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)
Conditions: Diabetes Mellitus, Type 2, Primary Care
Sponsor: QualiCCare

Project title 
QualiCCare Study on the Optimization of Treatment of Chronic Patients with 
Diabetes mellitus Type 2 in Primary Care (Project III) 
______________________________________________________________________________ 
 
Research legislation: Non-Clinical trial acc. to the ordinance on non-clinical research (HRO) [1]. 
Type of Research Project: Research project in which health-related personal data is collected  
Risk Categorization: A 
Project Lead: Prof. Dr. Emanuel Christ, University Hospital Basel, Petersgraben 4, 4031 Basel, Email: 
emanuel.christ@usb.ch 
 
  
PROTOCOL SIGNATURE FORM    
 
The project leader has approved the protocol version 4, dated 30.08.2017, and confirms hereby to 
conduct the project according to the protocol, the Swiss legal requirements [1, 2], current version of 
the World Medical Association Declaration of Helsinki [3] and the principles of Good Clinical Practice.  
 
Project leader: 
 
Name: Prof. Dr. med. Emanuel Christ 
Date: August 30, 2017 Signature: 
electronically signed  
 
 
Sponsors:  
QualiCCare Association  
 
Name: Member of the State Council Hans Stöckli, President 
Name: Dr. Astrid Czock, Managing Director 
Date: August 30, 2017 Signature: 
electronically signed  
 
 
  

1. BACKGROUND AND PROJECT RATIONALE  
In 2013 the QualiCCare association was founded, the purpose of which, according to the statutes, is to 
develop concrete and pragmatic measures for the treatment of the chronically ill in the extended 
primary care through the interprofessional cooperation of all stakeholders. This involves coordination 
with the national strategies in the field of chronic diseases (NCD, CVSD, etc.), as well as a continuous 
review of the measures developed in the "real-life" setting, i.e. in primary care.  
Based on international guidelines, the QualiCCare 2011-2013 project identified essential treatment 
elements for which there is potential for improvement in Switzerland compared with best practice 
examples. Four priorities were identified for diabetes mellitus type 2: (1) screening and diagnosis, (2) 
self-management training, (3) drug therapy of diabetes and co-risk factors, and (4) control and 
treatment of macrovascular and microvascular complications. Specific and pragmatic measures have 
been developed to improve treatment outcomes. Based on the NCQA recommendations (National 
Council Quality Assurance) and a best-practice comparison with other countries, developed as part of 
the QualiCCare project 2011-2013, the Swiss Society for Diabetology and Endocrinology (SGED) 
developed adapted "criteria for "good" disease management diabetes in primary care" (hereinafter 
"criteria") for Switzerland. The quality of care for patients with type 2 diabetes can be evaluated by 
calculating a score determined during the application of the criteria. In two pilot projects, the criteria 
were followed in a multi-year comparison: 
I. Pilot project I: all type 2 diabetes patients of a single primary care practice with several doctors over 
3 years;  
II. pilot project II: all type 2 diabetes patients in the Chronic Care Management Program in 5 group 
practices over 2 years. 
The aim of the Diabetes Project III is to establish the above-mentioned score in different practice 
infrastructures. The aim is to record the effect of the score on the quality of treatment and to evaluate 
its suitability for practical use. The score criteria will additionally include influenza vaccination as an 
important prevention measure and the drug therapy (oral antidiabetics and/or insulin, 
antihypertensives, and statins) in order to determine possible comorbidities based on the medication.  
At the same time, the present project is also an extension to the previous projects I and II in terms of 
measuring suitability for practice, as on the one hand a larger number of practices apply the criteria 
and on the other hand different practice structures are included in the project. 
In accordance with Art. 5 and Art. 10 of the Human Research Act (HFG), this project serves to improve 
public health and meets scientific requirements. The responsible scientific advisory board is 
independent in its decisions and bases them on the latest scientific findings in this field. In accordance 
with Art. 7 of the "Ordinance on Human Research Excluding Clinical Trials" (HFV), this is accompanying 
research of risk category A.  
2. PROJECT OBJECTIVES, DESIGN AND STATISTICS 
2.1 Hypothesis and primary objective  
By implementing evidence-based measures (by means of score), the treatment quality (corresponds 
to an improvement of the score) of patients with diabetes mellitus type 2 in the "Real World Setting" 
can be improved within 12 months.  
The score can be used in different practice infrastructures and does not result in differences in 
treatment quality. 

 
2.2 Primary and secondary endpoint(s) 
Primary endpoint: 
Change in score after use of this method to document care of patients with diabetes mellitus type 2 
(baseline vs. 12 months) 
Secondary endpoints: 
Evaluation of the practicability of the score in different GP practice structures 
Comparison of diabetes care (i.e. scores) between different organisational forms of practices 
(individual practices, group practices, practice chains) 
Evaluation of the software for the evaluation of the score. 
2.3 Project design  
Prospective, non-randomised study without control group.  
2.4 Statistics and methodology 
Statistical evaluation concept:  
Primary endpoint:  
Comparison of score baseline vs. 12 months using paired t-test. 
Secondary endpoints:  
Comparison of score changes between individual practices and practice networks using unpaired t-
test. 
Evaluation of the evaluation forms with regard to practical suitability and software by means of 
descriptive statistics.  
 
