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Trial registered on ANZCTR


Registration number
ACTRN12624000416594p
Ethics application status
Submitted, not yet approved
Date submitted
19/02/2024
Date registered
5/04/2024
Date last updated
5/04/2024
Date data sharing statement initially provided
5/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Using Nurse led Integrated Team Electronic Discharges (IT-EDs approach) for children with medical complexity: UNITED study
Scientific title
Effect of Using Nurse led Integrated Team Electronic Discharges (IT-EDs approach) on Electronic Discharge Completion for children with medical complexity :: UNITED study
Secondary ID [1] 311440 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Children with medical complexity 332931 0
Condition category
Condition code
Public Health 329649 329649 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study aims to include an evidence-based approach with a small 'open label' pilot randomized controlled study (RCT) to establish evidence for IT-EDS (integrated team electronic discharge summary) made by nursing and medical input together in a collaborative environment. The pharmacy team will be able to input medications into the electronic discharge summary and nurses will also liaise with the allied health staff to input the allied health aspects in the discharge summaries.

1) An educational module (IT-EDS module) to teach the nurses on how to make discharge summary will be created.
2) Clinical nurses (CN) / Nurse navigators (NN) in the intervention arm will receive training on the IT-EDS module so that they will be able to contribute to making and keeping the discharge summary document up to date

Intervention NN/CN will play an integral role in the discharge process and will be involved in following aspects of clinical care in the patients in intervention arm.
a. Clinical nurse will have EDS access and be trained in IT-EDS module
b. They will be Involved in making and updating medical discharge summaries; liaising with the medical staff as required.
c. Nurses will also Populate Allied health input in IT-EDS
d. Pharmacist will update the medications in IT-EDS
e. IT-EDS will be validated and signed by the medical team before distribution
f. The medical and nursing staff will use the same "Multidisciplinary-IT-EDS document" for discharge education of parents prior to discharge.
g. Both nursing and the medical teams will aim to counsel the patients/ carers together before discharge.
h. NN/CN will also aim to liaise with GPs post discharge for discharge communication.

IT-EDS training: will be provided using the IT-EDS module 2 weeks prior to the start of the trial. The module will enable self-directed training with a competency quiz at the end. Each nurse will be involved in making 5 discharge summaries and receive critical feedback from a general paediatrician involved in hospital wide discharge summaries improvement group.



IT-EDS module will include a step by step approach to making discharge summaries and include education to make effective and safe discharge summaries using the Hospital wide online Electronic Discharge Summary platform that is currently used to make the discharge summaries at the Queensland Children's Hospital.

Overall duration of intervention is estimated to be around 6 months.
Intervention code [1] 328018 0
Treatment: Other
Comparator / control treatment
Control group management:
The management of patients with medical complexity in the control group will be as per the hospital protocols.
Control group nurse (Clinical Nurse / Nurse navigator ) who will be involved with the control group patients would provide support to the family as their usual hospital protocols but not be involved in making discharge summaries or educating families using the discharge summaries or sending discharge summaries to the GPs.
The patients in the control arm will be provided EDS made by medical staff only as per the usual hospital processes.

Control group
Active

Outcomes
Primary outcome [1] 337434 0
EDS completion at discharge
Timepoint [1] 337434 0
at discharge of patient from the hospital
Primary outcome [2] 337436 0
Use of multi-disciplinary EDS for patient education in both groups
Timepoint [2] 337436 0
At discharge of patient from the hospital
Primary outcome [3] 337578 0
Electronic discharge summary dispensation at patient discharge in both groups
Timepoint [3] 337578 0
At the end of the study
Secondary outcome [1] 431850 0
Receipt of EDS by GP within 48 hours in both groups
Timepoint [1] 431850 0
At 48 hours from the patient discharge
Secondary outcome [2] 431851 0
PREM (Patient reported experience measures)
Timepoint [2] 431851 0
within the study period and aimed at within 14 days from discharge of patient
Secondary outcome [3] 431852 0
Time of completion of discharge summary in both groups (EDS finalized time stamp from the time of discharge time stamp)
Timepoint [3] 431852 0
During the study period
Secondary outcome [4] 431853 0
GP satisfaction with the intervention group measures vs control group
Timepoint [4] 431853 0
WIthin 14 days of the discharge of the patient from the hospital
Secondary outcome [5] 431855 0
Benefits, enablers and challenges with discharge summary process in the intervention and control arm. (composite outcome)
Timepoint [5] 431855 0
within 3 months of study completion
Secondary outcome [6] 431856 0
Quality assessment of discharge summaries in the two groups.
Timepoint [6] 431856 0
within 6 months of the study completion

Eligibility
Key inclusion criteria
All children with medical complexity (CMC) admitted to the General Paediatrics ward will be eligible for the trial.

