An observational study in Diabetes Mellitus, Type 2 and Primary Care, sponsored by QualiCCare. Completed at 1 site in Switzerland. Per ClinicalTrials.gov, last updated 2025-08-20.
Sponsored by QualiCCare · Observational
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.
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.
9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.
This study's enrollment of 738 is above the median of 300 across 1,588 observational studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →This is the only study on the registry with QualiCCare as lead sponsor.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
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
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
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)
Independent primary care practices with more than one medical doctor working in their responsibility without the intervention (not using Diabetes score).
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
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).
Time frame: one year
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.
Time frame: one year
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).
Time frame: one year
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
Time frame: one year
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
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