DECADE-pilot: decision aid, action planning, and follow-up support for patients to reduce the 10-year risk of cardiovascular diseases—a protocol of a randomized controlled pilot trial

Tinsel, Iris; Siegel, Achim; Schmoor, Claudia; Buchholz, Anika; Niebling, Wilhelm

doi:10.1186/s40814-017-0172-5

Cited by 6 publications

(5 citation statements)

References 33 publications

(41 reference statements)

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“…We have not synthesised data derived on enabling resources with regard to the effectiveness of the different approaches. Individual studies, however, were designed to prove effectiveness of specific resources available to GP teams such as the adherence to guidelines and its association with patient health outcomes (Klement A. et al., 2015), subjectively perceived support from quality circles (Heddaeus et al., 2015) or the feasibility to integrate digital tools and printed health information for patient counselling (Tinsel et al., 2017).…”

Section: Discussionmentioning

confidence: 99%

Preventive and health‐promoting activities in general practices in Germany: A scoping review

Dieckelmann

Schütze

Gerber

et al. 2022

Health Social Care Comm

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General practices are rooted in the local community and considered to be particularly well‐positioned for engaging in preventive and health‐promoting activities. The overall aim of the scoping review is to identify priorities and gaps in research published in the past 20 years on preventive and health‐promoting activities provided by general practitioners or their teams in general practices in Germany. MEDLINE and Embase databases were systematically searched in November 2020. Papers were selected in dual‐review mode and extracted in single‐review mode. Data analysis was finished by May 2021. In total, 530 papers were included in the synthesis. Little research has been carried out into collaboration opportunities both within the general practice team and in communities as a whole, with specialists (18%), hospitals (9%), and health insurance companies (6%) being the most frequent cooperation partners of GPs. 15%–20% of papers each dealt with ‘early detection’, ‘information provision’ and ‘cardiovascular prevention’. Secondary (53%) and tertiary prevention (43%) was more often the subject of research than primary (39%) and quaternary prevention (15%). Healthy subjects (26%) were less often studied than people with pre‐existing conditions (42%) and risk factors (48%). Little information was available on preventive activities in terms of gender, young people, migration background, housing conditions or educational background. Personal counselling (15%) was the most frequently described approach to health promotion in general practices, along with printed information materials (10%). This scoping review provides information on which to base targeted interventions and future research that can contribute towards transforming general practices into promoters of health within the community.

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Section: Discussionmentioning

confidence: 99%

Preventive and health‐promoting activities in general practices in Germany: A scoping review

Dieckelmann

Schütze

Gerber

et al. 2022

Health Social Care Comm

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“…In the iterative development process of the DECADE intervention, we involved outpatients and general population with lifestyle-related CVR factors, GPs and other experts to assess DECADE interventions in interviews, group discussions and in written form (see German Clinical Trial Register: https://www.drks.de/drks_web/setLocale_EN.do with the IDs: DRKS00003554; DRKS00010584, DRKS00025128). The process and results of the intervention development were presented and discussed in scientific congresses48–51 and published in open access 41 52. Especially qualitative assessments were used to improve the GP communication training and the technical usability of the DECADE website.…”

Section: Methods and Analysismentioning

confidence: 99%

Encouragement of patients’ self-management in primary care for the prevention of cardiovascular diseases (DECADE): protocol for a cluster randomised controlled trial

