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Trial registered on ANZCTR


Registration number
ACTRN12622001466730
Ethics application status
Approved
Date submitted
28/06/2022
Date registered
18/11/2022
Date last updated
18/11/2022
Date data sharing statement initially provided
18/11/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
IDEA: Improved Discharge Experience for All Project. Investigating the effect of a bundle of educational, process change and cultural interventions to optimise the paediatric hospital discharge summary processes.
Scientific title
Optimising communication between health care providers, parents and paediatric patients using a bundle of educational, process change and cultural interventions. The IDEA study: Improved Discharge Experience for All
Secondary ID [1] 304518 0
None
Universal Trial Number (UTN)
Trial acronym
IDEA = Improved Discharge Experience for All
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hospital admission and discharges (for any condition)
 322526 0
Condition category
Condition code
Other 325287 325287 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The IDEA research project looked at a number of strategies for embedded hypothetical questions and outcomes regarding a number of improvements in discharge processes. A bundle of educational, process change and cultural interventions to improve the discharge summary processes.

An eight point intervention bundle includes 1) Education package 2) Cultural change 3) Process change 4) Pharmacy involvement 5) Discharge summaries were used as an educational tool for parents 6) Discharge summary champions 7) Mnemonic IDEA and 8) Positive reinforcement and daily reminders.

INTERVENTION DURATION: The intervention was implemented initially for 3 months period and then outcomes will be assessed at 3 months and then at 12 and 24 months (with discharge summary completion rates).

Who will deliver intervention: The intervention (effective and timely discharge summaries using the intervention bundle to improve timely discharge summaries) is provided by registrars and residents.

Location: At Queensland Children’s Hospital (Quaternary children’s Hospital)

Monitoring: A phone application will be used to log in all patients getting timely discharge summaries in the intervention arm. PHONE APPLICATION: A customized phone application has been created to log all the patients in the study and their discharge completions. This application is only for study purposes to log in how many patients get the discharge summary at discharge. The application is part of the study process and will not be accessible to the patients.

EDUCATIONAL PACKAGE: includes education regarding how to make effective discharge summaries. We designed an “educational video” and a “power point presentation” specifically for this study. “The educational video instructs the registrars and residents how to use discharge summaries to educate the parents at discharge.”

All registrars are signed off after training (in intervention) by the principal investigator prior to their work initiation in the intervention teams.

Further ongoing education regarding study intervention including making timely discharge summaries and improving discharge summary quality using a standardized power point presentation is provided weekly (20 minutes) to all the junior doctors who rotate through the intervention team.

CULTURAL CHANGE: There is a focus on cultural change with discharge summary considered an integral part of the patient separation. The discharge summary is considered as the responsibility of entire clinical team rather than the most junior member of the staff. There is involvement of consultants and fellows in discharge summary process.

PROCESS CHANGE: The electronic discharge summaries (EDS) are started as early as possible in the admission to reduce the memory recall issues. The EDS are aimed to be nearly completed on the day prior to discharge using the discharge plans from the last ward rounds. The existing processes for the discharge summaries including the discharge summary incentives i.e. weekly rewards for the best performing team are not changed.

PHARMACY INVOLVEMENT: The pharmacy was involved in entering the current medications of complex patients at discharge in the discharge summary.

DISCHARGE SUMMARIES AS AN EDUCATIONAL TOOL: An important intervention included use of the Discharge summaries as an educational tool for the parents at discharge.

DISCHARGE SUMMARY CHAMPIONS: Certain clinical staff members were designated as Discharge summary champions who were provided face to face orientation to the study interventions (in a two hours face to face workshop) two weeks prior to the study implementation. Discharge summary champion role included reminding and encouraging the timely discharge summary process with the registrars and residents making discharge summaries.

MNEMONIC IDEA: was used to remind the intervention teams about the interventions. “I “= Initiate the discharge summary early. “D” = Doctor details e.g. GP details to be confirmed. “E” = Expected Date and time of Discharge “A”= Aftercare including patient education and the follow up appointments

DISCHARGE SUMMARY AUDIT TOOL: A discharge summary audit tool will be developed to assess the quality of discharge summaries. The tool is only for evaluating the quality of discharge summary for research purposes. The discharge summaries will be audited by staff who will not be involved in providing clinical care or making the discharge summary for these patients. The tool will be published as a supplement in a research publication and can be made available on request. The audit feedback will be provided to staff following the completion of the study.

A focus group discussion will be conducted to evaluate the effectiveness of the interventions at the completion of the study.
Intervention code [1] 323899 0
Behaviour
Comparator / control treatment
The control cohort had usual hospital discharge processes.

