RESUMEN
BACKGROUND: Type 2 Diabetes mellitus (T2DM) and periodontitis share common risk factors and influence one another. However, primary care and oral health care continue to operate separate from each other and fail to synchronize care for patients with T2DM and periodontitis. The purpose of this practice-based trial is to evaluate the implementation of a new integrated care pathway for patients with T2DM and periodontitis. The new approach integrates a screening for T2DM risk in dental care settings in patients with periodontitis, a screening for periodontitis risk in primary care settings in patients with T2DM, and mutual referrals between dentists and primary care physicians. METHODS: Two practice-based studies will be carried out in parallel: (i) In dental care settings: a practice-based, multi-centric, cluster-randomized, controlled trial with a control and an intervention group; (ii) in primary care settings: a practice-based, multi-centric, non-randomized, controlled trial with a synthetic control group calculated from claims data. Following a two-step recruitment approach, 166 dentists and 248 general practitioners will be recruited, who themselves will recruit a total of 3808 patients in their practices. Patient data will be collected at baseline, 12 months, and 24 months after study enrollment. The evaluation comprises: (i) impact evaluation, using a hierarchical linear mixed model; (ii) process evaluation, based on surveys alongside the trials; (iii) economic evaluation. In addition, a Discrete-Choice-Experiment will identify provider's payment preferences for the new care approach. DISCUSSION: Upon successful implementation, the intervention will enable health care providers to detect a risk for T2DM and periodontitis in patients at an early stage, thus providing patients an opportunity for timely diagnosis and therapy. Ultimately, this can lead to increased quality of life and reduced health care expenditures. On a methodologic level, the project provides novel insights into a complex intervention on the intersection of general practice and dental care. TRIAL REGISTRATION: The study was prospectively registered at the German Clinical Trials Register ( https://drks.de/search/de/trial/DRKS00030587 ) on 3. July 2023 under ID "DRKS00030587".
Asunto(s)
Diabetes Mellitus Tipo 2 , Periodontitis , Atención Primaria de Salud , Humanos , Diabetes Mellitus Tipo 2/complicaciones , Diabetes Mellitus Tipo 2/terapia , Alemania , Periodontitis/terapia , Prestación Integrada de Atención de Salud , Ensayos Clínicos Controlados Aleatorios como Asunto , Derivación y Consulta , Atención Odontológica/métodosRESUMEN
Objectives: The German Incentives for Physical Activity in Cardiac Patients trial is a three-arm, randomised controlled trial for secondary prevention of coronary heart disease (CHD). Guidance for developing complex interventions recommends pre-trial health economic modelling. The aim of this study is to model the long-term cost-effectiveness of the incentive-based physical activity interventions in a population with CHD. Methods: A decision-analytical Markov model was developed from a health services provider perspective, following a cohort aged 65 years with a previous myocardial infarction for 25 years. Monetary and social incentives were compared relative to no incentive. Intervention effects associated with physical activity were used to determine the costs, quality-adjusted life-years (QALYs) gained, incremental cost-effectiveness and cost-utility ratios. The probability of cost-effectiveness was calculated through sensitivity analyses. Results: The incremental QALYs gained from the monetary and social incentives, relative to control, were respectively estimated at 0.01 (95% CI 0.00 to 0.01) and 0.04 (95% CI 0.02 to 0.05). Implementation of the monetary and social incentive interventions increased the costs by 874 (95% CI 744 to 1047) and 909 (95% CI 537 to 1625). Incremental cost-utility ratios were 25 912 (95% CI 15 056 to 50 210) and 118 958 (95% CI 82 930 to 196 121) per QALY gained for the social and monetary incentive intervention, respectively. With a willingness-to-pay threshold set at 43 000/QALY, equivalent to the per-capita gross domestic product in Germany, the probability that the social and monetary incentive intervention would be seen as cost-effective was 95% and 0%, respectively. Conclusions: Exercise-based secondary prevention using inventive schemes may offer a cost-effective strategy to reduce the burden of CHD.
RESUMEN
INTRODUCTION: Telemedical lifestyle programmes for people with type 2 diabetes mellitus (T2DM) provide an opportunity to develop a healthier lifestyle and consequently to improve health outcomes. When implementing new programmes into standard care, considering patients' preferences may increase the success of the participants. This study aims to examine the preferences of people with T2DM with respect to telemedical lifestyle programmes, to analyse whether these preferences predict programme success and to explore the changes that may occur during a telemedical lifestyle intervention. METHODS AND ANALYSIS: We outline the protocol of the development and assessment of a discrete choice experiment (DCE) to examine patient preferences in a telemedical lifestyle programme with regard to the functions of the online portal, communication, responsibilities, group activities and time requirements. To develop the design of the DCE, we conducted pilot work involving healthcare experts and in particular people with T2DM using cognitive pretesting. The final DCE is being implemented within a randomised controlled trial for investigating whether participation in a telemedical lifestyle intervention programme sustainably improves the HbA1c values in 850 members of a large German statutory health insurance with T2DM. Preferences are being assessed before and after participants complete the programme. The DCE data will be analysed using regression and latent class analyses. ETHICS AND DISSEMINATION: The DCE study has been approved by the ethics committee of the medical faculty of the Heinrich Heine University Duesseldorf, registration number 2018-242-ProspDEuA, registered on 6 December 2018. The TeLIPro trial is registered at the US National Library of Medicine, registration number NCT03675919, registered on 15 September 2018. We aim to disseminate our results in peer-reviewed journals, at national and international conferences and among interested patient groups and the public.