Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000715875
Ethics application status
Approved
Date submitted
11/01/2021
Date registered
8/06/2021
Date last updated
8/06/2021
Date data sharing statement initially provided
8/06/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating the effect of an Admission Support Plan on improving the hospital admission experience of children and young people with developmental disabilities, communication difficulties and challenging behaviours.
Scientific title
Investigating the effect of an Admission Support Plan on improving the hospital admission experience of children and young people with developmental disabilities, communication difficulties and challenging behaviours.
Secondary ID [1] 303137 0
None
Universal Trial Number (UTN)
U1111-1263-6613
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Developmental disability 320246 0
Autism Spectrum Disorder 320680 0
Cerebral Palsy 320681 0
Attention Deficit Hyperactivity Disorder (ADHD) 320682 0
Down Syndrome 320683 0
Condition category
Condition code
Mental Health 318179 318179 0 0
Autistic spectrum disorders
Mental Health 318525 318525 0 0
Learning disabilities
Human Genetics and Inherited Disorders 318526 318526 0 0
Down's syndrome
Human Genetics and Inherited Disorders 318527 318527 0 0
Other human genetics and inherited disorders
Public Health 318528 318528 0 0
Health service research
Neurological 318529 318529 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Part 1 (Pre-intervention):
Families whose children with DDs (Autism Spectrum Disorder (ASD), cerebral palsy, unspecified language delay, Attention Deficit Hyperactivity Disorder (ADHD), intellectual disability (ID) and global developmental delay) who have been admitted to Starship Children’s Hospital within the last 6 months will be invited via their usual clinicians at Starship Hospital to complete an online or telephone assisted survey regarding their experience of their child’s most recent admission. The online survey will be delivered using ‘Survey Monkey’ technology that is compatible with computer, tablet and mobile devices. It will take approximately 20 minutes to complete online independently and up to 30 minutes with telephone assistance. The telephone assisted surveys will be completed by the primary investigator, Dr Elizabeth Keeling. In order to collect a breadth of responses and achieve thematic saturation, we will recruit approximately 20 participants, of which 50% Maori representation will be sought where possible.

Part 2 (Admission Support Plan design):
An Admission Support Plan (ASP) that caregivers complete at the start of a hospital admission or ahead of time (such as during an outpatient appointment) will be created. Previously described tools from the literature (Pratt et al, 2012), will be used to guide a New Zealand specific design, paying particular attention to the needs of Maori and Pacific Island patient groups. The specific content of this tool will be developed using a 3-step iterative co-design process including representation from a number of groups: patient/caregivers with Maori and Pacific Island participants, advocates from within the developmental disability sector and staff members (both clinical and non-clinical). It is anticipated that there will be up to 10 participants from the groups mentioned above. Principles for development include (1) ease of completion, (2) specificity for the child, (3) succinctness and (4) acceptability, particularly to the Maori and Pacific Island communities. It is anticipated that staff members on the ward will request completion of the (initially) paper form by families on admission to the ward. Staff will have access to the ASP, to help guide their care of the patient. The co-design process will begin within 2 months of the surveys from Part 1 being distributed. Up to 4, two hour group design sessions will be conducted in person and/or via Zoom and recorded with consent for tool design and editing purposes. These sessions will be conducted by the principal investigator Dr Elizabeth Keeling and supervised by senior researchers where able.

Part 3 (Implementation and review):
Approximately 2 months after the final co-design session, the ASP will be administered to patients by nursing staff as part of the documentation that is completed at the start of an admission to an inpatient ward at Starship Children’s Hospital, over a period of 2 months. The ASP will be designed to take no more than 10 minutes to complete independently. After the caregiver has completed the ASP, it will be inserted into the clinical notes for staff to access, with a copy in the child’s bedspace to increase visibility. The ASP will be stored along with the patient's clinical notes and may be used again in the rare situation that a patient is readmitted during the implementation phase. Ward staff will be reminded to use the Admission Support Plan where indicated, at the start and middle of the implementation period. As this is an initial rollout to collect patient experience data, data pertaining to whether the ASP was administered to all eligible patients is beyond the scope of the study.

A further online or telephone assisted survey, using the same outcome measures to evaluate satisfaction as in Part 1 of the study, will be conducted within 1 month of patient discharge. Families will be contacted using details they submitted when completing the ASP during the implementation period. Part 3 of the study aims to recruit approximately 20 participants of which 50% Maori representation will be sought where possible.