In the previous two pilot studies, a measurable improvement in treatment quality could be measured 
in one and five primary care practices, respectively, with an increase in the score to 58 + 20 points. In 
order to achieve the goal of a relevant improvement of the overall score by a total of 10 points (from 
56 to 66 points), 27 centres must be recruited with a significance level of 0.05 and a power of 80% (1). 
At a dropout rate of 10%, we will recruit 30 centers. 
Methodology 
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 GPs 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. 
2.5 Handling of missing data and dropouts 
Dropouts are also recorded because it is assumed that the treatment quality (score) of the collective 
is not changed. 
3. SUBJECTS AND STUDY PROCEDURES 
3.1 Project population, inclusion and exclusion criteria  
Reason for the number of patients:  
In order to achieve the goal of a relevant improvement of the overall score by a total of 10 points (from 
56 to 66 points), 27 centres must be recruited with a significance level of 0.05 and a power of 80%. The 
standard deviation of the total score in the individual practices is + 15, so that a patient population of 
> 50 patients per practice is necessary.  
At a dropout rate of 10%, we will recruit 30 centers.  
Inclusion and exclusion criteria:  
Inclusion criteria: 
All patients who have been diagnosed with type 2 diabetes mellitus according to their primary care 
provider, i.e. who have ever had HbA1c > 6.4% and/or are taking insulin and/or oral AD according to 
their patient dossier.  
AND are at least 9 months in treatment with the same physician (in group practice in the same practice)  
Exclusion:  
Supervision <9 months in practice (change of practice, move, death, complete external supervision 
regarding DM, etc.)  
Patients who do not agree to participate in the project  
Patients for whom the doctor decides that they cannot participate in the project due to their illness 
(frailty, end of life). 
All excluded patients will be anonymized and the reason for the exclusion will be stated. The excluded 
patients will not be considered for the evaluation.  
 
 

3.2 Recruitment, screening and informed consent procedure 
The general practitioners will be invited to participate by post with a letter and information about 
QualiCCare and the project. There will be 10 practices per organisational structure. Each practice 
documents its diabetes patients based on their patient dossiers according to inclusion criteria. In order 
to participate in the study, patients will be informed about the study at the next follow-up and asked 
to sign a letter of consent to participate. A document will be available to the practices for patient 
information. Patients will be given sufficient time to decide whether to participate in the study. 
The practice will receive CHF 50.00 per participating patient with documented score and free use of 
the diabetes management tool during the duration of the project. The medical services will be 
reimbursed according to usual tariff, Tarmed. In addition, the practice receives an evaluation of its 
practice performance compared to the overall collective. 
The patient does not receive any financial compensation.  
3.3 Study procedures 
The duration of the project is 3 years, including recruitment and publication, i.e. from December 2017 
until the end of 2020. After the recruitment of the primary care practices, training will take place in 
the form of an interprofessional workshop for the GPs and the responsible practice assistants on 
application and background of the score, as well as on its documatation in the tool. After the workshop, 
the practices will retrospectively create the baseline from their patient files. For the prospective data 
collection, the score criteria are recorded each time the patient visits the practice. In order to support 
the interprofessional cooperation with actors outside the GP's practice, the diabetes passport, revised 
by QualiCCare and distributed by Diabetesschweiz, can be used. Over a period of 12 months, all score 
criteria per patient must be recorded in the practice (primary endpoint). The project manager 
evaluates the difference between retrospective baseline and prospective score criteria 
documentation. The practices receive the evaluation of their practice and must answer a questionnaire 
to assess the recording tool with regard to practicability and suitability for practice. The results of the 
study will be published.  
A selection bias may occur by not considering patients with difficult psychosocial problems, but since 
the patient collective is relevant and not the individual patient, this bias is not significant.  
3.4 Withdrawal and discontinuation 
Exclusion from the project is based on the defined exclusion criteria. This can be done at any time 
during the project. These are: 
Change of practice, departure, or death of the patient; complete external care of the patient by a 
diabetologist, home, hospital, etc.; patients for whom the doctor decides that they can no longer 
participate in the project due to their illness (frailty, end of life). 
 
4. REGULATORY ASPECTS AND SAFETY 
4.1 Local regulations / Declaration of Helsinki 
This research project will be conducted in accordance with the protocol, the Declaration of Helsinki 
[3], the principles of Good Clinical Practice, the Human Research Act (HRA) [2] and the Human Research 
Ordinance (HRO) [1] as well as other locally relevant regulations. Project Lead and Sponsor 
acknowledge their responsibilities. 

