Characteristics and motives of non-responders in a stepwise cardiometabolic disease prevention program in primary care.

BACKGROUND: A high response rate is an important condition for effective prevention programs. We aimed at gaining insight into the characteristics and motives of non-responders in different stages of a stepwise prevention program for cardiometabolic diseases (CMD) in primary care. METHODS: We performed a non-response analysis within a randomized controlled trial assessing the effectiveness of a stepwise CMD prevention program in the Netherlands. Patients between 45 and 70 years without known CMD were invited for stage 1 of the program, completing a CMD risk score. Patients with an increased risk were advised to visit their general practice for additional measurements, stage 2 of the program. We analyzed determinants of non-response using data from the risk score, electronic medical records, questionnaires and Statistics Netherlands. RESULTS: Non-response in stage 1 was associated with a younger age, male sex, a migration background, a low prosperity score, self-employment, being single and having lower consultations rates in general practice. Non-response in stage 2 was associated with a low prosperity score, being employed, having no chronic illness, smoking, a normal waist circumference, a negative family history for cardiovascular disease or diabetes and having a lower consultation rate. More than half of the non-responders in stage 2 reported not visiting the GP because they did not expect to have any CMD, despite their increased risk. CONCLUSIONS: To achieve a larger and more equal uptake of prevention programs for CMD, we should use methods adapted to characteristics of non-responders, such as targeted invitation methods and improved risk communication.

Cost-effectiveness of a stepwise cardiometabolic disease prevention program: results of a randomized controlled trial in primary care.

BACKGROUND: Cardiometabolic diseases (CMD) are the major cause of death worldwide and are associated with a lower quality of life and high healthcare costs. To prevent a further rise in CMD and related healthcare costs, early detection and adequate management of individuals at risk could be an effective preventive strategy. The objective of this study was to determine long-term cost-effectiveness of stepwise CMD risk assessment followed by individualized treatment if indicated compared to care as usual. A computer-based simulation model was used to project long-term health benefits and cost-effectiveness, assuming the prevention program was implemented in Dutch primary care. METHODS: A randomized controlled trial in a primary care setting in which 1934 participants aged 45-70 years without recorded CMD or CMD risk factors participated. The intervention group was invited for stepwise CMD risk assessment through a risk score (step 1), additional risk assessment at the practice in case of increased risk (step 2) and individualized follow-up treatment if indicated (step 3). The control group was not invited for risk assessment, but completed a health questionnaire. Results of the effectiveness analysis on systolic blood pressure (- 2.26 mmHg; 95% CI - 4.01: - 0.51) and total cholesterol (- 0.15 mmol/l; 95% CI - 0.23: - 0.07) were used in this analysis. Outcome measures were the costs and benefits after 1-year follow-up and long-term (60 years) cost-effectiveness of stepwise CMD risk assessment compared to no assessment. A computer-based simulation model was used that included data on disability weights associated with age and disease outcomes related to CMD. Analyses were performed taking a healthcare perspective. RESULTS: After 1 year, the average costs in the intervention group were 260 Euro higher than in the control group and differences were mainly driven by healthcare costs. No meaningful change was found in EQ 5D-based quality of life between the intervention and control groups after 1-year follow-up (- 0.0154; 95% CI - 0.029: 0.004). After 60 years, cumulative costs of the intervention were 41.4 million Euro and 135 quality-adjusted life years (QALY) were gained. Despite improvements in blood pressure and cholesterol, the intervention was not cost-effective (ICER of 306,000 Euro/QALY after 60 years). Scenario analyses did not allow for a change in conclusions with regard to cost-effectiveness of the intervention. CONCLUSIONS: Implementation of this primary care-based CMD prevention program is not cost-effective in the long term. Implementation of this program in primary care cannot be recommended. TRIAL REGISTRATION: Dutch Trial Register NTR4277 , registered on 26 November 2013.

