ANZCTR - Registration

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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]

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

Condition category

Condition code

Human Genetics and Inherited Disorders

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]

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]

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]

3 months post implementation

Primary outcome [2]

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]

3 months post implementation

Secondary outcome [1]

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]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment hospital [1]

Queensland Children's Hospital - South Brisbane

Recruitment postcode(s) [1]

4101 - South Brisbane

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Children's Hospital Foundation

Address [1]

PO Box 8009, Woolloongabba QLD 4102

Country [1]

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]

University

Name [1]

Queesland University of Technology

Address [1]

2 George St, Brisbane City QLD 4000

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Children's Health Queensland Hospital and Health Service Human Research Ethics Committee

Ethics committee address [1]

Level 7, Centre for Children's Health Research, Queensland Children's Hospital Precinct, 62 Graham St, South Brisbane, QLD, 4101

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

26/09/2018

Approval date [1]

10/10/2018

Ethics approval number [1]

HREC/18/QCHQ/44458

Ethics committee name [2]

Queensland University of Technology Human Research Ethics Committee

Ethics committee address [2]

2 George St, Brisbane City QLD 4000

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

Approval date [2]

Ethics approval number [2]

1800001158

Ethics committee name [3]

The University of Queensland Human Research Ethics Comittee

Ethics committee address [3]

Human Ethics Research Office
Cumbrae- Stewart Building #72
The University of Queensland 
St Lucia, QLD 4072

Ethics committee country [3]

Australia

Date submitted for ethics approval [3]

Approval date [3]

08/11/2018

Ethics approval number [3]

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

Miss Bianca Richards

Address

Queensland Children's Hospital
501 Stanley St, South Brisbane QLD 4101

Country

Australia

Phone

+61 730681111

Fax

bianca.richards@health.qld.gov.au

Contact person for public queries

Name

Bianca Richards

Address

Queensland Children's Hospital
501 Stanley St, South Brisbane QLD 4101

Country

Australia

Phone

+61 730681111

Fax

bianca.richards@health.qld.gov.au

Contact person for scientific queries

Name

Bianca Richards

Address

Queensland Children's Hospital
501 Stanley St, South Brisbane QLD 4101

Country

Australia

Phone

+61 730681111

Fax

bianca.richards@health.qld.gov.au

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: CHQETHICS@health.qld.gov.au. The primary author can be contacted via email, as below.

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
2030	Study protocol			biancalrichards@gmail.com		377559-(Uploaded-08-05-2019-12-09-27)-Study-related document.docx
2031	Ethical approval			biancalrichards@gmail.com		377559-(Uploaded-08-05-2019-12-10-44)-Study-related document.pdf

Results publications and other study-related documents

Documents added manually

Current Study Results

Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
Plain language summary	No		Trial ongoing.

Update to Study Results

Doc. No.	Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
3312	Study results article	Yes	https://doi.org/10.1186/s12913-021-07373-5	Richards B, Osborne SR, Simons M. Introducing a MA... [More Details]

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No additional documents have been identified.

Trial Review

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