penetration and sustainability), and the context in which it is implemented, in order to support further refinement of MOHMQuit throughout the trial, and aid understanding and interpretation of the results of the trial.

Methods and analysis

The process evaluation is an integral part of the stepped-wedge trial. Its design is underpinned by implementation science frameworks and adopts a mixed methods approach. Quantitative evidence from participating leaders and clinicians in our study will be used to produce individual and site-level descriptive statistics. Qualitative evidence of leaders’ perceptions about the implementation will be collected using semistructured interviews and will be analysed descriptively within-site and thematically across the dataset. The process evaluation will also use publicly available data and observations from the research team implementing MOHMQuit, for example, training logs. These data will be synthesised to provide site-level as well as individual-level implementation outcomes.

Ethics and dissemination

The study received ethical approval from the Population Health Services Research Ethics Committee for NSW, Australia (Reference 2021/ETH00887). Results will be communicated via the study’s steering committee and will also be published in peer-reviewed journals and presented at conferences.

Trial registration number

Australian New Zealand Trials Registry ACTRN12622000167763. https://www.australianclinicaltrials.gov.au/anzctr/trial/ACTRN12622000167763.

Living with unsettled baby behaviours: Qualitative interview study exploring parental perceptions and experiences of help‐seeking

Abstract

Aim

To explore parents' perceptions/experiences of help-seeking for unsettled baby behaviours, including views and experiences of obtaining advice from primary healthcare professionals.

Design

Semi-structured qualitative interviews.

Methods

Recruitment occurred via social media, general practice and health visiting teams. Remote semi-structured interviews were conducted with parents of babies. Babies were under 12 months old at time of interview, and parents had perceived unsettled baby behaviours in their first 4 months of life. Interviews were transcribed and data analysed using reflexive thematic analysis.

Results

Based on interviews with 25 mothers, four main themes were developed. ‘The need for answers’ highlighted parental uncertainty about what constitutes normal baby behaviour, leading to help-seeking from multiple sources. ‘The importance of health professionals’ and ‘Experiencing health professional support’ identified perceptions about limited access, communication, mixed advice and how these influenced parental perception/management of behaviours. ‘Foundations to help-seeking’ highlighted important roles of social support and online help for valued shared experiences, emotional and practical support.

Conclusion

Health professional access and advice are important to parents, despite the increasing role of online help and importance of social support. More support and improved access to reliable sources of information is needed for parents.

Implications for the Profession and/or Patient Care

Findings will inform future research and clinical practice to address parental uncertainties. Qualitative research with front-line health professionals is necessary.

Impact

Findings can inform the development of resources to support professionals/families managing unsettled babies.

Reporting Method

Standards for Reporting Qualitative Research.

Public Involvement

A public contributor was involved throughout all stages of the research. Emerging findings were discussed at a parent group.

What does this paper contribute to the wider global clinical community?

Addressing parental uncertainties is important; about what is normal, non-pharmacological approaches and when pharmacological intervention is required. A digital information/self-management intervention may be useful for parents/clinicians.

Women's experiences with opting out of cervical cancer screening and the role of the nurse in the women's decision‐making process

Abstract

Aim

To explore Danish women's experiences with opting out of cervical cancer screening and the role of the nurse in the women's decision-making process.

Design

A qualitative study using semi-structured, individual interviews with a phenomenological-hermeneutic approach.

Methods

Interviews were conducted with 13 women with experience in opting out of cervical cancer screening. Women were recruited through a public flyer and interviewed virtually or by phone. The interviews were analysed using the theory of interpretation from Paul Ricoeur and consisted of three levels: naïve reading, structural analysis, and critical discussion and analysis. The present study adheres to the COREQ guidelines.

Results

The women experience various personal causes for opting out of cervical cancer screening, such as low accessibility of screening appointments, discomfort during the smear test, fear of being sick, and insufficient information about the relevance of screening to the individual woman. The perceived disadvantages of screening outweighed their perceived advantages. The women's experiences did not include the role of the nurse in the procedures and knowledge sharing related to cervical cancer screening. However, nurses were described as having good communicative and relational qualifications relevant to being involved in cervical cancer screening.