The association between GP organisational factors and the effectiveness of a prevention programme for cardiometabolic diseases: a prospective intervention study.

BACKGROUND: Owing to the rising disease burden of cardiometabolic diseases (CMD), prevention programmes for CMD are increasingly implemented in primary care. Organisational practice characteristics and availability of preventive services may be associated with a more effective programme. AIM: To identify possible organisational success factors from general practices related to an effective primary prevention programme for CMD. DESIGN & SETTING: A prospective intervention study involving 37 Dutch general practices was undertaken. METHOD: Patients aged 45-70 years without known CMD, hypertension, or hypercholesterolemia were invited for the prevention programme. The outcome measures were an improvement (yes/no) in four different CMD risk factors between baseline and 1-year follow-up on an individual level (body mass index [BMI], smoking, systolic blood pressure, and cholesterol ratio). Multivariate logistic regression analysis was used for assessing associations between practice organisational characteristics and outcomes. RESULTS: Just over half of the participants showed an improvement on one or more risk factors. Marginal differences were found in the four different outcomes between the practices with different organisational characteristics. None of the practice characteristics that were tested showed a significant association with an improvement in one of the outcome measures. CONCLUSION: In this study, general practice organisational and preventive service characteristics showed no impact on the effectiveness of a CMD prevention programme. Possible explanations could be the effectiveness of protocolised pharmaceutical treatment and only limited contribution of lifestyle programmes on the improvement of CMD risk factors.

Feasibility and success rates of response enhancing strategies in a stepwise prevention program for cardiometabolic diseases in primary care.

BACKGROUND: Prevention programs for cardiometabolic diseases (CMD), including cardiovascular disease, diabetes mellitus and chronic kidney disease are feasible, but evidence for the cost-effectiveness of selective CMD prevention programs is lacking. Response rates have an important role in effectiveness, but methods to increase response rates have received insufficient attention. The aim of the current study is to determine the feasibility and the success rate of a variety of response enhancing strategies to increase the participation in a selective prevention program for CMD. METHODS: The INTEGRATE study is a Dutch randomised controlled trial to assess the effectiveness and cost-effectiveness of a stepwise program for CMD prevention. During the INTEGRATE study we developed ten different response enhancing strategies targeted at different stages of non-response and different patient populations and evaluated these in 29 general practices. RESULTS: A face-to-face reminder by the GP increased the response significantly. Digital reminders targeted at patients with an increased CMD risk showed a positive trend towards participation. Sending invitations and reminders by e-mail generated similar response rates, but at lower costs and time investment than the standard way of dissemination. Translated materials, information gatherings at the practice, self-management toolkits, reminders by telephone, information letters, local media attention and SMS text reminders did not increase the response to our program. CONCLUSIONS: Inviting or reminding patients by e-mail or during GPs consultation may enhance response rates in a selective prevention program for CMD. Different response-enhancing strategies have different patient target populations and implementation issues, therefore practice characteristics need to be taken into account when implementing such strategies. TRIAL REGISTRATION: Dutch trial Register number NTR4277 . Registered 26 November 2013.

Mapping non-response in a prevention program for cardiometabolic diseases in primary care: How to improve participation?

Non-response in prevention programs for cardiometabolic diseases (CMD) in primary care is often overlooked. The aim for this study was to define factors that influence the primary response to a selective CMD prevention program and to determine response-enhancing strategies that influence the willingness to participate. We conducted a non-response analysis within a randomized controlled trial evaluating a selective CMD prevention program, the study was conducted from 2013 to 2018 in Netherlands. A random sample of 5616 patients from 15 general practices were invited to complete a risk score (RS) as initial step of the program. Non-responders received an additional questionnaire. The response on the risk score was 51% (n = 2872). From the 3558 non-response questionnaires sent, 786 (22%) were returned. In a multivariable multilevel regression analysis smoking was independently associated with non-response. Of all reported reasons for non-response 'forgot/no time' accounted for 45%. In total, 73% of the non-responders indicated to reconsider participation when approached differently. A personal approach by the patients' own GP, using advertisements and informative campaigns are potentially the best methods to enhance the response. Although a relatively high proportion did not respond to the invitation for the risk score, the majority of them indicated to be willing to participate if a different invitation strategy would be used. With more time and energy, response rates for CMD prevention programs could possibly increase substantially. A next logical step in this process is to test potential response enhancing strategies in research setting.

