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Trial registered on ANZCTR


Registration number
ACTRN12619001730190
Ethics application status
Approved
Date submitted
8/05/2019
Date registered
9/12/2019
Date last updated
9/12/2019
Date data sharing statement initially provided
9/12/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Implementing a comprehensive adherence protocol for children and adolescents living with Cystic Fibrosis – An implementation study.
Scientific title
Implementing a comprehensive adherence protocol for children and adolescents living with Cystic Fibrosis – feasibility, appropriateness and acceptability.
Secondary ID [1] 298183 0
Children's Hospital Foundation Grant Reference Number: 50231
Universal Trial Number (UTN)
U1111-1233-1741
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cystic Fibrosis
 312768 0
Condition category
Condition code
Human Genetics and Inherited Disorders 311264 311264 0 0
Cystic fibrosis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention in this study is the implementation of comprehensive adherence protocol to clinical care provision. The comprehensive adherence protocol will be adapted from the CF MyWay adherence protocol. This protocol involves the delivery of 5 items:
1. Written treatment plans to all patients provided 3 monthly
2. Problem solving intervention with both the child and parent involved provided 3 monthly
3. Assessment of knowledge using the Knowledge of Disease Management assessments(KoDM) for child and parent completed annually
4. Assessment of adherence level via Treatment Adherence Questionnaire (TAQ-CF) three monthly
5. Completion of Observed Skills Manual by treating therapist annually

All of the above interventions will be administered by a member of the treating team, face to face, during usual clinic encounters at the Queensland Children's Hospital Clinic.

Intervention code [1] 314416 0
Behaviour
Comparator / control treatment
No control group, prior to this intervention none of the intervention tools were in typical use therefore all data will be taken from time of implementation forward. The intervention will be administered as Business as usual for all staff and consumers of the clinic.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 320007 0
Feasibility has been selected as an outcome to evaluate the observed fit between the CF MyWay intervention and the clinic setting. The frequency of each intervention component’s use will be observed via medical records to evaluate the integration of these components into clinic practices.
Feasibility will be assessed through monthly audit data that reviews frequency of tools being implemented. Percentage calculations will outline the frequency of use compared to the desired frequency outlined by the protocol.
Timepoint [1] 320007 0
3 months post implementation
Primary outcome [2] 320008 0
Appropriateness outcomes explore the perceived successfulness of the new intervention according to quantitative data collected from individual clinicians and consumers. Data will be collected in the following ways:

Technical assistance logs- The ongoing consultation process, any top-up training and alterations to processes will be recorded in the research technical assistance log. This log will record key components impacting upon the implementation process using narrative description. Any modifications to the implementation blueprint over the three-month period will be recorded in the technical assistance logs.

Staff and consumer surveys-Structured study-specific surveys (based on analysis of pre implementation data collected) will be distributed at the end of the implementation phase to assess acceptability and appropriateness of the pilot protocol according to staff and consumer perspectives.


Timepoint [2] 320008 0
3 months post implementation
Secondary outcome [1] 370205 0
Acceptability outcomes will assess the level of satisfaction amongst individual clinicians and consumers regarding ongoing use of the intervention as assessed through focus groups, interviews and surveys.
Timepoint [1] 370205 0
3 months post implementation

Eligibility
Key inclusion criteria
Participants will be children aged between 8 and 18 (i) and/or caregivers of a children aged 0-18 (ii) with a confirmed diagnosis of CF (iii) that are receiving care from the QCH CF clinic (iv). Participants will also include clinicians including respiratory physicians, cystic fibrosis nurses, physiotherapists, social workers, occupational therapists and dieticians whom work within the QCH CF clinic at time of recruitment (v).
Minimum age
8 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded from the study if they receive care via outreach services or do not receive care at QCH during the implementation phase of the study. Staff will be excluded if they are not working within the QCH CF clinic at the time of recruitment.

Study design
Purpose of the study
Educational / counselling / training
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)
N/A
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
N/A
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
The clinician focus group and consumer interview data will be analysed to determine the appropriateness and acceptability of the proposed CF MyWay protocol and identify key contextual factors to consider prior to implementation. A thematic analysis process will be conducted on the focus group and interview transcripts by at least two coders. From this, a network of core themes and sub themes will be developed. The Consolidated Framework for Implementation Research (CFIR) will be used to guide evaluation of the factors influencing implementation; knowing these factors will allow for appropriate interventions to be included in the implementation strategy. The CFIR is a widely cited and rigorously developed determinants framework for implementation that was developed through a process of consolidating earlier published literature, including nineteen previously developed frameworks such as the Greenhalgh dissemination and sustainability model. The CFIR consists of five domains, each domain broken down into a number of constructs identified in the literature as impacting successful implementation. These findings will be analysed and actioned to inform the implementation plan. This information will inform the local needs assessment and creation of the implementation blueprint.

