Background Cardiovascular diseases (CVD) caused 17.9 million deaths worldwide in 2016, being the world’s leading cause of death. Prevention of CVD in high-income countries is expensive and fails to reach the population at risk. In low-income countries, it is under-developed. The SPICES project implements a community-based program to improve CVD prevention in 3 European countries and 2 Sub-Saharan countries, based on using community champions to effect behavioural changes. In France, the project operates in “Pays Centre Ouest Bretagne” (COB) which is the Central West Brittany area, and a vulnerable, rural setting. The aim of this study is to assess this innovative prevention strategy versus brief advice. Methods A two-step RCT hybrid type 1 implementation study will first of all screen a population using the Non-Laboratory INTERHEART Score (NL-IHRS) and will involve health-care students at public events in the COB area until 1000 participants have been recruited. Second, a RCT will be carried out. The research team will contact each participant with an intermediate NL-IHRS in order to include them. Participants will be over 18 years of age and work or live in the COB area. Participants will be equally randomised in two groups. The intervention group will receive brief advice plus behavioural change guidance carried out by community champions. The control group will receive brief advice only. The main objective for the RCT is to assess a difference of at least 15% in the NL-IHRS between the two groups after 24 months. The primary outcome will be analysed with intention to treat. Secondary outcomes for the RCT will be assessed using validated questionnaires: the WHOQOL-BREF, the DASH Q questionnaire, the IPAQ-short; smoking level will be assessed according to the NL-IHRS scoring system; a modified self-declared alcohol consumption questionnaire has been developed and gauges will be used to assess BMI. The implementation strategy will use mixed methods: qualitative research methods and quantitative epidemiological studies. Discussion A difference in the mean NL-IHRS of 15% will provide an argument in favour of reorganising prevention policies. A substantial change would favour relocating primary prevention from healthcare professionals to lay people and the community. Trial registration Clinical Trials NCT03886064 - the study was recorded on ClinicalTrials.gov, the 22nd of March 2019.
BackgroundIn 2019, cardiovascular diseases (CVD) caused 32% of deaths worldwide. The SPICES survey involved five countries in an international primary CVD prevention implementation study in the general population. The French SPICES survey was implemented in the Centre Ouest Bretagne area (COB), which is a rural, economically deprived, medically underserved territory with high cardiovascular mortality. A CVD screening in the general population was needed to select the implementation population without overburdening family practitioner (FP) workforces. The efficacy and the replicability of such a screening were unknown. The aims of this study were to identify the characteristics of the individuals undergoing CVD risk assessment with the Non-Laboratory Interheart risk score (NL-IHRS), and to identify barriers and explore facilitators when screening the general population.MethodsAn implementation study combining a cross-sectional descriptive study with qualitative interviews was undertaken. The NL-IHRS was completed by trained screeners selected from health students, pharmacists, nurses, and physiotherapists in the area with a dedicated e-tool in sport and cultural events and public places. After the screening, all screener groups were interviewed until theoretical saturation for each group. Thematic analysis was performed using double-blind coding.ResultsIn 5 months, 3,384 assessments were undertaken in 60 different places, mostly by health students. A total of 1,587, 1,309, and 488 individuals were at low, moderate, and high CVD risk. Stressed or depressed individuals were remarkably numerous (40.1 and 24.5% of the population, respectively). Forty-seven interviews were conducted. The main facilitators were willingness of the population, trust between screeners and the research team, and media publicity. The main barriers were lack of motivation of some screeners, some individuals at risk, some stakeholders and difficulties in handling the e-tool.ConclusionThe efficacy of CVD risk screening while using mostly health students was excellent and preserved the FP workforce. Replicability was highly feasible if research teams took great care to establish and maintain trust between screeners and researchers. The e-tools should be more user-friendly.
Background: the European General Practitioners Research Network (EGPRN) designed and validated a comprehensive definition of multimorbidity using a systematic literature review and qualitative research throughout Europe. Detecting risk factors for decompensation would be an interesting challenge for family physicians (FPs) in the management of multimorbid patients. The purpose of the survey was to assess which items belonging to the EGPRN multimorbidity definition could help to identify patients at risk of decompensation in a cohort pilot study over a 24-month follow-up among primary care outpatients. Method : 131 patients meeting the multimorbidity definition were included using two inclusion periods between 2014 and 2015. Over a 24-month follow-up, the « decompensation » or « nothing to report » status was collected. A logistic regression, following a Cox model, was then performed to identify risk factors for decompensation. Results : After 24 months of follow-up, 120 patients were analyzed. 3 clusters were identified. 44 patients, representing 36.6 % of the population, were still alive and had not been hospitalized for a period exceeding 6 days. Two variables were significantly linked to decompensation: the number of visits to the FP per year (HR 1.06, IC 95 %, 1,03-1,10, p-value <0,001) and the total number of diseases (HR 1,12, IC 95 %, 1,013-1,33, p-value = 0,039). Conclusion: FPs should be aware that a high number of consultations and a high total number of diseases are linked to severe outcomes such as death or unplanned hospitalization. A large-scale cohort in primary care seems feasible to confirm these results.
Background Colorectal cancer (CRC) is the second leading cause of cancer death in France (17,712 annual deaths). However, this cancer is preventable in the majority of cases by the early detection of adenomas. In France, the organized screening for CRC relies on general practitioners (GPs). The tests delivered by the GPs are carried out in 89% of cases. However, GPs do not systematically offer the test, because of time management and communication. Methods AmDepCCR is a cluster randomized trial. Patients are prospectively included by their GPs. The study is designed in 2 phases for the GPs: first, GPs who have never participated in motivational interviewing (MI) training will be recruited then randomly split in 2 groups. Secondly, a 6-day motivational interviewing training will be carried out for the intervention group. Then, patients will be included in both groups during a period of 1 year. The primary outcome will be the number of CRC screenings achieved in each group and its difference. The secondary outcome will be the reluctance to screening and the patient’s self-estimated life expectancy at 0, 6, 12, and 24 months using the Health Belief Model (HBM). Discussion This study will help to know if GPs motivational interviewing is useful to improve organized CRC screening. In addition, it may help to improve communication between patients and GPs. GPs will be able to improve their practice in other fields of application through motivational interviewing (other screenings, addictions…). Trial registration 2019-A01776-51 NCT04492215.
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