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Design of the ZWOT-CASE study: an observational study on the effectiveness of an integrated programme for cardiovascular risk management compared to usual care in general practice.

ABSTRACT: BACKGROUND:Cardiovascular diseases (CVD) contribute considerably to mortality and morbidity. Prevention of CVD by lifestyle change and medication is important and needs full attention. In the Netherlands an integrated programme for cardiovascular risk management (CVRM), based on the Chronic Care Model (CCM), has been introduced in primary care in many regions in recent years, but its effects are unknown. In the ZWOT-CASE study we will assess the effect of integrated care for CVRM in the region of Zwolle on two major cardiovascular risk factors: systolic blood pressure (SBP) and low-density lipoprotein cholesterol (LDL-cholesterol) in patients with or at high risk of CVD. METHODS:This study is a pragmatic observational study comparing integrated care for CVRM with usual care among patients aged 40-80?years with CVD (n?=?370) or with a high CVD risk (n?=?370) within 26 general practices. After 1 yr follow-up, primary outcomes (SBP and LDL-cholesterol level) are measured. Secondary outcomes include lifestyle habits (smoking, dietary habits, alcohol use, physical activity), risk factor awareness, 10-year risk of cardiovascular morbidity or mortality, health care consumption, patient satisfaction and quality of life. CONCLUSION:The ZWOT-CASE study will provide insight in the effects of integrated care for CVRM in general practice in patients with CVD or at high CVD risk. TRIAL REGISTRATION:The ZWOlle Transmural Integrated Care for CArdiovaScular Risk Management Study; ClinicalTrials.gov ; Identifier: NCT03428061; date of registration: 09-02-2018; This study has been retrospectively registered.

SUBMITTER: Marchal S

PROVIDER: S-EPMC6825359 | biostudies-literature | 2019 Nov

REPOSITORIES: biostudies-literature

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Design of the ZWOT-CASE study: an observational study on the effectiveness of an integrated programme for cardiovascular risk management compared to usual care in general practice.

Marchal Suzanne S Hollander Monika M Schoenmakers Marieke M Schouwink Michiel M Timmer Jorik R JR Bilo Henk J G HJG Schwantje Olof O van 't Hof Arnoud W J AWJ Hoes Arno W AW

BMC family practice 20191101 1

<h4>Background</h4>Cardiovascular diseases (CVD) contribute considerably to mortality and morbidity. Prevention of CVD by lifestyle change and medication is important and needs full attention. In the Netherlands an integrated programme for cardiovascular risk management (CVRM), based on the Chronic Care Model (CCM), has been introduced in primary care in many regions in recent years, but its effects are unknown. In the ZWOT-CASE study we will assess the effect of integrated care for CVRM in the ...[more]

PMID: 31675925

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Project description:ObjectivesTo assess the potential cost-effectiveness of the 45-49 year old health check versus usual care in Australian general practice using secondary data sources.MethodRisk factor profiles were generated for a hypothetical Australian cohort using data from the National Health Survey. Intervention effects were modelled based on a meta-analysis on risk factor changes in the 5 years after a health check. The Framingham Risk Equation was applied to estimate the 5-year cardiovascular disease (CVD) incidence in the health check and usual care group respectively. A Markov model was then constructed to extrapolate long-term CVD outcomes, health care costs and Quality Adjusted Life Years (QALYs) in both groups. Health check-related costs, applied to the health check group, were estimated from clinical guideline and experts' opinion. Lifetime costs, applied to both groups, included costs of hospitalization for CVD events and associated post-event health service use. The Incremental Cost-Effectiveness Ratio (ICER) was calculated for male and female patients respectively.ResultsCompared to usual care, the health check reduced CVD incidence for both males (RR = 0.87) and females (RR = 0.91) over a 5-year time. In a lifetime projection, health check led to an average 0.008 and 0.003 QALYs gained per male and female participants respectively. The estimates ICERs were AU $42,355 and AU $133,504 per QALY gained for males and females, respectively. A probabilistic sensitivity analysis demonstrated a probability of cost-effectiveness of 17.5% and 0% for male and female attendees, assuming a willingness to pay threshold of AU $28,000 per QALY gained.ConclusionThe 45-49 year old health check is associated with a small expected QALY gain per participant, though the persons avoiding CVD events experience large health gains. The mean ICER is larger than an empirical estimate of the threshold ICER and the evaluated health check is highly unlikely to be cost-effective.

