Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12618000620224
Ethics application status
Approved
Date submitted
11/04/2018
Date registered
20/04/2018
Date last updated
26/02/2020
Date data sharing statement initially provided
21/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Development of Recommendations for Speech-Language Pathologists in Paediatric Palliative Care Teams (ReSP3CT)
Scientific title
Development of Recommendations for Speech-Language Pathologists in Paediatric Palliative Care Teams (ReSP3CT): A modified Delphi study
Secondary ID [1] 294554 0
None
Universal Trial Number (UTN)
Trial acronym
ReSP3CT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Unspecified role and scope of practice of Speech-Language Pathologists working in Paediatric Palliative Care 307332 0
Condition category
Condition code
Public Health 306442 306442 0 0
Health service research

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This three-phase modified Delphi study is comprised of a survey, interview and Delphi panel phase. Initially, preliminary data needed for the creation of statements for consensus will be collected from clinicians currently working in the field by the lead investigators. This will be completed via distribution of cross-sectional online surveys to identify ‘specialists’, followed by an in-depth interview protocol to identify common themes to synthesise preliminary recommendations/statements for consensus within the final Delphi study phase. The ReSP3CT study will take place in various clinical and non-clinical settings within synchronous (real-time) and asynchronous environments; utilising email communication, online surveys and interviews via video-conferencing. It is anticipated that the total time required for data collection will be 12-18 months. For this study, participants be speech-language pathologists who have worked for a minimum of two years with a paediatric palliative caseload. Participants will be included in this study if they have native-level proficiency of English and are eligible for membership in their respective professional SLP associations.

Survey:
A cross-sectional survey will be distributed online following recruitment, to document characteristics in this sample of clinicians working with this population. Open and closed ended questions will be used in the online survey design and will be grouped thematically for ease of coding. Closed ended questions will be used to obtain participant characteristics such as sex, qualification level, years of practice as an SLP and years worked in a palliative context. Open ended questions will be used in the survey to obtain broader information about their perceptions of the SLP role within paediatric palliative care, each scope of practice area, and if relevant, palliative care teams.

Interview:
Following the cross-sectional survey, participants will be asked to participate in a 60-90 minute in-depth interview (one-on-one) in order to gather their opinions, experiences and concerns of working in paediatric palliative care settings and/or treating children who are being managed palliatively. Conducted by a university academic from La Trobe University, this phase will involve further exploration of any common or unique themes that emerged within the online survey. These interviews will be video/audio recorded to ensure accurate transcription of data to allow for analysis/coding of themes.

Delphi panel:
An online questionnaire will be disseminated to participants comprising of statements based on the themes/codes that arise from data gathered from the literature review and the first and second points of participant contact (survey and interview). To minimise researcher bias, the synthesis and iterations of each statement will be reviewed by co-investigators before sending these to participants. Statements will be presented to participants using a five-point Likert scale (responses include: strongly disagree – disagree - …etc.). Participants will have the opportunity to provide a comment on each item to qualify their response to assist with shaping/rephrasing the statement for future iterations to aid in reaching agreement – responses will be analysed using Colaizzi's seven-stage thematic analysis as described by Holloway and Galvin. This form of thematic analysis will be used to duplicate the data analysis protocol previously used for measurement of consensus and stability in Delphi studies. At the end of each questionnaire, participants will have the opportunity to rank the statements from ‘most’ to ‘least’ important in for SLPs working in PPC. The Delphi process for each statement will stop if a statement yields greater than or equal to 70% agreement among participants on a five-point Likert scale in the top two measures and an interquartile range (IQR) of less than or equal to 1, or, a ceiling of five rounds is reached.
Intervention code [1] 300959 0
Not applicable
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 305453 0
Level of agreement among participants for each clinical practice guideline recommendation, summarised as percentages (%) for each response on a Likert (five-point) statement-specific scale.
Timepoint [1] 305453 0
After commencement of the Delphi phase; at 2 weeks (primary timepoint), 4 weeks and in two-week increments until agreement is reached (stop criteria: five rounds/iterations, therefore, maximum timepoint is 10 weeks).
Secondary outcome [1] 345285 0
Composite outcome of demographic data obtained about speech-language pathologists working in paediatric palliative care from survey, including; countries worked, years worked within paediatric palliative care, qualification level, professional membership status, workload (full-time equivalent), types of clinical settings and speech-language pathology service provision.
Timepoint [1] 345285 0
Outcome assessed after all participants submit survey - 3 months post commencement of survey phase.
Secondary outcome [2] 345658 0
Convergence of participants towards agreement between each Delphi round summarised as interquartile range (IQR) for each response on a Likert (five-point) statement-specific scale.
Timepoint [2] 345658 0
After commencement of the Delphi phase; at 2 weeks (primary timepoint), 4 weeks and in two-week increments until agreement is reached (stop criteria: five rounds/iterations, therefore, maximum timepoint is 10 weeks).

