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01.12.2014 | Study protocol | Ausgabe 1/2014 Open Access

BMC Family Practice 1/2014

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

Zeitschrift:
BMC Family Practice > Ausgabe 1/2014
Autoren:
Ilse F Badenbroek, Daphne M Stol, Marcus MJ Nielen, Monika Hollander, Roderik A Kraaijenhagen, G Ardine de Wit, François G Schellevis, Niek J de Wit
Wichtige Hinweise

Electronic supplementary material

The online version of this article (doi:10.​1186/​1471-2296-15-90) contains supplementary material, which is available to authorized users.
Ilse F Badenbroek, Daphne M Stol contributed equally to this work.
An erratum to this article is available at http://​dx.​doi.​org/​10.​1186/​s12875-016-0438-7.

Competing interests

All authors declare that they have no competing interests.

Authors’ contributions

MN, MH, FS and NW wrote the study proposal and obtained funding for the study. IB and DS wrote the final manuscript for the study protocol. IB, DS, MN and MH will conduct the study. FS, NW, RK, GW participate in the coordination and supervision of the study. The manuscript for the study protocol was discussed, edited and revised by all authors. All authors read and approved the final manuscript.

Abstract

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.
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