Conclusion

It was challenging for the women to weigh the advantages and disadvantages of cervical cancer screening and thus to make an informed decision about participation. They expressed a need for more information on which to base their decision. This places nurses in a much needed, yet unexplored, role of identifying and lowering potential personal barriers that may outweigh the women's perceived benefits of participating in screening.

Implication for the profession and/or patient care

Nurses should play a more active role in cervical cancer screening such as improving general knowledge and facilitating two-way communication about its relevance.

Reporting Method

The present study adheres to the Consolidated Criteria for Reporting Qualitative Research (COREQ) guidelines.

Patient or Public Contribution

No patient or public contribution.

Integrating nurse practitioners into primary healthcare to advance health equity through a social justice lens: An integrative review

Abstract

Aim

To develop a framework to guide the successful integration of nurse practitioners (NPs) into practice settings and, working from a social justice lens, deliver comprehensive primary healthcare which advances health equity.

Design

Integrative review.

Methods

The integrative review was informed by the Whittemore and Knafl's framework and followed the Preferred Reporting for Systematic Reviews and Meta-Analyses guidelines. Quality was assessed using the Johns Hopkins Research Evidence Appraisal Tool. Findings were extracted and thematically analysed using NVivo. A social justice lens informed all phases.

Data Sources

Databases, including CINAHL, PubMed, Scopus and Web of Science, were searched for peer-reviewed literature published in English between 2005 and April 2022.

Results

Twenty-eight articles were included. Six themes were identified at the individual (micro), local health provider (meso), and national systems and structures (macro) levels of the health sector: (1) autonomy and agency; (2) awareness and visibility; (3) shared vision; (4) leadership; (5) funding and infrastructure; and (6) intentional support and self-care. The evidence-based framework is explicitly focused on the components required to successfully integrate NPs into primary healthcare to advance health equity.

Conclusion

Integrating NPs into primary healthcare is complex and requires a multilevel approach at macro, meso and micro levels. NPs offer the potential to transform primary healthcare delivery to meet the health needs of local communities. Health workforce and integration policies and strategies are essential if the contribution of NPs is to be realized. The proposed framework offers an opportunity for further research to inform NP integration.

Impact Statement

Nurse practitioners (NPs) offer the potential to transform primary healthcare services to meet local community health needs and advance health equity. Globally, there is a lack of guidance and health policy to support the integration of the NP workforce. The developed framework provides guidance to successfully integrate NPs to deliver comprehensive primary healthcare grounded in social justice. Integrating NPs into PHC is complex and requires a multilevel approach at macro, meso and micro levels. The framework offers an opportunity for further research to inform NP integration, education and policy.

Summary Statement

What problem did the study address: The challenges of integrating nurse practitioners (NPs) into primary healthcare (PHC) are internationally recognized. Attempts to establish NP roles in New Zealand have been ad hoc with limited research, evidence-informed frameworks or policy to guide integration initiatives. Our review builds on existing international literature to understand how NPs are successfully integrated into PHC to advance health equity and provide a guiding framework. What were the main findings: Six themes were identified across individual (micro), local health provider (meso) and national systems and structures (macro) levels as fundamental to NP integration: autonomy and agency; awareness and visibility of the NP and their role; a shared vision for the direction of primary healthcare utilizing NP scope of practice; leadership in all spaces; necessary funding and infrastructure; and intentional support and self-care. Where and on whom will the research have an impact: Given extant health workforce challenges together with persisting health inequities, NPs provide a solution to delivering comprehensive primary healthcare from a social justice lens to promote healthcare access and health equity. The proposed evidence-informed framework provides guidance for successful integration across the health sector, training providers, as well as the NP profession, and is a platform for future research.

Reporting Method

This integrative review adhered to the Preferred Reporting for Systematic Reviews and Meta-Analyses (PRISMA) method.

Patient or Public Contribution

No patient or public contribution.

