Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001085763
Ethics application status
Approved
Date submitted
26/07/2022
Date registered
5/08/2022
Date last updated
10/05/2024
Date data sharing statement initially provided
5/08/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of the Homeless Health Response Bundle on reattendances to an emergency department within 28-days
Scientific title
Pilot Implementation of the Homeless Health Response Bundle: A phase II hybrid randomised controlled trial
Secondary ID [1] 307656 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Homelessness 327162 0
Condition category
Condition code
Emergency medicine 324297 324297 0 0
Other emergency care
Public Health 324371 324371 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention Group

People attending the emergency department at St Vincent's Hospital Melbourne will be screened for homelessness by a research assistant. Those identified as experiencing any level of homelessness will be invited to participate in this study. Prior to randomisation, participants will be invited to complete a satisfaction with life domains scale.

Participants randomised to the intervention group will receive the Homeless Health Access to Care Tool. The Tool has 24-items and is designed to assess the level of health related vulnerability of a person experiencing homelessness. The Homeless Health Access to Care Tool will be administered by a member of the Assessment Liaison Emergency Early Referral Team (ALERT). The ALERT are a multidisciplinary team of social workers, nurses and support workers, who assess people attending the Emergency Department with a view to establishing social services support. It will take approximately 7 minutes to administer the Homeless Health Access to Care Tool. The Tool will be administered only once during a person's attendance to the Emergency Department. The Tool will be electronically embedded into the Emergency Department database.

The Homeless Health Access to Care Tool measures health-related vulnerability defined as a person’s burden of disease and/or injury combined with their capacity to access care, in terms of their ability to seek, perceive, reach, pay and engage healthcare (Levesque et al., 2013). The level of vulnerability identified by applying the Tool will be fed into a site-specific Decision Assistance Guide that will direct the prioritisation of care and healthcare providers’ response to the person experiencing homelessness. For example, a person presenting to the Emergency Department who is deemed highly vulnerable via the Homeless Health Access to Care Tool, will be comprehensively assessed with consideration of screening for chronic disease, cognitive impairment, housing assessment, and admission to the short stay unit in the Emergency Department. The application of the Decision Assistance Guide will be led by the ALERT staff member that administered the Homeless Health Access to Care Tool, in collaboration with the medical and nursing staff involved in the participant's care.

Once the Homeless Health Access to Care Tool has been administered, the participant will be assessed by a medical practitioner or nurse practitioner within the Emergency Department. As stated above, the Decision Assistance Guide will be applied to decisions relating to the persons care. Adherence to the Homeless Health Access to Care Tool and Decision Assistance Guide will be monitored daily by the research assistants and weekly by the on-site research coordinator.

Once the decision has been made to discharge or admit the participant, a research assistant will invite the participant to complete a satisfaction with care survey. The participant will then be provided with a $20 supermarket voucher.

The medical records of each participant will be reviewed at 28 days post attendance by a member of the research team, to identify the number of re-attendances during this period. The medical attendance record from their attendance will also be examined for their, length of time waiting to be seen, length of time in the Emergency Department, referrals to other health professionals, disposition, triage category.

At 30-days a research assistant will contact the participant by phone or in person to conduct the satisfaction with life domains scale. Once completed a $20 voucher will be provided to the participant. A participant involved all the way through this study will receive a maximum of two $20 vouchers.
Intervention code [1] 324109 0
Early detection / Screening
Comparator / control treatment
Control Group
The control group will receive usual care in the Emergency Department. This means they will not be assessed using the Homeless Health Access to Care Tool and the Decision Assistance Guide will not be used to facilitate the decision making around their care, as follows.

People attending the Emergency Department will be screened for homelessness by a research assistant. Those identified as experiencing any level of homelessness will be invited to participate in this study. Prior to randomisation, participants will be invited to complete a satisfaction with life domains scale.

The participant will then wait to be assessed by a medical practitioner or a nurse practitioner. Once the decision has been made to discharge or admit the participant, a research assistant will invite the participant to complete a satisfaction with care survey. The participant will then be provided with a $20 supermarket voucher.

The medical records of each participant will be reviewed at 28 days post attendance by a member of the research team, to identify the number of re-attendances during this period. The medical attendance record from their attendance will also be examined for their diagnosis, length of stay, assessment and investigations undertaken and referrals undertaken.

