Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001515886
Ethics application status
Approved
Date submitted
15/08/2021
Date registered
5/11/2021
Date last updated
16/06/2022
Date data sharing statement initially provided
5/11/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Screening for high risk pregnancies with an app
Scientific title
Identifying high risk pregnancies by using a self–created medical record using an electronic app to facilitate early antenatal hospital access
Secondary ID [1] 305048 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
SCREEN
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Antenatal care 323241 0
Preeclampsia 323242 0
Gestational Diabetes 323243 0
Fetal Growth Restriction 323244 0
Condition category
Condition code
Reproductive Health and Childbirth 320815 320815 0 0
Antenatal care
Reproductive Health and Childbirth 320816 320816 0 0
Fetal medicine and complications of pregnancy
Public Health 320817 320817 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The app (and its contents) have been designed by a group of clinicians by consensus and built by a specialized IT company. Women answer questions on an app and the app calculates maternal risk for a number of potential complications in pregnancy.

Women attending all the antenatal clinics, whilst in the hospital waiting for their booking visit, will be asked to participate in the study. Women will be randomised to completing the app questions as either ‘pre’ or ‘post’ their midwifery visit. Recruitment staff will provide a patient information sheet to participants with an opt-out explanation for those that do not want to participate. These information sheets will be translated into two other languages. Non-english speaking women will be provided the patient information sheet in the appropriate language. The app will be completed in the appropriate language. At the end of the survey the women will be asked to complete a short satisfaction survey about their experiences. Midwives will be asked about their time spent on various processes during their interview eg time spent counselling, collecting information or organizing appointments.

The questions being asked by the app are: demographic, family history, personal medical history, obstetric history, social history and well being assessment. Completion of the app takes approximately 10mins. They will complete the app on an iPad provided to them or can complete it on their phones (accessed by QR code or weblink).

The midwife interviews are conducted by a variety of midwives who run the booking-in clinics. They aim to cover the same range of topics as in the app. The midwives however also provide counselling and support and advice as a matter of routine clinical practice. The interviews will be conducted by the clinical midwives as per their usual practice. They will be undertaken face-to-face, will be in private [research staff will not enter the room], can take up to 1 hour and will occur after consent but may be before completing the app or after completing the app.

Intervention code [1] 321444 0
Early detection / Screening
Comparator / control treatment
Control is the maternal information gleaned by current practice which is the midwife booking visit.. Each patient will undertake both the app and the usual midwife booking-in visit- as such patients will serve as their own control.
Control group
Active

Outcomes
Primary outcome [1] 328621 0
Assess the comparison in identifying high risk women with the SCREEN app compared to the current practice (and the current gold standard) of midwifery booking-in assessment. (includes: identified as high risk for asthma, blood disorder, gestational diabetes, recurrent miscarriage, cardiac condition, preeclampsia, calcium disorder, premature labor, seizures, thromboembolism, thyroid disorder, recurrent UTI or psycho social support)

Data will be collected from the medical record based on the assessment of the index midwife versus the outcomes of the risk assessment og the app.

This has been established as a composite outcome. But as a secondary outcome- each of these will be assessed individually.
Timepoint [1] 328621 0
At completion of the app and midwifery visit (+/-7days)
Secondary outcome [1] 399671 0
Assess the inter-technique comparison of booking information derived from the app compared to the information derived form a regular booking visit for each of the diagnostic categories included in the composite of the primary outcome.

At the end each midwifery visit-an assessment will be made of risk of 1.PET (referral made to PET clinic),2. High risk GDM (sent for early GTT),3. Referral for cardiac assessment 4. Hematological condition and referral to haem clinic 5. Mental health concerns- referred to PIMS (local mental health support) 6. Thyroid disorder -referred to endocrine clinic 7. Recurrent UTI risk- referral to renal clinic 8. Seizure disorder- noted in notes and neurology liaison 9. Preterm labor - referral to feto-maternal unit for assessment 10. Asthma optimization- note in medical record and referral to asthma carer 11. Calcium disorders- referral to endocrinologist 12 Venous thromboembolism risk- as assessed on VTE form on the electronic medical record 13. Recurrent miscarriage- referral sent to feto maternal unit /therapy for miscarriage

Midwifery referrals sent will be assessed from the medical record and noted in the midwifery note of the encounter. The app is not linked to the medical record. Research staff will review the medical record. The app is programmed to assess risks for the issues listed above and the app will be able to provide the risk for each category listed above. The app output will be compared to the medical record.
Timepoint [1] 399671 0
Completion of app and satisfaction surveys and midwifery visit (+/- 7days)
Secondary outcome [2] 399672 0
Assess the accuracy of each of the answers to questions in the SCREEN app compared to the primary source of medical information - the electronic medical record as documented at the end of the interaction. eg DOB, aboriginality, Medicare number,
Timepoint [2] 399672 0
At completion of the app questionnaire and midwifery visit (+/-7days)
Secondary outcome [3] 399673 0
Assess patient reported experiences of app usage for booking in information with a simple study-specific satisfaction survey that the patients complete
Timepoint [3] 399673 0
At completion of the app questionnaire and midwifery visit (+/-7days)
Secondary outcome [4] 399676 0
Length of time to complete the survey- this will be undertaken via the analytics built in to the app
Timepoint [4] 399676 0
At completion of the app questionnaire
Secondary outcome [5] 399677 0
Proportion of time (and raw value for time) that health staff spent prior to the consult resolving issues and preparing. This will be undertaken by asking the midwives who are undertaking the clinical review. They will estimate the proportion of time spent on the various parts of the consultation and note start and finish times.
Timepoint [5] 399677 0
At completion of the app questionnaire and midwifery visit (+/-7days)
Secondary outcome [6] 399679 0
Compare app calculated gestation to ascertained gestation from the primary health record
Timepoint [6] 399679 0
At completion of the app questionnaire and midwifery visit (+/-7days)
Secondary outcome [7] 399680 0
Compare EDD from the app to the staff calculated estimated date of delivery

