Implementation of integrated care for type 2 diabetes Mellitus and Periodontitis in Germany: study protocol for a practice-based and cluster-randomized trial
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 tri...
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| Published in | BMC oral health Vol. 24; no. 1; pp. 879 - 12 |
|---|---|
| Main Authors | , , , , , , , , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
England
BioMed Central Ltd
02.08.2024
BioMed Central BMC |
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| Abstract | 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". |
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| AbstractList | 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. 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“. 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.BACKGROUNDType 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.METHODSTwo 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.DISCUSSIONUpon 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".TRIAL REGISTRATIONThe study was prospectively registered at the German Clinical Trials Register ( https://drks.de/search/de/trial/DRKS00030587 ) on 3. July 2023 under ID "DRKS00030587". BackgroundType 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.MethodsTwo 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.DiscussionUpon 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 registrationThe study was prospectively registered at the German Clinical Trials Register (https://drks.de/search/de/trial/DRKS00030587) on 3. July 2023 under ID “DRKS00030587“. 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. 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 ( Keywords: Screening, Periodontitis, Diabetes, Integration, Implementation, Germany, General practice, Dental practice, Oral health 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". |
| ArticleNumber | 879 |
| Audience | Academic |
| Author | Listl, Stefan Grobe, Thomas Hennrich, Patrick Awounvo, Sinclair Eigendorf, Julian Herzig, Nicole Vanella, Patrizio Gutscher, Andreas Wilm, Stefan Wensing, Michel Jepsen, Søren Dyczmons, Jan Altiner, Attila Santos, Sara Queder, Annika Kairies-Schwarz, Nadja Erdmann, Stella Kalmus, Olivier Kliemannel, Fabian |
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| Keywords | Screening Integration Periodontitis Dental practice General practice Diabetes Germany Implementation Oral health |
| Language | English |
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| PublicationTitle | BMC oral health |
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| References | A Schuppenies (4672_CR17) 2006; 53 NK Gale (4672_CR28) 2013; 13 DC Rodrigues (4672_CR11) 2003; 74 MR DiMatteo (4672_CR21) 2004; 42 BL Mealey (4672_CR4) 2006; 77 SE Choi (4672_CR32) 2020; 43 C Salisbury (4672_CR33) 2011; 61 F D’Aiuto (4672_CR8) 2018; 6 BL Pihlstrom (4672_CR7) 2005; 366 U Kuckartz (4672_CR30) 2014 LJ Damschroder (4672_CR24) 2009; 4 4672_CR2 GW Taylor (4672_CR5) 1998; 69 LJ Emrich (4672_CR20) 1991; 62 K Blaschke (4672_CR10) 2021; 172 M Sanz (4672_CR3) 2018; 137 G Schmalz (4672_CR22) 2021; 92 S Van Buuren (4672_CR27) 2006; 76 4672_CR23 4672_CR9 SA Flottorp (4672_CR25) 2013; 8 SG Grossi (4672_CR12) 1997; 68 JA Lewis (4672_CR26) 1999; 18 W Rathmann (4672_CR35) 2005; 15 M Kellerer (4672_CR14) 2019 PM Preshaw (4672_CR34) 2019; 227 K Sippli (4672_CR13) 2017; 17 4672_CR19 World Health Organization (4672_CR1) 2021 4672_CR18 A Srivastava (4672_CR29) 2009; 4 K Nasseh (4672_CR31) 2017; 26 G Kaur (4672_CR6) 2009; 36 4672_CR15 PEH Schwarz (4672_CR16) 2019; 14 |
| References_xml | – ident: 4672_CR2 doi: 10.5888/pcd16.180641 – volume: 76 start-page: 1049 issue: 12 year: 2006 ident: 4672_CR27 publication-title: J Stat Comput Simul doi: 10.1080/10629360600810434 contributor: fullname: S Van Buuren – volume: 366 start-page: 1809 issue: 9499 year: 2005 ident: 4672_CR7 publication-title: Lancet doi: 10.1016/S0140-6736(05)67728-8 contributor: fullname: BL Pihlstrom – volume: 6 start-page: 954 issue: 12 year: 2018 ident: 4672_CR8 publication-title: Lancet Diabetes Endocrinol doi: 10.1016/S2213-8587(18)30038-X contributor: fullname: F D’Aiuto – volume: 18 start-page: 1903 issue: 15 year: 1999 ident: 4672_CR26 publication-title: Stat Med doi: 10.1002/(SICI)1097-0258(19990815)18:15<1903::AID-SIM188>3.0.CO;2-F contributor: fullname: JA Lewis – volume: 172 start-page: 108641 year: 2021 ident: 4672_CR10 publication-title: Diabetes Res Clin Pract doi: 10.1016/j.diabres.2020.108641 contributor: fullname: K Blaschke – volume: 4 start-page: 72 issue: 2 year: 2009 ident: 4672_CR29 publication-title: JOAAG contributor: fullname: A Srivastava – volume: 42 start-page: 200 issue: 3 year: 2004 ident: 4672_CR21 publication-title: Med Care doi: 10.1097/01.mlr.0000114908.90348.f9 contributor: fullname: MR DiMatteo – volume: 227 start-page: 577 issue: 7 year: 2019 ident: 4672_CR34 publication-title: Br Dent J doi: 10.1038/s41415-019-0794-5 contributor: fullname: PM Preshaw – ident: 4672_CR9 doi: 10.1136/bmjdrc-2020-001666 – volume-title: Deutscher Gesundheitsbericht Diabetes 2020: Die Bestandsaufnahme year: 2019 ident: 4672_CR14 contributor: fullname: M Kellerer – ident: 4672_CR19 – volume: 43 start-page: 563 issue: 3 year: 2020 ident: 4672_CR32 publication-title: Diabetes Care doi: 10.2337/dc19-1201 contributor: fullname: SE Choi – volume: 137 start-page: 231 year: 2018 ident: 4672_CR3 publication-title: Diabetes Res Clin Pract doi: 10.1016/j.diabres.2017.12.001 contributor: fullname: M Sanz – volume: 68 start-page: 713 issue: 8 year: 1997 ident: 4672_CR12 publication-title: J Periodontol doi: 10.1902/jop.1997.68.8.713 contributor: fullname: SG Grossi – volume: 74 start-page: 1361 issue: 9 year: 2003 ident: 4672_CR11 publication-title: J Periodontol doi: 10.1902/jop.2003.74.9.1361 contributor: fullname: DC Rodrigues – volume: 8 start-page: 35 year: 2013 ident: 4672_CR25 publication-title: Implement Sci doi: 10.1186/1748-5908-8-35 contributor: fullname: SA Flottorp – volume: 61 start-page: e12 issue: 582 year: 2011 ident: 4672_CR33 publication-title: Br J Gen Pract doi: 10.3399/bjgp11X548929 contributor: fullname: C Salisbury – volume: 77 start-page: 1289 issue: 8 year: 2006 ident: 4672_CR4 publication-title: J Periodontol doi: 10.1902/jop.2006.050459 contributor: fullname: BL Mealey – volume: 26 start-page: 519 issue: 4 year: 2017 ident: 4672_CR31 publication-title: Health Econ doi: 10.1002/hec.3316 contributor: fullname: K Nasseh – volume: 92 start-page: 1163 issue: 8 year: 2021 ident: 4672_CR22 publication-title: J Periodontol doi: 10.1002/JPER.20-0297 contributor: fullname: G Schmalz – ident: 4672_CR15 – volume: 53 start-page: 386 issue: 10 year: 2006 ident: 4672_CR17 publication-title: Ernährungs-Umschau contributor: fullname: A Schuppenies – volume: 14 start-page: S319 issue: S02 year: 2019 ident: 4672_CR16 publication-title: Diabetol Und Stoffwechsel contributor: fullname: PEH Schwarz – volume: 69 start-page: 76 issue: 1 year: 1998 ident: 4672_CR5 publication-title: J Periodontol doi: 10.1902/jop.1998.69.1.76 contributor: fullname: GW Taylor – volume: 13 start-page: 117 year: 2013 ident: 4672_CR28 publication-title: BMC Med Res Methodol doi: 10.1186/1471-2288-13-117 contributor: fullname: NK Gale – volume: 36 start-page: 765 issue: 9 year: 2009 ident: 4672_CR6 publication-title: J Clin Periodontol doi: 10.1111/j.1600-051X.2009.01445.x contributor: fullname: G Kaur – volume: 17 start-page: 179 issue: 1 year: 2017 ident: 4672_CR13 publication-title: BMC Health Serv Res doi: 10.1186/s12913-017-2116-4 contributor: fullname: K Sippli – ident: 4672_CR18 – volume: 15 start-page: 627 issue: 6 year: 2005 ident: 4672_CR35 publication-title: Eur J Public Health doi: 10.1093/eurpub/cki037 contributor: fullname: W Rathmann – ident: 4672_CR23 – volume-title: Mixed methods: Methodologie, Forschungsdesigns Und Analyseverfahren year: 2014 ident: 4672_CR30 doi: 10.1007/978-3-531-93267-5 contributor: fullname: U Kuckartz – volume: 62 start-page: 123 issue: 2 year: 1991 ident: 4672_CR20 publication-title: J Periodontol doi: 10.1902/jop.1991.62.2.123 contributor: fullname: LJ Emrich – volume-title: Resolution WHA74/5. Oral health year: 2021 ident: 4672_CR1 contributor: fullname: World Health Organization – volume: 4 start-page: 50 year: 2009 ident: 4672_CR24 publication-title: Implement Sci doi: 10.1186/1748-5908-4-50 contributor: fullname: LJ Damschroder |
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| Snippet | Type 2 Diabetes mellitus (T2DM) and periodontitis share common risk factors and influence one another. However, primary care and oral health care continue to... Background Type 2 Diabetes mellitus (T2DM) and periodontitis share common risk factors and influence one another. However, primary care and oral health care... BackgroundType 2 Diabetes mellitus (T2DM) and periodontitis share common risk factors and influence one another. However, primary care and oral health care... Abstract Background Type 2 Diabetes mellitus (T2DM) and periodontitis share common risk factors and influence one another. However, primary care and oral... |
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| SubjectTerms | Care and treatment Clinical trials Delivery of Health Care, Integrated Dental Care - methods Dentists Diabetes Diabetes mellitus (non-insulin dependent) Diabetes Mellitus, Type 2 - complications Diabetes Mellitus, Type 2 - therapy Diagnosis Evaluation Family physicians Germany Gum disease Health care Humans Implementation Integrated delivery networks Integrated delivery systems Integration Management Oral administration Oral hygiene Patients Periodontitis Periodontitis - therapy Primary care Primary Health Care Quality of life Randomized Controlled Trials as Topic Referral and Consultation Risk factors Screening Study Protocol Type 2 diabetes |
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| Title | Implementation of integrated care for type 2 diabetes Mellitus and Periodontitis in Germany: study protocol for a practice-based and cluster-randomized trial |
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