Sustained Mood Improvement with Laughing Gas Exposure (SMILE): Study protocol for a randomized placebo-controlled pilot trial of nitrous oxide for treatment-resistant depression

by Karim S. Ladha, Jiwon Lee, Gabriella F. Mattina, Janneth Pazmino-Canizares, Duminda N. Wijeysundera, Fatemeh Gholamali Nezhad, Kaylyssa Philip, Vanessa K. Tassone, Fathima Adamsahib, Venkat Bhat, on behalf of the SMILE Study Investigators

Background

Nitrous oxide has shown potentially as an efficacious intervention for treatment-resistant depression, yet there remains insufficient evidence pertaining to repeated administration of nitrous oxide over time and active placebo-controlled studies with optimal blinding. Thus, we aim to examine the feasibility and preliminary efficacy of a six-week follow up study examining the effects of a 4 week course of weekly administered nitrous oxide as compared to the active placebo, midazolam.

Methods

In this randomized, active placebo-controlled, pilot trial, 40 participants with treatment-resistant depression will receive either inhaled nitrous oxide (1 hour at 50% concentration) plus intravenous saline (100mL) or inhaled oxygen (1 hour at 50% concentration) plus intravenous midazolam (0.02 mg/kg in 100mL, up to 2mg) once per week, for 4 consecutive weeks. Participants will be followed up for 6 weeks starting from the first treatment visit. Primary feasibility outcomes include recruitment rate, withdrawal rate, adherence, missing data, and adverse events. The primary exploratory clinical outcome is change in Montgomery-Åsberg Depression Rating Scale (MADRS) score at day 42 of the study. Other exploratory clinical outcomes include remission (defined as MADRS score Discussion

This pilot study will provide valuable information regarding the feasibility and preliminary efficacy of repeated nitrous oxide administration over time for treatment-resistant depression. If feasible, this study will inform the design of a future definitive trial of nitrous oxide as an efficacious and fast-acting treatment for treatment-resistant depression.

Trial registration

ClinicalTrials.gov NCT04957368. Registered on July 12, 2021.

Factors influencing implementation and sustainability of interventions to improve oral health and related health behaviours in adults experiencing severe and multiple disadvantage: a mixed-methods systematic review

Por: John · D. A. · Adams · E. A. · McGowan · L. J. · Joyes · E. C. · Richmond · C. · Beyer · F. R. · Landes · D. · Watt · R. G. · Sniehotta · F. F. · Paisi · M. · Bambra · C. · Craig · D. · Kaner · E. · Ramsay · S. E.
Objectives

Among people experiencing severe and multiple disadvantage (SMD), poor oral health is common and linked to smoking, substance use and high sugar intake. Studies have explored interventions addressing oral health and related behaviours; however, factors related to the implementation of these interventions remain unclear. This mixed-methods systematic review aimed to synthesise evidence on the implementation and sustainability of interventions to improve oral health and related health behaviours among adults experiencing SMD.

Methods

Bibliographic databases (MEDLINE, EMBASE, PsycINFO, CINAHL, EBSCO, Scopus) and grey literature were searched from inception to February 2023. Studies meeting the inclusion criteria were screened and extracted independently by two researchers. Quality appraisal was undertaken, and results were synthesised using narrative and thematic analyses.

Results

Seventeen papers were included (published between 1995 and 2022). Studies were mostly of moderate quality and included views from SMD groups and service providers. From the qualitative synthesis, most findings were related to aspects such as trust, resources and motivation levels of SMD groups and service providers. None of the studies reported on diet and none included repeated offending (one of the aspects of SMD). From the quantitative synthesis, no difference was observed in programme attendance between the interventions and usual care, although there was some indication of sustained improvements in participation in the intervention group.

Conclusion

This review provides some evidence that trust, adequate resources and motivation levels are potentially important in implementing interventions to improve oral health and substance use among SMD groups. Further research is needed from high quality studies and focusing on diet in this population.

PROSPERO registration number

CRD42020202416.

‘All we've ever known is Covid’: A follow‐up study with newly qualified nurses who worked as student nurses during the pandemic

Abstract

Aims and Objectives

To explore the experiences of nursing students in England who had worked through the first wave and transitioned to qualification in the ongoing pandemic.

Background

Experiences of health professionals and student nurses during the pandemic are now well documented, but the transition of students to qualification is less well understood. In Summer 2020, we interviewed 16 student nurses who had worked as health care assistants on paid extended placements as part of the COVID-19 response in the East of England, finding surprisingly positive experiences, including perceived heightened preparedness for qualification. A year later, we re-interviewed 12 participants from the original study to hear about transitioning to qualification during the ongoing pandemic. This study provides novel insights into their experiences.