Medical record data will be compared against the core components outlined in the audit checklist tool to determine level of protocol use and assess the feasibility of implementation. The audit checklist outlines each CF MyWay component and a set of criteria to determine whether core elements are executed. Protocol use will be quantified as a percentage (number of protocol components completed and documented compared to the total number of protocol components defined). Results will be compiled monthly to facilitate regular feedback to the clinical team and at the end of the implementation phase to report on final use figures. Audit cycles will be repeated monthly to collect valid and recent data. Data will be presented back to the team though summary feedback monthly via exiting team meetings. Feedback will be presented as a month to month comparison. From this, target behaviours to improve implementation will be identified with the clinical team and target goals created for the audit next cycle.
The descriptive data from the technical assistance logs will be analysed at project completion to quantify the number and type of issues experienced in implementation, modifications (planned or unplanned) to the implementation plan. This data will support audit data to determine the overall feasibility of the protocol in clinic. Clinician and consumer feedback via written surveys will be collated and evaluated to determine key themes relating to acceptability and appropriateness of using a local CF MyWay protocol as usual care at the end of the pilot period.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
3/12/2018
Date of last participant enrolment
Anticipated
20/12/2019
Actual
Date of last data collection
Anticipated
20/12/2019
Actual
Sample size
Target
98
Accrual to date
88
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 13716 0
Queensland Children's Hospital - South Brisbane
Recruitment postcode(s) [1] 26441 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 302723 0
Charities/Societies/Foundations
Name [1] 302723 0
Children's Hospital Foundation
Country [1] 302723 0
Australia
Primary sponsor type
Government body
Name
Children's Health Queensland - Hospital and Health Service
Address
Centre for Children's Health Research
Queensland Children's Hospital Precinct
62 Graham St, South Brisbane, QLD 4101
Country
Australia
Secondary sponsor category [1] 302653 0
University
Name [1] 302653 0
Queesland University of Technology
Address [1] 302653 0
2 George St, Brisbane City QLD 4000
Country [1] 302653 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303328 0
Children's Health Queensland Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 303328 0
Level 7, Centre for Children's Health Research, Queensland Children's Hospital Precinct, 62 Graham St, South Brisbane, QLD, 4101
Ethics committee country [1] 303328 0
Australia
Date submitted for ethics approval [1] 303328 0
26/09/2018
Approval date [1] 303328 0
10/10/2018
Ethics approval number [1] 303328 0
HREC/18/QCHQ/44458
Ethics committee name [2] 303330 0
Queensland University of Technology Human Research Ethics Committee
Ethics committee address [2] 303330 0
2 George St, Brisbane City QLD 4000
Ethics committee country [2] 303330 0
Australia
Date submitted for ethics approval [2] 303330 0
Approval date [2] 303330 0
Ethics approval number [2] 303330 0
1800001158
Ethics committee name [3] 303331 0
The University of Queensland Human Research Ethics Comittee
Ethics committee address [3] 303331 0
Human Ethics Research Office
Cumbrae- Stewart Building #72
The University of Queensland
St Lucia, QLD 4072
Ethics committee country [3] 303331 0
Australia
Date submitted for ethics approval [3] 303331 0
Approval date [3] 303331 0
08/11/2018
Ethics approval number [3] 303331 0
2018002220

Summary
Brief summary
Study Aim
The primary aim of this project is to evaluate the feasibility, acceptability and appropriateness of implementing a comprehensive adherence protocol into the Queensland Children's Hospital Cystic Fibrosis clinic.

Study Design
This is a mixed method, implementation study design. The four-phase Replicating Effective Programs (REP) framework developed to translate effective health services interventions into community-based settings, will inform implementation. Focus groups and interviews will form the needs assessment (pre-conditions), Descriptive data will be collected throughout implementation and interviews will be conducted post implementation to evaluate the change process.

Pre-Conditions Phase: The researchers will review literature, existing adherence promotion interventions, clinic processes and resources. From this, the team will determine the core components of the iCARE intervention and create an implementation strategy that will support translation into the existing LCCH clinic structure and resourcing.



Pre- Implementation Phase: The iCARE protocol, business case and draft implementation plan will be presented to the Cystic Fibrosis care team. Focus groups and consumer interviews will be used to gather qualitative data on adherence assessment and intervention and inform the implementation plan.

Implementation Phase: All children and family’s accessing the clinic will receive the adherence promotion protocol as part of their routine clinic attendance. The research team will continue to collaborate with consumers and staff to troubleshoot, provide feedback and booster training as indicated. The implementation plan will continue to be modified and refined according to staff and consumer input. The researchers will record all facilitator input via technical assistance and training logs. Retrospective chart audit and a protocol checklist will be utilised to monitor fidelity and uptake of each aspect of the protocol into routine care.

Maintenance and Evolution: Following three months of clinic implementation, the implementation process will be evaluated by the research team. Participants (staff and consumers) will be recruited to complete qualitative evaluation of the protocol and its components. Following the completion of the project, it is anticipated that the protocol will continue to be used in the clinic as standard care, if deemed acceptable to staff and consumers and sustainable within the existing resourcing of the clinic.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 93294 0
Miss Bianca Richards
Address 93294 0
Queensland Children's Hospital
501 Stanley St, South Brisbane QLD 4101
Country 93294 0
Australia
Phone 93294 0
+61 730681111
Fax 93294 0
Email 93294 0
[email protected]
Contact person for public queries
Name 93295 0
Bianca Richards
Address 93295 0
Queensland Children's Hospital
501 Stanley St, South Brisbane QLD 4101
Country 93295 0
Australia
Phone 93295 0
+61 730681111
Fax 93295 0
Email 93295 0
[email protected]
Contact person for scientific queries
Name 93296 0
Bianca Richards
Address 93296 0
Queensland Children's Hospital
501 Stanley St, South Brisbane QLD 4101
Country 93296 0
Australia
Phone 93296 0
+61 730681111
Fax 93296 0
Email 93296 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Audit data - deidentified from electronic medical records. Deidentified transcripts of qualitative interviews.
When will data be available (start and end dates)?
Data will be stored for 5 years following publication. Approximately January 2020- January 2025.
Available to whom?
Available only to persons requesting access from the data custodians with appropriate ethical and governace approvals from the Children’s Health Queensland Hospital and Health Service Human Research Ethics Commitee.
Available for what types of analyses?
Transcripts may be accessed for thematic analysis. Audit data may be accessed for descriptive analysis, where appropriate approvals have been gained.
How or where can data be obtained?
The Children’s Health Queensland Hospital and Health Service Human Research Ethics Commitee can be contacted at the following email: [email protected]. The primary author can be contacted via email, as below.


What supporting documents are/will be available?




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.