Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000894190
Ethics application status
Approved
Date submitted
12/06/2019
Date registered
26/06/2019
Date last updated
30/07/2019
Date data sharing statement initially provided
26/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Rural Patient Experiences in Accessing Acute Paediatric Appendicectomy
Scientific title
Prehospital Patient Factors in Paediatric Appendicitis – A Rural New Zealand Perspective
Secondary ID [1] 298482 0
Nil known
Universal Trial Number (UTN)
U1111-1235-1917
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Appendicitis 313260 0
Condition category
Condition code
Surgery 311701 311701 0 0
Other surgery
Public Health 311702 311702 0 0
Health service research
Oral and Gastrointestinal 311819 311819 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This study aims to identify barriers to accessing surgical care that are significant to health care consumers as well as investigate perceptions of rural living by investigating the clients’ family’s journey with accessing acute paediatric surgical care. Our investigators are all doctors who work with children in a surgical capacity.

The primary caregiver of a child (aged 16 or under) who has recently (within 60 days of the planned interview date) undergone an acute appendicectomy at Whangarei Hospital will be identified from electronic Hospital records. They will be contacted in person if the child is still an inpatient or by phone if they have been recently discharged. From here, the survey will be introduced and preliminary consent gained to participate in a face-to-face interview. The caregiver will be asked a suitable time and location for the interview – ideally in a location they feel comfortable and familiar with, such as their own home. Once there, an investigator will go over the information sheet and formal consent. If agreed, the investigator will undertake the interview which will be recorded and field notes taken on a case report form (CRF). If the child is present, they are of course welcome to participate, and voice their story, but this is not an expectation and their interaction will be determined by family wishes.

Data collection will be undertaken using a semi-structured interview, through a variety of open questions. Prompts for each domain will be provided to investigators that have been derived from pre-existing themes thought to be contributing factors through previous research or clinical practice experience. Each interview is expected to last approximately 30 minutes and no scheduled follow up visits or interactions are planned. Participants will be offered a small renumeration/koha for their time in the form of a local supermarket voucher.
Intervention code [1] 314731 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 320395 0
Barriers to accessing acute paediatric surgical care as assessed by thematic analysis of transcribed family interview.
Timepoint [1] 320395 0
Within 60 days of the acute paediatric appendicectomy.
Secondary outcome [1] 371463 0
Common experiences of rural families accessing acute paediatric surgical care as assessed by thematic analysis of transcribed family interview.
Timepoint [1] 371463 0
Within 60 days of the acute paediatric appendicectomy.

Eligibility
Key inclusion criteria
20 “study participants” will be interviewed. These participants will be defined as the one or more individuals who cared for and enabled a child to interact with health care services during an episode of acute appendicitis and the subsequent acute appendicectomy at Whangarei Base Hospital in three months prior to the date of the interview.

The actual number of individuals in each interview will be dynamic and decided on by the family to maximise participant comfort and a full discussion to be had. In some cases, we envision an extended whanau being present – a possibility that we will encourage.

Inclusion Criteria

• Participant is willing and able to give informed consent for participation in the study.
• Aged 18 years or above.
• Is a caregiver or family member of a child who was directly involved in the child’s accessing of healthcare in which the child has undergone an acute appendicectomy at Whangarei Base Hospital in the last three months.
• Either open or laparoscopic appendicectomy.
• Was involved in the child’s journey and access to healthcare during this time.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
The participant may not enter the study if ANY of the following apply:

• The listed caregiver contacted wasn’t involved in the child’s accessing of healthcare services leading up to and including their acute appendicectomy.
• The child was transferred to another District Health Board pre-operatively – for example to Starship Childrens Hospital, a Tertiary service in Auckland for definitive treatment.
• The appendicectomy was an elective procedure.
• The child underwent an interventional radiologic or percutaneous procedure.
• The child and their family doesn’t usually reside in the Northland District Health Board catchment area.
• Family decline consent.

