Feasibility and acceptability of using a shared decision making intervention to support patient choice of airway clearance techniques in bronchiectasis physiotherapy consultations in the NHS

ISRCTN	ISRCTN55381093
DOI	https://doi.org/10.1186/ISRCTN55381093
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Integrated Research Application System (IRAS)	316457
Protocol serial number	CPMS 70212
Sponsor	Newcastle upon Tyne Hospitals NHS Foundation Trust
Funder	National Institute for Health and Care Research

Submission date: 12/08/2025
Registration date: 10/12/2025
Last edited: 10/12/2025

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
Bronchiectasis is a long-term lung condition that causes the airways to become wider than normal. This can lead to a build-up of mucus, frequent coughing, and chest infections. Over 300,000 people in the UK live with bronchiectasis.
To help clear mucus from the lungs, patients are taught airway clearance techniques (ACTs) by a physiotherapist. These techniques can reduce infections and hospital visits. There are many types of ACTs, but there isn’t strong evidence to show which one works best.
This study aims to test whether using a shared decision-making (SDM) approach — where patients and professionals make decisions together — is a helpful and acceptable way to support patients in choosing the ACT that suits them best.

Who can participate?
Adults aged 18 years or over with a diagnosis of bronchiectasis (but not cystic fibrosis) may be able to take part.

What does the study involve?
Participants will attend a physiotherapy consultation where the SDM approach will be used to help them choose an ACT. They will have follow-up appointments at 1 and 3 months. During the study, participants will be asked to complete questionnaires and may be invited to take part in an interview to share their experiences. Some participants will also be asked to provide feedback through audio recordings of their consultations.

What are the possible benefits and risks of participating?
Participants may benefit from receiving extra support in choosing an ACT that works best for them. The study could also help improve care for other people with bronchiectasis in the future.
There are no expected risks from the intervention itself. However, taking part will involve some time to complete questionnaires and possibly attend an interview. To make this easier, interviews can be done online using Microsoft Teams.

Where is the study run from?
Newcastle upon Tyne Hospitals NHS Foundation Trust

When is the study starting and how long is it expected to run for?
June 2025 to June 2026

Who is funding the study?
National Institute for Health and Care Research (NIHR) (UK)

Who is the main contact?
Paul McCallion, p.mccallion2@newcastle.ac.uk

Contact information

Mr Paul McCallion
Public, Scientific, Principal investigator

Physiotherapy Department
Freeman Hospital
Freeman Road
Newcastle Upon Tyne
NE7 7DN
United Kingdom

ORCID ID	0000-0002-9097-1980
Phone	+44 191 2448218
Email	p.mccallion2@newcastle.ac.uk

