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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Optimisation of Treatment of Chronic Patients With Diabetes Mellitus Type 2 in Primary Care (Qualiccare Begleitforschung Zur Optimierung Der Behandlung Von Chronischen Patienten Mit Diabetes Mellitus Typ 2 in Der Grundversorgung)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04216875
• Other study ID #: QualiCCare Diabetes III
• Secondary ID: BASEC Nr. 2017-0
• Status: Completed
• Start date: January 1, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: April 2021
• Source: QualiCCare
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 738
• Est. completion date: December 31, 2020
• Est. primary completion date: June 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Primary Care

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
Switzerland	Hausarztmedizin KSSG	Saint Gallen	SG

Sponsors (7)

Lead Sponsor	Collaborator
QualiCCare	Concordia Versicherungen AG, Galenica, Novo Nordisk A/S, Roche Diabetes Care, Switzerland, Sanofi, Swiss Society of Endocrinology and Diabetology

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Evaluation of feasibility of the implementation of the diabetes score criteria in different primary care practice types	In order to test the feasibility of the use in different primary care practice types, the diabetes score criteria (as described above) are used in independent single practices and group practices. The above mentioned diabetes score consists of 8 score criteria concerning the diabetes management in primary care. The maximum amount of points are 100. it is desirable to achieve 70/100 points, whereas the points are attributed if 80% of the participating diabetes patients in the practice are treated according the the criteria.	one year
Secondary	Comparison of the diabetes treatment in regards to the different primary care settings	The resulting average score value of the diabetes treatment using the above described and mentioned diabetes score criteria in independent single primary care practices is compared with the resulting average score value of the diabetes treatment in group practices. The higher the score value, the better the treatment of diabetes patients in the respective practice structure (single or group practice).	one year
Secondary	Evaluation of practice tool used for the documentation and evaluation of the diabetes score	The participating primary care practices evaluate the practice tool and give feedback in regards to practicality and applicability in the respective practice setting	one year

External Links

•   official guideline platform of the Swiss medical Society FMH