Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000328976
Ethics application status
Approved
Date submitted
29/02/2020
Date registered
9/03/2020
Date last updated
2/03/2022
Date data sharing statement initially provided
9/03/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
An evaluation of patient outcomes from an innovative clinic delivering care in bronchiectasis in a regional centre
Scientific title
An evaluation of a Pilot, Innovative Interdisciplinary Care Clinic delivering targeted evidence-based care in bronchiectasis in a regional centre (PIICC)
Secondary ID [1] 300411 0
Nil known
Universal Trial Number (UTN)
U1111-1247-5916
Trial acronym
PIICC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
bronchiectasis 316057 0
Condition category
Condition code
Respiratory 314329 314329 0 0
Other respiratory disorders / diseases
Public Health 314783 314783 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The interdisciplinary clinic intervention:
The interdisciplinary clinic includes appointments with a respiratory nurse practitioner and a physiotherapist with expertise in respiratory disease. The clinic offers appointments for initial assessment (new clinic patients), three and 12 month reviews in the first year, with additional appointments if clinically indicated (patients with recurrent infection or requiring additional education in self-management techniques). A new clinic appointment is 60 minutes and a review clinic appointment 45 minutes in length. The study duration will be 14 months to allow for the collection of data after the 12 month clinic review appointment, and to account for a participant having an exacerbation, which will delay data collection until they are well.
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, positive expiratory pressure (PEP) devices (oscillating and non-oscillating), 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. 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. The medication action plan will be combined with the airway clearance therapy plan to form an individualized bronchiectasis action plan that has strategies suggested for when the patient is well and unwell.


Intervention code [1] 316701 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 322705 0
1. Quality of life- Bronchiectasis questionnaire
Timepoint [1] 322705 0
Baseline, 3 and 12 months
Primary outcome [2] 323140 0
2. Leicester Cough questionnaire
Timepoint [2] 323140 0
baseline, 3 and 12 months
Secondary outcome [1] 379371 0
Number of days in hospital for a primary admission of bronchiectasis- audit of medical record
Timepoint [1] 379371 0
12 months prior to the study and 12 months after enrollment
Secondary outcome [2] 379372 0
Number of exacerbations of bronchiectasis. An exacerbation will be defined as a deterioration in three or more of the following key symptoms for at least 48 h: cough; sputum volume and/or consistency; sputum purulence; breathlessness and/or exercise tolerance; fatigue and/or malaise; haemoptysis AND a clinician determines that a change in bronchiectasis treatment is required.
- measured for the 12 months prior to the study from participant self report and audit of the medical record
- measured for the 12 months after enrollment by participant 12 month diary and audit of the medical record
Timepoint [2] 379372 0
12 months prior to enrollment in the study and the 12 months after enrollment.
Secondary outcome [3] 379373 0
Number of adults with bronchiectasis referred to the clinic who attend an initial appointment with either the respiratory nurse practitioner or the physiotherapist (uptake)
- audit of clinic referrals against new clinic appointments from the bronchiectasis clinic share folder (Queensland Health hard drive folder, password protected)
Timepoint [3] 379373 0
12 months
Secondary outcome [4] 379374 0
Number of appointments for the interdisciplinary bronchiectasis clinic that were attended out of the appointments that were offered (attendance)
- audit of the medical record
Timepoint [4] 379374 0
12 months
Secondary outcome [5] 379657 0
Attendance at pulmonary rehabilitation of at least six weeks if referred from the clinic
- audit of the medical record
Timepoint [5] 379657 0
3 mths and 12 months

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
Sex
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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Nil
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Nil
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The interdisciplinary bronchiectasis clinic is held monthly. There are 60 new patient appointments per year. A convenience sample of 72 patients over a period of 2 years is predicted, based on 80% participation of included patients and a 25% drop out rate.

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

Quality of life, at baseline, three and 12 months will be compared using one-way repeated measures ANOVA. Mean and standard deviation will be calculated. Quality of life outcomes will be reported against published minimally clinically important differences (MCID). Health care utilization and exacerbation frequency will be compared for the 12 months prior to and the 12 months after the study using paired sample t tests. Clinic uptake and attendance, and pulmonary rehabilitation attendance will be presented as percentages.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
9/10/2020
Actual
1/02/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
31
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 15724 0
Rockhampton Base Hospital - Rockhampton
Recruitment postcode(s) [1] 29153 0
4700 - Rockhampton

Funding & Sponsors
Funding source category [1] 304833 0
Hospital
Name [1] 304833 0
Rockhampton Hospital
Country [1] 304833 0
Australia
Funding source category [2] 305165 0
University
Name [2] 305165 0
The University of Sydney
Country [2] 305165 0
Australia
Funding source category [3] 305166 0
University
Name [3] 305166 0
Monash University
Country [3] 305166 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] 305165 0
Hospital
Name [1] 305165 0
Central Queensland Hospital and Health Service
Address [1] 305165 0
Rockhampton Hospital
Canning St
Rockhampton QLD Australia 4700
Country [1] 305165 0
Australia
Secondary sponsor category [2] 305528 0
University
Name [2] 305528 0
Monash University
Address [2] 305528 0
Department of Physiotherapy
School of Primary and Allied Health Care
Monash University Building B,
McMahons Road
Frankston Victoria 3199
Country [2] 305528 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305244 0
HREC Central Queensland Hospital and Health Service
Ethics committee address [1] 305244 0
Ethics committee country [1] 305244 0
Australia
Date submitted for ethics approval [1] 305244 0
17/02/2020
Approval date [1] 305244 0
14/05/2020
Ethics approval number [1] 305244 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 99746 0
Mrs Kirsty Watson
Address 99746 0
Level 3
Rockhampton Hospital
Canning St
Rockhampton QLD 4700
Country 99746 0
Australia
Phone 99746 0
+61 416848214
Fax 99746 0
Email 99746 0
[email protected]
Contact person for public queries
Name 99747 0
Kirsty Watson
Address 99747 0
Level 3
Rockhampton Hospital
Canning St
Rockhampton QLD 4700
Country 99747 0
Australia
Phone 99747 0
+61 416848214
Fax 99747 0
Email 99747 0
[email protected]
Contact person for scientific queries
Name 99748 0
Kirsty Watson
Address 99748 0
Level 3
Rockhampton Hospital
Canning St
Rockhampton QLD 4700
Country 99748 0
Australia
Phone 99748 0
+61 416848214
Fax 99748 0
Email 99748 0
[email protected]

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 will be requested for the PIICC trial only. Any future use of participant data will require an additional ethics application.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
6688Study protocol  [email protected] 379172-(Uploaded-29-02-2020-11-15-04)-Study-related document.pdf
6690Informed consent form  [email protected] 379172-(Uploaded-29-02-2020-11-17-02)-Study-related document.pdf
6691Ethical approval  [email protected]



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.