ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12612000506897

Ethics application status

Approved

Date submitted

8/05/2012

Date registered

10/05/2012

Date last updated

11/05/2012

Type of registration

Retrospectively registered

Titles & IDs

Public title

Parental presence on bedside clinical rounds (PPBCR) in a neonatal intensive care unit (NICU).

Scientific title

Effect of parental participation on bedside clinical rounds for their child in NICU compared to non-participation on parental satisfaction and level of parental stress.

Secondary ID [1]

Nil

Universal Trial Number (UTN)

U1111-1130-6411

Trial acronym

PPBCR

Linked study record

Health condition

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

Parental presence on bedside clinical rounds in NICU

Condition category

Condition code

Public Health

Health service research

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

* The intervention involves the participant (parents or guardian) accompany health care professionals on their bedside clinical rounds to their child.

* After obtaining consent, the participant will be randomised to one of two arms:
1. Attending bedside clinical rounds with health care professionals (PPBCR) group or
2. Non-attending bedside clinical rounds with health care professionals (Non-PPCBR) group.

* Parents will rotate between the above two arms but they will have a break (washout period) before changing from one group to the other.

* The duration of time spent in each group and in washout period depends on their infant gestation. If the infant gestation is more than 30 weeks then duration will be 3 days in each group and washout period (that’s total of 9 days in the whole study). If the infant gestation is less than or equal 30 weeks then duration will be 7 days in each group and washout period (that’s total of 21 days in the whole study).

* At conclusion of each arm, the participant will be asked to complete:
1. NICU parental stressor scale and
2. A satisfaction survey about being involved in clinical bedside rounds.

Intervention code [1]

Other interventions

Comparator / control treatment

The comparator or control involves the parents not accompanying health care professionals on their bedside clinical rounds to their child.

Control group

Active

Outcomes

Primary outcome [1]

At the conclusion of each of the study arms [study (PPCBR)/control (PPCBR)], parents or guardians will be asked to complete satisfaction surveys which include questions pertaining to parent's insights regarding inclusion or exclusion from bedside clinical rounds. The survey includes questions regarding:
1. Knowledge and understanding
2. Communications and collaboration
3. Privacy and confidentiality
4. Parental Stressor Scale for hospitalized infants.

Timepoint [1]

The survey should be completed at the conclusion of each study arm:
1. After attending rounds for 3 or 7 days according to infant gestation
2. After being excluded from rounds for 3 or 7 days according to infant gestation.

Secondary outcome [1]

Nil

Timepoint [1]

Nil

Eligibility

Key inclusion criteria

Parents (mother and/or their partners) or guardians who fulfil the following criteria will be approached for inclusion in the study:

If their infant is anticipated to stay in NICU for minimal of 11 days. This cut-off is taken as the intervention (PPCBR and non-PPCBR) and washout period will take minimum of 3 days each. In addition we allowed first 2 days for not being included in the study as most mothers will be recovering from delivery/Caesarean Section/Anaesthesia …etc).

Minimum age

No limit

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Parents (mother and/or their partners) or guardians who fulfil the following criteria will be excluded from the study:

1. If their infant is anticipated to stay in NICU for less than 11 days

2. If their infant is anticipated to be transferred to another NICU or local hospital in less than 11 days after admission.

3. Refused to participate in the study

4. Parents or guardians who do not have good command of English (it is not practical to include an interpreter during the rounds as this might put pressure on interpreter service (eg. to attend rounds at 08:30 daily for 7 days per patient and also it will lead to significant delay in the rounds).

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)

Parents will be randomised to start with PPCBR or non-PPCBR intervention using computer generated randomisation protocol. This is done by accessing the trial management website (http://www.discoverquick.com/) which was designed by statistician and information technology consultant not involved in the trial. Access to the website require a password and is restricted to the research team. The randomisation protocol (allocation and sequence) is concealed from the research team and parents and is managed by the trial management website.

