Introduction Cervical cancer screening in general practice could be a routine moment to provide female smokers with stop smoking advice and support. The aim of this study is to assess the effect of... Show moreIntroduction Cervical cancer screening in general practice could be a routine moment to provide female smokers with stop smoking advice and support. The aim of this study is to assess the effect of a stop smoking strategy delivered by trained practice assistants after the cervical smear, and to evaluate the implementation process. Methods and analysis The study is a two-arm, pragmatic cluster randomised trial, in Dutch general practice. Randomisation takes place 1:1 at the level of the general practice. Practices either deliver the SUCCESS stop smoking strategy or the usual care condition. The strategy consists of brief stop smoking advice based on the Ask-Advise-Connect method and is conducted by trained practice assistants after routine cervical cancer screening. The primary outcome is the performance of a serious quit attempt in the 6 months after screening. Secondary outcomes are 7-day point prevalence abstinence, reduction in the number of cigarettes per day and transition in motivation to quit smoking. Follow-up for these measurements takes place after 6 months. Analysis on the primary outcome aims to detect a 10% difference between treatment arms (0.80 power, p=0.05, using a one-sided test), and will be performed according to the intention to treat principle. The process evaluation will assess feasibility, acceptability and barriers or enablers to the strategy's implementation. For this purpose, both qualitative and quantitative data will be collected via questionnaires and in-depth interviews, respectively, in both individual study participants and involved staff. Ethics and dissemination The Dutch Ministry of Health, Welfare and Sport approved of the trial after an advisory report from the Health Council (Nr. 2018/17). A licence was provided to conduct the study under the Population Screening Act. Study results will be disseminated through publications in peer-reviewed journals and conference presentations. Show less
Introduction Cervical cancer screening in general practice could be a routine moment to provide female smokers with stop smoking advice and support. The aim of this study is to assess the effect of... Show moreIntroduction Cervical cancer screening in general practice could be a routine moment to provide female smokers with stop smoking advice and support. The aim of this study is to assess the effect of a stop smoking strategy delivered by trained practice assistants after the cervical smear, and to evaluate the implementation process.Methods and analysis The study is a two-arm, pragmatic cluster randomised trial, in Dutch general practice. Randomisation takes place 1:1 at the level of the general practice. Practices either deliver the SUCCESS stop smoking strategy or the usual care condition. The strategy consists of brief stop smoking advice based on the Ask-Advise-Connect method and is conducted by trained practice assistants after routine cervical cancer screening. The primary outcome is the performance of a serious quit attempt in the 6 months after screening. Secondary outcomes are 7-day point prevalence abstinence, reduction in the number of cigarettes per day and transition in motivation to quit smoking. Follow-up for these measurements takes place after 6 months. Analysis on the primary outcome aims to detect a 10% difference between treatment arms (0.80 power, p=0.05, using a one-sided test), and will be performed according to the intention to treat principle. The process evaluation will assess feasibility, acceptability and barriers or enablers to the strategy’s implementation. For this purpose, both qualitative and quantitative data will be collected via questionnaires and in-depth interviews, respectively, in both individual study participants and involved staff. Show less
Bonten, T.N.; Verkleij, S.M.; Kleij, R.M.J.J. van der; Busch, K.; Hout, W.B. van den; Chavannes, N.H.; Numans, M.E. 2021
Introduction Lifestyle interventions are shown to be effective in improving cardiovascular disease (CVD) risk factors. It has been suggested that general practitioners can play an essential role in... Show moreIntroduction Lifestyle interventions are shown to be effective in improving cardiovascular disease (CVD) risk factors. It has been suggested that general practitioners can play an essential role in CVD prevention. However, studies into lifestyle interventions for primary care patients at high cardiovascular risk are scarce and structural implementation of lifestyle interventions can be challenging. Therefore, this study aims to (1) evaluate (cost-)effectiveness of implementation of an integrated group-based lifestyle programme in primary care practices; (2) identify effective intervention elements and (3) identify implementation determinants of an integrated group-based lifestyle intervention for patients with high cardiovascular risk. Methods and analysis The Healthy Heart study is a non-randomised cluster stepped-wedge trial. Primary care practices will first offer standard care during a control period of 2-6 months, after which practices will switch (step) to the intervention, offering participants a choice between a group-based lifestyle programme or standard care. Participants enrolled during the control period (standard care) will be compared with participants enrolled during the intervention period (combined standard care and group-based lifestyle intervention). We aim to include 1600 primary care patients with high cardiovascular risk from 55 primary care practices in the area of The Hague, the Netherlands. A mixed-methods process evaluation will be used to simultaneously assess effectiveness and implementation outcomes. The primary outcome measure will be achievement of individual lifestyle goals after 6 months. Secondary outcomes include lifestyle change of five lifestyle components (smoking, alcohol consumption, diet, weight and physical activity) and improvement of quality of life and self-efficacy. Outcomes are assessed using validated questionnaires at baseline and 3, 6, 12 and 24 months of follow-up. Routine care data will be used to compare blood pressure and cholesterol levels. Cost-effectiveness of the lifestyle intervention will be evaluated. Implementation outcomes will be assessed using the RE-AIM model, to assesses five dimensions of implementation at different levels of organisation: reach, efficacy, adoption, implementation and maintenance. Determinants of adoption and implementation will be assessed using focus groups consisting of professionals and patients. Ethics and dissemination This study is approved by the Ethics Committee of the Leiden University Medical Center (P17.079). Results will be shared with the primary care group, healthcare providers and patients, and will be disseminated through journal publications and conference presentations. Show less
Introduction Over a third of the world's population relies on solid fuels as their primary energy source. These fuels have damaging effects on health, air quality and forest resources.... Show moreIntroduction Over a third of the world's population relies on solid fuels as their primary energy source. These fuels have damaging effects on health, air quality and forest resources. Interventions to promote access to cleaner solid fuel cookstoves and clean fuels have existed for decades. However, the adoption by local communities has largely failed, which led to a waste of resources and suboptimal outcomes. Therefore, the objective of this umbrella review is to identify factors that determine implementation success for cleaner cooking interventions in low-resource settings and weigh their level of confidence in the evidence. Methods and analysis We identified systematic and narrative reviews examining factors that influence the acquisition, initial adoption or sustained use of cleaner solid fuel cookstoves and clean fuels at any scale by a literature search in PubMed, Embase, Global Health Database, Cochrane, PsycINFO, Emcare, Web of Science and CINAHL, without date or language restrictions. The search was conducted on 23 October 2017 and updated on 10 July 2019. Reviews based on qualitative, quantitative or mixed-methods studies were included and will be appraised using the Meta Quality Appraisal Tool combined with the Assessment of Multiple Systematic Reviews. Data will be extracted and factors affecting implementation will be coded using the Consolidated Framework for Implementation Research. The Grading of Recommendations Assessment, Development and Evaluation-Confidence in the Evidence from Reviews of Qualitative Research tool will be used to determine the level of confidence in the coded factors. Two researchers will independently conduct these steps. Ethics and dissemination This umbrella review does not require the approval of an ethical review board. Study results will be published in an international peer-reviewed journal. The outcomes will be converted into two practical tools: one for cleaner solid fuel cookstoves and one for clean fuels. These tools can guide the development of evidence-based implementation strategies for cleaner cooking interventions in low-income and middle-income countries to improve implementation success. These tools should be pilot-tested and promoted among regional and global initiatives. PROSPERO registration number CRD42018088687. Show less