et al. 2023

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IntroductionCardiovascular diseases are the most common cause of death in Germany and among the most frequent reasons for encounters in primary care. Most patients with cardiovascular risks (CVRs) have difficulties implementing health-promoting behavioural changes. In this study, a complex intervention containing evidence-based patient materials and structured follow-up consultations are intended to strengthen patients’ self-management to improve health behaviour.Methods and analysisIn this cluster randomised controlled trial, we investigate the effects of the intervention "Decision aid, action planning and follow-up support for patients to reduce the 10-year risk of cardiovascular diseases" (DECADE) using a 2×2 design. All patients, including the control group (CG), receive a CVR calculation. Three intervention groups (IGs) receive one or both of two different components of the DECADE intervention: IG1 (patient materials), IG2 (follow-up consultations) and IG3 (patient materials and follow-up consultations). The study was planned to be conducted with 77 general practitioners in 3 German regions and a target sample size of 924 patients. The observation period for each patient amounts to 12 months with three patient surveys: baseline (t0), after 6 and 12 months (t1 and t2). The primary outcome is patient activation (Patient Activation Measure 13 (PAM13-D)) at t1. Secondary outcomes include PAM13-D at t2 and further patient-reported and clinical outcomes at t1 and t2. We will also analyse the cost-effectiveness of the intervention, the degree of usage and satisfaction with the intervention.Ethics and disseminationThe study was first approved by the lead ethics committee of the University of Freiburg on 15 April 2021 (vote number: 21-1078) and subsequently by the other ethics committees in the study regions (Ethics committee of medical association Baden-Württemberg (B-F-2021-078), Ethics Committee of the Technische Universität Dresden, Dresden (BO-EK-251052021), Ethics Committee of the State Chamber of Physicians of Saxony (EK-BR-92/21-1), Ethics Committee of the Hamburg Medical Association (2021-200013-BO-bet)). Informed consent is required for patients to participate in the study. The results of this study will be published in peer-reviewed journals and presented at congresses by the DECADE team. The DECADE lead management will communicate the results to the funder of this study.Trial registration numberGerman Clinical Trials Register, DRKS00025401 (registration date: 21 June 2021); International Clinical Trials Registry Platform, DRKS00025401.

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“…The DECADE trial protocol gives another example of the use of surrogate endpoint in a pilot trial [ 13 ]. In this case one of the endpoints is the score for the 10-year risk of cardiovascular disease.…”

Section: Examplesmentioning

confidence: 99%

A randomised controlled trial is not a pilot trial simply because it uses a surrogate endpoint

Campbell

Lancaster

Eldridge

2018

Pilot Feasibility Stud

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BackgroundIt has been argued that true endpoints (or ‘hard’ endpoints) for clinical trials, which are meaningful to clinicians, researchers and patients alike, are limited to those that measure health status, survival and cost. Other endpoints are termed 'surrogate' endpoints and are intended to substitute and predict the true endpoint. A number of trials that describe using surrogate endpoints use the term ‘pilot’ in the title of the paper but the reason for this, as related by the authors, is the use of these surrogate endpoints in the trial. The conduct and reporting of such a trial may follow the traditional pattern for a conventional randomised controlled trial (RCT) as defined by the original CONSORT statement, with power-based sample size calculations, and significance tests of the results. However, this is contrary to the guidelines of the CONSORT extension for the reporting of pilot trials.Main bodyWe review the definition of a surrogate endpoint and the use of surrogate endpoints in clinical trials. We consider to what extent a trial could be considered a pilot trial if it uses a surrogate endpoint and discuss two examples that illustrate current practice.ConclusionTrials which use surrogate endpoints should only be described as ‘pilot’ when a definitive trial is a distinct possibility and the authors consider conditions which would indicate whether the definitive main trial was worthwhile and feasible. Simply because a trial uses a surrogate endpoint is not justification for calling it a pilot trial.

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DECADE-pilot: decision aid, action planning, and follow-up support for patients to reduce the 10-year risk of cardiovascular diseases—a protocol of a randomized controlled pilot trial

Cited by 6 publications

References 33 publications

Preventive and health‐promoting activities in general practices in Germany: A scoping review

Preventive and health‐promoting activities in general practices in Germany: A scoping review

Encouragement of patients’ self-management in primary care for the prevention of cardiovascular diseases (DECADE): protocol for a cluster randomised controlled trial

A randomised controlled trial is not a pilot trial simply because it uses a surrogate endpoint

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