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

The sequence will be generated by accessing a randomisation and sequence protocol. This is done by accessing the trial management website (http://www.discoverquick.com/) which was designed by statistician and information technology consultant not involved in the trial. Access to the website require a password and is restricted to the research team. The randomisation protocol (allocation and sequence) is concealed from the research team and parents and is managed by the trial management website.
To ensure that equal number of parents of extremely premature infants are randomised to start with PPCBR and non-PPCBR intervention, we will stratify the randomisation by infant's gestation (gestation less than or equal 30 and more than 30 weeks) using block randomisation.

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Crossover

Other design features

Nil

Phase

Not Applicable

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

15/04/2012

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

110

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Canberra Hospital Private Practice Trust Fund

Address [1]

Canberra Hospital Private Practice Trust Fund,
The Canberra Hospital,
Building 6, Level 3, Yamba Drive,
Garran, ACT 2605

Country [1]

Australia

Primary sponsor type

Individual

Name

A/Prof Abdel-Latif Mohamed

Address

Department of Neonatology, The Canberra Hospital, Building 11, Level 3, Yamba Drive,
Garran, ACT 2605

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Nil

Address [1]

Nil

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

ACT Health Human Research Ethics

Ethics committee address [1]

ACT Health Human Research Ethics Committee Secretariat, Canberra Hospital, Yamba Drive, Garran ACT 2605

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

14/07/2011

Approval date [1]

09/12/2011

Ethics approval number [1]

ETH.6.11.121

Summary

Brief summary

Why are we doing this study? 
* ACT Health and The Canberra Hospital are motivated to provide care that is both family and patient centred. Currently in the Centre for Newborn Care parents are not involved in clinical bedside rounds. This study will allow parents to attend these rounds for a specified period and gain feedback from the experience via surveys. 

* We aim to use the information gained from this study to introduce a new way of doing clinical beside rounds in our soon to be completed Womens’ and Childrens’ Hospital.


What does the study involve?
* After obtaining consent, the participant (parents or guardian) will be randomised to one of two arms: 
1. PPBCR group (attending bedside clinical rounds with health care professionals) or 
2. Non-PPCBR (non-attending bedside clinical rounds with health care professionals). 
* Each group depending on the baby’s gestation will rotate between attending and not attending rounds spending 3 (if the infant gestation is more than 30 weeks) or 7 (if the infant gestation is less than or equal 30 weeks) days in each group with a similar break in between. 
* The participant will be given regular updates on their baby condition during non-PPCBR and washout break
* At conclusion of each arm, the participant will be asked to complete: 
1. NICU parental stressor scale and 
2. A satisfaction survey about being involved in clinical bedside rounds



What do we hope to achieve with this study?
Through your involvement in this study we aim to:
* Improve communication between families and the clinical team within the Centre for Newborn Care.
* Families being more aware of current clinical management and care plan for their babies, in turn reducing stressors they may experience.

Trial website

Nil

Trial related presentations / publications

Nil

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

Margaret Broom

Address

Department of Neonatology, The Canberra Hospital, Building 11, Level 3, Yamba Drive, Garran, ACT 2605

Country

Australia

Phone

+61 2 6244 3111

Fax

+61 2 6244 3112

Margaret.Broom@act.gov.au

Contact person for scientific queries

Name

A/Prof Abdel-Latif Mohamed

Address

Department of Neonatology, The Canberra Hospital, Building 11, Level 3, Yamba Drive, Garran ACT 2605

Country

Australia

Phone

+61 2 6244 4056

Fax

+61 2 6244 3112

Abdel-Latif.Mohamed@act.gov.au

No information has been provided regarding IPD availability

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

Source	Title	Year of Publication	DOI
Embase	Parental presence on neonatal intensive care unit clinical bedside rounds: Randomised trial and focus group discussion.	2015	https://dx.doi.org/10.1136/archdischild-2014-306724

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically