Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000648224
Ethics application status
Approved
Date submitted
16/04/2018
Date registered
23/04/2018
Date last updated
29/04/2019
Date data sharing statement initially provided
29/04/2019
Date results information initially provided
29/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Bronchiectasis Management and Guideline use: Interviews
Scientific title
Management of bronchiectasis: What are the barriers and enablers to bronchiectasis management and the use of guidelines in outpatient care?
Secondary ID [1] 294602 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bronchiectasis 307424 0
Condition category
Condition code
Respiratory 306516 306516 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Questionnaires and semi moderated guided interviews will be conducted to obtain quantitative, semi quantitative, and qualitative data from participants ( Health professionals and patients with bronchiectasis) about their attitudes and experiences with bronchiectasis management and the use of guidelines.
The questionnaire will collect demographic information and responses to statements on 7 point Likert scales. After questionnaires are completed at the same visit qualitative data will be obtained through one-on-one interviews using a semi-structured moderated guide. It is estimated that this will take 40 mins for health professions and 1-1.5 hours for patients. Bronchiectasis patients will also complete a quality of life questionnaire and a eFACED severity score will be calculated to determine impact of disease. Interviews will be audio recorded and these will be transcribed by the researcher soon after completion of interview. The interview will be moderated or guided by the principle investigator using a developed series of interview questions with some additional prompts guided by participant responses.
Intervention code [1] 300905 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 305526 0
1. To examine sample populations of health professionals, using questionnaire with 7 point likert scale rating and semi-moderated interview exploring their practices to determine their general attitudes to:
a) bronchiectasis management
b) use of guidelines
Data collected will be coded in NVivo and thematic analysis will occur.
This is a composite primary outcome
Timepoint [1] 305526 0
One off interview
Primary outcome [2] 305527 0
2. To examine sample populations of patients using questionnaire with 7 point likert scale rating and semi-moderated interview exploring their practices to determine their general attitudes to
a) bronchiectasis management
b) the impact of their disease
c) guideline knowledge
Data collected will be coded in NVivo and thematic analysis will occur
This is a composite primary outcome
Timepoint [2] 305527 0
one off interview
Secondary outcome [1] 345589 0
Evaluate participant opinion through completion of questionnaire using likert scale rating and semi structured moderated guided interview to determine use of guidelines with focus on:
• Action plan and emergency pack use
• Vaccination
• Sputum clearance
• Sputum testing when well
• Use of antibiotics (duration and use of macrolides)
• Management of opportunistic infections
• Impact of comorbid conditions
• Clinical assessment in outpatients
• Documentation of clinical review
Data collected will be coded in NVIVo software program and thematic analysis will occur
Timepoint [1] 345589 0
One off interview
Secondary outcome [2] 345590 0
To explore patterns and common themes in attitudes to bronchiectasis management and the use of guidelines with consideration to the 18 domains of the Theoretical Domains Framework.. Data collected will be coded using NViVo software and thematic analysis of this data will occur.
Timepoint [2] 345590 0
Based on one off interview collation of results at end of study. Expected completion August 2018
Secondary outcome [3] 345833 0
Evaluation of Impact of disease through completion of an eFACED severity score for Bronchiectasis (validated tool).
Data will be collected scores will be entered on the data collection sheet, results will be reviewed by 2 researchers to independently determine the impact of disease based on the combination of eFACED and Bronchiectasis QOL results.
Timepoint [3] 345833 0
One off completion at interview
Secondary outcome [4] 345946 0
Evaluation of Impact of disease through completion of Quality of life assessment using Bronchiectasis Quality of life validated tool
Data will be collected scores will be entered on the data collection sheet, results will be reviewed by 2 researchers to independently determine the impact of disease based on the combination of eFACED and Bronchiectasis QOL results.
Timepoint [4] 345946 0
One off interview

Eligibility
Key inclusion criteria
Health Professionals: Respiratory medical physicians, respiratory nurses and respiratory physiotherapists working with bronchiectasis patients in an outpatient setting for greater than 12 months in the last 5 years.
Bronchiectasis Patients: Clinical diagnosis of bronchiectasis and moderate - severe bronchiectasis as determined by eFACED severity score
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Health professionals: unwilling to participate
Patients: not being followed up in outpatient respiratory clinic for management of bronchiectasis..Non-English speaking. Patients with mild bronchiectasis

