The Danish Centre for Strategic Research in Type 2 Diabetes (DD2) study: implementation of a nationwide patient enrollment system

Abstract

This paper aims to describe the patient enrollment system and implementation strategy for the new nationwide Danish Centre for Strategic Research in Type 2 Diabetes (DD2) project. The paper will also describe the design, current content, and pilot testing of the DD2 registration form. The challenge of the DD2 project was to construct a registration system functioning in the entire Danish health care system, where new type 2 diabetes patients are initially met, and with the capacity to enroll 200 newly diagnosed diabetes patients per week nationwide. This requires a fast and simple registration that is part of everyday clinical practice in hospital outpatient clinics and general practitioner (GP) clinics. The enrollment system is thus built on a tested, rational design where patients need only one visit and only specific limited data about physical activity, anthropometric measures, and family history of diabetes are collected during a brief patient interview. Later, supplemental data will be extracted by computerized linkage with existing databases. The feasibility of this strategy was verified in a pilot study. For maximum flexibility, three different ways to fill in the DD2 registration form were provided and an interactive webpage was constructed. The DD2 project also involves collection of blood and urine samples from each diabetes patient, to be stored in a biobank. Clinicians may obtain the samples themselves or refer patients to the nearest clinical biochemical department. GPs have the additional option of referring patients to the nearest hospital outpatient diabetes clinic to obtain interview data, clinical data, and samples. At present, the enrollment system is in use at 17 hospital outpatient diabetes clinics and 45 GP clinics nationwide, together enrolling 40 new type 2 diabetes patients per week in the DD2 project. A total of 990 patients have now been enrolled and the DD2 is ready to expand nationwide.

Keywords: DD2; data registration; health information technology; implementation; logistics; type 2 diabetes.

Figure 1

The DD2 registration form to be filled during the patient interview conducted during patient enrollment in the Danish Centre for Strategic Research in Type 2 Diabetes project. Note: Variables are filled out successively from page one to page three during the DD2 registration interview. Abbreviation: DD2, Danish Centre for Strategic Research in Type 2 Diabetes.

Figure 2

This figure shows how the Danish Centre for Strategic Research in Type 2 Diabetes (DD2) enrollment is arranged and how it can be conducted by both hospitals and general practitioners. Notes: The enrollment consists of patient registration and blood sampling and preparation (-prep). For a detailed description see text. Red arrows indicate patient migration, green arrows indicate data transferred to the DD2 database, and dark red dots indicate blood and urine samples sent to the DD2 biobank.

Figure 3

Map of Denmark showing the hospital outpatient diabetes clinics currently enrolling patients in the Danish Centre for Strategic Research in Type 2 Diabetes (DD2) project (the yellow dots), those that have agreed to start enrolling (purple dots), and those that have not yet been contracted officially by the DD2 (blue dots).

Figure 4

Map of the Region of Southern Denmark showing the location of the 84 general practitioners (blue dots) who have signed to start the Danish Centre for Strategic Research in Type 2 Diabetes (DD2) project.