ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12624000035527

Ethics application status

Approved

Date submitted

17/10/2023

Date registered

16/01/2024

Date last updated

25/07/2024

Date data sharing statement initially provided

16/01/2024

Type of registration

Prospectively registered

Titles & IDs

Public title

Wait a Minute or More: A pragmatic stepped wedge cluster randomised implementation trial assessing a quality improvement program to increase delayed cord clamping for preterm infants.

Scientific title

Wait a Minute or More: A pragmatic stepped wedge cluster randomised implementation trial assessing the effect of a quality improvement program on duration of delayed cord clamping for infants <37 weeks gestation in up to 20 maternity hospitals.

Secondary ID [1]

CTC 0395

Universal Trial Number (UTN)

U1111-1299-1262

Trial acronym

WAMM

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Delayed cord clamping

Premature birth <37 weeks

Condition category

Condition code

Public Health

Health service research

Reproductive Health and Childbirth

Childbirth and postnatal care

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

The intervention comprises a funded, locally adapted quality improvement (QI) program, in addition to basic, accurate data collection and sharing of average number of seconds before cord clamping (NSCC) with staff within and across sites.

The overall study duration is 92 weeks, divided consecutively into a "Pre-Study Period" of 14 weeks (data collection only), 5 x Study Periods ("Study Period 1", "Study Period 2", etc.) of 14 weeks (data collection and sharing, and stepped QI program), and a "Sustained Implementation Period" of 8 weeks (data collection and sharing only).

At the start of each 14-week study period from Study Period 2 onwards, a cluster group of up to 5 hospitals will commence a funded locally adapted QI program in addition to basic data collection and sharing, in a stepped manner. The QI program period will range between 14 weeks (for those allocated to commence in Study Period 5) and 56 weeks (for those allocated to commence in Study Period 2), depending on the randomly allocated step to which that cluster is assigned. The QI program period will cease at the conclusion of Study Period 5 at all sites. The study will continue for a further 8 weeks until the conclusion of the Sustained Implementation Period.

The locally adapted QI program period includes local QI team building, QI education (virtual workshop), implementation of locally adapted change ideas, virtual check-in monitoring meetings with a central QI facilitator, data sharing with other clusters also receiving the locally adapted QI program (as opposed to sharing with the central coordinating centre or with all sites, regardless of QI program status) and collaborative learning via quarterly meetings. The QI education will comprise training in "Evidence-based Practice for Improving Quality" (EPIQ). Individual teams will use EPIQ methods to identify causes and drivers preventing delayed cord clamping specific to their site. The intervention is the same for all sites in the study (i.e. all sites will be asked to implement the above components), with the exception of the duration of the program and noting that individual sites will identify change ideas specific to their circumstances.

Local QI team formation and implementation of local change ideas is expected within 4 weeks of transition to the QI program step for a given site. Local QI teams are recommended be comprised of 6-8 members, including an obstetrician, a neonatologist/paediatrician, a neonatal nurse, a midwife, a nurse or midwifery educator, a clinical nurse or midwife and a parent. In-keeping with EPIQ methodology, local QI teams will determine the most appropriate means to address their local change ideas. Local QI teams will be supported by a central QI facilitator, who will provide the QI education (virtual workshop) and ongoing support. Local QI teams are recommended to meet with the central facilitators every 4-6 weeks for the duration of their QI program duration (varies between 14 - 56 weeks). Virtual check-in meetings will be held quarterly (i.e. every 3 months) across the study for sites who have commenced their QI program step.

Details of local QI team membership, change ideas identified, implementation of individual change ideas, check-in meetings and virtual meeting attendance will be recorded in the study database.

Intervention code [1]

Prevention

Comparator / control treatment

The comparator in this trial will be basic, accurate data collection and sharing of average NSCC with staff within and across sites alone.

Basic accurate data collection and sharing will commence from Study Period 1 for all sites, and last for 92 weeks. This is comprised of funding to have dedicated staff collect and enter weekly accurate data on average NSCC for all infants born <37 weeks, as well as access to an electronic dashboard to view anonymised average NSCC rates for other centres. Data collection will occur via entry by site staff into a study database (REDCap), and data sharing will be facilitated by an electronic API dashboard using data entered into the study database. Nil study-specific training is required for data entry.

Control group

Active

Outcomes

Primary outcome [1]

The absolute mean difference in the number of seconds before cord clamping. Data will be collected from the medical record by site staff and entered into the study database.

Timepoint [1]

At the conclusion of the study, comparing NSCC during the data sharing plus locally adapted QI program period, with NSCC during the data sharing period (alone).

