Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000676617
Ethics application status
Approved
Date submitted
2/05/2023
Date registered
22/06/2023
Date last updated
4/04/2024
Date data sharing statement initially provided
22/06/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
No More Shame: Investigating the effect of changing health providers recognition and response to elder abuse on associated stigma
Scientific title
No More Shame: Investigating the effect of changing health providers recognition and response to elder abuse on associated stigma
Secondary ID [1] 309363 0
MRFF Application ID: 2015995
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Elder abuse 329579 0
Condition category
Condition code
Public Health 326499 326499 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Sub-acute health providers that work at participating hospital sites will be given access to a multicomponent intervention ("No More Shame") comprising a screening tool, online training focused on elder abuse, and a site champion.

The training course was developed through co-design methods, with input from different stakeholders (older people, family carers of older people, and health providers). The screening tool, Australian Elder Abuse Screening Instrument (AUSI), was co-designed and piloted.

The training course comprises 4 modules. The first module is about knowledge of elder abuse, and therefore includes a definition of elder abuse, types of elder abuse, who perpetrates elder abuse, etc. The second module focuses on the drivers elder abuse e.g. ageism as a key driver. The third module is about screening for abuse, taking into consideration sensitive enquiry, timing, who should screen for abuse, and additionally how to use the screening tool. The fourth module focuses on management of abuse, including the types of responses and referral pathways available.

The mode of training used will be multimedia slides with a combination of text, short videos, voiceovers, quizzes, scenario-based reflective exercises, and links to further resources (e.g., national and state-based elder abuse services, helplines, advocacy groups, and informational videos discussing elder abuse).

The training will be accessed by participants entering a username and password on the National Ageing Research Institute's online learning management system. The training will be self-paced and will take approximately 50-60 minutes in total to complete. Adherence to the training will be monitored via the online learning management system's reporting and analytics features.

The screening tool is designed to screen for elder abuse using a traffic light coded system due to the very sensitive nature of the topic. This strategy was employed to minimise the amount of sensitive questions that the patient is asked by the health provider. Therefore, the screening tool takes approximately 5 minutes to complete for patients that are in the green zone. For other patients, where their responses prompt further screening questions, the screening tool can take 10-15 minutes to complete.

The screening tool will be a hard copy or electronic questionnaire, based on whether the hospital site has a paper-based or electronic system for each patient file. Health providers will be trained on how to use the screening tool during the online training course. Health provider participants in the intervention arm will be asked to use the screening tool with each newly admitted eligible patient for the 9-month duration of the randomised control trial.

Adherence to the screening tool will be evaluated via qualitative data collected during a multi-method process evaluation. The process evaluation will be conducted approximately 3 months after implementation of the screening tool. A member of the research team will visit the intervention sites and observe how the screening tool works in practice, and interview the site champion and 2-3 health provider participants to gather qualitative information about use of the screening tool on the wards. Additionally, the site champion will collect quantitative data about how many times the screening tool has been administered during the 9-month trial period via an audit of patient records.

After the 9-month trial follow-up, health provider participants allocated to the intervention group will be asked to rate the acceptability of the intervention (i.e., online elder abuse training, AUSI screening tool, site champion) on a scale of 0-100 (with 0 being completely unacceptable to 100 being completely acceptable).

The site champion will recruit both health provider and older adult participants. The site champion will only screen and consent older adult participants, as health provider participants will complete an online screening form and be required to provide e-consent. The site champion will be involved in data collection, encouraging and providing support on uptake of the screening tool amongst health provider participants. The site champion will contribute to community of practice through regular meetings.
Intervention code [1] 325796 0
Behaviour
Comparator / control treatment
The control group will be sub-acute health providers who do not undertake the training course during the trial but will be given access to the training and screening tool after completion of the trial (i.e., when data collection for the 9-month follow-up of older adults is completed).
Control group
Active

Outcomes
Primary outcome [1] 334463 0
Change in sub-acute health providers recognition and response to elder abuse, as measured by scores on the adapted Knowledge and Management of Abuse Instrument (KAMA).

