Evaluation of Quality Improvement for People with Type 2 Diabetes
| ISRCTN | ISRCTN52205353 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN52205353 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 340839 |
| Protocol serial number | CPMS 61114, NIHR168871 |
| Sponsor | Northumbria University |
| Funder | NIHR Evaluation, Trials and Studies Co-ordinating Centre (NETSCC) |
- Submission date
- 11/03/2025
- Registration date
- 12/03/2025
- Last edited
- 12/03/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
There are about 65,000 young adults in England with type 2 diabetes who have high blood glucose levels, which can lead to serious health problems and early death. Different groups of general practices, called Primary Care Networks (PCNs), vary in how well they help patients manage their blood glucose levels. This study aims to find out if providing extra support to PCNs can help them improve patient care and if these methods are cost-effective.
Who can participate?
All PCNs in England will be randomly assigned to one of three groups to participate in the study.
What does the study involve?
PCNs will receive one of the following:
Medium-intensity support through virtual meetings and NDA feedback.
Low-intensity support through email and NDA feedback.
NDA feedback alone, with support provided later.
Researchers will analyze data on patient care and outcomes, including blood glucose levels, and recordings of virtual meetings.
What are the possible benefits and risks of participating?
The findings will help the National Diabetes Audit to decide whether to provide support in the same way in future. The findings will also help other national clinical audits (e.g. for cancer, heart disease) decide whether to provide similar support to improve patient care. For healthcare professionals in Primary Care Networks participating in the study, there are no added risks and minimal burden as they would be eligible for and receive the support for improvement if not participating in the study.
For young adults with diabetes there are no added risks from research participation because the intervention seeks to implement recommended practice and their relevant primary care teams would also receive the support for improvement if they were not participating in the study.
Where is the study run from?
Northumbria University (UK)
When is the study starting and how long is it expected to run for?
January 2025 to June 2027
Who is funding the study?
National Institute for Health and Care Research (NIHR) (UK).
Who is the main contact?
Dr Michael Sykes, michael.sykes@northumbria.ac.uk
Contact information
Public, Scientific, Principal investigator
Coach Lane Campus
Northumbria University
Newcastle upon Tyne
NE7 7XA
United Kingdom
 ORCID ID |
0000-0002-2039-7397 |
|---|---|
| Phone | +44 (0)191 232 6002 |
| michael.sykes@northumbria.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Interventional randomized controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | An evaluation of two large-scale quality improvement interventions embedded with a national clinical audit to improve the care for young adults with type 2 diabetes (EQUIPD2) |
| Study objectives | Aim: To evaluate two facilitation co-interventions added to NDA feedback to improve the achievement of blood glucose goals in young adults with type 2 diabetes. Objectives Assess the effectiveness of NDA feedback with (i) medium-intensity facilitation and (ii) low-intensity facilitation compared to NDA feedback alone in reducing the HbA1c of young adults with type 2 diabetes and HbA1c ≥58 mmol/mol. Understand facilitation implementation, engagement, fidelity and tailoring of actions. Estimate the cost-effectiveness of medium- and low-intensity facilitation. |
| Ethics approval(s) |
Approved 25/02/2025, Northumbria University (Coach Lane Campus, Northumbria University, Newcastle upon Tyne, NE7 7XA, United Kingdom; +44 191 232 6002; ETHICSSUPPORT@NORTHUMBRIA.AC.UK), ref: Sykes 2025-8864-10621 |
| Health condition(s) or problem(s) studied | Type 2 diabetes |
| Intervention | We will undertake a three-arm cluster randomized controlled trial to evaluate the effectiveness of NDA feedback with low- or medium intensity facilitation compared to NDA feedback alone in reducing the number of young adults with a raised blood glucose. Medium-intensity feedback facilitation: Email invite to PCN-level clinical pharmacists and diabetes leads to join two webinars and subsequent multi-site facilitated calls with peers about type 2 diabetes. The email will contain information about health consequences and feedback on outcome of behaviour from a credible source. Participants will be invited to a choice of webinar dates. The 2 one-hour webinars include behaviour change techniques specified in the logic model (e.g. information about health and social consequences, instruction on how to identify patients and analyse influences upon performance). The webinar seeks to implement improvement actions tailored to their local context by each PCN. After the webinar, the medium-intensity feedback facilitation arm PCNs will be invited to five bi-monthly multisite calls (one-hour each). It will be possible to attend the calls without having attended the webinar. The facilitated virtual calls will prompt monitoring, ask participants to describe work undertaken and encourage collaboration through shared lessons and resources (e.g. patient leaflet, staff training materials). Low-intensity feedback facilitation: The low-intensity intervention will include similar content (e.g. information about health and social consequences, instruction on how to identify patients and analyse influences upon performance) to the medium-intensity feedback facilitation delivered through email and virtual worksheets. |
| Intervention type | Other |
| Primary outcome measure(s) |
HbA1c level at 18 months post-randomisation in young adults (18-39 years) with type 2 diabetes and baseline HbA1c ≥58 mmol/mol measured using measured using National Diabetes Audit data |
| Key secondary outcome measure(s) |
Measured in young adults (18-39 years) with type 2 diabetes and baseline HbA1c ≥58 mmol/mol: |
| Completion date | 30/06/2027 |
Eligibility
| Participant type(s) | Other |
|---|---|
| Age group | Other |
| Sex | All |
| Target sample size at registration | 1263 |
| Key inclusion criteria | Primary care networks in England |
| Key exclusion criteria | None |
| Date of first enrolment | 17/03/2025 |
| Date of final enrolment | 31/03/2027 |
Locations
Countries of recruitment
- United Kingdom
Study participating centre
Wellington House
133-155 Waterloo House
London
SE1 8UG
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| IPD sharing plan | The current data sharing plans for this study are unknown and will be available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| 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 |
Editorial Notes
11/03/2025: Trial's existence confirmed by the National Institute for Health and Care Research (NIHR) (UK).
