Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000775213
Ethics application status
Approved
Date submitted
8/12/2017
Date registered
8/05/2018
Date last updated
30/05/2019
Date data sharing statement initially provided
30/05/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
How has the Perth Children’s Hospital work environment impacted on patient, family and nurse experience?
Scientific title
How has the Perth Children’s Hospital work environment impacted on patient outcomes, nurses’ work practice and the patient, family and nurse experience?
Secondary ID [1] 293428 0
nil
Universal Trial Number (UTN)
Trial acronym
The PCH EVAL Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
New paediatric hospital environment 306295 0
Patient experience 306296 0
Family experience 306297 0
Nurse experience 306298 0
Nurse work practice 306300 0
Nurse sensitive patient outcomes 306301 0
Condition category
Condition code
Public Health 304814 304814 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The new hospital environment has mainly single patient rooms with in-room parent sleeping facilities, automated medication dispensing pathway, decentralised nurses’ station, and hands free communication platform.
The intervention is a process-of-care change, specifically a new hospital environment. It is anticipated that the technologies of Automated Dispensing Machines (ADM) and wireless hands free communication will contribute to an increase in nurse time at bedside, supporting nurses in the delivery of patient centred care.
Materials: Specific components of the intervention are: 1) ADM devices that control and provide access to medications in ward areas. ADMs are locked cabinets that control access to medication, aiming to facilitate efficient and safe retrieval of medications and to track and record staff access. ADMs enhance security of medication and reduce selection errors by guiding the dispenser toward the correct drug. ADMs provide real time electronic stock control to ward areas with medications stored in individual compartments. Access to ADM is gained by fingerprint or passcode. Decentralised ADMs are considered part of standard practice in the majority of hospitals in North America however there has been limited assessment of the impact of ADMs on the administration process in hospitals in Australia. 2) Hands free communication connects users by voice prompts using wireless technology as a framework for hospital wide communication. This facilitates communication between caregivers through spoken voice, replaces paging and connects bedside calls directly to the primary care nurse, reducing the overall time to respond to patient call bell and bedside monitor alarms.
Processes: The new work environment will be resourced to increase nurse engagement with families and to decrease interruptions to nurses.
Mode of delivery: It is anticipated that all inpatients will move to the new hospital on June 10th 2018.
Number of times: The intervention will occur once and for the purpose of this study is for 12 months duration.
Location: The existing Princess Margaret Hospital for Children is located on Roberts Road in Subiaco, Western Australia and was founded in 1909. The new Perth Children's Hospital is located at the corner of Winthrop Avenue and Monash Avenue in the nearby suburb of Nedlands,
Intervention code [1] 299669 0
Treatment: Other
Comparator / control treatment
The old hospital environment consists of many shared patient rooms and very limited sleeping facilities for parents, non-automated medication dispensing, a centralised nurses’ station, and traditional call bell communication. The new hospital environment has mainly single patient rooms with in-room parent sleeping facilities, automated medication dispensing pathway, decentralised nurses’ station, and hands free communication platform.
There is no control group, however data will be collected before and after the move from Princess Margaret Hospital (PMH) to Perth Children's Hospital (PCH) - the new work environment (PCH) constitutes the primary intervention. The baseline (control) period occurs before the move, data collection began at PMH 12 months before the anticipated move to PCH.
Control group
Active

Outcomes
Primary outcome [1] 304077 0
Nurse time spent with the patient post move to the Perth Children's Hospital (PCH) as observed by a time and motion observation of nurse workflow for a total of 60 hours for 15 nurses working in 3 inpatient areas.
Timepoint [1] 304077 0
T4 (2nd evaluation phase – one year post move to PCH) compared to T1 (baseline – pre move to PCH).
Primary outcome [2] 304078 0
Effective communication between patients and nursing staff post move to PCH as reported by nurses, patients and families using an interrupted time series method, The experiences of 15 children, 15 families and 15 nurses per week for 10 weeks will be captured using purposefully designed surveys at three time periods: The surveys are named 'Voice of Child', 'Voice of Family' and 'Voice of Nurse.'
Timepoint [2] 304078 0
T4 (2nd evaluation phase – one year post move to PCH) compared to T1 (baseline – pre move to PCH) and T3 (1st evaluation phase – three months post move to PCH).
Primary outcome [3] 304079 0
Patient experience of the PCH environment as reported by patients at focus groups or interviews.
Parent/carer experience of the PCH environment as reported by parents or carers at focus groups or interviews.
Timepoint [3] 304079 0
T3 (1st evaluation phase - three months post move to PCH) and T4 (2nd evaluation phase – one year post move to PCH) .