Timepoint [1] 334463 0
Baseline, 4 months (primary timepoint) and 9 months after baseline.
Primary outcome [2] 334464 0
Change in older people's sense of safety, as measured by Personal Safety domain score on the Adult Social Care Outcomes Toolkit (ASCOT).
Timepoint [2] 334464 0
Baseline, 4 months (primary timepoint) and 9 months after baseline.
Primary outcome [3] 334884 0
Change in older people's quality of life, as measured by the overall quality of life composite score on the Adult Social Care Outcomes Toolkit (ASCOT).
Timepoint [3] 334884 0
Baseline, 4 months (primary timepoint) and 9 months after baseline.
Secondary outcome [1] 420786 0
Change in sub-acute health providers recognition and response to elder abuse, as measured by scores on the Caregiver Scenario Questionnaire (CSQ).
Timepoint [1] 420786 0
Baseline, 4 months and 9 months after baseline.
Secondary outcome [2] 420787 0
Change in sub-acute health providers ageist attitudes, as measured by scores on the Carolina Opinions on Care of Older Adults (COCOA).
Timepoint [2] 420787 0
Baseline, 4 months and 9 months after baseline.
Secondary outcome [3] 420788 0
Change in older people's mental health status, as measured by scores on the 12-item Short-Form Health Survey (SF-12v2).
Timepoint [3] 420788 0
Baseline, 4 months and 9 months after baseline.
Secondary outcome [4] 420789 0
Change in total health and social care costs (combined) per patient to trial end based on patient-level data from the adapted Resource Utilisation index lite (a-RUD-lite)
Timepoint [4] 420789 0
Baseline, 4 months and 9 months after baseline.
Secondary outcome [5] 420790 0
A multi-method process evaluation of the multicomponent training intervention. A member of the research team will visit the intervention sites for a duration of 2-3 days to conduct the process evaluation. The researcher will collect qualitative data about the multicomponent training intervention by observing how the screening tool works in practice, and by interviewing the site champion and 2-3 health provider participants per site.
Timepoint [5] 420790 0
Approximately 3 months after implementation of the intervention.
Secondary outcome [6] 420791 0
Cost-analysis of the training intervention for improving the safety, quality of life and mental health of older people based on SF-12, ASCOT, and a-RUD-lite.
Timepoint [6] 420791 0
Baseline, 4 months and 9 months after baseline.
Secondary outcome [7] 420792 0
Sub-acute hospital sites' number of elder abuse cases detected via discussion with multidisciplinary team (prospective cases), review of electronic or paper-based medical records (prospective and retrospective cases)
Timepoint [7] 420792 0
9 months prior to the trial until baseline, baseline, 4 months and 9-months after baseline.
Secondary outcome [8] 422295 0
Sub-acute hospital sites' number of elder abuse cases referred via discussion with multidisciplinary team (prospective cases), review of electronic or paper-based medical records (prospective and retrospective cases).
Timepoint [8] 422295 0
9 months prior to the trial until baseline, baseline, 4 months and 9-months after baseline.
Secondary outcome [9] 422298 0
Sub-acute hospital sites' number of referral types (e.g. Social Work, Safety planning, etc.) via discussion with multidisciplinary team (prospective cases), review of electronic or paper-based medical records (prospective and retrospective cases).
Timepoint [9] 422298 0
9 months prior to the trial until baseline, baseline, 4 months and 9-months after baseline.
Secondary outcome [10] 422339 0
Sub-acute hospital sites' total cases for each specific type of abuse detected (e.g. financial abuse) via discussion with multidisciplinary team (prospective cases), review of electronic or paper-based medical records (prospective and retrospective cases)
Timepoint [10] 422339 0
9 months prior to the trial until baseline, baseline, 4 months and 9-months after baseline.

Eligibility
Key inclusion criteria
Sub-acute health providers: either medical, nursing, or allied health staff, work in sub-acute care, work directly with older people, come from one of our hospital site partners; their place of work (the site) must also be able to nominate a site coordinator to champion the intervention in the intervention arm as well as collect site data (both arms).

Older people: patients at the site, aged 65+ (or aged 50+ if Aboriginal or Torres Strait Islander), capable of consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Sub-acute health providers: who do not expect to be working at the site for at least 12 months post-baseline, and have participated in co-designing the training.

Older people: receiving palliative care, or lack decision-making capacity in any domain. Consent will not be sought by proxies (e.g. families, carers) as they might include perpetrators of abuse.

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)
The research team will not be aware of randomised allocation when determining if health provider participants are eligible for inclusion in the trial. Randomisation of hospital sites will occur following completion of health provider baseline.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation using minimisation, stratifying by state.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
It is not possible to conceal allocation from the sub-acute health provider participants either undertaking the training or being assigned to the wait list control, or the older participants recruited through a cluster intervention site or cluster control site. Hence, this will be a single-blinded trial, where allocation is concealed from the outcome assessor for the adapted KAMA (primary outcome) and the statistician conducting the analyses.