Primary outcome [2]

Absolute percentage change in delayed cord clamping after 60 seconds (DCC60). Data will be collected from the medical record by site staff and entered into the study database.

Timepoint [2]

Primary outcome [3]

Absolute percentage change in delayed cord clamping after 60 seconds (DCC60). Data will be collected from the medical record by site staff and entered into the study database.

Timepoint [3]

At the conclusion of the study, comparing DCC60 during the data sharing plus locally adapted QI program period, with DCC60 during the data sharing period (alone).

Secondary outcome [1]

Fidelity of the intervention, as measured by a composite of: 1) delivery of QI education program within 4 week transition window, 2) establishment of local QI teams within the 4 week transition window, 3) creation and implementation of one or more local change ideas within the 4 week transition window; 4) attendance at ongoing check-in monitoring meetings; and 5) participation in at least one quarterly virtual meeting of the study sites. Data for each component will be recorded in the study database.

Timepoint [1]

At the conclusion of the study

Secondary outcome [2]

Dose of the intervention, as measured by a composite of the number of check-in monitoring meetings and the number of completed Plan-Do-Study-Act cycles for individual sites as recorded in the study database.

Timepoint [2]

At the conclusion of the study

Secondary outcome [3]

Reach of the intervention, as measured by the number of clinical staff who engage with the local QI team to design local change ideas, as documented in the study database.

Timepoint [3]

At the conclusion of the study.

Secondary outcome [4]

Acceptability of the intervention, as measured by a composite of 1) quantitative responses to the Acceptability of Intervention Measure (AIM), 2) Intervention Appropriateness Measure (IAM), 3) Feasibility of Intervention Measure (FIM) and 4) qualitative semi-structured interviews with staff and key stakeholders

Timepoint [4]

Quantitative responses will be collected at the commencement of the study and at the conclusion of the study. Qualitative interviews will be collected at the conclusion of the study.

Secondary outcome [5]

Mechanisms of impact, explored through semi-structured interviews with staff and key stakeholders

Timepoint [5]

At the conclusion of the study

Secondary outcome [6]

Contextual barriers and enablers of implementation, through semi-structured interviews with staff and key stakeholders

Timepoint [6]

At the conclusion of the study

Secondary outcome [7]

Fidelity of the intervention, as measured by delivery of QI education program within the 4 week transition window. Dates of QI education program and QI program step commencement will be captured in the study database.

Timepoint [7]

Within 4 weeks of QI program step commencement for a given site. Assessed at the conclusion of the study.

Secondary outcome [8]

Fidelity of the intervention, as measured by establishment of local QI teams comprised of 6-8 members within the 4 week transition window consisting of lead obstetrician, lead neonatologist/paediatrician, WAMM-funded neonatal nurse, WAMM-funded midwife, nurse or midwifery educator, clinical nurse or midwife, parent(s). Date of team formation and membership will be captured in the study database.

Timepoint [8]

Within 4 weeks of QI program step commencement for a given site. Assessed at the conclusion of the study.

Secondary outcome [9]

Fidelity of the intervention, as measured by creation and implementation of one or more local change ideas within the 4 week transition window. List of change ideas and date of change idea creation will be captured in the study database.

Timepoint [9]

Within 4 weeks of QI program step commencement for a given site. Assessed at the conclusion of the study.

Secondary outcome [10]

Fidelity of the intervention, measured by ongoing check-in monitoring meetings between central and local QI facilitator on a 4-6 weekly basis after the first 4 weeks, as captured in the study database.

Timepoint [10]

Commencing from 4 weeks after QI program step commencement for a given site, until conclusion of Study Period 5 (conclusion of QI program period). Assessed at the conclusion of the study.

Secondary outcome [11]

Fidelity of the intervention, measured by participation in at least one quarterly virtual meeting of the study sites, as captured in the study database.

Timepoint [11]

At any time from QI program step commencement for a given site, until conclusion of Study Period 5 (conclusion of QI program period). Assessed at the conclusion of the study.

Secondary outcome [12]

Dose of the intervention, measured by number of check-in monitoring meetings as recorded in the study database.

Timepoint [12]

Commencing from 4 weeks after QI program step commencement for a given site, until conclusion of Study Period 5 (conclusion of QI program period). Assessed at the conclusion of the study.

Secondary outcome [13]

Dose of the intervention, measured by the number of completed Plan-Do-Study-Act cycles for individual sites as recorded in the study database

Timepoint [13]

Commencing from 4 weeks after QI program step commencement for a given site, until conclusion of Study Period 5 (conclusion of QI program period). Assessed at the conclusion of the study.

