跳至主要内容
临床试验/NCT07181915
NCT07181915招募中不适用

Changing Outcomes Through Achievement Emails in COPD Using Routine Healthcare Audits

University of Leeds1 个研究点 分布在 1 个国家目标入组 270 人开始时间: 2025年12月1日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
270
试验地点
1
主要终点
ICS/LABA inhaler use change.

研究概览

简要总结

This study is exploring how to improve prescribing for people with chronic obstructive pulmonary disease (COPD) in primary care. COPD is a long-term lung condition. Guidelines recommend the most effective inhalers for different patient groups, but in practice, some patients still receive treatments that are less effective or no longer recommended.

One proven way to support better prescribing is "audit and feedback." This involves giving GP practices reports showing how their prescribing compares with guidance and with other practices. Audit and feedback can change behaviour, particularly when focused on medicines and when practices have scope to improve.

In West Yorkshire, the NHS Integrated Care Board (ICB) is running a quality improvement project (QIP) to reduce inappropriate prescribing in COPD. Every GP practice already receives regular feedback reports. This study will run within that project.

The research will test whether the type of email sent with these reports influences prescribing. Practices will be randomly assigned to one of two groups:

  • Personalised emails: highlighting their own performance, recognising progress, and giving practical suggestions.
  • Generic emails: a simple notification that the report is available, with no tailored advice.

All practices will receive the same reports, seven times over one year; only the email wording will differ.

The main outcome will be the change in how many COPD patients are prescribed inhalers that combine a long-acting beta agonist and inhaled corticosteroid (LABA/ICS), which are no longer recommended in COPD. Secondary outcomes will include other COPD prescribing measures identified by a clinical expert panel. The study will also explore factors that might influence effectiveness, such as practice size, deprivation, and COPD caseload.

Data will come from existing NHS sources. The ICB already collects anonymised prescribing data for improvement work. For this study, the data will be pseudonymised so researchers cannot identify practices. The University of Leeds will analyse the results, but the research team will not know which code relates to which practice.

This study will not change patient care directly. All patients will continue with their usual GP treatment. The aim is to understand whether small changes in delivering audit and feedback make it more effective in supporting best prescribing. In the long term, this could improve the safety and quality of COPD care.

详细描述

Audit and feedback (A&F) is defined by Ivers et al. as the "provi(sion of) a recipient with a summary of their performance over a specified period of time" and has long history of use within a diverse area of research and business to promote clinician and organisational behaviour change. In healthcare, A&F has been used either alone, or as part of a composite quality improvement project (QIP), to improve health practitioner practice based on guidelines or targets. A 2012 Cochrane review systematically reviewed 140 papers on A&F spanning several decades and produced a meta-analysis showing an absolute risk difference (RD) in practitioners changing behaviour to comply with the preferred practice of 4.3% (interquartile range 0.5% to 16%). Their investigation emphasised that A&F is particularly effective when it is targeted specifically at prescribing practices (mean adj. RD 13.1% verses diabetes management 0.5%) and where baseline compliance is low.

Meta-regression of the Cochrane data showed that the effect size of A&F has remained largely unchanged over the last two decades of study, leading the authors to postulate that there is no longer reasonable clinical equipoise to question if A&F is effective. However, they also conclude that studies aiming to isolate how A&F can be utilised most effectively by comparing different A&F variations are few and far between and that this should be the target of future A&F research.

A&F has previously been used successfully within the West Yorkshire Clinical Commissioning Group (CCG) - now replaced by the NHS West Yorkshire Integrated Care Board (ICB) - to effect change on primary care prescribing practices. The ASPIRE cluster Randomised Controlled Trial (cRCT) of A&F in this region produced a reduction in risky prescribing (odds ratio 0.82), while the CROP quasi-experimental controlled interrupted time series analysis of A&F correlated with 15,000 fewer patients being inappropriately prescribed opioids over a period of a year compared to controls (35,36). Both studies utilised a similar A&F design, utilising a theoretical structure based around the Theoretical Domains Framework (TDF) that is ideal for determining the possible perceptions of interventions by its intended targets. They also operated the Behaviour Change Taxonomy (BCT) to describe their employed behavioural change techniques and their intended effects.

The combined Long-Acting Beta Agonist / Inhaled CorticoSteroid (LABA+ICS) inhaler category has been used to treat COPD patients who present with asthmatic features of partially reversible lung function in the past. The most recent Global Initiative for Chronic Obstructive Lung disease (GOLD) guidelines move away from this however, by actively suggesting their use should be discouraged in favour of LABA-Long-Acting-Muscarinic-Antagonist-ICS (LABA-LAMA-ICS) triple inhalers. This is based on two separated studies suggesting LABA-LAMA-ICS inhalers reduced exacerbations of COPD in a subset of patients compared to LABA-ICS. In 2018, an observational study in the UK suggested that LABA/ICS usage in the COPD population was approximately 20%.

Precision feedback is a concept that suggests that aligning feedback messaging to individual, objective performance and goals may improve the performance of audit and feedback to create change. Here we propose to use the opportunity provided by a pre-planned QIP into COPD prescribing in West Yorkshire to undertake a randomised controlled trial to address this question.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Double (Investigator, Outcomes Assessor)

入排标准

性别
All
接受健康志愿者

入选标准

  • All registered NHS primary care practices within the pre-planned COPD prescribing QIP that are within the boundary of the NHS West Yorkshire ICB will automatically be recruited as study participants.

排除标准

  • Non-NHS primary care practices will be excluded as study participants.
  • All prescribing outside of the primary care practice setting (such as that occurring through neighbourhood initiatives, hospice-based prescribers, or secondary care) will be excluded.
  • Practices that opt-out of the pre-planned COPD prescribing QIP or are outside the boundary of the NHS West Yorkshire ICB.

结局指标

主要结局

ICS/LABA inhaler use change.

时间窗: Post 1-year intervention relative to the baseline proportion.

The change in proportion of patients with COPD on ICS/LABA inhalers over the course of the intervention in each intervention group.

次要结局

  • Post-bronchodilator test showing an FEV1/FVC ratio <0.7.(Post 1-year intervention relative to the baseline proportion.)
  • High-dose ICS-containing inhalers(Post 1-year intervention relative to the baseline proportion.)
  • COPD exacerbations(Post 1-year intervention relative to the baseline proportion.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Owen Thomas

Principle Investigator; GP; NIHR In-Practice Fellow

University of Leeds

研究点 (1)

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