Targeted prevention in primary care aimed at lifestyle-related diseases: a study protocol for a non-randomised pilot study

Lars Bruun Larsen, Anders Larrabee Sonderlund, Jens Sondergaard, Janus Laust Thomsen, Anders Halling, Niels Christian Hvidt, Elisabeth Assing Hvidt, Troels Mønsted, Line Bjornskov Pedersen, Ewa M Roos, Pia Vivian Pedersen, Trine Thilsing, Lars Bruun Larsen, Anders Larrabee Sonderlund, Jens Sondergaard, Janus Laust Thomsen, Anders Halling, Niels Christian Hvidt, Elisabeth Assing Hvidt, Troels Mønsted, Line Bjornskov Pedersen, Ewa M Roos, Pia Vivian Pedersen, Trine Thilsing

Abstract

Background: The consequences of lifestyle-related disease represent a major burden for the individual as well as for society at large. Individual preventive health checks to the general population have been suggested as a mean to reduce the burden of lifestyle-related diseases, though with mixed evidence on effectiveness. Several systematic reviews, on the other hand, suggest that health checks targeting people at high risk of chronic lifestyle-related diseases may be more effective. The evidence is however very limited. To effectively target people at high risk of lifestyle-related disease, there is a substantial need to advance and implement evidence-based health strategies and interventions that facilitate the identification and management of people at high risk. This paper reports on a non-randomized pilot study carried out to test the acceptability, feasibility and short-term effects of a healthcare intervention in primary care designed to systematically identify persons at risk of developing lifestyle-related disease or who engage in health-risk behavior, and provide targeted and coherent preventive services to these individuals.

Methods: The intervention took place over a three-month period from September 2016 to December 2016. Taking a two-pronged approach, the design included both a joint and a targeted intervention. The former was directed at the entire population, while the latter specifically focused on patients at high risk of a lifestyle-related disease and/or who engage in health-risk behavior. The intervention was facilitated by a digital support system. The evaluation of the pilot will comprise both quantitative and qualitative research methods. All outcome measures are based on validated instruments and aim to provide results pertaining to intervention acceptability, feasibility, and short-term effects.

Discussion: This pilot study will provide a solid empirical base from which to plan and implement a full-scale randomized study with the central aim of determining the efficacy of a preventive health intervention.

Trial registration: Registered at Clinical Trial Gov (Unique Protocol ID: TOFpilot2016 ). Registered 29 April 2016. The study adheres to the SPIRIT guidelines.

Keywords: Intersectoral collaboration; Primary care; Targeted health checks.

Conflict of interest statement

Ethics approval and consent to participate

The study adheres to the SPIRIT guidelines and has been approved by the Danish Data Protection Agency (J.nr 2015–57-0008) and registered at Clinical Trial Gov (Unique Protocol ID: TOFpilot2016). According to Danish regulations (Act on Research Ethics Review of Health Research Projects (section 14,2)) this study does not need approval from a health research ethics committee as no research on human tissue or other biological material is performed. The study complies with the Helsinki declaration with informed consent to study participation and to disclosure of data from the GPs EPR obtained from all participants before enrolment. Participants were asked to read the information and electronically sign the consent form that was supplemented with short videos of the principal investigator and a GP describing the purpose of the study and the intervention. Before linking project data and national registers from Statistics Denmark participants will be pseudomized. Data management and data analysis of quantitative data will be performed on secure servers at Statistics Denmark.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Screen dump from digital support system (in Danish)

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