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Quantitative and semi qualitative data obtained from the questionnaires will be investigated using IBM Statistical Package for Social Science (SPSS) Statistics Version 24.0.
Qualitative data will be transcribed and two researchers will code the responses to improve reliability of data rating. The coding method of deductive thematic analysis will be used to categorise responses into the 18 domains of the Theoretical Domains Framework. Coded responses will be entered and analysed in NViVo software version 11.0.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/05/2018
Actual
9/05/2018
Date of last participant enrolment
Anticipated
27/07/2018
Actual
10/10/2018
Date of last data collection
Anticipated
27/07/2018
Actual
10/10/2018
Sample size
Target
32
Accrual to date
Final
28
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 10683 0
The Queen Elizabeth Hospital - Woodville
Recruitment hospital [2] 10684 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 22403 0
5011 - Woodville
Recruitment postcode(s) [2] 22404 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 299221 0
University
Name [1] 299221 0
University of Adelaide
Country [1] 299221 0
Australia
Funding source category [2] 299271 0
Hospital
Name [2] 299271 0
Respiratory Medicine Unit
Country [2] 299271 0
Australia
Primary sponsor type
Individual
Name
Kathryn Lawton
Address
Respiratory Nursing Service
4A Respiratory Medicine Unit
The Queen Elizabeth Hospital
28 Woodville Rd
Woodville South, 5011
South Australia
Country
Australia
Secondary sponsor category [1] 298485 0
None
Name [1] 298485 0
Address [1] 298485 0
Country [1] 298485 0
Other collaborator category [1] 280061 0
Individual
Name [1] 280061 0
Karen Royals
Address [1] 280061 0
Respiratory Nursing Service
4A Respiratory Medicine Unit
The Queen Elizabeth Hospital
28 Woodville Rd Woodville South, 5011
South Australia
Country [1] 280061 0
Australia
Other collaborator category [2] 280062 0
Individual
Name [2] 280062 0
Dr Antony Veale
Address [2] 280062 0
4A Respiratory Medicine Unit
The Queen Elizabeth Hospital
28 Woodville Rd Woodville South, 5011
South Australia
Country [2] 280062 0
Australia
Other collaborator category [3] 280063 0
Individual
Name [3] 280063 0
Professor Brian Smith
Address [3] 280063 0
QE Specialist Centre, 35 Woodville Rd Woodville South 5011 South Australia
Country [3] 280063 0
Australia
Other collaborator category [4] 280064 0
Individual
Name [4] 280064 0
Dr Kristin Carson-Chahhoud
Address [4] 280064 0
University of South Australia
North Tce Adelaide, 5000
South Australia
and
The University of Adelaide
North Tce, Adelaide, 5000
South Australia
Country [4] 280064 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300143 0
Central Adelaide Local Health Network, Human Research Ethics Committee
Ethics committee address [1] 300143 0
Central Adelaide Local Health Network
Human Research Ethics Committee
Level 3, Roma Mitchell House
North Terrace, Adelaide SA
Australia 5000
Ethics committee country [1] 300143 0
Australia
Date submitted for ethics approval [1] 300143 0
20/03/2018
Approval date [1] 300143 0
27/03/2018
Ethics approval number [1] 300143 0
HREC Reference number: HREC/18/CALHN/176

Summary
Brief summary
The aim of this study is to identify and categorize barriers and facilitators to the use of guidelines in the management of bronchiectasis and to clarify current bronchiectasis care.
Objectives:
1.To examine sample populations of health professionals and patients working or living with bronchiectasis to determine their attitudes to bronchiectasis management and the use of guidelines.
2.To examine opinions to bronchiectasis guideline specific areas of patient management including action plan/ emergency pack use, vaccination, sputum clearance, use of antibiotics, impact of co-morbid disease, clinical assessment and documentation of review.
3.To explore patterns and common themes in attitudes to bronchiectasis management and use of guidelines
Study design:
Questionnaires and semi moderated guided interviews will be conducted to obtain quantitative, semi quantitative, and qualitative data from participants.
Participants will be health professionals (Respiratory physicians, respiratory nurses and respiratory physiotherapists) and bronchiectasis patients. It is expected recruitment will be between 12-18 people from each of these 2 groups. If data saturation is not reached more participants will be recruited.
Study procedure
At interview participants will bring consent form and sign, answer the questionnaire and then take part in the semi structured interview. Bronchiectasis patients will complete an additional Quality of life assessment using the quality of life bronchiectasis questionnaire. A eFACED severity score will also be calculated for patients to allow grouping of patients responses with like disease severity/ impact.
Data Analysis
Transcribed interviews will be coded by 2 researchers using deductive thematic analysis to categorise the responses into the 18 Domains of the Theoretical Domains Framework.
Date will be analyses using IBM Statistical Package for Social Science (SPSS) Statistics Version 24.0. for quantitative data and coded responses will be entered and analysed in NViVo software version 11.0.
Data collected will be safely and securely managed. Audio recordings will be kept for 15 yrs, data will be de-identified through use of a study code. All data will be stored securely with password protection on secure network or locked filling cabinet accessible by trial researchers only.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2595 2595 0 0
/AnzctrAttachments/374908-R20180324 Approval Letter.pdf

Contacts
Principal investigator
Name 82690 0
Mrs Kathryn Lawton
Address 82690 0
Respiratory Nurse Consultant
Respiratory Nursing Service
4A Respiratory Medicine Unit
The Queen Elizabeth Hospital
28 Woodville Rd Woodville South, 5011
South Australia
Country 82690 0
Australia
Phone 82690 0
+61 08 82226906
Fax 82690 0
+61 08 82226041
Email 82690 0
[email protected]
Contact person for public queries
Name 82691 0
Kathryn Lawton
Address 82691 0
Respiratory Nurse Consultant
Respiratory Nursing Service
4A Respiratory Medicine Unit
The Queen Elizabeth Hospital
28 Woodville Rd Woodville South, 5011
South Australia
Country 82691 0
Australia
Phone 82691 0
+61 08 82226906
Fax 82691 0
+61 08 82226041
Email 82691 0
[email protected]
Contact person for scientific queries
Name 82692 0
Kathryn Lawton
Address 82692 0
Respiratory Nurse Consultant
Respiratory Nursing Service
4A Respiratory Medicine Unit
The Queen Elizabeth Hospital
28 Woodville Rd Woodville South, 5011
South Australia
Country 82692 0
Australia
Phone 82692 0
+61 08 82226906
Fax 82692 0
+61 08 82226041
Email 82692 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
Individual participant data not shared as not part of consent/ ethics process to share individual responses and data is relevant to context of individual health service. Happy to be contacted by researchers looking to replicate study in their health service.
Will upload supporting documents of clinical study report when completed


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Conference abstractNo TSANZ Conference 2019 TO 008 Barriers and enable... [More Details]

Documents added automatically
No additional documents have been identified.