Effectiveness of a stepwise cardiometabolic disease prevention program: Results of a randomized controlled trial in primary care.

Effective preventive strategies for cardiometabolic disease (CMD) are needed. We aim to establish the effectiveness of a stepwise CMD risk assessment followed by individualized treatment if indicated compared to care as usual. We conducted a RCT between 2014 and 2017. Individuals (45-70 years) without CMD or CMD risk factors were invited for stepwise CMD risk assessment through a risk score (step1), additional risk assessment at the practice in case of high-risk (step2) and individualized follow-up treatment if indicated (step3). We compared newly detected CMD and newly prescribed drugs during one-year follow-up, and change in CMD risk profile between baseline and one-year follow-up among participants who completed step2 to matched controls. A CMD was diagnosed almost three times more often (OR 2.90, 95% CI 2.25: 3.72) in the intervention compared to the control group, in parallel with newly prescribed antihypertensive and lipid lowering drugs (OR 2.85, 95% CI 1.96: 4.15 and 3.23, 95% CI 2.03: 5.14 respectively). Waist circumference significantly decreased between the intervention compared to the control group (mean -3.08 cm, 95% CI -3.73: -2.43). No differences were observed for changes in BMI and smoking. Systolic blood pressure (mean -2.26 mmHg, 95% CI -4.01: -0.51) and cholesterol ratio (mean -0.11, 95% CI -0.19: -0.02) significantly decreased within intervention participants between baseline and one-year follow-up. In conclusion, implementation of the CMD prevention program resulted in the detection of two- to threefold more patients with CMD. A significant drop in systolic blood pressure and cholesterol levels was found after one year of treatment. Modelling of these results should confirm the effect on long term endpoints. Trial registration: Dutch trial Register number NTR4277.

Uptake and detection rate of a stepwise cardiometabolic disease detection program in primary care-a cohort study.

BACKGROUND: Early detection and treatment of cardiometabolic diseases (CMD) in high-risk patients is a promising preventive strategy to anticipate the increasing burden of CMD. The Dutch guideline 'the prevention consultation' provides a framework for stepwise CMD risk assessment and detection in primary care. The aim of this study was to assess the outcome of this program in terms of newly diagnosed CMD. METHODS: A cohort study among 30 934 patients, aged 45-70 years without known CMD or CMD risk factors, who were invited for the CMD detection program within 37 general practices. Patients filled out a CMD risk score (step 1), were referred for additional risk profiling in case of high risk (step 2) and received lifestyle advice and (pharmacological) treatment if indicated (step 3). During 1-year follow-up newly diagnosed CMD, prescriptions and abnormal diagnostic tests were assessed. RESULTS: Twelve thousand seven hundred and thirty-eight patients filled out the risk score of which 865, 6665 and 5208 had a low, intermediate and high CMD risk, respectively. One thousand seven hundred and fifty-five high-risk patients consulted the general practitioner, in 346 of whom a new CMD was diagnosed. In an additional 422 patients a new prescription and/or abnormal diagnostic test were found. CONCLUSIONS: Implementation of the CMD detection program resulted in a new CMD diagnosis in one-fifth of high-risk patients who attended the practice for completion of their risk profile. However, the potential yield of the program could be higher given the considerable number of additional risk factors-such as elevated glucose, blood pressure and cholesterol levels-found, requiring active follow-up and presumably treatment in the future.

Implementation of selective prevention for cardiometabolic diseases; are Dutch general practices adequately prepared?

