PDF(Pubmed)
Abstract：
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.
CONCLUSIONS: 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.
BACKGROUND: 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\".
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.
CONCLUSIONS: 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.
BACKGROUND: 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\".
摘要：
背景：2型糖尿病（T2DM）和牙周炎具有共同的危险因素，并且相互影响。然而,初级保健和口腔保健继续彼此分开运作,未能对T2DM和牙周炎患者进行同步护理.这项基于实践的试验的目的是评估T2DM和牙周炎患者新的综合护理路径的实施情况。新方法整合了在牙周炎患者的牙科护理环境中筛查T2DM风险。在T2DM患者的初级保健机构中筛查牙周炎风险，以及牙医和初级保健医生之间的相互转诊。
方法：将并行进行两项基于实践的研究：（i）在牙科护理环境中：基于实践的，多中心,集群随机化，有对照组和干预组的对照试验；(Ii)在初级保健机构：基于实践的，多中心,非随机化，根据索赔数据计算的具有合成对照组的对照试验。遵循两步招聘方法，将招募166名牙医和248名全科医生，他们自己将招募总共3808名患者。患者数据将在基线时收集，12个月,和研究登记后24个月。评估包括：（i）影响评估，使用分层线性混合模型；(Ii)过程评估，基于与试验相关的调查；(iii)经济评估。此外,离散选择实验将确定提供者对新护理方法的支付偏好。
结论：成功实施后，该干预措施将使医疗保健提供者能够在早期阶段检测患者的T2DM和牙周炎风险，从而为患者提供及时诊断和治疗的机会。最终,这可能导致生活质量的提高和医疗保健支出的减少。在方法论层面上，该项目提供了对综合实践和牙科护理交叉的复杂干预的新颖见解。
背景：该研究在德国临床试验注册（https://drks。de/search/de/trial/DRKS00030587)on3.2023年7月，ID为“DRKS00030587”。
方法：将并行进行两项基于实践的研究：（i）在牙科护理环境中：基于实践的，多中心,集群随机化，有对照组和干预组的对照试验；(Ii)在初级保健机构：基于实践的，多中心,非随机化，根据索赔数据计算的具有合成对照组的对照试验。遵循两步招聘方法，将招募166名牙医和248名全科医生，他们自己将招募总共3808名患者。患者数据将在基线时收集，12个月,和研究登记后24个月。评估包括：（i）影响评估，使用分层线性混合模型；(Ii)过程评估，基于与试验相关的调查；(iii)经济评估。此外,离散选择实验将确定提供者对新护理方法的支付偏好。
结论：成功实施后，该干预措施将使医疗保健提供者能够在早期阶段检测患者的T2DM和牙周炎风险，从而为患者提供及时诊断和治疗的机会。最终,这可能导致生活质量的提高和医疗保健支出的减少。在方法论层面上，该项目提供了对综合实践和牙科护理交叉的复杂干预的新颖见解。
背景：该研究在德国临床试验注册（https://drks。de/search/de/trial/DRKS00030587)on3.2023年7月，ID为“DRKS00030587”。
