Cost-effectiveness of care for patients with type two diabetes: an evaluation of an innovative shared diabetes care model

ISRCTN	ISRCTN66124817
DOI	https://doi.org/10.1186/ISRCTN66124817
Protocol serial number	N/A
Sponsor	VU University Medical Centre (The Netherlands)
Funder	The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)

Submission date: 26/02/2007
Registration date: 26/02/2007
Last edited: 30/06/2014

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr A van der Heijden
Scientific

Emgo-Instituut
Van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands

Phone	+31 (0)20 444 8409
Email	A.vanderHeijden@vumc.nl

Study information

Primary study design	Interventional
Study design	A quasi-experimental pre-test-post-test control group design
Secondary study design	Non randomised controlled trial
Scientific title
Study objectives	The intervention will primarily affect the level of patient control with regard to glycemia, lipid levels and blood pressure. We will expect a substantial decline in the occurrence and severity of complications and mortality and an improved quality of life. The innovative shared diabetes care is expected to be more cost-effective than the usual diabetes care.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Diabetes Mellitus type two (DM type II)
Intervention	An innovative shared diabetes care model ('ketenzorgmodel') will be implemented in general practices in Amstelland. The 'ketenzorgmodel' will be implemented with a central organisation of the diabetes care with a central database, a central coordinating role for diabetes nurses (changed professional roles), and an active recall system. The annual diabetes check is offered to patients by the central organisation, in combination with patient education, by a diabetes nurse and a consultation with a dietician. In addition, structured education will be offered to general practitioners and their assistants, and a diabetes nurse will support diabetes care in general practice. Diabetes patients in the control group will receive the current usual diabetes care. The control group will consist of patients of GP's who are affiliated to the Netherlands Institute for Health Services Research (NIVEL) Continuous Morbidity Registration Centres (CMR sentinel stations [CMR-Peilstations]). NIVELs 'CMR-Peilstations' consitute a representative group of 60 Dutch GPs in 45 practices throughout the Netherlands.
Intervention type	Other
Primary outcome measure(s)	1. The risk of developing coronary heart disease (using the United Kingdom Prospective Diabetes Study [UKPDS] risk engine at baseline, two years before and year one and two after baseline) 2. All direct and indirect costs (cost diary) 3. Costs per life year gained
Key secondary outcome measure(s)	1. Absolute levels of fasting glucose 2. HbA1c level 3. Blood pressure 4. Cholesterol 5. Percentages adequately controlled patients (in accordance with the Dutch College of Family Physicians [NHG] standards) 6. Diabetes specific and generic quality of life 7. Patient satisfaction 8. Quality of life 9. Quality of care as experienced by the patient: a. percentage of patients that received all three-monthly check-ups b. a complete annual check-up c. were hospitalised 10. Total mortality measured by life expectancy 11. Total morbidity measured by morbidity-free life expectancy and the Net Present Value (NPV) of the number of life years gained 12. Quality Adjusted Life Years (QALYs) gained for the intervention scenario compared to the current practice scenario 13.The NPV of total intervention costs 14. The NPV of total costs of care for diabetes and its complications 15. Incremental costs per QALY gained
Completion date	01/01/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Not Specified
Key inclusion criteria	1. Patients with type two diabetes 2. Age 40 to 75 years 3. Written informed consent 4. Capable to fill in questionnaires 5. Understanding of Dutch language
Key exclusion criteria	Patients will be excluded for participation in this study if no beneficial effects can be expected in favour of the patient, according to the opinion of the General Practitioner (GP).
Date of first enrolment	01/03/2007
Date of final enrolment	01/01/2010

Locations

Countries of recruitment

Netherlands

Study participating centre

Emgo-Instituut

Amsterdam
1081 BT
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	25/06/2014		Yes	No