Heidelberg Institute of Global Health Section for Oral Health, Heidelberg University Hospital, Im Neuenheimer Feld 130.3, 69120, Heidelberg, Germany.
Department for General Practice and Health Services Research, Heidelberg University Hospital, Im Neuenheimer Feld 130.3, 69120, Heidelberg, Germany.
BMC Oral Health. 2024 Aug 2;24(1):879. doi: 10.1186/s12903-024-04672-1.
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.
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.
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.
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".
2 型糖尿病（T2DM）和牙周炎有共同的危险因素并相互影响。然而，初级保健和口腔保健仍然彼此独立，未能为 T2DM 和牙周炎患者同步提供护理。本基于实践的试验旨在评估一种新的 T2DM 和牙周炎患者综合护理途径的实施情况。新方法将在牙周炎患者的牙科护理环境中筛查 T2DM 风险、在 T2DM 患者的初级保健环境中筛查牙周炎风险以及牙医和初级保健医生之间相互转诊相结合。
将并行开展两项基于实践的研究：（i）在牙科护理环境中：一项基于实践的、多中心、集群随机对照试验，设有对照组和干预组；（ii）在初级保健环境中：一项基于实践的、多中心、非随机对照试验，采用从索赔数据中计算得出的综合对照组。通过两步招募方法，将招募 166 名牙医和 248 名全科医生，他们将在自己的诊所共招募 3808 名患者。将在研究入组后基线、12 个月和 24 个月收集患者数据。评估包括：（i）使用分层线性混合模型进行影响评估；（ii）基于试验的调查进行过程评估；（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。
如果成功实施，干预措施将使医疗保健提供者能够及早发现患者 T2DM 和牙周炎的风险，从而为患者提供及时诊断和治疗的机会。最终，这可以提高生活质量并降低医疗保健支出。在方法学层面上，该项目为一般实践和牙科护理交叉领域的复杂干预措施提供了新的见解。
该研究于 2023 年 7 月 3 日在德国临床试验注册中心（https://drks.de/search/de/trial/DRKS00030587）前瞻性注册，登记号为“DRKS00030587”。
