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Trial registered on ANZCTR


Registration number
ACTRN12617001135303
Ethics application status
Approved
Date submitted
26/07/2017
Date registered
3/08/2017
Date last updated
17/07/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Feasibility of a community engagement program for developing improved hand hygiene practices to reduce healthcare associated infections in hospitals.
Scientific title
Feasibility of a community engagement program involving patients, carers and healthcare workers for developing improved hand hygiene practices to reduce healthcare associated infections in hospitals.
Secondary ID [1] 292089 0
Nil known.
Universal Trial Number (UTN)
Nil known.
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
hand hygiene practices of healthcare workers 304186 0
healthcare-associated infections 304187 0
Condition category
Condition code
Infection 303512 303512 0 0
Studies of infection and infectious agents
Public Health 303513 303513 0 0
Health promotion/education
Public Health 303514 303514 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
QUT has developed a methodology for community engagement and consultation based on design thinking and facilitated by an interactive booth (known as the InstaBooth), containing different kinds of interactive opportunities (e.g. pin-boards for post-it notes, drawing surfaces, interactive screens, projectors, cameras, small printers, scanners, digitising pens). This community engagement strategy invites participants to leave messages, share comments, memories, drawings or photos with the general public to foster discussion about a specific topic. This study intends to install the InstaBooth for a 2-week period into the outpatient department of Cancer Care Services at the study site to engage consumers, carers, healthcare workers and visitors to the hospital to share their experiences and suggestions for improving hand hygiene practices and/or reducing healthcare-associated infections. The InstaBooth installation with be supervised by nursing staff and members of the research team during opening hours. Research staff will inform healthcare workers, consumers, carers and visitors to the hospital about the InstaBooth by displaying posters, handing out flyers, newsletters, social media and/or TV interviews and will supervise the InstaBooth during the two-week installation period and be available to answer any questions potential participants may have about the study and/or InstaBooth. Consumers, carers, healthcare workers and/or visitors to the hospital who choose to interact with the InstaBooth, will be able to provide feedback using whichever aspect of the booth they choose.

QUT and Metro North Hospital and Health Service Consumer Engagement will also facilitate two-three collaborative workshops to be held before and after the InstaBooth installation to ensure the project (composition of InstaBooth components, data collection, data analysis and intervention development) is participant-centred from its inception. These collaborative workshops will invite consumers, carers and/or healthcare workers to share their experiences about a specific healthcare problem to inform the development of possible solutions. The workshops will be 2-8hrs in duration, depending on the stage of intervention design and preferences of the participants. The first workshop will occur within 1 month prior to InstaBooth installation. This workshop will ask participants to suggest topics/research questions that could inform the development of interactive components of the InstaBooth, that aim to engage the public about sharing their experiences and suggestions for improving hand hygiene practices and/or reducing healthcare-associated infections. The second and final workshops will facilitate co-analysis of the data collected from the InstaBooth by workshop participants and inform the development of possible solutions to improve hand hygiene practices and/or reduce healthcare-associated infections across the hospital. The second and final workshops will occur 3-8 weeks post InstaBooth removal and may be combined or held separately; dependent on the collaborative decision of the workshop participants. The workshop facilitators are qualified researchers who have completed their PhD and have experience in qualitative research. The workshop facilitators have previously led similar workshops in conjunction with the InstaBooth to promote community engagement on other topics, such as urban planning and domestic violence. Their role in the workshops for this study will involve employing design thinking and EBCD strategies to promote participant engagement, guide data analysis and intervention design.

Once the workshops are completed, one of the possible solutions developed during this project will be implemented into Cancer Care Services, Royal Brisbane and Women's Hospital as part of a separate study.
Intervention code [1] 298725 0
Prevention
Intervention code [2] 298726 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 302889 0
As a pilot study, the main outcome is feasibility. Feasibility will be established by a composite analysis of participant demand; acceptability; implementation; practicality; adaptation; integration; expansion; and limited-efficacy testing.
Timepoint [1] 302889 0
Feasibility for the InstaBooth installation will be assessed during its two-week installation period by data collected from InstaBooth participants using surveys and/or semi-structured interviews and a detailed log book of all tasks, processes, organisational requirements, additional equipment or staff time utilised during this project. The InstaBooth will be installed at the study site in 2017.

Feasibility for the collaborative workshops will be assessed by data collected from workshop participants, using surveys and/or semi-structured interviews during 2017.

The Health Service Co-Design Framework: engage, plan, explore, develop, decide and change (Boyd, McKernon & Old, 2010) and the EBCD toolkit (The King's Fund, 2013) guided the development of interview questions and a survey instrument specifically for this study.
Secondary outcome [1] 337342 0
Evaluate whether InstaBooth participants prefer to share their healthcare experiences and provide feedback using the InstaBooth, compared to completing patient experience surveys (standard practice).
Timepoint [1] 337342 0
Directly after participating in the InstaBooth, invite participants to provide feedback about their experience through a semi-structured interview and/or survey. Interview questions and survey items were specifically developed for this study using an EBCD framework.

Eligibility
Key inclusion criteria
Consumers and/or carers were invited via the Metro North Hospital & Healthcare Service Consumer Registry to participate in the collaborative workshops for this study. There are no set inclusion criteria to participate in the collaborative workshops, however it is desirable to engage consumers and/or carers who had experienced healthcare-associated infection/s, observed poor hand hygiene practices or were interested in developing possible solutions to these healthcare solutions. Healthcare workers who were employed by Cancer Care Services at the study site were invited to participate in the collaborative workshops.

There are no set inclusion criteria to participate in the InstaBooth during its two-week installation. It is an interactive booth open to the public.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Adults who are 18 years or older will be invited to provide written consent to participate in the collaborative workshops. People of all ages are invited to participate in the InstaBooth during its two-week installation.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequence generation not employed.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Given the intent of the InstaBooth installation is to achieve a maximal participation rate and assess the feasibility of this community engagement method, no sample size calculation was needed.

The sample size for the collaborative workshops was determined based on the previous experiences of the QUT workshop facilitators, who have led several collaborative workshops using design thinking strategies. The QUT workshop facilitators have previous found that workshops with four to eight participants aid collaborations between participants and the development of possible solutions for the topic of interest. Thus, we will invite between four to eight consumers, carers and/or healthcare workers to attend each of the workshops for this study.

Participant demand of the InstaBooth and collaborative workshops will be assessed using counts and percentages. Participant experiences measured in the semi-structured interviews for the InstaBooth installation and workshops will be analysed using thematic analysis. Survey data collected from workshop and InstaBooth participants will be analysed using descriptive statistics and thematic analysis.

A detailed log book will be kept of all tasks, processes, organisational requirements, additional equipment or staff time utilised throughout this study. Descriptive data will be analysed from these log book records to determine whether the implementation, practicality, adaptation and integration of the InstaBooth was feasible.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
28/07/2017
Date of last participant enrolment
Anticipated
31/10/2017
Actual
5/10/2017
Date of last data collection
Anticipated
30/11/2017
Actual
5/10/2017
Sample size
Target
500
Accrual to date
Final
594
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 8619 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 16727 0
4029 - Herston

Funding & Sponsors
Funding source category [1] 296620 0
Government body
Name [1] 296620 0
Metro North Hospital & Healthcare Service (MNHHS) Leading Innovation through Networking and Knowledge-sharing (LINK) Innovation Program
Country [1] 296620 0
Australia
Primary sponsor type
Individual
Name
Nicole Gavin
Address
Cancer Care Services
Royal Brisbane and Women's Hospital
Building 34, Level 2
Butterfield St
Herston
QLD 4029
Country
Australia
Secondary sponsor category [1] 295580 0
Individual
Name [1] 295580 0
Sarah Northfield
Address [1] 295580 0
Cancer Care Services
Royal Brisbane and Women's Hospital
Building 34, Level 2
Butterfield St
Herston
QLD 4029
Country [1] 295580 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297853 0
Royal Brisbane and Women's Hospital Human Research Ethics Committee
Ethics committee address [1] 297853 0
Human Research Ethics Office
Royal Brisbane and Women's Hospital
Level 7, Block 7
Butterfield St
Herston
QLD 4029
Ethics committee country [1] 297853 0
Australia
Date submitted for ethics approval [1] 297853 0
15/05/2017
Approval date [1] 297853 0
23/06/2017
Ethics approval number [1] 297853 0
HREC/17/QRBW/266
Ethics committee name [2] 298280 0
Queensland University of Technology Human Research Ethics Committee
Ethics committee address [2] 298280 0
Office of Research Ethics and Integrity, Queensland University of Technology
Level 4, 88 Musk Avenue
Kelvin Grove QLD 4059
Ethics committee country [2] 298280 0
Australia
Date submitted for ethics approval [2] 298280 0
Approval date [2] 298280 0
18/07/2017
Ethics approval number [2] 298280 0
1700000665

Summary
Brief summary
The overall objective of this study is to pilot test the feasibility of a community and consumer engagement strategy using design thinking and EBCD methodologies in the healthcare setting. This study aims to invite consumers, carers, healthcare workers and/or visitors to the hospital to attend collaborative workshops and/or the InstaBooth (an interactive booth) to share their experiences and suggestions for improving hand hygiene practices and/or reducing hospital-acquired infections and inform the design of possible solutions to these healthcare problems. After data analysis is completed, one of the possible solutions designed in the collaborative workshops will be implemented at the study site and its impact will be evaluated.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1911 1911 0 0
/AnzctrAttachments/373052-Collaborative Engagement Strategy Study_RBWH HREC Approval Letter_23 06 2017.pdf (Ethics approval)

Contacts
Principal investigator
Name 75266 0
Ms Nicole Gavin
Address 75266 0
Cancer Care Services
Royal Brisbane and Women's Hospital
Building 34, Level 2
Butterfield St
Herston
QLD 4029
Country 75266 0
Australia
Phone 75266 0
+61 7 3646 5833
Fax 75266 0
Email 75266 0
nicole.gavin@health.qld.gov.au
Contact person for public queries
Name 75267 0
Nicole Gavin
Address 75267 0
Cancer Care Services
Royal Brisbane and Women's Hospital
Building 34, Level 2
Butterfield St
Herston
QLD 4029
Country 75267 0
Australia
Phone 75267 0
+61 7 3646 5833
Fax 75267 0
Email 75267 0
nicole.gavin@health.qld.gov.au
Contact person for scientific queries
Name 75268 0
Nicole Gavin
Address 75268 0
Cancer Care Services
Royal Brisbane and Women's Hospital
Building 34, Level 2
Butterfield St
Herston
QLD 4029
Country 75268 0
Australia
Phone 75268 0
+61 7 3646 5833
Fax 75268 0
Email 75268 0
nicole.gavin@health.qld.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
No additional documents have been identified.