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| [ Print-friendly version ] |
| A team approach in diabetes care - Does the chronic care model work in routine care for diabetes patients in primary care? |
| ISRCTN | ISRCTN05947538 |
| ClinicalTrials.gov identifier | |
| Public title | A team approach in diabetes care - Does the chronic care model work in routine care for diabetes patients in primary care? |
| Scientific title | The chronic care for diabetes study (CARAT): A cluster randomised controlled trial |
| Acronym | CARAT |
| Serial number at source | N/A |
| Study hypothesis | The 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. |
| Lay summary | |
| Ethics approval | The ethics board of the Kanton Zurich (Kantonale Ethik-Kommission Zürich) approved on the 25th of January 2010 (KEK-ZH-NR: 2009-0094/1) |
| Study design | Single centre cluster-randomised open label two-armed interventional study |
| Countries of recruitment | Switzerland |
| Disease/condition/study domain | Diabetes type II; primary care |
| Participants - inclusion criteria |
1. 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 |
| Participants - exclusion criteria |
1. 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 |
| Anticipated start date | 01/01/2010 |
| Anticipated end date | 01/05/2011 |
| Status of trial | Completed |
| Patient information material | Not available in web format, please use contact details below to request a patient information sheet |
| Target number of participants | 12 patients and 14 practices are recruited in each arm (target total recruitment number 336). Randomisation at GP level. |
| Interventions |
1. 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. |
| Primary outcome measure(s) | Glycated Haemoglobin (HbA1c) level, measured at baseline (T0) and 1 year (T1) |
| 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) |
| Sources of funding |
1. Institute of General Practice Medicine - University of Zurich (Institut für Hausarztmedizin der Universität Zürich) (Switerland)
2. Swiss Academy for Medical Sciences (SAMW) (Switzerland) (grant number RRMA 8-09) 3. Menarini AG (Switzerland) |
| Trial website | http://www.hausarztmedizin.uzh.ch |
| Publications | 2010 protocol in http://www.ncbi.nlm.nih.gov/pubmed/20550650 |
| Contact name | Dr Anja Frei |
| Address |
Institut für Hausarztmedizin der Universität Zürich
Universitätsspital Zürich Sonneggstrasse 6 |
| City/town | Zürich |
| Zip/Postcode | 8091 |
| Country | Switzerland |
| Tel | +41 (0)44 255 87 11 |
| Fax | +41 (0)44 255 90 97 |
| anja.frei@usz.ch | |
| Sponsor | Institute of General Practice Medicine - University of Zurich (Institut für Hausarztmedizin der Universität Zürich) (Switerland) |
| Address |
University Hospital of Zurich
Sonneggstrasse 6 |
| City/town | Zürich |
| Zip/Postcode | 8091 |
| Country | Switzerland |
| Tel | +41 (0)44 255 98 55 |
| Fax | +41 (0)44 255 90 97 |
| thomas.rosemann@usz.ch | |
| Sponsor website: | http://www.hausarztmedizin.uzh.ch |
| Date applied | 22/02/2010 |
| Last edited | 17/09/2010 |
| Date ISRCTN assigned | 03/03/2010 |
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| © 2012 ISRCTN unless otherwise stated. | |
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