 
4.2 Notification of safety and protective measures (HRO Art. 20) 
If immediate safety and protective measures have to be taken during the conduct of the research 
project, the project lead shall immediately be notified (within 24 hours). The project lead must notify 
the Ethics Committee via BASEC within 7 days and explain the circumstances. 
4.3 Serious events (HRO Art. 21) 
If a serious event occurs, the research project must be interrupted until the Ethics Committee reaches 
a decision on the continuation. A serious event is defined as any adverse event where it cannot be 
excluded, that the event is attributable to the sampling of biological material or the collection of 
health-related personal data, and which: 
a. requires inpatient treatment not envisaged in the protocol or extends a current hospital stay; 
b. results in permanent or significant incapacity or disability; or 
c. is life-threatening or results in death. 
The project lead must notify the Ethics Committee via BASEC within 7 days and explain the 
circumstances.  
4.4 Radiation 
N/A 
4.5 Amendments 
Substantial changes to project set-up, the protocol and relevant project documents acc. to HRO Art.18  
must be approved by the Ethics Committee before being implemented. Exceptions are measures which 
have to be taken immediately in order to protect participants. 
4.6 End of project 
Upon project termination the Ethics Committee is notified within 90 days.  
 
4.7 Insurance 
N/A  
5. FURTHER ETHICAL ASPECTS 
5.1 Overall ethical considerations 
The criteria are based on the latest international scientific knowledge and correspond to the best 
practice criteria of the Medical Society for Endocrinology and Diabetology.  
5.2 Risk-Benefit Assessment  
 There are no additional risks, costs or inconveniences for the patient. Written patient information 
about the project is provided for submission. The project serves to implement the best practice criteria 
in primary care, which should ultimately lead to an optimization of the treatment of diabetes patients.  
 
 
 

5.3 Rationale for the inclusion of vulnerable subjects  
N/A. No vulnerable patient groups are included. 
 
6. QUALITY CONTROL AND DATA PROTECTION 
6.1 Quality assurance 
The involved documenting personnel are trained for quality assurance purposes. Data monitoring in 
the sense of an industrial study is not planned and not possible, but a regular plausibility check in the 
sense of descriptive statistics is carried out. This is carried out centrally by the study coordinator.  
6.2 Data recording and source data 
The patient data is entered in encrypted form: Only the patient's gender and year of birth are entered. 
Central data analysis does not allow any conclusions to be drawn on the names of patients. For quality 
assurance purposes, a patient number is listed which could be used for queries to the practice in the 
event of inconsistencies in the entry (e.g. invalid value entry). The patient number is password-
protected and can only be accessed by the staff of the corresponding practice. The number 
corresponds to the patient file in the practice, i.e. the medical assistant assigns the patient number in 
the documentation or takes it from the patient file. 
The data recorded in the software is stored in a cloud of the independent hosting company Atos 
(www.de.atos.net/de-de/home.html) in D-Fürth. The patient data is only accessible to the physician 
(and his practice staff). The data backup is secured in accordance with the European Data Protection 
Act and complies with Swiss data protection regulations.  
Project data will be handled with uttermost discretion and is only accessible to authorised personnel 
who require the data to fulfil their duties within the scope of the research project. On the CRFs and 
other project specific documents, subjects are only identified by a unique subject number.  
6.3 Retention and destruction of study data and biological material 
The study data is stored for 10 years in the study coordination office and then properly destroyed.  
 
7. FUNDING / PUBLICATION / DECLARATION OF INTEREST 
The QualiCCare association is financed by membership fees, which are used for the project 
management and standard operation of the association. For this project, Sanofi SA, a member 
organization of QualiCCare, made an additional payment to the QualiCCare Research Fund. The 
diabetes management tool eQuality from emminens of Roche Diabetes Care will be made available 
free of charge to the participating primary care practices for data collection. Since the evaluation of 
this tool is defined as a secondary endpoint of the study, an evaluation questionnaire must be 
answered in return.  
The scientific advisory board is independent in its decisions and has no conflicts of interest. A contact 
to the sponsors takes place within the framework of an annual sponsoring board, where the sponsors 
are informed on the course of the project.  
After completion of the project, a publication is planned, naming the sponsors.  
 
 

8. REFERENCES 
(1) Ordinance on Human Research with the Exception of Clinical trials (HRO)  
http://www.admin.ch/opc/en/classified-compilation/20121177/201401010000/810.301.pdf    
(2) Human Research Act (HRA) 
http://www.admin.ch/opc/en/classified-compilation/20121176/201401010000/810.305.pdf   
(3) Declaration of Helsinki (http://www.wma.net/en/30publications/10policies/b3/index.html) 
 
9. GLOSSARY OF ABBREVATIONS 
BASEC Business Administration System for Ethical Committees 
CRF Case report form 
EC Ethics Committee 
FOPH Federal Office of Public Health 
GCP Good clinical practice 
HRA Human Research Act 
HRO Ordinance on Human 
ICH International Conference on Harmonization