Study information

Primary study design	Interventional
Study design	Multi-centre interventional non randomized feasibility and acceptability study
Secondary study design	Non randomised study
Study type	Participant information sheet
Scientific title	Feasibility and acceptability of using a Shared Decision Making intervention to support patient choice of Airway Clearance Techniques in bronchiectasis physiotherapy consultations in the NHS. The FAST-ACT Study
Study acronym	FAST-ACT
Study objectives	1. Determine the feasibility and acceptability of an SDM intervention to support patient choice of ACTs in bronchiectasis physiotherapy consultations in the NHS. 2. Evaluate the fidelity to training in the use of SDM as an intervention.
Ethics approval(s)	Approved 04/06/2025, HRA and Health and Care Research Wales (HCRW) (Floor Four, North, Welsh Government Offices, Cathays Park, King Edward VII Avenue, Cardiff, CF10 3NQ, United Kingdom; +44 2920 230457; healthandcareresearch@wales.nhs.uk), ref: 25/EE/0111
Health condition(s) or problem(s) studied	Bronchiectasis
Intervention	The intervention is the provision of a Shared Decision Making (SDM) Patient Decision Aid. This was developed over the past 2 years as part of the wider PhD study. We conducted a qualitative study involving respiratory physiotherapists and patients living with bronchiectasis. We explored their experiences of airway clearance techniques (ACT) prescription, and the anticipated acceptability on the use of SDM to support choice of ACT in adults with bronchiectasis. We used the information from this study and published literature to co-produce an SDM intervention consisting of an SDM decision aid and training package. The SDM decision aid includes three types of ACT choices; 1) the active cycle of breathing technique, 2) autogenic drainage and 3) an oscillating positive expiratory pressure device (for this study we will use the OPEP called “Aerobika”). Aerobika OPEP devices have been used in routine care in bronchiectasis physiotherapy clinics in the UK for several years. Aerobika, and all OPEP devices, are a non-pharmacologic techniques that can increase mobilization and removal of mucus from the lungs. All ACTs in the SDM decision aid are prescribed as part of usual care in physiotherapy bronchiectasis clinics. The SDM training package was designed for respiratory physiotherapists on how to use the decision aid. This training package consists of an existing publicly available SDM training course aimed at healthcare professionals. This training package was created and is hosted by NICE (available at: https://www.nice.org.uk/guidance/ng197/resources/shared-decision-making-learning-package-9142488109). There will be additional bronchiectasis specific components that the 4 physiotherapists involved in delivering the intervention will view. These are example video case studies using the SDM patient decision aid created by the study co-production team. These will be an addition to the NICE SDM training package, and available to the physiotherapists delivering the intervention. Our co-production team involved several stakeholders including respiratory physiotherapists, patients living with bronchiectasis, experts in SDM, representatives from Asthma and Lung UK (a UK lung charity) and clinical researchers. We will now aim to test the acceptability and feasibility of this SDM intervention to support patient choice of ACT in adults with bronchiectasis. The intervention will be delivered once. It will be delivered in a physiotherapy bronchiectasis clinic which patients are attending as part of their usual care. One of the feasibility outcomes is to explore if this intervention can be delivered in the usual physiotherapy consultation allocated timeslot (30 minutes). The two follow up physiotherapy consultations (1 month and 3 months post intervention) will be above usual care.
Intervention type	Behavioural
Primary outcome measure(s)	1. Feasibility of recruitment is measured using the proportion of patients approached who agree to undertake the study at baseline 2. Feasibility of retention is measured using the proportion of patients attending follow-up consultations at each follow-up timepoint 3. Feasibility of data collection is measured using completion rates of outcome data (e.g., questionnaires) at each data collection timepoint 4. Feasibility of intervention delivery is measured using the proportion of physiotherapy consultations in which the intervention is delivered within 30 minutes at each initial consultation 5. Health-related quality of life is measured using the Quality of Life-Bronchiectasis (QOL-B) questionnaire at baseline and each follow-up timepoint 6. Acceptability of shared decision-making is measured using the 9-item Shared Decision-Making Questionnaire (SDM-Q-9) for patients at the initial consultation and each follow-up consultation 7. Acceptability of shared decision-making is measured using the Shared Decision-Making Questionnaire for clinicians (SDM-Q-Doc) at the initial consultation 8. Fidelity to shared decision-making training is measured using OPTION 5 ratings of audio-recorded initial consultations selected by random sampling at baseline 9. Decisional conflict is measured using the Decisional Conflict Scale (DCS) for patients after the initial consultation only 10. Decision regret is measured using the Decision Regret Scale (DRS) for patients at each follow-up visit in relation to their initial chosen airway clearance technique
Key secondary outcome measure(s)	Adherence to ACTs measured with REDcap (https://projectredcap.org) via a mobile phone as a new reporting system for adherence to ACTs in bronchiectasis
Completion date	01/06/2026

Eligibility

Participant type(s)	Health professional, Patient
Age group	Mixed
Lower age limit	18 Years
Upper age limit	100 Years
Sex	All
Target sample size at registration	50
Key inclusion criteria	1. ≥18 years old 2. Radiological and clinical diagnosis of bronchiectasis 3. Capacity to consent and participate in SDM 4. Patient or their carer owns a mobile telephone 5. First visit to specialist bronchiectasis clinic
Key exclusion criteria	1. Patients with cystic fibrosis (CF) bronchiectasis as aetiology
Date of first enrolment	01/09/2025
Date of final enrolment	01/01/2026

Locations

Countries of recruitment

United Kingdom
England

Study participating centres

The Newcastle upon Tyne Hospitals NHS Foundation Trust

Freeman Hospital
Freeman Road
High Heaton
Newcastle upon Tyne
NE7 7DN
England

University Hospital Birmingham

Queen Elizabeth Hospital
Edgbaston
Birmingham
B15 2TH
England

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Data sharing statement to be made available at a later date
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

13/08/2025: Trial's existence confirmed by NHS HRA.