At 30-days a research assistant will contact the participant by phone or in person to conduct the satisfaction with life survey. Once completed a $20 voucher will be provided to the participant. A participant involved all the way through this study will receive a maximum of two $20 vouchers.
Control group
Active

Outcomes
Primary outcome [1] 332109 0
Emergency Department reattendances within 28-days will be assessed by review of patient medical records.
Timepoint [1] 332109 0
28-days post attendance to the Emergency Department.
Secondary outcome [1] 412441 0
Cost effectiveness analysis will be undertaken using cost estimates of the services received by the participants in the intervention and non-intervention arms. For example, cost of length of stay in the department, cost of specific investigations.
Timepoint [1] 412441 0
Undertaken at 3-months - at the end of the trial,
Secondary outcome [2] 412442 0
To investigate the acceptability of the Homeless Health Response Bundle to Emergency Department staff members.
Timepoint [2] 412442 0
A series of 40-minute focus groups will be held with staff members to explore their acceptance of using the Homeless Health Response Bundle. These will be undertaken at the end of the 3-month trial period.
Secondary outcome [3] 412443 0
To investigate the effect of the Homeless Health Response Bundle on patient satisfaction with the healthcare received.
Timepoint [3] 412443 0
The Australian Hospital Patient Experience Question Set developed by the Australian Commission on Safety and Quality in Health Care, will be administered to study participants on completion of their episode of care. This 12-item questionnaire will provide feedback on their satisfaction of the care they have received. The patient experience survey will be administered by a research assistant.
Secondary outcome [4] 412444 0
To investigate the effect of the Homeless Health Response Bundle on patient quality of life.
Timepoint [4] 412444 0
The Satisfaction with Life Domains Scale has 15-items, each rated using a choice of 7-smiling to grimacing faces. The Satisfaction with Life Domains Scale has been used previously to evaluate quality of life in people experiencing homelessness (Gentil et al., 2020, 2019). The Satisfaction with Life Domains Scale will be administered by a research assistant at two time points, firstly when the participant consents to participate in the study, and secondly at 30-days post enrolment to the study.
Secondary outcome [5] 412445 0
Impact on access to care measured by:
o Did not wait to be seen
o Referrals to other health professionals
o Disposition (admission/discharge)
o Length of time waiting to be seen
o Triage category
o Length of time in the emergency department
Timepoint [5] 412445 0
Medical records of participants will be analysed at 28-days post study enrolment to identify the number that did not wait to be seen, the referrals that were made during their attendance, whether they were admitted or discharged, the length of time waiting to be seen and their triage category.
Secondary outcome [6] 412446 0
To determine the feasibility of using a similar methodology in a Phase III clinical trial powered to evaluate the clinical benefits of the Homeless Health Response Bundle.
Timepoint [6] 412446 0
All of the data collected through this study will be considered to identify the effect of the Bundle on the outcomes and whether it is feasible to conduct a Phase III trial.
Secondary outcome [7] 412592 0
Implementation outcome - Feasibility of Intervention Measure
Timepoint [7] 412592 0
The Feasibility of Intervention Measure developed by Weiner et al., (2017) will be used to explore the perceptions of the Emergency Department staff members on the feasibility of the Homeless Health Response Bundle. The survey will be administered via Microsoft Forms. Participants will be invited by email at 3-months, once the trial has ended, with one reminder email sent to them a week later.
Secondary outcome [8] 412593 0
Implementation outcome -Acceptability of Intervention Measure
Timepoint [8] 412593 0
The Acceptability of Intervention Measure developed by Weiner et al., (2017) will be used to explore the perceptions of the Emergency Department staff members on the acceptability of the Homeless Health Response Bundle. The survey will be administered via Microsoft Forms. Participants will be invited by email at 3-months, once the trial has ended, with one reminder email sent to them a week later.
Secondary outcome [9] 412594 0
Implementation outcome - Appropriateness of Intervention Measure
Timepoint [9] 412594 0
The Appropriateness of Intervention Measure developed by Weiner et al., (2017) will be used to explore the perceptions of the Emergency Department staff members on the appropriateness of the Homeless Health Response Bundle. The survey will be administered via Microsoft Forms. Participants will be invited by email at 3-months, once the trial has ended, with one reminder email sent to them a week later.

