Changing Outcomes Through Achievement Emails in COPD Using Routine Healthcare Audits

NCT07181915 | Active Not Recruiting

• 1 other identifier: 2025-NCT48
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

COPD (Chronic Obstructive Pulmonary Disease)

Keywords

audit and feedback; implementation sciences; Inhalers

Outcome Measures

Primary Outcomes (1)

• ICS/LABA inhaler use change.

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

  Post 1-year intervention relative to the baseline proportion.

Secondary Outcomes (3)

• Post-bronchodilator test showing an FEV1/FVC ratio <0.7.

  Post 1-year intervention relative to the baseline proportion.

• COPD exacerbations

  Post 1-year intervention relative to the baseline proportion.

• High-dose ICS-containing inhalers

  Post 1-year intervention relative to the baseline proportion.

Study Arms (2)

Control GP practice group

ACTIVE COMPARATOR

A GP practice allocated to the control intervention within the West Yorkshire Integrated Care Board boundary, UK, that is taking part in the pre-planned COPD quality improvement project (ICONIC).

Other: Generic email - control

Intervention GP practice group

EXPERIMENTAL

A GP practice allocated to the personalised email intervention within the West Yorkshire Integrated Care Board boundary, UK, that is taking part in the pre-planned COPD quality improvement project (ICONIC).

Other: Personalised email - Intervention

Interventions

Generic email - control OTHER

A generic email delivered to a GP practice alongside a digital feedback report. The generic control email will be the same text each time for all practices within that arm and will contain no suggestions for improving practice.

Control GP practice group

Personalised email - Intervention OTHER

A personalised achievement email delivered to a GP practice alongside a digital feedback report. The personalised email wording will change based on the achievement of the practice and the content in the feedback reports, which is being distributed as part of the pre-existing quality improvement project, rather than this research study. The recommendations in bullet points within the personalised emails suggesting how to improve care will be informed as relevant succinct summaries of the key guidance contained with the feedback reports, which will be based on either national guidelines or respected published literature. This will be written by the lead researcher for this project (who is the author of the QIP feedback reports themselves) and will be reviewed by the same group that reviews the QIP feedback report content before publication.

Intervention GP practice group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Leeds: lead

Study Sites (1)

NHS West Yorkshire Integrated Care Board

Leeds, United Kingdom

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Owen Thomas, MBBS; MSc

  University of Leeds

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator; GP; NIHR In-Practice Fellow

Study Record Dates

• First Submitted: September 2, 2025
• First Posted: September 18, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): January 4, 2027
• Last Updated: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)