Improving diabetes care through professional behaviour change
| ISRCTN | ISRCTN66498413 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN66498413 |
| Secondary identifying numbers | 14053 |
- Submission date
- 04/04/2013
- Registration date
- 04/04/2013
- Last edited
- 04/05/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
The aim of this study is to evaluate the effectiveness and costs of training for GPs and practice nurses to improve the care they provide for people with type 2 diabetes. We are targeting six areas that were found in our previous study to require improvement: prescribing medicine for high blood pressure and blood glucose control, providing self-management and weight advice, general education, and foot examinations.
Who can participate?
GPs and practice nurses who provide diabetes care in 44 general practices in north east England.
What does the study involve?
Practices are randomly allocated to either the intervention or the control group. GPs and primary care nurses in the intervention group practices attend a single training session about providing the best diabetes care. The control group do not receive any training during the study, but will be provided with access to the training materials after the study is over. We survey the GPs and practice nurses in both groups before the training and again 12 months later. We also conduct interviews with GPs and practice nurses to see what they thought of the training, what they liked, what they didn’t like, and how it could be improved. At the 12-month follow-up, patients with type 2 diabetes will be randomly selected from practice lists and asked about their care.
What are the possible benefits and risks of participating?
GPs and practice nurses will receive training to help them to provide better care for patients with type 2 diabetes. There are no risks involved in this study.
Where is the study run from?
Institute of Health and Society, Newcastle University (UK).
When is the study starting and how long is it expected to run for?
March 2013 to March 2015.
Who is funding the study?
Diabetes UK.
Who is the main contact?
Joan Mackintosh
joan.mackintosh@ncl.ac.uk
Contact information
Scientific
21-23 Claremont Place
Newcastle Upon Tyne
NE2 4AA
United Kingdom
| j.e.mackintosh@newcastle.ac.uk |
Study information
| Study design | Theory-based two-armed cluster randomised controlled trial Design type: Process of Care |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | The Improving Diabetes care through Examining, Advising, and prescribing (IDEA) trial: A theory-based cluster randomised controlled trial of a multiple health professional behaviour change intervention in primary care |
| Study acronym | DRN 782 |
| Study objectives | Moving clinical research findings into routine care is recognised as an inconsistent process with implications for the quality of care offered to people with Type 2 diabetes. Providing evidence based care often requires clinicians to change their behaviour. Based on findings from a UK wide study of theory based factors associated with high quality diabetes care, this study will evaluate the effectiveness and cost of an intervention targeting primary care clinicians to improve the behaviours involved in providing high quality type 2 diabetes care. We will conduct a theory based two armed cluster randomised controlled trial in 44 general practices in the north east of England. We will target improvement in six underperformed clinical behaviours highlighted in NICEs quality standards: prescribing for hypertension and glycaemic control, providing self management and weight advice, general education and foot examinations. The intervention will be delivered within a group session by a community diabetologist, patient representative, GP, a psychologist and a nurse. The main outcomes will be the proportion of patients prescribed (using anonymised computer records) and advised (using anonymous patient surveys) after 12 months. We will also investigate whether the intervention was delivered as designed (fidelity) and operated as hypothesised (process evaluation) by analysing responses to theory based surveys before and after the trial, and by conducting qualitative interviews with relevant primary care clinicians. More details can be found at: http://public.ukcrn.org.uk/search/StudyDetail.aspx?StudyID=14053 |
| Ethics approval(s) | NRES Committee London - Riverside, 17/10/2012, ref: 12/LO/1742 |
| Health condition(s) or problem(s) studied | Topic: Diabetes Research Network; Subtopic: Type 2; Disease: Hypertension, Diabetic Control, Diabetic foot, Education, Nutrition, Prevention/screening, Service delivery |
| Intervention | IDEA training session: The intervention will consist of a single training session for GPs and primary care nurses involved in providing care for patients with type 2 diabetes. The training sessions will look at providing optimal care and will include role identification, discussion with colleagues, goal setting and barriers elicitation with the aim of identifying relevant solutions, reinforced through practice, planning and case studies using scenarios. We plan to oversample our intervention group by four practices in order that we can conduct some qualitative interviews with practice staff to see what they thought of the intervention, what they liked, what they didn't like, how it could be improved etc. We will randomly select four practices from the intervention group after the intervention has been received and these practices will be excluded from the main trial outcomes. Follow Up Length: 12 month(s) |
| Intervention type | Other |
| Primary outcome measure | Clinician advising, prescribing and examining behaviours collected via patient questionnaires and electronic queries; Timepoint(s): 12 months |
| Secondary outcome measures | We will collect QOF data for diabetes mellitus and practice organisation for each participating practice; we will also conduct a process evaluation (using quantitative and qualitative methods), a cost analysis and fidelity of delivery assessment. |
| Overall study start date | 04/03/2013 |
| Completion date | 31/03/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | UK Sample Size: 2002; Description: 242 GPs and primary care nurses 1,760 patients with type 2 diabetes |
| Key inclusion criteria | 1. Male & Female ; Lower Age Limit 18 years 2. Primary health care professionals delivering care to people with type 2 diabetes within their practice. 3. People with type 2 diabetes registered with participating practices. |
| Key exclusion criteria | 1. Health care professionals providing care to patients with type 2 diabetes from more than one GP practice, e.g. district nurses and podiatrists 2. GP registrars 3. Patients for whom the questionnaire would not be appropriate (decided by practice staff) 4. Patients aged under 18 years |
| Date of first enrolment | 04/03/2013 |
| Date of final enrolment | 01/06/2013 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
NE2 4AA
United Kingdom
Sponsor information
Hospital/treatment centre
Bevan House
1 Esh Plaza
Sir Bobby Robson Way Great Park
Newcastle upon Tyne
NE13 9BA
England
United Kingdom
| Website | http://www.northoftyne.nhs.uk/ |
|---|
Funders
Funder type
Charity
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- DIABETES UK LIMITED, British Diabetic Association
- Location
- United Kingdom
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 | 24/05/2014 | Yes | No | |
| Results article | results | 02/05/2018 | Yes | No |
Editorial Notes
04/05/2018: Publication reference added.