Eligibility
Key inclusion criteria
Patients attending the St Vincent’s Hospital Melbourne Emergency Department between 7.30am-7.30pm Monday to Friday, will be invited to be screened for homelessness. Of those who are experiencing homelessness, consent will be sought for their participation in this study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• are less than 18 years of age;
• are cognitively impaired (due to inability to provide informed consent);
• are undergoing an emergency procedure or are too unwell (e.g. myocardial infarction);
• are unable to provide informed consent (e.g. heavily intoxicated, too distressed, psychotic, unconscious).
• not experiencing homelessness within the past 6-months

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation to the intervention or control group will be concealed to the research assistants by the use of pre-prepared sealed envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
In random blocks of 4, 6 and 8 to ensure even allocation to each treatment group.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Primary outcome
Data will firstly be transferred into SPSS v27 for analysis (IBM Corp., Armonk, NY). Categorical outcomes such as the proportion of hospital readmittance within 28 days, will be described using frequencies and percentages and analysed using logistic regression. Continuous outcome variables such as quality of life will be described using means and standard deviations and analysed using general linear models. Mixed models will be used when analysing longitudinal data. Balance between control and intervention demographics will be examined and variables out of balance and related to the outcome will be adjusted for in the final model. Estimates will be presented as difference in means and odds ratios between intervention and control groups with 95% confidence intervals. Assumptions of all models will be assessed by examining the residuals of models with descriptive statistics and plots, with appropriate solutions provided as required (e.g. Bootstrapping or log transformation).

Secondary outcomes
Quantitative survey responses will be collected via Microsoft Forms and exported to Xcel or SPSS for descriptive analysis. A confirmatory factor analysis will be undertaken of the completed Homeless Health Access to Care Tool data. Open ended survey answers and the qualitative focus group data will be transcribed verbatim and analysed descriptively through thematic analysis (Braun & Clark, 2006) via NVivo (V.12, QRS International) software.

Cost effectiveness analysis will be undertaken using cost estimates of the services received by the participants in the intervention and non-intervention arms.

Feasibility of Phase III trial
Descriptive statistics will be used to calculate rate of recruitment, the number of eligible patients who agreed to participate, the number of patients who received the correct protocol and the number of patients who completed the trial. Acceptability of the intervention will be evaluated by using descriptive statistics to determine the number of intervention group participants who were subject to the Homeless Health Response Bundle.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
22/08/2022
Actual
15/11/2022
Date of last participant enrolment
Anticipated
2/12/2022
Actual
28/07/2023
Date of last data collection
Anticipated
2/01/2023
Actual
28/08/2023
Sample size
Target
208
Accrual to date
Final
190
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 22862 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment postcode(s) [1] 38167 0
3065 - Fitzroy

Funding & Sponsors
Funding source category [1] 311917 0
Hospital
Name [1] 311917 0
St Vincent's Hospital Melbourne
Country [1] 311917 0
Australia
Funding source category [2] 311918 0
Hospital
Name [2] 311918 0
St Vincent's Hospital Sydney
Country [2] 311918 0
Australia
Primary sponsor type
Hospital
Name
Quenesland University of Technology
Address
2 George Street
Brisbane
Queensland
4000
Country
Australia
Secondary sponsor category [1] 313401 0
Hospital
Name [1] 313401 0
St Vincent's Hospital Melbourne
Address [1] 313401 0
41 Victoria Parade
Fitzroy
VIC3065
Country [1] 313401 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311353 0
St Vincent's Hospital Melbourne
Ethics committee address [1] 311353 0
Ethics committee country [1] 311353 0
Australia
Date submitted for ethics approval [1] 311353 0
14/06/2022
Approval date [1] 311353 0
14/11/2022
Ethics approval number [1] 311353 0

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

Contacts
Principal investigator
Name 120818 0
A/Prof Jane Currie
Address 120818 0
Queensland University of Technology, School of Nursing, Faculty of Health, 149 Victoria Street, N Block, Kelvin Grove, QLD 4059
Country 120818 0
Australia
Phone 120818 0
+61416647340
Fax 120818 0
Email 120818 0
[email protected]
Contact person for public queries
Name 120819 0
Jane Currie
Address 120819 0
Queensland University of Technology, School of Nursing, Faculty of Health, 149 Victoria Street, N Block, Kelvin Grove, QLD 4059
Country 120819 0
Australia
Phone 120819 0
+61416647340
Fax 120819 0
Email 120819 0
[email protected]
Contact person for scientific queries
Name 120820 0
Jane Currie
Address 120820 0
Queensland University of Technology, School of Nursing, Faculty of Health, 149 Victoria Street, N Block, Kelvin Grove, QLD 4059
Country 120820 0
Australia
Phone 120820 0
+61416647340
Fax 120820 0
Email 120820 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
The data may contain medical in confidence information


What supporting documents are/will be available?




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.