Design

A qualitative study design was used.

Methods

Twelve newly qualified nurses who had participated in the original study took part in qualitative, online interviews where they shared their experiences of working and transitioning to qualification during the ongoing pandemic since we spoke to them a year earlier. The data was analysed using thematic analysis. COREQ guidelines were used in developing and reporting this study.

Results

Three themes were identified. Constant change: in the clinical environment and arising out of the transition to newly qualified nurse, mental health and well-being and reflecting on the past to learn for the future.

Conclusions

Participants experienced a unique transition to qualification. The perceived heightened preparedness for qualification that participants who had worked as students during the first wave of the pandemic had become a reality, ameliorating some of the known effects of transition. However, increased expectations and added responsibilities in extremely busy, fluctuating clinical environments with minimal support add weight to calls for mandatory preceptorship programmes. While heightened resilience was evident, provision of ongoing mental health and well-being support is strongly recommended.

Relevance to Clinical Practice

We need a partnership approach with nurse educators and practice colleagues which ensures preparation for qualified practice is appropriate. If we do not effectively prepare students for qualified nurse posts, patient care will almost certainly be compromised.

Qualitative exploration of the perceptions of exercise in patients with cancer initiated during chemotherapy: a meta-synthesis

Por: Andersen · C. · Adamsen · L. · Damhus · C. S. · Piil · K. · Missel · M. · Jarden · M. · Larsen · A. · Larsen · H. B. · Moller · T.
Objective

To synthesise qualitative literature on (1) the perceptions of patients with cancer of participating in an exercise intervention while undergoing chemotherapy and (2) to inform and guide professionals in oncology and haematology practice.

Design

A qualitative meta-synthesis based on Noblit and Hare’s seven-step meta-ethnography.

Data sources

Six electronic databases: Cochrane Central Register of Controlled Trials (CENTRAL), CINAHL, EMBASE, PubMed, SCI-Expanded—SSCI and Scopus (final search June 2022) were used to identify qualitative literature containing individual or focus group interviews. The transparency of reporting for each study was assessed using the Consolidated criteria for Reporting Qualitative research checklist.

Results

The search identified 5002 articles, 107 of which were selected for full-text review. Seventeen articles from five countries with patients undergoing chemotherapy during exercise interventions were included. Eleven articles were included in the meta-synthesis, which comprised 193 patients with various cancer diagnoses, disease stages, sexes and ages. Four main themes were identified: chemotherapy overpowers the body; exercise in battle with side effects; a break from gloomy thoughts; and a question of survivorship.

Conclusions and implications

The meta-synthesis emphasised that patients with cancer undergoing chemotherapy and simultaneously participating in exercise interventions may experience momentary relief from overwhelming side effects, even though full bodily recovery may be perceived as a distant prospect. The synthesis offers a sparse empirical basis for gaining insight into what patients experience existentially following exercise interventions. It is up to patients to independently apply the transfer value of exercise to their own existential circumstances.

Field study examining the mucosal microbiome in equine glandular gastric disease

by Linda J. Paul, Aaron C. Ericsson, Frank M. Andrews, Zachary McAdams, Michael L. Keowen, Michael P. St Blanc, Heidi E. Banse

Equine glandular gastric disease (EGGD) is a common disease among athletic horses that can negatively impact health and performance. The pathophysiology of this EGGD remains poorly understood. Previous studies using controlled populations of horses identified differences in the gastric glandular mucosal microbiome associated with disease. The objective of this study was to compare the gastric microbiome in horses with EGGD and those without across multiple barns and differing management practices. We hypothesized that alterations in the microbiome of the gastric glandular mucosa are associated with EGGD. A secondary objective was to perform a risk factor analysis for EGGD using the diet and management data collected. Microbial populations of biopsies from normal pyloric mucosa of horses without EGGD (control biopsies), normal pyloric mucosa of horses with EGGD (normal biopsies) and areas of glandular mucosal disruption in horses with EGGD (lesion biopsies) were compared. Lesion biopsies had a different microbial community structure than control biopsies. Control biopsies had a higher read count for the phylum Actinomycetota compared to lesion biopsies. Control biopsies also had an enrichment of the genera Staphylococcus and Lawsonella and the species Streptococcus salivarius. Lesion biopsies had an enrichment of the genera Lactobacillus and Actinobacillus and the species Lactobacillus equigenerosi. These results demonstrate differences in the gastric glandular microbiome between sites of disrupted mucosa in horses with EGGD compared to pyloric mucosa of horses without EGGD. Risk factor analysis indicated that exercise duration per week was a risk factor for EGGD.

