A team approach in diabetes care - Does the chronic care model work in routine care for diabetes patients in primary care?

ISRCTN ISRCTN05947538
DOI https://doi.org/10.1186/ISRCTN05947538
Protocol serial number N/A
Sponsor Institute of General Practice Medicine - University of Zurich (Institut für Hausarztmedizin der Universität Zürich) (Switerland)
Funders Institute of General Practice Medicine - University of Zurich (Institut für Hausarztmedizin der Universität Zürich) (Switerland), Swiss Academy for Medical Sciences (SAMW) (Switzerland) (grant number RRMA 8-09), Menarini AG (Switzerland)
Submission date
22/02/2010
Registration date
03/03/2010
Last edited
15/10/2012
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 Anja Frei
Scientific

Institut für Hausarztmedizin der Universität Zürich
Universitätsspital Zürich
Sonneggstrasse 6
Zürich
8091
Switzerland

+41 (0)44 255 87 11
anja.frei@usz.ch

Study information

Primary study designInterventional
Study designSingle centre cluster-randomised open label two-armed interventional study
Secondary study designRandomised controlled trial
Study type Participant information sheet
Scientific titleThe chronic care for diabetes study (CARAT): A cluster randomised controlled trial
Study acronymCARAT
Study objectivesThe implementation of several elements of the Chronic Care Model (CCM) via a specially trained practice nurse improves the HbA1c level of diabetes type II patients in small, single handed practices in Switzerland significantly after one year (estimated change: 0.5% in HbA1c) and increases the proportion of patients who achieve the recommended targets regarding blood pressure (<130/80), HbA1c (=<6.5) and LDL-cholesterol (<1.8 mmol/l) significantly. Furthermore, this implementation improves patients’ quality of life, and several evidence based quality indicators for diabetes care. Finally, these improvements in care, aiming at a better accordance with the CCM, will be experienced by the patients as well as by the practice team.
Ethics approval(s)The ethics board of the Kanton Zurich (Kantonale Ethik-Kommission Zürich) approved on the 25th of January 2010 (KEK-ZH-NR: 2009-0094/1)
Health condition(s) or problem(s) studiedDiabetes type II; primary care
Intervention1. Practices in the control group:
Treatment as usual (patients will be treated by the GP as usual)

2. Practices in the intervention group:
2.1. Intervention on the practice nurse:
Participation in a 6-day educational course “Treatment of long term patients - module diabetes” (“Betreuung von Langzeitpatienten - Modul Diabetes“) organised by the “Schweizerischer Verband medizinischer Praxisassistentinnen” (18 - 24/04/2010): Content: treatment of diabetes patients (medical basics, diet, practical tips, communication etc.), role of the practice nurse in a team providing structured care for chronically ills, how to perform a follow-up with the CARAT-monitoring-tool
2.2. Intervention on the GPs:
Two interactive workshops of 4 hours (second 2 hours together with the practice nurses):
2.2.1. Evidenced based treatment of diabetes in a primary care setting, implementing structured and proactive care according to the Chronic Care model in practice (29/04/2010)
2.2.2. Exchange of experience and cardiovascular risk management (autumn 2010)
3. Intervention on the team:
One outreach visit will be performed by a study nurse of the study centre after completing the courses for GPs and practice nurses. The aims are to assess if the structures in the practices are appropriate to perform care according to this study protocol, to reveal possible problems which might have occurred, to discuss and implement appropriate solutions, and to check that the CARAT-tool is used as intended.
4. Intervention on the patient:
Patients will be treated by the special trained practice nurse in conjunction with the GP, treatment will be structured according to the Chronic Care Model.
Intervention typeOther
Primary outcome measure(s)

Glycated Haemoglobin (HbA1c) level, measured at baseline (T0) and 1 year (T1)

Key secondary outcome measure(s)

All measures will be assessed at baseline (T0) and 1 year (T1):

1. Guideline adherence (recommended treatment goals): Proportion of patients who achieve the recommended targets regarding:
1.1. HbA1c (=<6.5)
1.2. Blood pressure (<130/80)
1.3. Low-density lipoprotein-cholesterol (LDL-cholesterol) (<1.8 mmol/l)
2. Quality of Life, assessed by SF-36 questionnaire
3. Process quality:
3.1. Proportion of patients receiving at least one eye examination per year
3.2. Proportion of patients receiving at least one food examination per year
3.3. Proportion of patients receiving at least one nephropathy screening per year
3.4. Proportion of patients receiving at least one neurological testing per year
4. Accordance to the Chronic Care Model:
4.1. Patient Assessment of Chronic Illness Care questionnaire (PACIC-5A)
4.2. Assessment of Chronic Illness Care questionnaire (ACIC)

Completion date01/05/2011

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexAll
Target sample size at registration336
Key inclusion criteria1. Diabetes type II patients (Glucose in blood plasma > 7,0 mmol /l)
2. At least one measure of HbA1c > 7.0% within the last year
3. Aged older than 18 years
4. Male and female
Key exclusion criteria1. Insufficient German language skills
2. Patients who contacted the practice for emergencies only or as a substitute practice
3. Patients with oncological diseases and/or an estimated life expectancy of less than six months due to severe diseases
Date of first enrolment01/01/2010
Date of final enrolment01/05/2011

Locations

Countries of recruitment

  • Switzerland

Study participating centre

Institut für Hausarztmedizin der Universität Zürich
Zürich
8091
Switzerland

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 15/06/2012 Yes No
Protocol article protocol 15/06/2010 Yes No
Participant information sheet Participant information sheet 11/11/2025 11/11/2025 No Yes
Study website Study website 11/11/2025 11/11/2025 No Yes
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