A short online survey of staff members who have used the ASP will also be conducted to determine the acceptability, feasibility and preliminary evidence of efficacy within 1 month of completion of the implementation phase. A range of staff members will be approached to include both clinical (for example, nursing and medical staff) and non clinical roles (for example, play specialists). Similarly to Part 1, the online surveys will be delivered using ‘Survey Monkey’ technology that is compatible with computer, tablet and mobile devices.
Intervention code [1] 320194 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 326166 0
Part 1-
Recent hospital admission experiences, including barriers and facilitators, of families whose children with developmental disabilities have been admitted to Starship Children’s Hospital within the last 6 months will be assessed using an online or telephone assisted survey designed specifically for this study.
Timepoint [1] 326166 0
This will be assessed in a single survey prior to intervention design (Part 2) and implementation (Part 3) phases.
Primary outcome [2] 327097 0
Part 3-
Patient satisfaction with the Admission Support Plan (designed during Part 2) will be assessed using an online or telephone assisted survey designed specifically for this study.
Timepoint [2] 327097 0
This will be assessed in a single survey within 1 month following discharge from hospital (Part 3)
Secondary outcome [1] 393779 0
Part 3-
Acceptability to health care staff and feasibility of use of the Admission Support Plan will be assessed using a short online survey designed specifically for this study.
Timepoint [1] 393779 0
A short online survey of staff members will be conducted within 1 month of the end of the 2 month implementation phase (Part 3)
Secondary outcome [2] 395170 0
Part 3-
Staff self-reported levels of knowledge and confidence in providing care for children with developmental disability.
Timepoint [2] 395170 0
A short online survey (designed specifically for this study using the Survey Monkey platform) of staff members will be conducted within 1 month of the end of the 2 month implementation phase (Part 3)
Secondary outcome [3] 395171 0
Part 3-
Staff feelings when caring for children with communication and behaviour difficulties
Timepoint [3] 395171 0
A short online survey (designed specifically for this study using the Survey Monkey platform) of staff members will be conducted within 1 month of the end of the 2 month implementation phase (Part 3)

Eligibility
Key inclusion criteria
Part 1:
Participants will be parents/caregivers of children and young people with developmental disability including but not limited to, communication difficulties such as Autism Spectrum Disorder (ASD), cerebral palsy or language delay, behavioural challenges such as Attention Deficit Hyperactivity Disorder (ADHD) and intellectual disability or global developmental delay, including children with genetic conditions such as Down syndrome.
Patients will have been inpatients at Starship Children's Hospital during the preceding 6 months.
Parents/caregivers will have sufficient understanding of English in order to complete the survey

Part 2:
Participants will have sufficient understanding of English in order to participate in the co-design process.
Participants will be available for all sections of the co-design process.
Ideally participants will have experience of hospital admission either as the parent/caregiver of a child or young person or as part of their professional role.

Part 3:
Patients must have been admitted to a ward at Starship Children's Hospital and must have used the ASP during their admission within the 2 month intervention period.
Parent/caregiver contact details must have been entered onto the ASP in order to facilitate participation.
Parents/caregivers will have sufficient understanding of English in order to complete the survey.
Staff who have completed or used the ASP as part of their care of a patient with developmental disability.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
NA
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
NA
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
As a mixed methods study, both quantitative and qualitative data will be collected during Part 1 and Part 3.

Quantitative data:
Part 1+3
Family survey: patient characteristics such as age, gender, ethnicity, specific diagnoses and measures of satisfaction with the quality of hospital admission experience (using validated Likert scales)

Part 3
Staff survey: staff characteristics such as age, gender, ethnicity and role within Starship Children’s Hospital and overall measure of satisfaction with the Admission Support Plan (using validated Likert scales).

Qualitative data:
Part 1+3
Family survey: challenges encountered during the admission (for example staff/patient interaction, sensory or environmental stressors and behavioural events); caregiver suggestions for child-centred improvement of the hospital admission experience.

Part 3
Staff survey: self-reported levels of knowledge and confidence in providing care for children with developmental disability, the feelings of staff when caring for children with communication and behaviour difficulties, and staff suggestions for further support in caring for patients with these challenges.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
9/06/2021
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
8/08/2022
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 23370 0
New Zealand
State/province [1] 23370 0
Auckland

Funding & Sponsors
Funding source category [1] 307541 0
Charities/Societies/Foundations
Name [1] 307541 0
Starship Foundation
Country [1] 307541 0
New Zealand
Primary sponsor type
Government body
Name
Auckland District Health Board
Address
2 Park Road, Grafton, Auckland 1023
Country
New Zealand
Secondary sponsor category [1] 309410 0
None
Name [1] 309410 0
Address [1] 309410 0
Country [1] 309410 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307607 0
Auckland Health Research Ethics Committee (AHREC)
Ethics committee address [1] 307607 0
Ethics committee country [1] 307607 0
New Zealand
Date submitted for ethics approval [1] 307607 0
15/02/2021
Approval date [1] 307607 0
24/05/2021
Ethics approval number [1] 307607 0
AH21889

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

Contacts
Principal investigator
Name 107842 0
Dr Elizabeth Keeling
Address 107842 0
Starship Children's Hospital
2 Park Road
Grafton
Auckland 1023
Country 107842 0
New Zealand
Phone 107842 0
+64 221819689
Fax 107842 0
Email 107842 0
[email protected]
Contact person for public queries
Name 107843 0
Elizabeth Keeling
Address 107843 0
Starship Children's Hospital
2 Park Road
Grafton
Auckland 1023
Country 107843 0
New Zealand
Phone 107843 0
+64 221819689
Fax 107843 0
Email 107843 0
[email protected]
Contact person for scientific queries
Name 107844 0
Elizabeth Keeling
Address 107844 0
Starship Children's Hospital
2 Park Road
Grafton
Auckland 1023
Country 107844 0
New Zealand
Phone 107844 0
+64 221819689
Fax 107844 0
Email 107844 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


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.