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Trial registered on ANZCTR


Registration number
ACTRN12620000377932p
Ethics application status
Submitted, not yet approved
Date submitted
29/02/2020
Date registered
19/03/2020
Date last updated
19/03/2020
Date data sharing statement initially provided
19/03/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Acceptability of a bronchiectasis clinic
Scientific title
Acceptability of a Pilot, Innovative Interdisciplinary Care Clinic delivering targeted evidence-based care in bronchiectasis in a regional centre
Secondary ID [1] 300466 0
Nil known
Universal Trial Number (UTN)
U1111-1247-7925
Trial acronym
PIICC
Linked study record
This trial is evaluating the acceptability of an interdisciplinary bronchiectasis clinic to participants (qualitative analysis) and is linked to ACTRN12620000328976 which is evaluating the quantitative outcomes from an interdisciplinary bronchiectasis clinic.

Health condition
Health condition(s) or problem(s) studied:
bronchiectasis 316134 0
Condition category
Condition code
Respiratory 314425 314425 0 0
Other respiratory disorders / diseases
Public Health 314846 314846 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All participants will receive care from the interdisciplinary bronchiectasis outpatient clinic. Participants will attend an initial assessment which is 60 minutes in duration and a review appointment at three months which is 45 minutes long. The overall duration of the intervention is three months. Additional appointments will be scheduled if clinically indicated after interdisciplinary team decision making (patients with recurrent infection and/or hospital admission or requiring additional education in self-management techniques). Patients will receive a follow up telephone call two weeks after the initial assessment from the physiotherapist to answer any questions from the bronchiectasis action plan developed. Patients will also be encouraged to contact the work telephone number of the physiotherapist if they have further questions prior to the scheduled three month review appointment.

The targeted evidence-based interventions of the clinic will depend on patient need and will include any of the following: a medication action plan, an airway clearance plan, referral to pulmonary rehabilitation or home exercise prescription, physical activity (PA) and sedentary behaviour (SB) advice according to the Australian PA guidelines, and education relating to smoking cessation, avoidance of environmental airborne pollutants, hydration, the management of co morbidities such as sinusitis, and musculoskeletal pain and strategies for breathlessness and infection control.

The medication action plan will be commenced by the respiratory physician prior to referral to the clinic, and then completed by the respiratory nurse practitioner at the clinic, along with education on medication timing and technique. The airway clearance therapy plan will be developed by a physiotherapist with expertise in respiratory disease and will involve the use of a range of possible techniques including the active cycle of breathing technique (ACBT), positive expiratory pressure (PEP) devices, patient positioning, forced expiratory technique (FET), percussion/vibrations and inhalation therapies. Education on hydration will involve targeting the colour of urine to achieve optimal hydration of secretions to improve airway clearance. Sinusitis management will assess the need for sinus wash out and/or ongoing medications to minimize the effect of sinus discharge into the respiratory tract. Musculoskeletal pain will be evaluated for its role in affecting cough and airway clearance therapy effectiveness. Pain profiles will influence the components/techniques used in the airway clearance therapy plan, with strategies to minimize pain prescribed. If breathlessness at rest or during activity is a feature of the presentation, specific advice on activity pacing, positioning, relaxed breathing techniques and fan therapy will be tailored to the individual. All patients will be given infection control advice relating to general respiratory hygiene and the cleaning of any airway clearance equipment or nebulisers used to minimize the potential for recurrent infection.





Intervention code [1] 316764 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 323085 0
The primary outcome will be the measurement of clinic acceptability through semi structured interviews.
-an interview guide will be used for the semi structured interviews with questions that describe the components of the theoretical framework of acceptability including: affective attitude, burden, ethicality, intervention coherence, opportunity costs, perceived effectiveness and self-efficacy.
- this is a composite measure
Timepoint [1] 323085 0
After the 3 month clinic review appointment
Secondary outcome [1] 380734 0
Nil secondary measures
Timepoint [1] 380734 0
Nil

Eligibility
Key inclusion criteria
All patients > 18 years of age with clinically significant bronchiectasis who have been referred to the interdisciplinary bronchiectasis outpatient clinic at the Sub-Acute and Chronic Care Rehabilitation (SACCR) service at the Central Queensland Hospital and Health Service (CQHHS) will be invited to participate.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will be excluded if they have attended a bronchiectasis outpatient clinic with the inclusion of a respiratory physician or respiratory nurse practitioner and a physiotherapist outside of the CQHHS in the 12 months prior to the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Participants will be recruited, and interviews conducted until no additional themes are emerging from the analysis (minimum 10 participants).

Baseline characteristics will be analysed using frequencies and descriptive statistics. Mean, median and 95% confidence intervals will be estimated for continuous variables. Data analysis will be performed using SPSS (Version 25 for Windows IBM, USA).