Study design
Purpose
Psychosocial
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Data collection will be undertaken using a semi-structured interview, through a variety of open questions. Prompts for each domain will be provided to investigators that have been derived from pre-existing themes thought to be contributing factors through previous research or clinical practice experience. Each interview is expected to last approximately 30 minutes and no scheduled follow up visits or interactions are planned.

The interviews and notes will be transcribed, deidentified and anonymised through means of a study identification number. A dynamic thematic analysis method will be used with the gathering and analysis of data occurring concurrently as to add depth and quality to these processes. Investigators will deeply familiarise themselves with the data, transcribe interviews and consider both latent and manifest content in data analysis. Subsequently open coding will involve collecting codes under potential subcategories/subthemes or categories/themes, and comparing the emerged coding’s clusters together and in relation to the entire data set classifications. Several investigators will be involved in generating initial codes, defining and naming themes, reviewing themes, and searching for themes.

The study population number of 20 families was chosen as it is the average number of paediatric appendicectomies done in Northland over 3 months.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
22/07/2019
Actual
24/07/2019
Date of last participant enrolment
Anticipated
30/08/2019
Actual
Date of last data collection
Anticipated
30/09/2019
Actual
Sample size
Target
20
Accrual to date
1
Final
Recruitment outside Australia
Country [1] 21599 0
New Zealand
State/province [1] 21599 0
Northland

Funding & Sponsors
Funding source category [1] 303027 0
Hospital
Name [1] 303027 0
Whangarei Hospital, Northland District Health Board
Country [1] 303027 0
New Zealand
Primary sponsor type
Individual
Name
Dr Brodie Elliott
Address
General Surgical Office,
Ground Floor, Whangarei Hospital
Maunu Road
Private Bag 9742, Whangarei, 0148
New Zealand
Country
New Zealand
Secondary sponsor category [1] 303005 0
Individual
Name [1] 303005 0
Mr Christopher Harmston
Address [1] 303005 0
General Surgical Office,
Ground Floor, Whangarei Hospital
Maunu Road
Private Bag 9742, Whangarei, 0148
New Zealand
Country [1] 303005 0
New Zealand
Other collaborator category [1] 280807 0
Individual
Name [1] 280807 0
Dr Henry Witcomb-Cahill
Address [1] 280807 0
General Surgical Offices,
Ground Floor, Whangarei Hospital
Maunu Road
Private Bag 9742, Whangarei, 0148
New Zealand
Country [1] 280807 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303576 0
HDEC
Ethics committee address [1] 303576 0
Ethics committee country [1] 303576 0
New Zealand
Date submitted for ethics approval [1] 303576 0
12/06/2019
Approval date [1] 303576 0
16/07/2019
Ethics approval number [1] 303576 0
19/CEN/99

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

Contacts
Principal investigator
Name 94142 0
Dr Brodie Elliott
Address 94142 0
Department of General Surgery
Whangarei Hospital, Maunu Road.
Private Bag 9742, Whangarei, 0148
Country 94142 0
New Zealand
Phone 94142 0
+64278285931
Fax 94142 0
Email 94142 0
brodie.elliott@gmail.com
Contact person for public queries
Name 94143 0
Brodie Elliott
Address 94143 0
Department of General Surgery
Whangarei Hospital, Maunu Road.
Private Bag 9742, Whangarei, 0148
Country 94143 0
New Zealand
Phone 94143 0
+64278285931
Fax 94143 0
Email 94143 0
brodie.elliott@gmail.com
Contact person for scientific queries
Name 94144 0
Brodie Elliott
Address 94144 0
Department of General Surgery
Whangarei Hospital, Maunu Road.
Private Bag 9742, Whangarei, 0148
Country 94144 0
New Zealand
Phone 94144 0
+64278285931
Fax 94144 0
Email 94144 0
brodie.elliott@gmail.com

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 quantitative study where sensitive information could be shared in an interview setting. Specific quotes or data made public could lead to easily identifiable information and therefore a breech of participant confidentiality.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
2329Study protocol    377771-(Uploaded-20-06-2019-13-39-59)-Study-related document.docx
2330Informed consent form    377771-(Uploaded-12-06-2019-22-13-00)-Study-related document.docx



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.