The effectiveness and cost-effectiveness of an integrated cardio-metabolic risk assessment and treatment program in primary care: the INTEGRATE study

The INTEGRATE study aims at contributing to the reduction of cardio-metabolic morbidity and mortality by establishing the effectiveness and cost-effectiveness of established procedures for identifying persons at high risk for cardio-metabolic diseases, followed by an individually tailored intervention including lifestyle advice and treatment. This is called the “Personalized Prevention Approach for cardio-metabolic risk” [PPA CMR]. Although elements of PPA CMR are theoretically evidence based and have been tested on their feasibility, the (cost)effectiveness of the entire program needs to be established urgently to justify a wide scale implementation. The increasing prevalence of cardio-metabolic diseases is a major health problem in developed countries and mainly caused by an unhealthy lifestyle. Smoking, obesity and physical inactivity are responsible for about one quarter of the disease burden of the Dutch population. The need for early detection and management of persons at risk for these disorders is urgent in order to prevent future health problems. Recent studies have shown that screening for cardio-metabolic disorders could be more efficient when embedded in primary care. PPA CMR is built on two existing prevention programs. PreventieConsult CMR (PC CMR) aims at identifying persons at high risk for cardio-metabolic diseases and guide these persons to indicated risk reduction interventions. PreventieKompas (PK) is an internet based system for personal risk profiling aiming to detect high risk individuals and to raise awareness, to educate, motivate and empower individuals to promote their own health. PK offers users a personal health plan with a link to best-practice interventions. PPA CMR includes the risk assessment according to the PC CMR and the lifestyle intervention of the PK. In the INTEGRATE study the (cost)effectiveness of PPA CMR will be assessed in terms of cardio-metabolic morbidity, cardio-metabolic risk profile, and lifestyle by studying: 1) the number of newly detected cardio-metabolic diseases and changes in risk factors for cardio-metabolic diseases in one year, and the related costs and benefits of PPA CMR; 2) the number and profile of participants and non participants in the PPA CMR. The INTEGRATE study is a randomized controlled trial with a waiting list control group (‘stepped wedge design’). Eligible persons (aged 45-70 without a known cardio-metabolic disorder) in 60 general practices (estimated N= 28,800) will be allocated at random at practice level to an intervention group or a waiting list control group and will be invited by their personal general practitioner (GP) to participate in the study by giving informed consent. PPA CMR includes a stepwise assessment of the cardio-metabolic risk and lifestyle, followed by an individually tailored intervention including lifestyle advice and treatment according to existing clinical practice guidelines if applicable. In half of the participating practices high risk patients are treated in an integrated life-style intervention program, while in the other half of the practices high risk patients receive care as usual (non-integrated program). The control group will be invited to participate in the PPA CMR 12 months after a baseline risk estimation and lifestyle assessment. The effectiveness of the PPA CMR will be established on the basis of the difference between the intervention and control group in the number of newly detected cardio-metabolic diseases, changes in cardio-metabolic risk, and changes in lifestyle after 12 months. Also, the effect on cardio-metabolic morbidity and mortality extrapolated to 5, 10, 20 years and lifetime will be estimated using a Markov-type population based model. The cost-effectiveness of PPA CMR will be established on the basis of incremental cost-utility ratios (ICER). ICERs will be generated by calculating the net incremental costs of PPA CMR, including follow-up interventions to change lifestyle and pharmaceutical interventions to change biological risk factors, compared to the control group, divided by the incremental effects in terms of Quality Adjusted Life Years gained. Data on newly detected cardio-metabolic diseases will be provided by the GP in addition to Electronic Medical Record (EMR) data. Cardio-metabolic risk includes the risk score on a risk estimation questionnaire based on the FINDRISK. Lifestyle behavior (smoking, physical activity, nutrition) will be measured via questionnaires with validated instruments. Data about medication use and biomedical tests will be derived from EMRs. Data about participation will be derived from the number of invitees and respondents in the PPA CMR. A questionnaire will be sent to a random sample of 1,500 non-responders on the first invitation to examine reasons for non-participation. All questionnaires can be completed online or on paper, and will be available in Dutch, English, Turkish and Moroccan to lower the threshold for participation.