Plain English Summary
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
Trial website
Contact information
Type
Scientific
Primary contact
Mrs Joan Mackintosh
ORCID ID
Contact details
21-23 Claremont Place
Newcastle Upon Tyne
NE2 4AA
United Kingdom
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j.e.mackintosh@newcastle.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
14053
Study information
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
Acronym
DRN 782
Study hypothesis
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
NRES Committee London - Riverside, 17/10/2012, ref: 12/LO/1742
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
Trial setting
GP practices
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
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 trial start date
04/03/2013
Overall trial end date
31/03/2015
Reason abandoned (if study stopped)
Eligibility
Participant 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.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
UK Sample Size: 2002; Description: 242 GPs and primary care nurses 1,760 patients with type 2 diabetes
Participant 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
Recruitment start date
04/03/2013
Recruitment end date
01/06/2013
Locations
Countries of recruitment
United Kingdom
Trial participating centre
21-23 Claremont Place
Newcastle Upon Tyne
NE2 4AA
United Kingdom
Sponsor information
Organisation
NHS North of Tyne (UK)
Sponsor details
Bevan House
1 Esh Plaza
Sir Bobby Robson Way Great Park
Newcastle upon Tyne
NE13 9BA
United Kingdom
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Charity
Funder name
Diabetes UK (UK); Grant Codes: 11/0004367
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
Other non-profit organizations
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24886606
2018 results in: http://www.ncbi.nlm.nih.gov/pubmed/29720209
Publication citations
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Protocol
Presseau J, Hawthorne G, Sniehotta FF, Steen N, Francis JJ, Johnston M, Mackintosh J, Grimshaw JM, Kaner E, Elovainio M, Deverill M, Coulthard T, Brown H, Hunter M, Eccles MP, Improving Diabetes care through Examining, Advising, and prescribing (IDEA): protocol for a theory-based cluster randomised controlled trial of a multiple behaviour change intervention aimed at primary healthcare professionals., Implement Sci, 2014, 9, 61, doi: 10.1186/1748-5908-9-61.