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 |
| Secondary identifying numbers | N/A |
- 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
Scientific
Institut für Hausarztmedizin der Universität Zürich
Universitätsspital Zürich
Sonneggstrasse 6
Zürich
8091
Switzerland
| Phone | +41 (0)44 255 87 11 |
|---|---|
| anja.frei@usz.ch |
Study information
| Study design | Single centre cluster-randomised open label two-armed interventional study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Other |
| Participant information sheet | Not available in web format, please use contact details below to request a patient information sheet |
| Scientific title | The chronic care for diabetes study (CARAT): A cluster randomised controlled trial |
| Study acronym | CARAT |
| Study objectives | 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. |
| 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) studied | Diabetes type II; primary care |
| Intervention | 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. |
| Intervention type | Other |
| Primary outcome measure | Glycated Haemoglobin (HbA1c) level, measured at baseline (T0) and 1 year (T1) |
| Secondary outcome measures | 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) |
| Overall study start date | 01/01/2010 |
| Completion date | 01/05/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 12 patients and 14 practices are recruited in each arm (target total recruitment number 336). Randomisation at GP level. |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/01/2010 |
| Date of final enrolment | 01/05/2011 |
Locations
Countries of recruitment
- Switzerland
Study participating centre
Institut für Hausarztmedizin der Universität Zürich
Zürich
8091
Switzerland
8091
Switzerland
Sponsor information
Institute of General Practice Medicine - University of Zurich (Institut für Hausarztmedizin der Universität Zürich) (Switerland)
University/education
University/education
University Hospital of Zurich
Sonneggstrasse 6
Zürich
8091
Switzerland
| Phone | +41 (0)44 255 98 55 |
|---|---|
| thomas.rosemann@usz.ch | |
| Website | http://www.hausarztmedizin.uzh.ch |
"ROR" |
https://ror.org/02crff812 |
Funders
Funder type
University/education
Institute of General Practice Medicine - University of Zurich (Institut für Hausarztmedizin der Universität Zürich) (Switerland)
No information available
Swiss Academy for Medical Sciences (SAMW) (Switzerland) (grant number RRMA 8-09)
No information available
Menarini AG (Switzerland)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 15/06/2010 | Yes | No | |
| Results article | results | 15/06/2012 | Yes | No |
