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Trial registered on ANZCTR


Registration number
ACTRN12618000641291
Ethics application status
Approved
Date submitted
18/04/2018
Date registered
23/04/2018
Date last updated
23/04/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Exploring health professional and patient perspectives of best practice care for people with chronic obstructive pulmonary disease, in the hospital and outpatient setting
Scientific title
Exploring health professional and patient perspectives of best practice care for people with chronic obstructive pulmonary disease, in the hospital and outpatient setting
Secondary ID [1] 294618 0
Nil known
Universal Trial Number (UTN)
U1111-1212-4534
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Pulmonary Disease 307470 0
adherence to COPD guidelines 307471 0
views of health professionals and consumers 307472 0
Condition category
Condition code
Respiratory 306556 306556 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Identifying the views of health professional and patients about best practice care for people with Chronic Obstructive Pulmonary Disease (COPD) in the hospital and outpatient setting.
The evidence base to reduce mortality and optimise COPD management, is consistently developing and high quality national and international Clinical Practice Guidelines (CPGs) have been developed to assist facilitation of integration this knowledge into practice, However studies highlight that up to 40% of patients do not receive guideline concordant care. This issue with guideline uptake in practice is interesting given that CPGs improve quality of care by standardising practice according to high level available evidence.
Hence there is a need to consider other potential strategies, including the use of respiratory nurses that will improve delivery of these guideline recommended management strategies.issue it is important to explore themes relating to barriers and facilitators to guideline concordant care and the role of using nurses more actively to facilitate this, from the perspective of both health professionals and patients.
Materials used in the intervention for people with COPD: questionnaire for demographic information, COPD Assessment Test via http://www.catestonline.org, Chronic Respiratory Questionnaire (CRQ) licence obtained from McMaster University, 41 question moderator guide.
Materials used in the intervention for health professionals: questionnaire for demographic information, 7 point Likert scale questionnaire on COPD management and a 42 question moderator guide.
All moderator guides are performed by semi-structured interview and based on the Theoretical Domains Framework.
This project is a qualitative investigation using semi-structured interviews. This will be combined with quantitative methods and between-individual comparisons for triangulation of data.
Interviews for people with COPD will be held at the Basil Hetzel Institute/ Level 4 TQEH Respiratory Medicine Unit (according to room availability). Interviews will run for approximately 1 hour.
Interviews with health professionals will be held at a mutually agreeable time and location that is convenient for the participant. Interviews are expected to run for approximately 1 hour
Two researchers (a Research Officer/PhD Candidate and a Respiratory Nurse Consultant with experience in acute and outpatient COPD management and whom has experience and training in interview techniques) will conduct the interview sessions,The researchers will initially be observed by a research Supervisor to ensure competency in performing the semi-structured interview. One interviewer will be dedicated to questioning and the second interviewer in charge of transcribing the discussion and taking note of any participant behavioural cues that may supplement their responses during the session. All sessions will be audio recorded to support the transcription process, although participants may be contacted at a later date to validate the content if required.
Intervention code [1] 300938 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 305561 0
To identify barriers to COPD guideline uptake and adherence. As assessed by thematic analysis of the interview based on moderator guide questions.
Timepoint [1] 305561 0
At time of once only interview based on past and present experiences.
Primary outcome [2] 305592 0
To identify facilitators to COPD guideline uptake and adherence. As assessed by thematic analysis of the interview based on moderator guide questions.
Timepoint [2] 305592 0
At one time only interview based on past and present experiences.
Secondary outcome [1] 345773 0
To identify potential strategies to improve motivation to access and use guidelines in practice. As assessed by thematic analysis of the interview based on moderator guide questions.
Timepoint [1] 345773 0
At time of once only interview based on past and present experiences.
Secondary outcome [2] 345774 0
To explore perceptions on the use of respiratory nurses in managing people with COPD as per guidelines. As assessed by thematic analysis of the interview based on moderator guide questions.
Timepoint [2] 345774 0
At time of once only interview based on past and present experiences.
Secondary outcome [3] 345851 0
To identify current participant symptom impact through use of the COPD Assessment Test (a 7-point Likert scale based tool).
Timepoint [3] 345851 0
At time of once only interview based on present experience.
Secondary outcome [4] 345852 0
To identify current participant quality of life using the Chronic Respiratory Questionnaire (7-point Likert based tool).
Timepoint [4] 345852 0
At the time of once only interview based on present experience of the last two weeks.
Secondary outcome [5] 345956 0
To identify health professional's perspectives on current COPD management. As assessed by thematic analysis based on moderator guide questions. This will be cross-verified using a 7-point Likert scale questionnaire which was specifically developed for this study.
Timepoint [5] 345956 0
At the time of once only interview based on present and past experience.