Project description:IntroductionThe prevalence of cardiovascular disease (CVD) is increasing. Furthermore, asymptomatic individuals may not receive timely preventive initiatives to minimise the risk of further CVD events. Paradoxically, 80% of CVD events are preventable by early detection, followed by prophylactic initiatives. Consequently, we introduced the population-based Viborg Screening Programme (VISP) for subclinical and manifest CVD, focusing on commonly occurring, mainly asymptomatic conditions, followed by prophylactic initiatives.The aim of the VISP was to evaluate the health benefits, harms and cost-effectiveness of the VISP from a healthcare sector perspective. Furthermore, we explored the participants' perspectives.Methods and analysisFrom August 2014 and currently ongoing, approximately 1100 men and women from the Viborg municipality, Denmark, are annually invited to screening for abdominal aortic aneurysm, peripheral arterial disease, carotid plaque, hypertension, diabetes mellitus and cardiac arrhythmia on their 67th birthday. A population from the surrounding municipalities without access to the VISP acts as a control. The VISP invitees and the controls are followed on the individual level by nationwide registries. The primary outcome is all-cause mortality, while costs, hospitalisations and deaths from CVD are the secondary endpoints.Interim evaluations of effectiveness and cost-effectiveness are planned every 5 years using propensity score matching followed by a Cox proportional hazards regression analysis by the 'intention-to-treat' principle. Furthermore, censoring-adjusted incremental costs, life-years and quality-adjusted life-years are estimated. Finally, the participants' perspectives are explored by semistructured face-to-face interviews, with participant selection representing participants with both negative and positive screening results.Ethics and disseminationThe VISP is not an interventional trial. Therefore, approval from a regional scientific ethical committee is not needed. Data collection from national registries was approved by the Regional Data Protection Agency (record no. 1-16-02-232-15). We ensure patient and public involvement in evaluating the acceptability of VISP by adopting an interviewing approach in the study.Trial registration numberNCT03395509.

Project description:To assess cost-effectiveness and cost utility of telerehabilitation (TR) versus standard rehabilitation (SR) after total knee replacement (TKR).Markov decision modelling of cost-effectiveness and cost-utility analysis based on patient-level and secondary data sources employing Italian National Health Service (NHS; Ita-NHS) and Society perspectives.Primary care units (PCUs) in Italy.Patients discharged after TKR.Mixed SR-TR service (10 face-to-face sessions and 10 telesessions) versus SR (20 face-to-face sessions)The incremental cost per additional knee flexion range of motion (ROM) and per QALY gained by SR-TR compared with SR. Second, we considered the probability of being cost-effective and the probability of being more effective and less expensive.TR appears to be the cost-effective in the base case and in all of the considered scenarios, but is no longer more effective and less expensive if transportation costs are excluded. Comparing SR-TR with SR, the incremental cost-effectiveness ratio (ICER) adopting the Ita-NHS perspective for the base case was -€117/ROM gained. The cost-effectiveness probability for SR-TR was 0.98 (ceiling ratio: €50/ROM), while the joint probability of being more effective and less expensive was 0.87. Assuming that TR would increase health-related quality of life (HRQOL) utilities by 2.5%, the ICER adopting Ita-NHS perspective is -€960/QALY (cost-effectiveness probability: 1; ceiling ratio: €30 000/QALY). All the performed sensitivity analyses did not change the conclusions, but if transportation costs were excluded, the probability for SR-TR of being more clinically effective and less expensive reduced to 0.56.The analysis suggested SR-TR to be cost-effective, even less expensive and more effective if the PCUs provide ambulance transportations. However, the uncertainty related to TR costs, HRQOL and long-term clinical outcomes raises important topics for future research, which should be addressed to confirm our estimates.ISRCTN45837371.

Project description:Objective To evaluate a "telephone first" approach, in which all patients wanting to see a general practitioner (GP) are asked to speak to a GP on the phone before being given an appointment for a face to face consultation.Design Time series and cross sectional analysis of routine healthcare data, data from national surveys, and primary survey data.Participants 147 general practices adopting the telephone first approach compared with a 10% random sample of other practices in England.Intervention Management support for workload planning and introduction of the telephone first approach provided by two commercial companies.Main outcome measures Number of consultations, total time consulting (59 telephone first practices, no controls). Patient experience (GP Patient Survey, telephone first practices plus controls). Use and costs of secondary care (hospital episode statistics, telephone first practices plus controls). The main analysis was intention to treat, with sensitivity analyses restricted to practices thought to be closely following the companies' protocols.Results After the introduction of the telephone first approach, face to face consultations decreased considerably (adjusted change within practices -38%, 95% confidence interval -45% to -29%; P<0.001). An average practice experienced a 12-fold increase in telephone consultations (1204%, 633% to 2290%; P<0.001). The average duration of both telephone and face to face consultations decreased, but there was an overall increase of 8% in the mean time spent consulting by GPs, albeit with large uncertainty on this estimate (95% confidence interval -1% to 17%; P=0.088). These average workload figures mask wide variation between practices, with some practices experiencing a substantial reduction in workload and others a large increase. Compared with other English practices in the national GP Patient Survey, in practices using the telephone first approach there was a large (20.0 percentage points, 95% confidence interval 18.2 to 21.9; P<0.001) improvement in length of time to be seen. In contrast, other scores on the GP Patient Survey were slightly more negative. Introduction of the telephone first approach was followed by a small (2.0%) increase in hospital admissions (95% confidence interval 1% to 3%; P=0.006), no initial change in emergency department attendance, but a small (2% per year) decrease in the subsequent rate of rise of emergency department attendance (1% to 3%; P=0.005). There was a small net increase in secondary care costs.Conclusions The telephone first approach shows that many problems in general practice can be dealt with over the phone. The approach does not suit all patients or practices and is not a panacea for meeting demand. There was no evidence to support claims that the approach would, on average, save costs or reduce use of secondary care.

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Design of the ZWOT-CASE study: an observational study on the effectiveness of an integrated programme for cardiovascular risk management compared to usual care in general practice.

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Design of the ZWOT-CASE study: an observational study on the effectiveness of an integrated programme for cardiovascular risk management compared to usual care in general practice.

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