Secondary outcome [1] 340876 0
Clinical incidents Severity Assessment Code 2 (count.) Data collected routinely and reported monthly.
Timepoint [1] 340876 0
Collected continuously for 12 months prior to the move to PCH and 12 months post move at monthly intervals
Secondary outcome [2] 340877 0
Clinical Incidents Severity Assessment Code 3 (count). Data collected routinely and reported monthly.
Timepoint [2] 340877 0
Collected continuously for 12 months prior to the move to PCH and 12 months post move at monthly intervals
Secondary outcome [3] 340880 0
Self reported consumer complaints (count). Data collected routinely and reported monthly.
Timepoint [3] 340880 0
Collected continuously for 12 months prior to the move to PCH and 12 months post move at monthly intervals
Secondary outcome [4] 342861 0
Self reported consumer compliments (count). Data collected routinely and reported monthly.
Timepoint [4] 342861 0
Collected continuously for 12 months prior to the move to PCH and 12 months post move at monthly intervals
Secondary outcome [5] 342862 0
WA Emergency Access Target (count)Data collected routinely and reported monthly.
Timepoint [5] 342862 0
collected continuously for 12 months prior to the move to PCH and 12 months post move at monthly intervals
Secondary outcome [6] 342863 0
Number of readmissions to an acute designated mental health inpatient unit within 28 days (count)Data collected routinely and reported monthly.
Timepoint [6] 342863 0
Collected continuously for 12 months prior to the move to PCH and 12 months post move at monthly intervals
Secondary outcome [7] 342864 0
Healthcare associated SA blood stream infection (count) Data collected routinely and reported monthly.
Timepoint [7] 342864 0
Collected continuously for 12 months prior to the move to PCH and 12 months post move at monthly intervals
Secondary outcome [8] 342865 0
Healthcare associated MRSA infections (count)Data collected routinely and reported monthly.
Timepoint [8] 342865 0
Collected continuously for 12 months prior to the move to PCH and 12 months post move at monthly intervals
Secondary outcome [9] 342867 0
Hospital identified Clostridium Difficile infection presentations for children older than 2 years (count). Data is collected routinely and reported monthly.
Timepoint [9] 342867 0
Collected continuously for 12 months prior to the move to PCH and 12 months post move at monthly intervals
Secondary outcome [10] 342868 0
Self report of occupational exposures to blood and body fluid (count ). Data collected routinely and reported monthly.
Timepoint [10] 342868 0
Collected continuously for 12 months prior to the move to PCH and 12 months post move at monthly intervals
Secondary outcome [11] 342869 0
Staff hand hygiene compliance with adherence as assessed by "the 5 moments" as assessed by trained auditors (count). Data collected routinely and reported monthly.
Timepoint [11] 342869 0
collected continuously for 12 months prior to the move to PCH and 12 months post move at monthly intervals
Secondary outcome [12] 342870 0
Reported medication errors/incidents SAC 1-3 (count). Data is collected from the Government of Western Australia (WA) Department of Health Clinical Incident Management System (CIMS). Reporting is the responsibility of all clinical staff. Data is collected routinely and reported monthly.
Timepoint [12] 342870 0
Collected continuously for 12 months prior to the move to PCH and 12 months post move at monthly intervals
Secondary outcome [13] 342872 0
Patient identification incidents SAC 1-3 (count). Data is collected from the Government of WA CIMS. Reporting is the responsibility of all clinical staff. Data is collected routinely and reported monthly.
Timepoint [13] 342872 0
Collected continuously for 12 months prior to the move to PCH and 12 months post move at monthly intervals
Secondary outcome [14] 342873 0
Incidents related to Clinical Handover Severity Assessment Code 1 to 3 (count). Data is collected from the Government of WA CIMS. Reporting is the responsibility of all clinical staff. Data is collected routinely and reported monthly.
Timepoint [14] 342873 0
Collected continuously for 12 months prior to the move to PCH and 12 months post move at monthly intervals
Secondary outcome [15] 342875 0
Pressure injury (count). Data is collected from the Government of WA CIMS. Reporting is the responsibility of all clinical staff. Data is collected routinely and reported monthly.
Timepoint [15] 342875 0
Collected continuously for 12 months prior to the move to PCH and 12 months post move at monthly intervals
Secondary outcome [16] 342877 0
Medical Emergency Team (MET) calls (count). Data is collected from the Government of WA CIMS. Reporting is the responsibility of all clinical staff. Data is collected routinely and reported 6 monthly.