The staff calculated EDD data will be assessed by review of medical records. The app estimated date of delivery will also be assessed by accessing app analytics
Timepoint [7] 399680 0
At completion of the app questionnaire and midwifery visit (+/-7days)
Secondary outcome [8] 399681 0
The app is supposed to automatically generate an email of a PDF containing all the patient answers that is sent to a nominated email. We will check with the analytics of the app whether if patients completed the survey whether a PDF was sent. This will be correlated with checking the email for receipt of the PDF.
Timepoint [8] 399681 0
At completion of the app questionnaire and midwifery visit (+/-7days)
Secondary outcome [9] 401029 0
Proportion of time (and raw value for time) that health staff spent on the consult. The midwife undertaking the visit with estimate the proportion of time.
Timepoint [9] 401029 0
At completion of the app questionnaire and midwifery visit (+/-7days)
Secondary outcome [10] 401030 0
Proportion of time (and raw value for time) that health staff spent after the consult resolving issues and organizing referrals. The midwife will be asked to nominate the amount of time they spent undertaking this task.
Timepoint [10] 401030 0
At completion of the app questionnaire and midwifery visit (+/-7days)

Eligibility
Key inclusion criteria
1. Pregnant women attending booking-in visit at any of the antenatal clinics at SWSLHD
2. Aged 16years or older
Minimum age
16 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Unable to give consent as opt-in
2. Illiterate
3. Patients who are not literate in English, Vietnamese or Arabic.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
No concealment of the allocation. The randomisation has been undertaken prior to recruitment and the staff will recruit each woman sequentially based on the allocation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The sequence was generated suing sealed enveloped.

Sealed Envelope Ltd. 2021. Create a blocked randomisation list. [Online] Available from: https://www.sealedenvelope.com/simple-randomiser/v1/lists [Accessed 5 Nov 2021].
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Blocked randomization- blocks of 8
Phase
Not Applicable
Type of endpoint/s
Bio-equivalence
Statistical methods / analysis
Data will be collected by the app as women complete the questionnaires. This data is predominantly categorical or ordinal data. The Redcap database will also collect electronically in a secure database. The databases will be combined and facilitate analysis. Continuous data will be assessed as parametric or not and appropriately statistical methods use to display the information. Where comparing between the App and the clinical results paired tests will be undertaken as appropriate. The primary outcome will be analysed by calculating the Cohen’s (kappa) coefficients to assess the comparison between the app and clinical assessment. This will also be the case for many of the secondary outcomes.


Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
13/08/2021
Date of last participant enrolment
Anticipated
31/12/2021
Actual
1/03/2022
Date of last data collection
Anticipated
28/01/2022
Actual
1/03/2022
Sample size
Target
280
Accrual to date
Final
284
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 309446 0
Other Collaborative groups
Name [1] 309446 0
WHITU (Womens Health Initiative Translational Unit)
Country [1] 309446 0
Australia
Primary sponsor type
Government body
Name
South West Sydney Local Health District
Address
Elizabeth St
Liverpool Hospital
Liverpool NSW 2170
Country
Australia
Secondary sponsor category [1] 310413 0
None
Name [1] 310413 0
None
Address [1] 310413 0
Country [1] 310413 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309238 0
South West Sydney Local Health District (SWSLHD) HREC
Ethics committee address [1] 309238 0
Ethics committee country [1] 309238 0
Australia
Date submitted for ethics approval [1] 309238 0
14/08/2020
Approval date [1] 309238 0
16/12/2020
Ethics approval number [1] 309238 0
2020/ETH02171

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

Contacts
Principal investigator
Name 113454 0
Prof Angela Makris
Address 113454 0
Renal Department
South Western Sydney Local Health District (SWSLHD)
Locked Bag 7103 Liverpool BC NSW 1871
Country 113454 0
Australia
Phone 113454 0
+61 2 8738 3788
Fax 113454 0
+61 2 8738 3718
Email 113454 0
angela.makris@health.nsw.gov.au
Contact person for public queries
Name 113455 0
Nilou Roshan Hesari
Address 113455 0
Ingham Institute
Campbell St
Liverpool NSW 2170
Country 113455 0
Australia
Phone 113455 0
+61 2 8738 9154
Fax 113455 0
Email 113455 0
niloufar.roshanhesari@health.nsw.gov.au
Contact person for scientific queries
Name 113456 0
Angela Makris
Address 113456 0
Renal Department
South Western Sydney Local Health District (SWSLHD)
Locked Bag 7103 Liverpool BC NSW 1871
Country 113456 0
Australia
Phone 113456 0
+61 2 8738 3788
Fax 113456 0
+61 2 8738 3718
Email 113456 0
angela.makris@health.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
App and patient data
When will data be available (start and end dates)?
After trial submitted for publication for a further 5 years
Available to whom?
Researchers with appropriate expertise and in collaboration
Available for what types of analyses?
Will assess based on requests
How or where can data be obtained?
Correspondence with primary investigator
Best contact is email : angela.makris@health.nsw.gov.au


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
12880Study protocol    382599-(Uploaded-16-09-2021-21-23-49)-Study-related document.doc
12881Informed consent form    382599-(Uploaded-16-09-2021-21-27-04)-Study-related document.doc
12882Ethical approval    382599-(Uploaded-15-08-2021-15-46-51)-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.