Clinical trial NCT04216875: Best Practice Study of Diabetes Type 2 Management in Primary Care in Switzerland
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 2
Primary Care
Keywords: Best practice
optimisation of treatment
diabetes score
diabetes in primary care
Lead sponsor: QualiCCare
Sponsor class: OTHER
Collaborators: name: Swiss Society of Endocrinology and Diabetology
name: Roche Diabetes Care
name: Sanofi
name: Concordia Versicherungen AG
name: Novo Nordisk A/S
name: Galenica
First posted: 2020-01-03
Enrollment: 738
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: Change in score result before and after the introduction of the diabetes score criteria for treatment of diabetes patients in the primary care setting
timeFrame: one year
Secondary outcomes:
measure: Evaluation of feasibility of the implementation of the diabetes score criteria in different primary care practice types
timeFrame: one year
measure: Comparison of the diabetes treatment in regards to the different primary care settings
timeFrame: one year
measure: Evaluation of practice tool used for the documentation and evaluation of the diabetes score
timeFrame: one year
Other outcomes:
Locations:
city: Saint Gallen
country: Switzerland
facility: Hausarztmedizin KSSG
state: SG
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Emanuel Christ, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.