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Open Access Study protocol

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

Ilse F Badenbroek12*, Daphne M Stol12, Marcus MJ Nielen1, Monika Hollander2, Roderik A Kraaijenhagen3, G Ardine de Wit24, François G Schellevis15 and Niek J de Wit2

Author Affiliations

1 Netherlands Institute for Health Services Research (NIVEL), P.O. Box 1568, 3500 BN Utrecht, The Netherlands

2 Julius Center, University Medical Center Utrecht, Utrecht, The Netherlands

3 NDDO Institute for Prevention and Early Diagnostics (NIPED), Amsterdam, The Netherlands

4 Centre for Nutrition, Prevention and Health Care, National Institute of Public Health and the Environment (RIVM), Bilthoven, The Netherlands

5 Department of General Practice & Elderly Care Medicine/EMGO Institute for health and care research, VU University Medical Center, Amsterdam, The Netherlands

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BMC Family Practice 2014, 15:90  doi:10.1186/1471-2296-15-90

Published: 9 May 2014

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.

Keywords:
Cardiometabolic disease; Prevention; (Primary) screening; Non-participation; Primary care; Family practice; Effectiveness; Economic evaluation; RCT