Eligibility
Key inclusion criteria
Participants must:
- Be speech-language pathologists working in Australia, Canada, New Zealand, United Kingdom, Ireland or United States of America
- Have worked for a minimum of two years with a paediatric palliative caseload.
- Be eligible for membership in their respective professional speech-language pathology associations.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants will be excluded from this study if they do not have a native-level proficiency of English.

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/04/2018
Actual
26/04/2018
Date of last participant enrolment
Anticipated
Actual
5/12/2018
Date of last data collection
Anticipated
30/06/2019
Actual
3/06/2019
Sample size
Target
50
Accrual to date
Final
52
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 10267 0
New Zealand
State/province [1] 10267 0
Country [2] 10268 0
United States of America
State/province [2] 10268 0
Country [3] 10269 0
United Kingdom
State/province [3] 10269 0
Country [4] 10270 0
Canada
State/province [4] 10270 0
Country [5] 10271 0
Ireland
State/province [5] 10271 0

Funding & Sponsors
Funding source category [1] 299178 0
Government body
Name [1] 299178 0
Australian Government Research Training Program (RTP) Scholarship
Country [1] 299178 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
La Trobe University
Bundoora, VIC, 3086
AUSTRALIA
Country
Australia
Secondary sponsor category [1] 298436 0
None
Name [1] 298436 0
Address [1] 298436 0
Country [1] 298436 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300102 0
La Trobe University Science, Health & Engineering College Human Ethics Sub-Committee
Ethics committee address [1] 300102 0
Ethics committee country [1] 300102 0
Australia
Date submitted for ethics approval [1] 300102 0
Approval date [1] 300102 0
05/04/2018
Ethics approval number [1] 300102 0
HEC18080

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

Contacts
Principal investigator
Name 82570 0
Dr Lindsay Carey
Address 82570 0
Palliative Care Unit
Department of Public Health
School of Psychology and Public Health
La Trobe University
Bundoora, Victoria, 3086, AUSTRALIA
Country 82570 0
Australia
Phone 82570 0
+61 3 9479 8808
Fax 82570 0
Email 82570 0
[email protected]
Contact person for public queries
Name 82571 0
Lillian Krikheli
Address 82571 0
Palliative Care Unit
Department of Public Health
School of Psychology and Public Health
La Trobe University
Bundoora, Victoria, 3086, AUSTRALIA
Country 82571 0
Australia
Phone 82571 0
+61 3 9479 8808
Fax 82571 0
Email 82571 0
[email protected]
Contact person for scientific queries
Name 82572 0
Lillian Krikheli
Address 82572 0
Palliative Care Unit
Department of Public Health
School of Psychology and Public Health
La Trobe University
Bundoora, Victoria, 3086
Country 82572 0
Australia
Phone 82572 0
+61 3 9479 8808
Fax 82572 0
Email 82572 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
This is a very small population in a niche field on an international scale; thus published IPD data could be used to identify the participants.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
1679Study protocol    https://spcare.bmj.com/content/early/2018/12/04/bm... [More Details]
1680Ethical approval    374878-(Uploaded-20-03-2019-21-31-56)-Study-related document.pdf



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.