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

NCT04216875 | Completed

• 2 other identifiers: QualiCCare Diabetes IIIBASEC Nr. 2017-01340
• Study Type: observational
• Target: 738
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2; Primary Care

Keywords

Best practice; optimisation of treatment; diabetes score; diabetes in primary care

Outcome Measures

Primary Outcomes (1)

• Change in score result before and after the introduction of the diabetes score criteria for treatment of diabetes patients in the primary care setting

  The change is measured at baseline, before the introduction of the diabetes score criteria and one year after the introduction. There are 8 score criteria for the good diabetes management in primary care (such as 1x/y lifestyle consultation, 1x/foot control, etc). Each criteria gets a certain number of points if 80% of the participating patients are treated in accordance to the given criteria. In total, a maximum of 100 points can be achieved. The objective is to achieved a minimum of 70% (= 70 points).

  one year

Secondary Outcomes (3)

• Evaluation of feasibility of the implementation of the diabetes score criteria in different primary care practice types

  one year

• Comparison of the diabetes treatment in regards to the different primary care settings

  one year

• Evaluation of practice tool used for the documentation and evaluation of the diabetes score

  one year

Study Arms (4)

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.

Procedure: Best Practice Diabetes Management in Primary Care

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.

Procedure: Best Practice Diabetes Management in Primary Care

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)

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).

Interventions

Best Practice Diabetes Management in Primary Care PROCEDURE

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

Also known as: Diabetes Score

primary care group practice intervention; single primary care practices intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study population comprises two different kinds of primary care practices who either get the intervention or have no intervention (4 groups in total): single practices with one general practioner and group practices with several general practitioners. On the practice level, the study population comprises all diabetes patients who correspond to the inclusion criteria.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• QualiCCare: lead
• Swiss Society of Endocrinology and Diabetology: collaborator
• Roche Diabetes Care: collaborator
• Sanofi: collaborator
• Concordia Versicherungen AG: collaborator
• Novo Nordisk A/S: collaborator
• Galenica: collaborator

Study Sites (1)

Hausarztmedizin KSSG

Sankt Gallen, Canton of St. Gallen, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 35925612 DERIVED

Related Links

• official guideline platform of the Swiss medical Society FMH

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Primary Health Care

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Comprehensive Health Care; Patient Care Management; Health Services Administration

Study Officials

• Emanuel Christ, Prof.

  University Hospital, Basel, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 31, 2019
• First Posted: January 3, 2020
• Study Start: January 1, 2018
• Primary Completion: June 1, 2019
• Study Completion: December 31, 2020
• Last Updated: August 20, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)