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.

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.