Eligibility
Key inclusion criteria
People with COPD who have experienced a COPD related hospital admission in the past 12 months. If data saturation is not met for the outpatient focussed component of this study, this pool will be supplemented by people with a confirmed diagnosis of COPD who are known to the Respiratory Nursing Service of TQEH – noting that these individuals also often admit or present to hospital with an exacerbation of COPD.
Inclusion Criteria: Clinical diagnosis of COPD per guidelines or doctor diagnosed, resides in metropolitan Adelaide, hospital admission for COPD in the last 12 months, known to the Respiratory Nursing Service (TQEH)
Health Professionals:
Inclusion criteria: Is currently working on a hospital ward admitting COPD patients (e.g. general or respiratory), is currently working as a specialist respiratory nurse managing people with COPD , has treated COPD patients regularly for >12 months in the last 5 years•, has worked as a doctor in the general medicine specialty, has worked as a doctor in the thoracic specialty, or has worked as a junior medical officer with at least one rotation through a general medical (dealing with people with COPD) or respiratory ward
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion Criteria for both Health professionals and for people with COPD: Unable to consent, aged < 18 years old, non-English speaking, cognitive deficit e.g. dementia

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Both
Statistical methods / analysis
Previous research has suggested that 12 interviews should suffice where the aim is to understand perceptions and experiences within the sample population on the same topic. We have identified five groups (as identified below) that cover core COPD treatment, management and education. To ensure we obtain an adequate amount of qualitative data, 3-5 participants will be recruited into each category, totalling 15-30 participants in this group overall. For the interviews involving people with COPD, we will recruit a minimum of 15 individuals.
However, in both groups (COPD patients and health professionals), if there is still a large variation of information, additional participants will be recruited until data saturation is reached.
Health Professionals will include ward nurses, specialist respiratory nurses, general medicine doctors, respiratory specialists and junior medical officers.

Quantitative data from the questionnaires will be explored using IBM Statistical Package for Social Science (SPSS) Statistics Version 22.0.

Qualitative data will be transcribed and coded by two researchers to improve inter-rater reliability. Deductive thematic analysis will be used as the coding method to categorise responses into the 18 domains of the Theoretical Domains Framework. These will be entered and analysed in NViVo software version 11.0.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2018
Actual
Date of last participant enrolment
Anticipated
30/09/2018
Actual
Date of last data collection
Anticipated
30/09/2018
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 10742 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 10743 0
The Queen Elizabeth Hospital - Woodville
Recruitment postcode(s) [1] 22466 0
5000 - Adelaide
Recruitment postcode(s) [2] 22467 0
5011 - Woodville

Funding & Sponsors
Funding source category [1] 299235 0
University
Name [1] 299235 0
The University of Adelaide
Country [1] 299235 0
Australia
Primary sponsor type
University
Name
The University of Adelaide
Address
The University of Adelaide
SA 5005
AUSTRALIA
Country
Australia
Secondary sponsor category [1] 298506 0
None
Name [1] 298506 0
Address [1] 298506 0
Country [1] 298506 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300157 0
Central Adelaide Local Health Network Human Research Ethics Committee
Ethics committee address [1] 300157 0
Ethics committee country [1] 300157 0
Australia
Date submitted for ethics approval [1] 300157 0
13/03/2018
Approval date [1] 300157 0
26/03/2018
Ethics approval number [1] 300157 0
HREC/18/CALHN/150

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2599 2599 0 0
/AnzctrAttachments/374918-Q20180303 Approval Letter.pdf (Ethics approval)

Contacts
Principal investigator
Name 82730 0
Ms Zoe Kopsaftis
Address 82730 0
Clinical Practice Unit – Respiratory Medicine
The Queen Elizabeth Hospital
28 Woodville Road, Woodville South SA 5011
Country 82730 0
Australia
Phone 82730 0
+61 8 8222 7886
Fax 82730 0
+61 8 8222 6041
Email 82730 0
zoe.kopsaftis@adelaide.edu.au
Contact person for public queries
Name 82731 0
Zoe Kopsaftis
Address 82731 0
Clinical Practice Unit – Respiratory Medicine
The Queen Elizabeth Hospital
28 Woodville Road, Woodville South SA 5011
Country 82731 0
Australia
Phone 82731 0
+61 8 8222 7886
Fax 82731 0
+61 8 8222 6041
Email 82731 0
zoe.kopsaftis@adelaide.edu.au
Contact person for scientific queries
Name 82732 0
Zoe Kopsaftis
Address 82732 0
Clinical Practice Unit – Respiratory Medicine
The Queen Elizabeth Hospital
28 Woodville Road, Woodville South SA 5011
Country 82732 0
Australia
Phone 82732 0
+61 8 8222 7886
Fax 82732 0
+61 8 8222 6041
Email 82732 0
zoe.kopsaftis@adelaide.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



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.