OBJECTIVE: Current guidelines acknowledge the need for cardiometabolic disease (CMD) prevention and recommend five-yearly screening of a targeted population. In recent years programs for selective CMD-prevention have been developed, but implementation is challenging. The question arises if general practices are adequately prepared. Therefore, the aim of this study is to assess the organizational preparedness of Dutch general practices and the facilitators and barriers for performing CMD-prevention in practices currently implementing selective CMD-prevention. DESIGN: Observational study. SETTING: Dutch primary care. SUBJECTS: General practices. MAIN OUTCOME MEASURES: Organizational characteristics. RESULTS: General practices implementing selective CMD-prevention are more often organized as a group practice (49% vs. 19%, p = .000) and are better organized regarding chronic disease management compared to reference practices. They are motivated for performing CMD-prevention and can be considered as 'frontrunners' of Dutch general practices with respect to their practice organization. The most important reported barriers are a limited availability of staff (59%) and inadequate funding (41%). CONCLUSIONS: The organizational infrastructure of Dutch general practices is considered adequate for performing most steps of selective CMD-prevention. Implementation of prevention programs including easily accessible lifestyle interventions needs attention. All stakeholders involved share the responsibility to realize structural funding for programmed CMD-prevention. Aforementioned conditions should be taken into account with respect to future implementation of selective CMD-prevention. Key Points  There is need for adequate CMD prevention. Little is known about the organization of selective CMD prevention in general practices.  â€¢ The organizational infrastructure of Dutch general practices is adequate for performing most steps of selective CMD prevention.  â€¢ Implementation of selective CMD prevention programs including easily accessible services for lifestyle support should be the focus of attention.  â€¢ Policy makers, health insurance companies and healthcare professionals share the responsibility to realize structural funding for selective CMD prevention.

Design of the INTEGRATE study: effectiveness and cost-effectiveness of a cardiometabolic risk assessment and treatment program integrated in primary care.

BACKGROUND: The increasing prevalence of cardiometabolic disease (CMD) in combination with an ageing population is a major public health problem. Early detection and management of individuals at risk for CMD is required to prevent future health problems with associated costs. General practice is the optimal health care setting to accomplish this goal. Prevention programs for identification and treatment of patients with an increased risk for CMD in primary care have been proven feasible. However, the effectiveness and cost-effectiveness have yet to be demonstrated. The 'Personalized Prevention Approach for CardioMetabolic Risk' (PPA CMR) is such a prevention program. The objective of the INTEGRATE study is to investigate the effectiveness and cost-effectiveness of PPA CMR, as well as to establish determinants for participation and compliance. METHODS: The INTEGRATE study is designed as a stepped-wedge randomized controlled trial with a waiting list control group. In approximately 40 general practices, all enlisted patients without CMD aged 45-70 years, are invited to participate in PPA CMR. After an online risk estimation, patients with a score above risk threshold are invited to the GP for additional measurements, detailed risk profiling and tailored treatment of risk factors through medication and/or lifestyle counseling. At baseline and after twelve months of follow-up lifestyle, health and work status of all participants are established with online questionnaires. Additionally after twelve months, we will determine health care utilization, costs of PPA CMR and compliance. Primary endpoints are the number of newly detected patients with CMD and changes in individual risk factors between the intervention and waiting list control group. Medical data will be extracted from the GPs' electronic medical records. In order to assess factors related to participation, we will send questionnaires to non-participants and assess characteristics of participating practices. For all participants, additional demographic characteristics will be available through Statistics Netherlands. DISCUSSION: The INTEGRATE study will provide insight into the effectiveness and cost-effectiveness of PPA CMR as well as determinants for participation and compliance, which represents essential information to guide further large-scale implementation of primary prevention programs for CMD. TRIAL REGISTRATION NUMBER: NTR4277, The Netherlands National Trial Register, 26-11-2013.