Secondary outcome [14]

Acceptability of the intervention, as measured by the Acceptability of Intervention Measure (AIM)

Timepoint [14]

At the commencement of the study and at the conclusion of the study

Secondary outcome [15]

Acceptability of the intervention, as measured by the Intervention Appropriateness Measure (IAM)

Timepoint [15]

At the commencement of the study and at the conclusion of the study

Secondary outcome [16]

Acceptability of the intervention, as measured by the Feasibility of Intervention Measure (FIM)

Timepoint [16]

At the commencement of the study and at the conclusion of the study

Secondary outcome [17]

Acceptability of the intervention, as measured by qualitative semi-structured interviews with staff and key stakeholders

Timepoint [17]

At the conclusion of the study

Eligibility

Key inclusion criteria

Site inclusion criteria:
1) Tertiary or non-tertiary Australian maternity hospital (public or private)
2) Willing and able to comply with all study requirements including intervention, timing and/or nature of required assessments for duration of study period

Infant inclusion criteria:
i) Infants born less than 37 weeks' gestation.

Minimum age

No limit

Maximum age

37 Weeks

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

There are no site exclusion criteria.

Infants requiring immediate resuscitation are excluded from receiving deferred cord clamping, except at sites who have the facilities to provide resuscitation with intact umbilical cord.

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)

Randomisation of all sites prior to the start of the first data sharing period (a single point in time) by central statistician.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Randomisation of sites will be performed by minimisation, a computer generated algorithm, allocating sites to commence the QI program at step 1, 2, 3 or 4. As there is no sequential order, sites will be randomly selected for the order of randomisation. Randomisation will be stratified by neonatal intensive care type (tertiary vs. non-tertiary) and average baseline NSCC as determined in the data collection establishment phase (less than the median vs. greater than or equal to the median).

Masking / blinding

Who is / are masked / blinded?

Intervention assignment

Other

Other design features

Stepped wedge cluster randomised

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

15/07/2024

Actual

15/07/2024

Date of last participant enrolment

Anticipated

19/04/2026

Actual

Date of last data collection

Anticipated

19/04/2026

Actual

Sample size

Target

10000

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Australian Government, Department of Health and Aged Care - Medical Research Future Fund

Address [1]

16 Marcus Clarke St, Canberra ACT 2601

Country [1]

Australia

Primary sponsor type

University

Name

University of Sydney

Address

NHMRC Clinical Trials CentreLocked Bag 77Camperdown NSW 1450

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Hunter New England Human Research Ethics Committee

Ethics committee address [1]

HNELHD Research Office, Level 3 POD, Hunter Medical Research Institute, Lot 1 Kookaburra Circuit, New Lambton 2305, NSW

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

31/07/2023

Approval date [1]

17/08/2023

Ethics approval number [1]

2023/ETH01558

Summary

Brief summary

Delayed umbilical cord clamping after 60 seconds improves outcomes for preterm infants born before 37 weeks. However, delayed clamping is neither reliably recorded nor routinely implemented across Australian hospitals. This study will investigate whether funded basic, accurate data collection and sharing between sites together with a funded, locally adapted quality improvement program increases the average number of seconds before cord clamping (NSCC) by 30 seconds, compared to funded basic, accurate data collection and sharing alone.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof William Tarnow-Mordi

Address

c/o WAMM Coordinating Centre; NHMRC Clinical Trials Centre; Locked Bag 77, Camperdown NSW 1450

Country

Australia

Phone

+61 2 9562 5000

Fax

[email protected]

Contact person for public queries

Name

Sarah Finlayson

Address

c/o WAMM Coordinating Centre; NHMRC Clinical Trials Centre; Locked Bag 77, Camperdown NSW 1450

Country

Australia

Phone

+61 295625000

Fax

[email protected]

Contact person for scientific queries

Name

William Tarnow-Mordi

Address

c/o WAMM Coordinating Centre; NHMRC Clinical Trials Centre; Locked Bag 77, Camperdown NSW 1450

Country

Australia

Phone

+61 2 9562 5000

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

Doc. No.	Type	Email
20245	Study protocol	[email protected]
20524	Analytic code	[email protected]
20525	Statistical analysis plan	[email protected]
20526	Informed consent form	[email protected]
20527	Clinical study report	[email protected]
20528	Ethical approval	[email protected]

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.

Trial Review

Documents added manually

Documents added automatically