Best Practice Study of Diabetes Type 2 Management in Primary Care in Switzerland

NCT ID: NCT04216875

Last Updated: 2025-08-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 738 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-01-01
• Study Completion Date: 2020-12-31

Brief Summary

This observational study intends to evaluate the use and adherence of different types of primary care practices to the diabetes criteria-protocol (diabetes score), developed by the Swiss Society of Endocrinology and Diabetology. This diabetes score comprises visits to the doctor, lifestyle consultations, clinical measures such as blood pressure, cholesterol or blood sugar, as well as measures concerning the prevention of secondary complications like kidney, eye or feet issues. The participating primary care practices need to treat 80% of their diabetes patients (their "diabetes population") in accordance to the score-criteria. In addition to the adherence to the eight score-criteria, the practices are required to also document statistically if their diabetes patients get the following medication: oral antidiabetics, insulin, blood pressure medication, statins and / flu vaccine. As this observational study is and before-and-after study, the primary care practices need to document for each of their diabetes patients the care they provided in the year before the introduction of the score-criteria and in the year following their introduction. Participating primary care practices ask their diabetes patients' consent to the documentation and anonymous transmittance of their data. Data evaluation is anonymous and on a population-based level (as opposed to individual-based). The hypothesis of the study is to prove that the implementation of evidence-based measures, such as a diabetes score can increase the treatment quality of diabetes patients in primary care practices and this increase is independent of the primary care practice structure in which it is applied.

Detailed Description

Information of the primary care practices regarding the background and goal of the project by means of a letter and informative documentation.

Recruitment of primary care practices, divided into three different practice organisations (individual practices and group practices run on a private basis and with financial autonomy, as well as forms of joint practices with employed physicians without financial autonomy).

A signed contract between QualiCCare and participating primary care practices regulates the collaboration.

Procedure:

A baseline documentation takes place retrospectively from the training/workshop for the past 12 months, and a second, prospective documentation of the treatment is done during the following 12 months.

Training of the participating general practioners (GP) and practice coordinator on the project including evaluation software, data entry and background to the criteria.

Documentation of the treatment quality of all patients with diabetes mellitus type 2 in a practice structure that meets the inclusion criteria according to the score criteria (baseline).

After 12 months, the treatment quality of the included patients with diabetes type 2 is recorded again using the same score.

Conditions

Diabetes Mellitus, Type 2; Primary Care

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

single primary care practices intervention

Independent primary care practices with one single medical doctor in the practice, usually ther owner of the practice working in his responsibility following the best practice procedure of the diabetes score.

Best Practice Diabetes Management in Primary Care

Intervention Type: PROCEDURE

Practice adherence to best practice guidelines treating diabetes patients in different primary care practices is shown in this before- and after observational study

primary care group practice intervention

Independent primary care practices with more than one medical doctor working in their responsibility following the best practice procedure of the diabetes score.

Best Practice Diabetes Management in Primary Care

Intervention Type: PROCEDURE

Practice adherence to best practice guidelines treating diabetes patients in different primary care practices is shown in this before- and after observational study

single primary care practices no intervention

Independent primary care practices with one single medical doctor in the practice, usually ther owner of the practice working in his responsibility without the intervention (not using Diabetes score)

No interventions assigned to this group

primary care group practice no intervention

Independent primary care practices with more than one medical doctor working in their responsibility without the intervention (not using Diabetes score).

No interventions assigned to this group

Interventions

Best Practice Diabetes Management in Primary Care

Practice adherence to best practice guidelines treating diabetes patients in different primary care practices is shown in this before- and after observational study

Intervention Type: PROCEDURE

Other Intervention Names

Diabetes Score

Eligibility Criteria

Inclusion Criteria

• all patients in the primary care practice with a diabetes diagnosis, meaning their patient record shows that the patient either had an HbA1c value higher than 6.4 percent, takes insulin or oral antidiabetics and is treated at least during nine months in the participating primary care practice.

Exclusion Criteria

• treatment in participating primary care practice during less than nine months (due to change of primary care provider, death, diabetes treatment solely by specialist);
• patients who do not give their patient consent to participate in study;
• patients whom the primary care provider excludes from study due to frailty, end of life or other reasons.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Swiss Society of Endocrinology and Diabetology

UNKNOWN

Sponsor Role: collaborator

Roche Diabetes Care

INDUSTRY

Sponsor Role: collaborator

Sanofi

INDUSTRY

Sponsor Role: collaborator

Concordia Versicherungen AG

UNKNOWN

Sponsor Role: collaborator

Novo Nordisk A/S

INDUSTRY

Sponsor Role: collaborator

Galenica

UNKNOWN

Sponsor Role: collaborator

QualiCCare

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Emanuel Christ, Prof.

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Basel, Switzerland

Locations

Hausarztmedizin KSSG

Sankt Gallen, Canton of St. Gallen, Switzerland

Countries

Switzerland

References

Christ E, Czock A, Renstrom F, Ammeter T, Ebrahimi F, Zechmann S, Kutz A, Diem P, Hauptle C, Brandle M. Evaluation of type 2 diabetes care management in nine primary care practices before and after implementation of the Criteria of Good Disease Management of Diabetes established by the Swiss Society of Endocrinology and Diabetology. Swiss Med Wkly. 2022 Jul 26;152:w30197. doi: 10.4414/smw.2022.w30197. eCollection 2022 Jul 18.

Reference Type: DERIVED

PMID: 35925612 (View on PubMed)

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form: Study protocol and statistical Analysis Plan

View Document

Document Type: Informed Consent Form: Informed Consent Form document (translated)

View Document

Related Links

https://www.guidelines.fmh.ch/index_detail.cfm?id=7B1EBC1C450FBB40A7CE5FA9B4DC4D6F

official guideline platform of the Swiss medical Society FMH

Other Identifiers

BASEC Nr. 2017-01340

Identifier Type: OTHER

Identifier Source: secondary_id

QualiCCare Diabetes III

Identifier Type: -

Identifier Source: org_study_id