Clinical impacts of an integrated electronic health record-based smoking cessation intervention during hospitalisation

Por: Banerjee · S. · Alabaster · A. · Adams · A. S. · Fogelberg · R. · Patel · N. · Young-Wolff · K.
Objective

To assess the effects of an electronic health record (EHR) intervention that prompts the clinician to prescribe nicotine replacement therapy (NRT) at hospital admission and discharge in a large integrated health system.

Design

Retrospective cohort study using interrupted time series (ITS) analysis leveraging EHR data generated before and after implementation of the 2015 EHR-based intervention.

Setting

Kaiser Permanente Northern California, a large integrated health system with 4.2 million members.

Participants

Current smokers aged ≥18 hospitalised for any reason.

Exposure

EHR-based clinical decision supports that prompted the clinician to order NRT on hospital admission (implemented February 2015) and discharge (implemented September 2015).

Main outcomes and measures

Primary outcomes included the monthly percentage of admitted smokers with NRT orders during admission and at discharge. A secondary outcome assessed patient quit rates within 30 days of hospital discharge as reported during discharge follow-up outpatient visits.

Results

The percentage of admissions with NRT orders increased from 29.9% in the year preceding the intervention to 78.1% in the year following (41.8% change, 95% CI 38.6% to 44.9%) after implementation of the admission hard-stop intervention compared with the baseline trend (ITS estimate). The percentage of discharges with NRT orders increased acutely at the time of both interventions (admission intervention ITS estimate 15.5%, 95% CI 11% to 20%; discharge intervention ITS estimate 13.4%, 95% CI 9.1% to 17.7%). Following the implementation of the discharge intervention, there was a small increase in patient-reported quit rates (ITS estimate 5.0%, 95% CI 2.2% to 7.8%).

Conclusions

An EHR-based clinical decision-making support embedded into admission and discharge documentation was associated with an increase in NRT prescriptions and improvement in quit rates. Similar systemic EHR interventions can help improve smoking cessation efforts after hospitalisation.

Changes in soft drinks purchased by British households associated with the UK soft drinks industry levy: a controlled interrupted time series analysis

Por: Rogers · N. T. · Pell · D. · Mytton · O. T. · Penney · T. L. · Briggs · A. · Cummins · S. · Jones · C. · Rayner · M. · Rutter · H. · Scarborough · P. · Sharp · S. · Smith · R. · White · M. · Adams · J.
Objective

To determine changes in household purchases of drinks 1 year after implementation of the UK soft drinks industry levy (SDIL).

Design

Controlled interrupted time series.

Participants

Households reporting their purchasing to a market research company (average weekly n=22 091), March 2014 to March 2019.

Intervention

A two-tiered tax levied on soft drinks manufacturers, announced in March 2016 and implemented in April 2018. Drinks with ≥8 g sugar/100 mL (high tier) are taxed at £0.24/L, drinks with ≥5 to

Main outcome measures

Absolute and relative differences in the volume of, and amount of sugar in, soft drinks categories, all soft drinks combined, alcohol and confectionery purchased per household per week 1 year after implementation.

