A study to explore knowledge, views and behaviours surrounding inhaler selection and whether knowledge of the carbon footprint of inhalers is important to patients

ISRCTN	ISRCTN16609010
DOI	https://doi.org/10.1186/ISRCTN16609010
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Integrated Research Application System (IRAS)	332630
Protocol serial number	CPMS 58381, IRAS 332630
Sponsor	Portsmouth Hospitals NHS Trust
Funder	RESPIACTION CIC

Submission date: 25/10/2023
Registration date: 09/11/2023
Last edited: 09/11/2023

Recruitment status: Recruiting
Overall study status: Ongoing
Condition category: Respiratory

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
The NHS contributes substantially to the UKs carbon footprint with an estimated 23 million tonnes gCO2Eq per year, 3% of which comes from pMDIs. There are a number of alternative inhalers, such as DPIs, which do not use propellant and therefore have a significantly lower carbon footprint. There is a call to move towards greener inhalers as part of the NHS long term plan for sustainability, to reduce the carbon footprint and therefore the environmental impact and help protect the health of our patients today and in the future.

We are looking to explore knowledge, views and behaviours surrounding inhaler selection and in particular whether knowledge of the carbon footprint of inhalers is important to patients when discussing their inhaled treatments as well as to better understand how carbon footprint information should be provided to patients. This will potentially facilitate a drive to greener inhaler prescribing practices whilst further empowering patients to have an active role in decisions around their inhaler treatments.

Who can participate?
All inpatients, outpatients, staff and visitors attending primary and secondary care sites across the Wessex Asthma Network, who regularly use an inhaler for a diagnosed respiratory condition will be invited to take part.

What does the study involve?
We have designed a online questionnaire which should take no longer than 10 minutes to complete. It includes questions to determine attitudes towards and current knowledge of the carbon footprint of inhalers and whether participants feel this is something that should be included in discussions around inhaler choice and how this information is best presented. There are also 2 very simple case scenarios which are not a test of knowledge, but which will assess thoughts on inhaler switching with participants being automatically randomised into one of two groups (one with the carbon footprint of each inhaler, and the other without). We will also assess current inhaler recycling practices.

What are the possible benefits and risks of participating?
None

Where is the study run from?
Portsmouth Hospitals NHS Trust (UK)

When is the study starting and how long is it expected to run for?
August 2023 to October 2026

Who is funding the study?
RESPIACTION CIC (UK)

Who is the main contact?
Laura.wiffen@porthosp.nhs.uk

Contact information

Dr Laura Wiffen
Scientific

Portsmouth Hospitals University NHS Trust
Queen Alexandra Hospital
Southwick Hill Road
Portsmouth
PO6 3LY
United Kingdom

Phone	+44 2392286236
Email	Laura.wiffen@porthosp.nhs.uk

Study information

Primary study design	Interventional
Study design	Interventional randomized controlled trial
Secondary study design	Randomised controlled trial
Participant information sheet	44485 REDUCE+Carbon+patients+Long+PIS+V1.1+26.09.2023+Clean Logo update.pdf
Scientific title	A randomised controlled trial to explore knowledge, views and behaviours surrounding inhaler selection and whether the carbon footprint of inhalers is important to patients
Study acronym	REDUCE- Carbon for Patients
Study objectives	We are looking to explore knowledge, views and behaviours surrounding inhaler selection and in particular whether knowledge of the carbon footprint of inhalers is important to patients when discussing their inhaled treatments as well as to better understand how carbon footprint information should be provided to patients.
Ethics approval(s)	Approved 13/10/2023, South Central Berkshire Research Ethics Committee (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 207 1048233; berkshire.rec@hra.nhs.uk), ref: 23/SC/0310
Health condition(s) or problem(s) studied	Asthma
Intervention	Participants will be randomised into either: - The Control arm- Participants will not receive any information regarding the carbon footprint of individual inhalers - The Intervention arm- Participants will be provided with the carbon footprint for individual inhalers. The study is an online questionnaire based on the Wessex Asthma Network inhaler guidelines consisting of questions and two very simple case scenarios. It is not a test of knowledge and will take about 10 minutes to complete.
Intervention type	Behavioural
Primary outcome measure(s)	Measured by questionnaire at point of questionnaire completion: 1. The number and proportion of participants preferring high or low carbon inhalers 2. The number and proportion of participants who think carbon footprint should be included in inhaler choice discussions 3. The number and proportion of participants who would be willing to change their inhaler to a lower carbon option
Key secondary outcome measure(s)	Measured by questionnaire at point of questionnaire completion: 1. The rank order of preference of the following factors in carbon-containing and non-carbon containing groups: Cost of the inhaler, Carbon footprint of the inhaler, How many times a day the inhaler needs to be used, The view of the healthcare professional prescribing the inhaler 2. With sensitivity analyses of the order of preference for the following factors in both groups: Age, Respiratory condition, Level of education attainment, Number of inhalers used by the participant, Length of time participant has been using inhalers 3. The number and proportion of participants who are aware of the environmental impact of inhalers 4. The number and proportion of participants matching the inhaler carbon footprint to the equivalent car journey 5. The rank order of preference of the following options in the provision of inhaler carbon footprint: By the healthcare professional prescribing the inhaler, as gCO2Eq on the inhaler packaging, access to a website displaying the carbon footprint of all inhalers, by the pharmacist when collecting prescriptions, would not want to receive the information 6. The rank order of preference of the following options of how inhaler carbon footprint should be made available : By using a traffic light system to demonstrate high/medium/low carbon footprints, As an exact value (in grams of carbon dioxide equivalent), Using everyday measures as a comparator, Would not want to receive the information 7. The proportion of participants that try to recycle their inhalers. 8. The proportion of participants that would use inhaler recycling facilities if available
Completion date	24/10/2026

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	5492
Key inclusion criteria	1. Aged >= 18 years 2. Have a diagnosed respiratory condition and take an inhaler regularly 3. Able to provide e-consent 4. Able to understand and complete the clinical case scenarios
Key exclusion criteria	Inability to understand or comply with study procedures and/or inability to give fully informed consent.
Date of first enrolment	25/10/2023
Date of final enrolment	24/10/2026

Locations

Countries of recruitment

United Kingdom

Study participating centres

Portsmouth Hospitals University National Health Service Trust

Queen Alexandra Hospital
Southwick Hill Road
Cosham
Portsmouth
PO6 3LY
United Kingdom

Hampshire Hospitals NHS Foundation Trust

Basingstoke and North Hampshire Hos
Aldermaston Road
Basingstoke
RG24 9NA
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Published as a supplement to the results publication
IPD sharing plan	All data generated or analysed during this study will be included in the subsequent results publication

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	version 1.1	26/09/2023	08/11/2023	No	Yes
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Study website	Study website	11/11/2025	11/11/2025	No	Yes

Additional files

44485 REDUCE+Carbon+patients+Long+PIS+V1.1+26.09.2023+Clean Logo update.pdf: Participant information sheet

Editorial Notes

25/10/2023: Trial's existence confirmed by the National Institute for Health and Care Research (NIHR) (UK).