The definition of Children with medical complexity will be as per the American Academy of Paediatrics which is: "Children with medical complexity (CMC), have multiple significant chronic health problems that affect multiple organ systems and result in functional limitations, high health care need or utilization, and often the need for or use of medical technology. An example of a child with medical complexity is one with a genetic syndrome with an associated congenital heart defect, difficulty with swallowing, cerebral palsy, and a urologic condition.
Minimum age
0 Years
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Using sequentially numbered and sealed opaque envelopes. The envelopes will be opened by the administrative officer on the ward.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Using computer generated randomization numbers
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The data will be analysed with Stata 17 statistical software. We will use means ±SD to describe the normally distributed continuous variables, median and interquartile ranges for the non-parametric variables and proportions with 95% confidence intervals to describe the categorical variables. Chi square and Fisher exact test as appropriate will be used to compare the categorical variables, Student’s t-test to compare normally distributed continuous variables and Mann-Whitney test to compare the non-parametric variables. Kappa statistics will be used for comparison of rating of the discharge summaries by two raters. Logistic regression analysis will be used to assess predictors for the completion of the discharge summaries. Log transformation or other transformations will be used where appropriate. Survival analyses using cox-proportional hazard models will be used for assessment of time to discharge summaries and to evaluate the predictors for completion of the discharge summaries.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
22/04/2024
Actual
Date of last participant enrolment
Anticipated
30/09/2024
Actual
Date of last data collection
Anticipated
31/12/2024
Actual
Sample size
Target
46
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 26187 0
Queensland Children's Hospital - South Brisbane
Recruitment postcode(s) [1] 42063 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 315716 0
Hospital
Name [1] 315716 0
Queensland Children's Hospital SERTA grant (Study, Education and Research Trust Account grant of 15,000 AUD
Country [1] 315716 0
Australia
Primary sponsor type
Hospital
Name
Queensland Children's Hospital
Address
Country
Australia
Secondary sponsor category [1] 318004 0
None
Name [1] 318004 0
Address [1] 318004 0
Country [1] 318004 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 314581 0
Children’s Health Queensland Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 314581 0
Ethics committee country [1] 314581 0
Australia
Date submitted for ethics approval [1] 314581 0
16/01/2024
Approval date [1] 314581 0
Ethics approval number [1] 314581 0

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

Contacts
Principal investigator
Name 132078 0
Dr vishal Kapoor
Address 132078 0
Department of Paediatrics, Queensland Children's Hospital, 501 Stanley Street, Brisbane, Queensland 4101
Country 132078 0
Australia
Phone 132078 0
+61400889748
Fax 132078 0
Email 132078 0
vishal.kapoor@health.qld.gov.au
Contact person for public queries
Name 132079 0
vishal Kapoor
Address 132079 0
Department of Paediatrics, Queensland Children's Hospital, 501 Stanley Street, Brisbane, Queensland 4101
Country 132079 0
Australia
Phone 132079 0
+61400889748
Fax 132079 0
Email 132079 0
vishal.kapoor@health.qld.gov.au
Contact person for scientific queries
Name 132080 0
vishal Kapoor
Address 132080 0
Department of Paediatrics, Queensland Children's Hospital, 501 Stanley Street, Brisbane, Queensland 4101
Country 132080 0
Australia
Phone 132080 0
+61400889748
Fax 132080 0
Email 132080 0
vishal.kapoor@health.qld.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
There is no individual participant data as the trial does not deal with clinical characteristics or outcomes of individual or a cohort of patients


What supporting documents are/will be available?

No Supporting Document Provided



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.