Timepoint [16] 342877 0
Collected continuously for 12 months prior to the move to PCH and 12 months post move at monthly intervals
Secondary outcome [17] 342878 0
Code Blue calls (count). Data is collected from the Government of WA CIMS. Reporting is the responsibility of all clinical staff. Data is collected routinely and reported 6 monthly.
Timepoint [17] 342878 0
Collected continuously for 12 months prior to the move to PCH and 12 months post move at monthly intervals
Secondary outcome [18] 342879 0
Failure to activate rapid response system (count). Data is collected from the Government of WA CIMS. Reporting is the responsibility of all clinical staff. Data is collected routinely and reported monthly.
Timepoint [18] 342879 0
Collected continuously for 12 months prior to the move to PCH and 12 months post move at monthly intervals
Secondary outcome [19] 342880 0
A reported failure /insufficient recognition of a significant change in patient status (count). Data is collected from the Government of WA CIMS. Reporting is the responsibility of all clinical staff. Data is collected routinely and reported monthly.
Timepoint [19] 342880 0
Collected continuously for 12 months prior to the move to PCH and 12 months post move at monthly intervals
Secondary outcome [20] 342881 0
Readmission rates (count). Data is collected from the Government of WA CIMS. Data is collected routinely and reported monthly.
Timepoint [20] 342881 0
Collected continuously for 12 months prior to the move to PCH and 12 months post move at monthly intervals
Secondary outcome [21] 342882 0
Unplanned elevation of care to intensive care setting (count). Data is collected from the Government of WA CIMS. Data is collected routinely and reported annually.
Timepoint [21] 342882 0
Collected continuously for 12 months prior to the move to PCH and 12 months post move at monthly intervals
Secondary outcome [22] 342883 0
Unplanned return to surgery (count). Data is collected from the Government of WA CIMS. Data is collected routinely and reported monthly.
Timepoint [22] 342883 0
Collected continuously for 12 months prior to the move to PCH and 12 months post move at monthly intervals
Secondary outcome [23] 342884 0
Early warning score miscalculated (count). Data collected routinely and reported 6 monthly. Early warning scores are calculated in assessment tools that track changes in physiological parameters, including the Children's Early Warning Tool chart, these tools are audited.
Timepoint [23] 342884 0
Collected continuously for 12 months prior to the move to PCH and 12 months post move at monthly intervals
Secondary outcome [24] 342886 0
Failure to rescue, defined as “mortality of patients who experienced a hospital-acquired complication" (count). Data is collected from the Government of WA CIMS. Data is collected routinely and reported monthly.
Ref: Twigg Diane E. DC, Evans Gemma. The critical role of nurses to the successful implementation of the National Safety and Quality Health Service Standards. Australian Health Review. 2013:7. doi:doi.org/10.1071/AH12013,
Timepoint [24] 342886 0
Collected continuously for 12 months prior to the move to PCH and 12 months post move at monthly intervals
Secondary outcome [25] 342887 0
Falls (count). Data is collected from the Government of WA CIMS. Reporting is the responsibility of all clinical staff. Data is collected routinely and reported monthly.
Timepoint [25] 342887 0
collected continuously for 12 months prior to the move to PCH and 12 months post move at monthly intervals
Secondary outcome [26] 342888 0
Mortality (count). Data is collected from the Government of WA CIMS. Data is collected routinely and reported monthly.
Timepoint [26] 342888 0
collected continuously for 12 months prior to the move to PCH and 12 months post move at monthly intervals
Secondary outcome [27] 342889 0
Patient length of stay (count). Data is collected from the Government of WA CIMS. Data is collected routinely and reported monthly.
Timepoint [27] 342889 0
collected continuously for 12 months prior to the move to PCH and 12 months post move at monthly intervals
Secondary outcome [28] 342890 0
Nursing hours per patient day (count). Data is collected routinely from RoStar, the hospital rostering system, and reported monthly.
Timepoint [28] 342890 0
Collected continuously for 12 months prior to the move to PCH and 12 months post move at monthly intervals
Secondary outcome [29] 342891 0
Nursing staff personal leave in days (count). Data is collected routinely from RoStar, the hospital rostering system, Data is collected routinely and reported monthly.
Timepoint [29] 342891 0
Collected continuously for 12 months prior to the move to PCH and 12 months post move at monthly intervals
Secondary outcome [30] 342892 0
Nursing staff turnover (count). Data is collected routinely from RoStar, the hospital rostering system, and reported monthly.
Timepoint [30] 342892 0
Collected continuously for 12 months prior to the move to PCH and 12 months post move at monthly intervals
Secondary outcome [31] 342893 0
Nurse Full time equivalent staff number (count). Data is collected routinely from RoStar, the hospital rostering system, and reported monthly.
