Letters in Addition to Emailed Audit and Feedback in Refining Asthma Treatment in Primary Care

NCT05761873 | Completed

• 1 other identifier: CLEARAIR321442
• Study Type: interventional
• Target: 273
• Locations: 1 country
• Sites: 1

Brief Summary

Public Health England have estimated that 36,000 excess deaths occur each year due to UK air pollution. Respiratory inhalers produce 3% of NHS greenhouse gas production. The two main inhaler device categories are pressurised Metered Dose Inhalers (pMDIs) and Dry Powder Inhalers (DPIs). The chemical propellant in pMDIs is the majority cause of inhaler carbon footprint, with pMDIs having an 18 times higher carbon footprint than DPIs. The rates of asthma in the UK population are amongst the highest worldwide and its mortality rate remains amongst the worst in Europe. A pre-existing Audit and Feedback (A\&F) quality improvement project (QIP) is being undertaken by NHS West Yorkshire Integrated Care Board (ICB) with the aim of improving asthma outcomes and reducing the environmental impact of inhalers in primary care. The A\&F being utilised here has been validated locally in two peer reviewed studies and is now standard practice in the region. There is convincing evidence that A\&F has a positive effect on enacting behaviour change, especially where behaviour change is related to prescribing with low baseline compliance with guidelines. However, the evidence base is poor on which design features of A\&F produce enhanced results. There is supporting evidence from local studies suggesting that posted paper A\&F may be more effective at producing behaviour change than emailed copies of A\&F alone. This study seeks to randomise the primary care practices within the pre-arranged QIP, to receive either a paper and emailed A\&F report bimonthly for the duration of the study period, or to receive an emailed A\&F report alone. The primary outcome of the study would be a comparison of the number of 'low-global warming potential' inhalers prescribed as a percentage of the total prescribed inhalers from each intervention group.

Conditions

Asthma

Keywords

Paper; Email; Audit and Feedback; Behavioural Change Taxonomy; Inhalers; Climate change; Environment; Carbon dioxide; pMDI; DPI; Spacer; Primary care; Prescribing; Theoretical Domains Framework

Outcome Measures

Primary Outcomes (1)

• High-global warming potential' pMDI inhalers use

  The number of 'high-global warming potential' preventer pMDI inhalers prescribed as a proportion of the total prescribed preventer inhalers for patients with asthma from each primary care practice - limited to those aged over 5.

  1 year

Secondary Outcomes (7)

• 6 or more SABA's prescriptions

  1 year

• 12 or more SABA's prescriptions

  1 year

• 3 or less inhaled corticosteroids prescriptions

  1 year

• 2 or more courses of oral prednisolone prescriptions

  1 year

• Children with second-hand smoke status recorded

  1 year

Study Arms (2)

Paper audit and feedback only

ACTIVE COMPARATOR

Provision of A\&F reports by email (standard practice in the region) to allocated practices depending on randomisation status.

Other: Provision of audit and feedback via paper only

Paper and email audit and feedback

EXPERIMENTAL

Provision of A\&F reports by paper via the post (new intervention being trialled) and email (standard practice) to allocated practices depending on randomisation status.

Other: Provision of audit and feedback via email and paper

Interventions

Provision of audit and feedback via email and paper OTHER

Provision of A\&F reports by paper via the post (new intervention being trialled) and email (standard practice) to allocated practices depending on randomisation status.

Paper and email audit and feedback

Provision of audit and feedback via paper only OTHER

Provision of A\&F reports by email (standard practice in the region) to allocated practices depending on randomisation status.

Paper audit and feedback only

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Must be a primary care practice in the West Yorkshire ICB region.
• Must consent to data sharing, and not opted out of the West Yorkshire QIP

You may not qualify if:

• Not a primary care practice in the West Yorkshire ICB region.
• A primary care practice that has not consented to data sharing, or opted out of the West Yorkshire QIP

Sponsors & Collaborators

• University of Leeds: lead
• NHS West Yorkshire Integrated Care Board: collaborator

Study Sites (1)

White Rose House

Wakefield, West Yorkshire, WF1 1LT, United Kingdom

Location

Related Publications (4)

• Ivers NM, Sales A, Colquhoun H, Michie S, Foy R, Francis JJ, Grimshaw JM. No more 'business as usual' with audit and feedback interventions: towards an agenda for a reinvigorated intervention. Implement Sci. 2014 Jan 17;9:14. doi: 10.1186/1748-5908-9-14.

  PMID: 24438584 BACKGROUND

• Ivers N, Jamtvedt G, Flottorp S, Young JM, Odgaard-Jensen J, French SD, O'Brien MA, Johansen M, Grimshaw J, Oxman AD. Audit and feedback: effects on professional practice and healthcare outcomes. Cochrane Database Syst Rev. 2012 Jun 13;2012(6):CD000259. doi: 10.1002/14651858.CD000259.pub3.

  PMID: 22696318 BACKGROUND

• Alderson SL, Farragher TM, Willis TA, Carder P, Johnson S, Foy R. The effects of an evidence- and theory-informed feedback intervention on opioid prescribing for non-cancer pain in primary care: A controlled interrupted time series analysis. PLoS Med. 2021 Oct 4;18(10):e1003796. doi: 10.1371/journal.pmed.1003796. eCollection 2021 Oct.

  PMID: 34606504 BACKGROUND

• Wood S, Foy R, Willis TA, Carder P, Johnson S, Alderson S. General practice responses to opioid prescribing feedback: a qualitative process evaluation. Br J Gen Pract. 2021 Sep 30;71(711):e788-e796. doi: 10.3399/BJGP.2020.1117. Print 2021 Oct.

  PMID: 33979300 BACKGROUND

MeSH Terms

Conditions

Asthma

Interventions

Paper

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Owen Thomas, MBBS

  University of Leeds

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The research team will remain blinded to the identity of which practice has been assigned which pseudonym. However, clearly it is impossible for the ICB and the practices themselves to be blinded to the assignment status of each practice due to the nature of the intervention. The ICB will retain the process of sending out reports by email and post, as would be standard practice in such a quality improvement project.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Model Details: The study design is a cluster Randomised Controlled trial, where primary care practices within the NHS West Yorkshire ICB region would be randomised by Primary Care Network (PCN) to receive either paper copies of A\&F reports and emailed PDF A\&F reports, or emailed PDF A\&F reports alone. The research team will randomise (using a simple computerised Random Number Generator) each cluster of PCN practice pseudonyms to receive their audit and feedback report either by email alone, or by email and a physical copy through the post. To prevent contamination effects and for ease of analysis, cluster randomisation would be utilised on a Primary Care Network (PCN) basis. Once randomised, each practice will receive 7 A\&F reports over the course of a year in their allocated format, informing them of their progress.

Study Record Dates

• First Submitted: February 27, 2023
• First Posted: March 9, 2023
• Study Start: April 24, 2023
• Primary Completion: May 17, 2024
• Study Completion: April 17, 2025
• Last Updated: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)