Data from the semi structured interviews will be analysed according to the phases of thematic analysis including: familiarizing yourself with the data; generating initial codes; searching for themes; reviewing themes; defining and naming themes and producing the report. The first and second transcript will be coded by the principal investigator (PI) and chief researcher (CR) independently to generate initial codes and compare for consistency of coding. Coding will occur in categories which correspond to the seven components of the theoretical framework of acceptability (affective attitude, burden, ethicality, intervention coherence, opportunity costs, perceived effectiveness and self-efficacy). The PI will then code the remaining transcripts, discussing themes that emerge with the CR and co investigators. As themes emerge, purposive sampling will occur to gain further information in developing categories. NVivo 12 software will be used for the coding and analysis of the interviews. Participant consent will be gained to use quotations from the interviews that demonstrate the themes that emerge from the data.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 16032 0
Rockhampton Base Hospital - Rockhampton
Recruitment postcode(s) [1] 29545 0
4700 - Rockhampton

Funding & Sponsors
Funding source category [1] 304880 0
Hospital
Name [1] 304880 0
Rockhampton Hospital
Address [1] 304880 0
Allied Health
Level 6 Rockhampton Hospital
Canning St
Rockhampton QLD 4700
Country [1] 304880 0
Australia
Funding source category [2] 305170 0
University
Name [2] 305170 0
The University of Sydney
Address [2] 305170 0
Sydney School of Health Sciences
Faculty of Medicine and Health
O Block Cumberland Campus
The University of Sydney NSW 2141
Country [2] 305170 0
Australia
Funding source category [3] 305171 0
University
Name [3] 305171 0
Monash University
Address [3] 305171 0
Department of Physiotherapy
School of Primary and Allied Health Care
Monash University Building B,
McMahons Road
Frankston Victoria 3199
Country [3] 305171 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
Sydney School of Health Sciences
Faculty of Medicine and Health
O Block Cumberland Campus
The University of Sydney NSW 2141
Country
Australia
Secondary sponsor category [1] 305221 0
Hospital
Name [1] 305221 0
Central Queensland Hospital and Health Service
Address [1] 305221 0
Rockhampton Hospital
Canning St
Rockhampton QLD 4700 Australia
Country [1] 305221 0
Australia
Secondary sponsor category [2] 305531 0
University
Name [2] 305531 0
Monash University
Address [2] 305531 0
Department of Physiotherapy
School of Primary and Allied Health Care
Monash University Building B,
McMahons Road
Frankston Victoria 3199

Country [2] 305531 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 305297 0
Central Queensland Hospital and Health Service
Ethics committee address [1] 305297 0
Canning St
Rockhampton QLD 4700
Ethics committee country [1] 305297 0
Australia
Date submitted for ethics approval [1] 305297 0
17/02/2020
Approval date [1] 305297 0
Ethics approval number [1] 305297 0

Summary
Brief summary
To evaluate whether an interdisciplinary bronchiectasis clinic will be acceptable to patients in a regional area.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 99898 0
Mrs Kirsty Watson
Address 99898 0
Level 3 ICU
Rockhampton Hospital
Canning St
Rockhampton QLD 4700
Country 99898 0
Australia
Phone 99898 0
+61 416848214
Fax 99898 0
Email 99898 0
kirsty.watson@sydney.edu.au
Contact person for public queries
Name 99899 0
Mrs Kirsty Watson
Address 99899 0
Level 3 ICU
Rockhampton Hospital
Canning St
Rockhampton QLD 4700
Country 99899 0
Australia
Phone 99899 0
+61 416848214
Fax 99899 0
Email 99899 0
kirsty.watson@sydney.edu.au
Contact person for scientific queries
Name 99900 0
Mrs Kirsty Watson
Address 99900 0
Level 3 ICU
Rockhampton Hospital
Canning St
Rockhampton QLD 4700
Country 99900 0
Australia
Phone 99900 0
+61 416848214
Fax 99900 0
Email 99900 0
kirsty.watson@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Participant consent is being requested for the use of data in this study only. If participant information is to be used for any other purpose, an additional ethics application will need to be submitted.
What supporting documents are/will be available?
Study protocol
Informed consent form
Ethical approval
How or where can supporting documents be obtained?
Type [1] 7176 0
Study protocol
Citation [1] 7176 0
Link [1] 7176 0
Email [1] 7176 0
kirsty.watson@sydney.edu.au
Other [1] 7176 0
Attachment [1] 7176 0
Type [2] 7177 0
Informed consent form
Citation [2] 7177 0
Link [2] 7177 0
Email [2] 7177 0
Other [2] 7177 0
Type [3] 7178 0
Ethical approval
Citation [3] 7178 0
Link [3] 7178 0
Email [3] 7178 0
kirsty.watson@sydney.edu.au
Other [3] 7178 0
Attachment [3] 7178 0
Summary results
No Results