Trial ID: ISRCTN82176651
Other - Phase Unknown - No longer available
Background and study aims People with diabetes who have raised blood sugar levels are at increased risk of complications such as sight loss, kidney disease and nerve damage. An insulin pump is a small electronic device that reduces blood sugar by giving insulin throughout the day via a small tube. Since 2008, national guidelines have recommended insulin pumps for people with type 1 diabetes people who have high blood sugar. Around 90,000 people in England have high blood sugar but do not use an insulin pump. Importantly, insulin pump use varies according to where people live and their age, sex and ethnicity. People with diabetes, healthcare professionals and NHS England have all said that increasing insulin pump use is important. The National Diabetes Audit (NDA) measures how many people with diabetes receive care recommended by guidelines. The NDA aims to drive changes that improve care by providing feedback to patients, policymakers and clinical teams. Despite giving feedback since 2016, large gaps in insulin pump use remain. Researchers think that they can increase insulin pump use by supporting specialist diabetes teams (doctors, nurses and others) to act more effectively following NDA feedback. They have developed and tried a programme of workshops, coaching and sessions where teams learn from each other. The programme helps teams to choose actions according to their own circumstances and commit to these actions. The programme will be delivered virtually by the NDA and will be free to the teams. This study will evaluate whether the support leads to greater change than feedback alone, understand how the support is delivered and how teams respond, and evaluate whether the support is value for money. Who can participate? Teams providing specialist diabetes care to adults in England and Wales What does the study involve? Participating teams will be randomly assigned to get the support or not during the study. The teams will be able to opt-out from the research but still receive the support. The researchers will measure how many people start and stay on the pumps for 3 months by gathering prescription data. This data is routinely extracted from medical records unless patients opt out. The researchers will compare insulin pump use between those diabetes teams that got the support and those that did not. Immediately after the study, they will give the support to all teams that did not receive it during the study. To see how those involved deliver and use the programme, the researchers will observe what happens in the virtual workshops, coaching and shared learning meetings. They will read documents that are produced and will interview people who delivered the support programme and diabetes team members who did or did not receive the support. They will describe the cost of delivering and receiving the support and evaluate whether the benefits outweigh the costs. What are the possible benefits and risks of participating? The findings will help the NDA 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 specialist diabetes teams participating in the study, there are no added risks and minimal burden as they would be eligible for and receive the quality improvement collaborative (QIC) if not participating in the study. For people with diabetes who are eligible for insulin pumps there are no added risks from research participation because pumps are already recommended in routine clinical management and their relevant specialist diabetes teams would also receive the QIC 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? July 2022 to April 2025 Who is funding the study? The National Institute for Health and Social Care Research (NIHR) (UK) Who is the main contact? Dr Michael Sykes, michael.sykes@northumbria.ac.uk
Northumbria University
Source: https://www.isrctn.com/