The usual hospital discharge summary process includes making a medical discharge summary often after the patient has left the hospital with variable time lag. Usually therefore the patients do not walk out of the hospital with a discharge summary. Discharge summaries are not used to educate the parents about their child's stay in the hospital.
Control group
Active

Outcomes
Primary outcome [1] 329602 0
Discharges finalized within 24 hours of hospital discharge by reviewing the hospital records
Timepoint [1] 329602 0
At 24 hours after discharge and at/by hospital discharge
Primary outcome [2] 329603 0
Discharges finalised at or prior to discharge in the intervention and the control arms (as a composite outcome) using hospital records.
Timepoint [2] 329603 0
At time of hospital discharge
Primary outcome [3] 329604 0
Proportion of patients in the intervention arm that were given discharge summaries at discharge using the data from the app.
Timepoint [3] 329604 0
At time of hospital discharge
Secondary outcome [1] 403141 0
Median time to discharge summary in the intervention and the control arms using hospital records and app analytics
Timepoint [1] 403141 0
Cumulative data will be assessed at the conclusion of the study'.
Secondary outcome [2] 403145 0
Completion of discharge summaries at different time points 6, 12, 24 , 48, 72 , 96 , 168 hours after discharge (using the hospital records and app analytics)
Timepoint [2] 403145 0
6, 12, 24 , 48, 72 , 96 , 168 (7 days) hours after discharge (using the hospital records)
Secondary outcome [3] 403146 0
Pre-intervention discharge summary completion rates in the intervention and the control teams (using the hospital records )
Timepoint [3] 403146 0
Pre-study : for previous 3 months prior to implementation of intervention
Secondary outcome [4] 403147 0
Quality of discharge summaries will be assessed in the intervention versus control arms using the hospital records.
Timepoint [4] 403147 0
Post intervention ( after 3 months post intervention)
Secondary outcome [5] 403148 0
Staff surveys : opinions : both the intervention and the control arms will analyzed as a composite secondary outcome. A staff survey questionnaire was designed for this study specifically which will be made available as a supplement in the research publication.
Timepoint [5] 403148 0
3 months post intervention
Secondary outcome [6] 403149 0
Focussed group discussion : semi-structured face-to-face audio recorded 60 minute focussed group discussion involving to discuss barriers and challenges of implementing the intervention and providing timely discharge summaries will be conducted with intervention staff member team.
Timepoint [6] 403149 0
After the 3 months post implementation
Secondary outcome [7] 411318 0
Patient satisfaction : patient reported experience measures on a survey specifically designed for this study.
Timepoint [7] 411318 0
At or after the discharge of the patient
Secondary outcome [8] 411319 0
Qualitative survey of patient survey responses specifically designed for this study
Timepoint [8] 411319 0
After the discharge of the patient from the hospital (within 2-4 weeks post discharge from the hospital)

Eligibility
Key inclusion criteria
All paediatric patients discharged from the department of paediatrics at the Queensland Children's Hospital
Minimum age
0 Days
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients discharged from units other than Paediatrics or shifted to other units so that the discharge occurred from another unit. Hospital in the home patients. Patients who had actively complaints. Patients who were discharged from the Emergency department itself and were discharged with a discharge letter from emergency department and did not require a electronic disharge summary.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Intervention cohort study with parallel comparison cohort design,
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
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 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. Further Logistic regression analysis will be used to assess predictors for the completion of the discharge summaries if applicable. 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. The regression and survival analyses will only be undertaken if there is enough data variables to regress on. As this is currently unfunded study we do not know whether we will be able to collect enough patient level data to do some of the analyses.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
18/06/2021
Date of last participant enrolment
Anticipated
Actual
21/09/2021
Date of last data collection
Anticipated
31/12/2022
Actual
Sample size
Target
300
Accrual to date
Final
1176
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 21127 0
Queensland Children's Hospital - South Brisbane
Recruitment postcode(s) [1] 35983 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 308881 0
Hospital
Name [1] 308881 0
Queensland Children's Hospital
Country [1] 308881 0
Australia
Primary sponsor type
Hospital
Name
Queensland Children's Hospital
Address
501 Stanley Street, Brisbane, Queensland,4101, Australia.
Country
Australia
Secondary sponsor category [1] 311272 0
None
Name [1] 311272 0
None
Address [1] 311272 0
None
Country [1] 311272 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308786 0
CHILDREN’S HEALTH QUEENSLAND HOSPITAL AND HEALTH SERVICE HUMAN RESEARCH ETHICS COMMITTEE
Ethics committee address [1] 308786 0
Ethics committee country [1] 308786 0
Australia
Date submitted for ethics approval [1] 308786 0
31/05/2021
Approval date [1] 308786 0
10/06/2021
Ethics approval number [1] 308786 0
HREC/21/QCHQ/73758

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

Contacts
Principal investigator
Name 111882 0
Dr Vishal Kapoor
Address 111882 0
Queensland Children's Hospital
501 Stanley Street
Brisbane 4101
Queensland
Australia
Country 111882 0
Australia
Phone 111882 0
+61 400889748
Fax 111882 0
Email 111882 0
vishal.kapoor@health.qld.gov.au
Contact person for public queries
Name 111883 0
Vishal Kapoor
Address 111883 0
Queensland Children's Hospital
501 Stanley Street
Brisbane 4101
Queensland
Country 111883 0
Australia
Phone 111883 0
+610730681111
Fax 111883 0
Email 111883 0
vishal.kapoor@health.qld.gov.au
Contact person for scientific queries
Name 111884 0
Vishal Kapoor
Address 111884 0
Queensland Children's Hospital
501 Stanley Street
Brisbane 4101
Queensland
Country 111884 0
Australia
Phone 111884 0
+610730681111
Fax 111884 0
Email 111884 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 participant data. Patient satisfaction forms were de-identified and the data will be published in an aggregated form.


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.