Results

In March 2019, compared with the counterfactual, purchased volume of high tier drinks decreased by 140.8 mL (95% CI 104.3 to 177.3 mL) per household per week, equivalent to 37.8% (28.0% to 47.6%), and sugar purchased in these drinks decreased by 16.2 g (13.5 to 18.8 g), or 42.6% (35.6% to 49.6%). Purchases of low tier drinks decreased by 170.5 mL (154.5 to 186.5 mL) or 85.8% (77.8% to 93.9%), with an 11.5 g (9.1 to 13.9 g) reduction in sugar in these drinks, equivalent to 87.8% (69.2% to 106.4%). When all soft drinks were combined irrespective of levy tier or eligibility, the volume of drinks purchased increased by 188.8 mL (30.7 to 346.9 mL) per household per week, or 2.6% (0.4% to 4.7%), but sugar decreased by 8.0 g (2.4 to 13.6 g), or 2.7% (0.8% to 4.5%). Purchases of confectionery and alcoholic drinks did not increase.

Conclusions

Compared with trends before the SDIL was announced, 1 year after implementation, volume of all soft drinks purchased combined increased by 189 mL, or 2.6% per household per week. The amount of sugar in those drinks was 8 g, or 2.7%, lower per household per week. Further studies should determine whether and how apparently small effect sizes translate into health outcomes.

Trial registration number

ISRCTN18042742.

Molecular characterization of <i>G6PD</i> mutations identifies new mutations and a high frequency of intronic variants in Thai females

by Kamonwan Chamchoy, Sirapapha Sudsumrit, Jutamas Wongwigkan, Songsak Petmitr, Duantida Songdej, Emily R. Adams, Thomas Edwards, Ubolsree Leartsakulpanich, Usa Boonyuen

Glucose-6-phosphate dehydrogenase (G6PD) deficiency is an X-linked enzymopathy caused by mutations in the G6PD gene. A medical concern associated with G6PD deficiency is acute hemolytic anemia induced by certain foods, drugs, and infections. Although phenotypic tests can correctly identify hemizygous males, as well as homozygous and compound heterozygous females, heterozygous females with a wide range of G6PD activity may be misclassified as normal. This study aimed to develop multiplex high-resolution melting (HRM) analyses to enable the accurate detection of G6PD mutations, especially among females with heterozygous deficiency. Multiplex HRM assays were developed to detect six G6PD variants, i.e., G6PD Gaohe (c.95A>G), G6PD Chinese-4 (c.392G>T), G6PD Mahidol (c.487G>A), G6PD Viangchan (c.871G>A), G6PD Chinese-5 (c.1024C>T), and G6PD Union (c.1360C>T) in two reactions. The assays were validated and then applied to genotype G6PD mutations in 248 Thai females. The sensitivity of the HRM assays developed was 100% [95% confidence interval (CI): 94.40%–100%] with a specificity of 100% (95% CI: 88.78%–100%) for detecting these six mutations. The prevalence of G6PD deficiency was estimated as 3.63% (9/248) for G6PD deficiency and 31.05% (77/248) for intermediate deficiency by phenotypic assay. The developed HRM assays identified three participants with normal enzyme activity as heterozygous for G6PD Viangchan. Interestingly, a deletion in intron 5 nucleotide position 637/638 (c.486-34delT) was also detected by the developed HRM assays. G6PD genotyping revealed a total of 12 G6PD genotypes, with a high prevalence of intronic variants. Our results suggested that HRM analysis-based genotyping is a simple and reliable approach for detecting G6PD mutations, and could be used to prevent the misdiagnosis of heterozygous females by phenotypic assay. This study also sheds light on the possibility of overlooking intronic variants, which could affect G6PD expression and contribute to enzyme deficiency.

Shaping care home COVID-19 testing policy: a protocol for a pragmatic cluster randomised controlled trial of asymptomatic testing compared with standard care in care home staff (VIVALDI-CT)

Por: Adams · N. · Stirrup · O. · Blackstone · J. · Krutikov · M. · Cassell · J. A. · Cadar · D. · Henderson · C. · Knapp · M. · Gosce · L. · Leiser · R. · Regan · M. · Cullen-Stephenson · I. · Fenner · R. · Verma · A. · Gordon · A. · Hopkins · S. · Copas · A. · Freemantle · N. · Flowers · P. · Sh
Introduction

Care home residents have experienced significant morbidity, mortality and disruption following outbreaks of SARS-CoV-2. Regular SARS-CoV-2 testing of care home staff was introduced to reduce transmission of infection, but it is unclear whether this remains beneficial. This trial aims to investigate whether use of regular asymptomatic staff testing, alongside funding to reimburse sick pay for those who test positive and meet costs of employing agency staff, is a feasible and effective strategy to reduce COVID-19 impact in care homes.

