Updates are available Correction dated 2024-12-27

Article History

Received: 19 April 2022

Accepted: 4 May 2022

First Online: 5 July 2022

Change Date: 23 December 2024

Change Type: Update

Change Details: The original online version of this article was revised: the authors reported errors in the ‘Method’ section and ‘Ethics approval and consent to participate’.

Change Date: 27 December 2024

Change Type: Correction

Change Details: A Correction to this paper has been published:

Change Details: https://doi.org/10.1186/s12875-024-02694-w

Declarations

:

: The protocol for this study has been reviewed and approved by the Drug Research Committee (CEIm) at the IDIAP Jordi Gol, code CEIm 21/051-P to ensure its safety. There is no risk of participating in this study.The IMA-cRCT is a low-intensity intervention clinical trial conducted solely in Spain, where groups of subjects are allocated to the intervention groups. The benefit of participating in this research study is to contribute to the development of strategies to improve initiation of prescribed treatments for CVD and diabetes. Therefore, informed consent will be obtained by simplified means. Simplified informed consent requires that the same information stated under the Article 30 of the Regulation (EU) No 536/2014 [] is provided before anyone is enrolled in the trial, and after being informed, the patient does not object to participate. Therefore, no written informed consent will be obtained as approved by the CEIm Idiap Jordi Gol (CEIm 21/051-P) National Spanish Law is in line with the European regulation regarding the simplified means for obtaining informed consent. All conditions described in Regulation (EU) No 536/2014 [] and the Real Decreto 1090/2015 [] are fulfilled.Following the indications of the Idiap Jordi Gol Clinical Research Ethics Committee, informed consent in the present study will be obtained by displaying posters in prominent locations of the participating PC centres notifying people that a clinical trial is being conducted in the centre and that patients could be part of this comparative study. The posters will contain information on how and why the trial is being conducted and what the implications of participating in the study are. Potential participants are assured that there is no risk to taking part in the study and it will be clearly stated that patients can request extra information and decline to participate in the study. Furthermore, professionals in the intervention and control PC teams will be trained to deal with patients’ queries regarding the study. Finally, if patients decline to participate in the study, this information will be documented by physicians in the electronic health records and data from those patients will not be used for the trial. Furthermore, patients can withdraw at any time from the clinical trial without any detriment.Participation of healthcare professionals is entirely voluntary. All healthcare professionals participating in the study will sign an informed consent at the time of the first training session. They have the right to refuse to participate and to withdraw from the study at any time.All deviations from the study protocol will be detailed in the methods section of all papers presenting results from the trial. The trial registry on ClinicalTrials.gov will be modified accordingly.

: Not applicable.

: The authors declare that they have no competing interests.