Timepoint [31] 342893 0
Collected continuously for 12 months prior to the move to PCH and 12 months post move at monthly intervals
Secondary outcome [32] 342894 0
Work place injury rates (count). Data is collected from the Government of WA Database. Reporting is the responsibility of all clinical staff. Data is collected routinely and reported monthly.
Timepoint [32] 342894 0
Collected continuously for 12 months prior to the move to PCH and 12 months post move at monthly intervals
Secondary outcome [33] 345650 0
Clinical Incidents Severity Assessment Code 1 (count). Data is collected from the Government of WA CIMS. Reporting is the responsibility of all clinical staff. Data is collected routinely and reported monthly.
Timepoint [33] 345650 0
Collected continuously for 12 months prior to the move to PCH and 12 months post move at monthly intervals

Eligibility
Key inclusion criteria
Child participants: patients from selected wards of the hospital who are able to agree to participate (sufficiently mature and parents to indicate consent in electronic format on the initial screen of the survey), Patients who are considered well enough to participate (as identified by the Clinical Nurse Manager).
Parent participants: English speaking parents whose baby or child was admitted to the participating ward.
Nurse participants: All nurses employed at the hospital who are not on leave during the period of data collection
Minimum age
4 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Child participants: child is under the care of child protective services, too ill or distressed to take part, non-English speaking, or if the capacity to participate is deemed impaired by the ward Clinical Nurse Manager (or delegate) due to cognitive impairment, mental illness, or intellectual disability
Parent participants: parents whose child is under the care of child protective services.
Nurse participants: Time and motion study - Nurses who know at T1 that they will not be working at PCH at T4, and the shift coordinator.
Focus groups - Nurses who are employed in the ward on a casual basis

Study design
Purpose of the study
Treatment
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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/11/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/11/2019
Actual
Sample size
Target
3047
Accrual to date
1420
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 9454 0
Princess Margaret Hospital - Subiaco
Recruitment hospital [2] 9455 0
Perth Children's Hospital - Nedlands
Recruitment postcode(s) [1] 18180 0
6008 - Subiaco
Recruitment postcode(s) [2] 18181 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 298055 0
Government body
Name [1] 298055 0
Child and Adolescent Health Service
Country [1] 298055 0
Australia
Funding source category [2] 298543 0
Charities/Societies/Foundations
Name [2] 298543 0
Channel 7 Telethon Trust
Country [2] 298543 0
Australia
Primary sponsor type
Government body
Name
Child and Adolescent Health Service
Address
Roberts Road, Subiaco, Western Australia, 6008
Mailing Address, GPO Box D184, Perth Western Australia 6840
Country
Australia
Secondary sponsor category [1] 297128 0
Hospital
Name [1] 297128 0
Perth Children's Hospital
Address [1] 297128 0
Mailing Address, GPO Box D184, Perth Western Australia 6840
Country [1] 297128 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299074 0
Child and Adolescent Service Human Research Ethics Committee
Ethics committee address [1] 299074 0
Ethics committee country [1] 299074 0
Australia
Date submitted for ethics approval [1] 299074 0
18/09/2017
Approval date [1] 299074 0
19/10/2017
Ethics approval number [1] 299074 0
RGS0000000567

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

Contacts
Principal investigator
Name 79206 0
Dr Fenella Gill
Address 79206 0
Child and Adolescent Health Service
GPO Box D184,
Perth Western Australia 6840
Country 79206 0
Australia
Phone 79206 0
+61 402881604
Fax 79206 0
Email 79206 0
[email protected]
Contact person for public queries
Name 79207 0
Fenella Gill
Address 79207 0
Child and Adolescent Health Service
GPO Box D184,
Perth Western Australia 6840
Country 79207 0
Australia
Phone 79207 0
+61402881604
Fax 79207 0
Email 79207 0
[email protected]
Contact person for scientific queries
Name 79208 0
Fenella Gill
Address 79208 0
Child and Adolescent Health Service
GPO Box D184,
Perth Western Australia 6840
Country 79208 0
Australia
Phone 79208 0
+61402881604
Fax 79208 0
Email 79208 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
IPD will not be available


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
SourceTitleYear of PublicationDOI
EmbaseA new children's hospital with a larger floor space, single rooms, and V-shaped ward design: A pre-post evaluation of nurse time providing patient care and nurse, patient, and family experiences.2023https://dx.doi.org/10.1177/13558196221146658
N.B. These documents automatically identified may not have been verified by the study sponsor.