Methods and analysis

The VIVALDI-Clinical Trial is a multicentre, open-label, cluster randomised controlled, phase III/IV superiority trial in up to 280 residential and/or nursing homes in England providing care to adults aged >65 years. All regular and agency staff will be enrolled, excepting those who opt out. Homes will be randomised to the intervention arm (twice weekly asymptomatic staff testing for SARS-CoV-2) or the control arm (current national testing guidance). Staff who test positive for SARS-CoV-2 will self-isolate and receive sick pay. Care providers will be reimbursed for costs associated with employing temporary staff to backfill for absence arising directly from the trial.

The trial will be delivered by a multidisciplinary research team through a series of five work packages.

The primary outcome is the incidence of COVID-19-related hospital admissions in residents. Secondary outcomes include the number and duration of outbreaks and home closures. Health economic and modelling analyses will investigate the cost-effectiveness and cost consequences of the testing intervention. A process evaluation using qualitative interviews will be conducted to understand intervention roll out and identify areas for optimisation to inform future intervention scale-up, should the testing approach prove effective and cost-effective. Stakeholder engagement will be undertaken to enable the sector to plan for results and their implications and to coproduce recommendations on the use of testing for policy-makers.

Ethics and dissemination

The study has been approved by the London—Bromley Research Ethics Committee (reference number 22/LO/0846) and the Health Research Authority (22/CAG/0165). The results of the trial will be disseminated regardless of the direction of effect. The publication of the results will comply with a trial-specific publication policy and will include submission to open access journals. A lay summary of the results will also be produced to disseminate the results to participants.

Trial registration number

ISRCTN13296529.

Remote and technology‐mediated working during the COVID‐19 pandemic: A qualitative exploration of the experiences of nurses working in general practice (the GenCo Study)

Abstract

Aim

To explore how nurses working in general practice experienced remote and technology-mediated working during the COVID-19 pandemic.

Design

Exploratory qualitative study with nursing team members working in general practices in England and national nurse leaders.

Methods

Data were collected between April and August 2022. Forty participants took part in either semi-structured interviews or focus groups. Data were analysed using Framework Analysis informed by the PERCS (Planning and Evaluating Remote Consultation Services) Framework. University of York ethics approval [HSRGC/2021/458/I] and Health Research Authority approval were obtained [IRAS:30353. Protocol number: R23982. Ref 21/HRA/5132. CPMS: 51834]. The study was funded by The General Nursing Council for England and Wales Trust.

Results

Participants continued to deliver a significant proportion of patient care in-person. However, remote and technology-mediated care could meet patients' needs and broaden access in some circumstances. When remote and technology-mediated working were used this was often part of a blended model which was expected to continue. This could support some workforce issues, but also increase workload. Participants did not always have access to remote technology and were not involved in decision-making about what was used and how this was implemented. They rarely used video consultations, which were not seen to add value in comparison to telephone consultations. Some participants expressed concern that care had become more transactional than therapeutic and there were potential safety risks.

Conclusion

The study explored how nurses working in general practice during the COVID-19 pandemic engaged with remote and technology-mediated working. It identifies specific issues of access to technology, workload, hybrid working, disruption to therapeutic relationships, safety risks and lack of involvement in decision-making. Changes were implemented quickly with little strategic input from nurses. There is now an opportunity to reflect and build on what has been learned in relation to remote and technology-mediated working to ensure the future development of safe and effective nursing care in general practice.

Impact

The paper contributes to understanding of remote and technology-mediated working by nurses working in general practice during the COVID-19 pandemic and indicates to employers and policy makers how this can be supported moving forward.

Reporting method

Standards for Reporting Qualitative Research (O'Brien et al., 2014).

Patient or public contribution

This was a workforce study so there was no patient or public contribution.

Implications for the profession and patient care

The paper highlights specific issues which have implications for the development of remote, technology-mediated and blended working for nurses in general practice, care quality and patient safety. These require full attention to ensure the future development of safe and effective nursing care in general practice moving forward.

