Northumbria University, Newcastle Upon Tyne, UK.
University of Leeds, Leeds, UK.
Implement Sci. 2023 Aug 31;18(1):37. doi: 10.1186/s13012-023-01293-0.
People with type 1 diabetes and raised glucose levels are at greater risk of retinopathy, nephropathy, neuropathy, cardiovascular disease, sexual health problems and foot disease. The UK National Institute for Health and Care Excellence (NICE) recommends continuous subcutaneous 'insulin pump' therapy for people with type 1 diabetes whose HbA1c is above 69 mmol/mol. Insulin pump use can improve quality of life, cut cardiovascular risk and increase treatment satisfaction. About 90,000 people in England and Wales meet NICE criteria for insulin pumps but do not use one. Insulin pump use also varies markedly by deprivation, ethnicity, sex and location. Increasing insulin pump use is a key improvement priority. Audit and feedback is a common but variably effective intervention. Limited capabilities of healthcare providers to mount effective responses to feedback from national audits, such as the National Diabetes Audit (NDA), undermines efforts to improve care. We have co-developed a theoretically and empirically informed quality improvement collaborative (QIC) to strengthen local responses to feedback with patients and carers, national audits and healthcare providers. We will evaluate whether the QIC improves the uptake of insulin pumps following NDA feedback.
We will undertake an efficient cluster randomised trial using routine data. The QIC will be delivered alongside the NDA to specialist diabetes teams in England and Wales. Our primary outcome will be the proportion of people with type 1 diabetes and an HbA1c above 69 mmol/mol who start and continue insulin pump use during the 18-month intervention period. Secondary outcomes will assess change in glucose control and duration of pump use. Subgroup analyses will explore impacts upon inequalities by ethnicity, sex, age and deprivation. A theory-informed process evaluation will explore diabetes specialist teams' engagement, implementation, fidelity and tailoring through observations, interviews, surveys and documentary analysis. An economic evaluation will micro-cost the QIC, estimate cost-effectiveness of NDA feedback with QIC and estimate the budget impact of NHS-wide QIC roll out.
Our study responds to a need for more head-to-head trials of different ways of reinforcing feedback delivery. Our findings will have implications for other large-scale audit and feedback programmes.
ISRCTN82176651 Registered 18 October 2022.
1 型糖尿病患者和血糖升高的人群患视网膜病变、肾病、神经病变、心血管疾病、性健康问题和足部疾病的风险更高。英国国家卫生与保健优化研究所（NICE）建议，HbA1c 高于 69mmol/mol 的 1 型糖尿病患者使用连续皮下“胰岛素泵”治疗。胰岛素泵的使用可以改善生活质量，降低心血管风险，提高治疗满意度。在英格兰和威尔士，大约有 9 万人符合 NICE 对胰岛素泵的标准，但没有使用胰岛素泵。胰岛素泵的使用也因贫困程度、种族、性别和地点而有很大差异。增加胰岛素泵的使用是一个关键的改进重点。审核和反馈是一种常见但效果不同的干预措施。医疗保健提供者应对国家审计（如国家糖尿病审计（NDA））反馈的能力有限，这削弱了改善护理的努力。我们共同开发了一个理论和经验丰富的质量改进合作（QIC），以加强患者和护理人员、国家审计和医疗保健提供者对反馈的本地反应。我们将评估 QIC 是否会提高 NDA 反馈后胰岛素泵的使用率。
我们将使用常规数据进行高效的集群随机试验。QIC 将与 NDA 一起提供给英格兰和威尔士的专科糖尿病团队。我们的主要结果将是在 18 个月的干预期间，HbA1c 高于 69mmol/mol 的 1 型糖尿病患者开始并继续使用胰岛素泵的比例。次要结果将评估血糖控制和泵使用时间的变化。亚组分析将通过种族、性别、年龄和贫困程度探索不平等的影响。一项基于理论的过程评估将通过观察、访谈、调查和文件分析来探讨糖尿病专科团队的参与、实施、一致性和调整。一项经济评估将对 QIC 进行微观成本核算，估计 QIC 对 NDA 反馈的成本效益，并估计 NHS 范围内 QIC 推广的预算影响。
我们的研究回应了对不同强化反馈传递方式进行更多头对头试验的需求。我们的研究结果将对其他大规模的审计和反馈计划产生影响。
ISRCTN82176651 于 2022 年 10 月 18 日注册。
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