The well‐being of nurses working in general practice during the COVID‐19 pandemic: A qualitative study (The GenCo Study)

Abstract

Aim

Exploration of experiences of nurses working in general practice during the COVID-19 pandemic to evaluate the impact on nurses' professional well-being.

Design

An exploratory qualitative study comprised of case studies of three general practice sites in England and a nationwide interview study of nurses working in general practice and nurse leaders. The study was funded by The General Nursing Council for England and Wales Trust. University of York ethics approval (HSRGC/2021/458/I) and Health Research Authority approval was obtained (IRAS: 30353, Protocol number: R23982, Ref 21/HRA/5132, CPMS: 51834).

Methods

Forty participants took part. Case site data consisted of interviews/focus groups and national data consisted of semi-structured interviews. Data collection took place between April and August 2022. Analysis was underpinned by West et al.'s The courage of compassion. Supporting nurses and midwives to deliver high-quality care, The King's fund, 2020 ABC framework of nurses' core work well-being needs.

Findings

The majority of participants experienced challenges to their professional well-being contributed to by lack of recognition, feeling undervalued and lack of involvement in higher-level decision-making. Some participants displayed burnout and stress. Structural and cultural issues contributed to this and many experiences pre-dated, but were exacerbated by, the COVID-19 pandemic.

Conclusions

By mapping findings to the ABC framework, we highlight the impact of the COVID-19 pandemic on the well-being of nurses working in general practice and contributing workplace factors. The issues identified have implications for retention and for the future of nursing in general practice. The study highlights how this professional group can be supported in the future.

Impact

The study contributes to our understanding of the experiences of nurses working in general practice during the COVID-19 pandemic and beyond. Findings have implications for this skilled and experienced workforce, for retention of nurses in general practice, the sustainability of the profession more broadly and care quality and patient safety.

Reporting Method

Standards for Reporting Qualitative Research (O'Brien et al. in Journal of the Association of American Medical Colleges, 89(9), 1245–1251, 2014).

Patient or Public Contribution

As this was a workforce study there was no patient or public contribution.

Stigma, social and structural vulnerability, and mental health among transgender women: A partial least square path modeling analysis

Abstract

Introduction

Existing literature suggests that transgender women (TW) may be at high risk for adverse mental health due to stress attributed to combined experiences of stigma and complex social and structural vulnerabilities. Little research has examined how these co-occurring experiences relate to mental health. We aimed to test a theoretically driven conceptual model of relationships between stigma, social and structural vulnerabilities, and mental health to inform future intervention tailoring.

Design/Methods

Partial least square path modeling followed by response-based unit segmentation was used to identify homogenous clusters in a diverse community sample of United States (US)-based TW (N = 1418; 46.2% White non-Hispanic). This approach examined associations between latent constructs of stigma (polyvictimization and discrimination), social and structural vulnerabilities (housing and food insecurity, unemployment, sex work, social support, and substance use), and mental health (post-traumatic stress and psychological distress).

Results

The final conceptual model defined the structural relationship between the variables of interest within stigma, vulnerability, and mental health. Six clusters were identified within this structural framework which suggests that racism, ethnicism, and geography may be related to mental health inequities among TW.

Conclusion

Our findings around the impact of racism, ethnicism, and geography reflect the existing literature, which unfortunately shows us that little change has occurred in the last decade for TW of color in the Southern US; however, the strength of our evidence (related to sampling structure and sample size) and type of analyses (accounting for co-occurring predictors of health, i.e., stigma and complex vulnerabilities, reflecting that of real-world patients) is a novel and necessary addition to the literature. Findings suggest that health interventions designed to offset the negative effects of stigma must include anti-racist approaches with components to reduce or eliminate barriers to resources that contribute to social and structural vulnerabilities among TW. Herein we provide detailed recommendations to guide primary, secondary, and tertiary prevention efforts.

Clinical Relevance

This study demonstrated the importance of considering stigma and complex social and structural vulnerabilities during clinical care and design of mental health interventions for transgender women who are experiencing post-traumatic stress disorder and psychological distress. Specifically, interventions should take an anti-racist approach and would benefit from incorporating social support-building activities.

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