Recruitment and screening of older adults will occur following randomisation of the hospital sites, which occurs after the baseline for health providers. However, older adults' baseline occurs after randomisation. Therefore, when recruiting older adults allocation will not be concealed from the site champion.

This is a common issue in cluster RCTs where the intervention is on health providers but patient outcomes are being assessed. We will control for this in the analysis (e.g., through a difference-in-differences analysis or similar)
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
We calculated that 60 health providers would be sufficient to detect a medium effect (Cohen's d of 0.5) on the KAMA at a power of 80% and a significance level of 1%. We calculated that we need 10 clusters (5 intervention, 5 control) with 40 older people in each cluster to detect a medium effect at a power of 80% and a significance level of 5%. This assumes an ICC of 0.1 and uses the standard deviation of 0.2, as previously reported. Calculated using the Shiny Calculator for Sample Size for Cluster Randomised Trials. Assuming 53% refusal rate to participate/unable to consent as observed our prior work, the total sample size is 92 health providers and 612 older people (~60 older people/site).

The primary analysis will be performed according to intention to treat, including all clusters and participants in the allocated groups. Between group difference for both primary outcomes (health provider and older people) will be analysed using mixed effects regression models with a fixed effect for the intervention group and random effect for participants to account for repeated measures. Primary outcomes relevant to older people will also include cluster site as a random effect. We will similarly analyse secondary outcomes. Continuous outcomes will be analysed using mixed effects linear regression models and adjustment for baseline values. Statistics will be reported with their respective 95% confidence intervals and P values.

For the multi-method process evaluation thematic analysis will be conducted, using NVivo 12. Revisions to the Theory of Change will be iteratively discussed by the research team, and a final determination of the Theory of Change will be reached by team consensus.

A trial-based analysis to describe the additional costs (savings) and consequences arising from the intervention as compared to our usual care control condition, will be undertaken. The cost-effectiveness analysis will capture two types of costs 1) participant direct medical (primary and allied care, medications, acute and subacute admissions) and social care costs (paid and unpaid home care and transitions to residential care) estimated from an adapted a-RUD-lite, plus supplementary self-report at baseline, 4-months and 9-months follow-up; and 2) costs associated with implementing the intervention and control conditions estimated from administrative and fidelity data. We will relate cost per participant to patient-level measures of safety, quality of life and mental health. In line with the main analysis, the primary outcome for the economic evaluation will be social care quality adjusted life-years (QALYs) to final follow-up calculated based on ASCOT scores at baseline, 4-months and 9-months. The secondary outcome for the economic evaluation will be health QALYs to final follow-up calculated based on SF12v2-based SF6D scores at baseline, 4-months and 9-months. Following recent recommendations, results will be expressed as (i) cost per ASCOT-based social care QALY, and (ii) cost per SF6D-based health QALY. We will summarise sampling error and decision uncertainty using the bootstrap acceptability method to calculate confidence intervals and generate cost-effectiveness acceptability curves


Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
16/10/2023
Actual
7/02/2024
Date of last participant enrolment
Anticipated
29/11/2024
Actual
Date of last data collection
Anticipated
29/08/2025
Actual
Sample size
Target
709
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,WA,VIC
Recruitment hospital [1] 24517 0
St John of God Hospital, Mt Lawtley - Mt Lawley
Recruitment hospital [2] 24519 0
War Memorial Hospital - Waverley
Recruitment hospital [3] 24521 0
Sunshine Hospital - St Albans
Recruitment hospital [4] 24836 0
The Queen Elizabeth Hospital - Woodville
Recruitment hospital [5] 24837 0
Hampstead Rehabilitation Centre - Northfield
Recruitment hospital [6] 25694 0
Osborne Park Hospital - Stirling
Recruitment hospital [7] 25695 0
The Mornington Centre - Mornington
Recruitment hospital [8] 26363 0
Barwon Health - McKellar Centre campus - North Geelong
Recruitment hospital [9] 26364 0
Sacred Heart Health Service - Darlinghurst
Recruitment hospital [10] 26365 0
Bentley Health Service - Bentley
Recruitment postcode(s) [1] 40106 0
6050 - Mt Lawley
Recruitment postcode(s) [2] 40108 0
2024 - Waverley
Recruitment postcode(s) [3] 40110 0
3021 - St Albans
Recruitment postcode(s) [4] 40485 0
5011 - Woodville
Recruitment postcode(s) [5] 40486 0
5085 - Northfield
Recruitment postcode(s) [6] 41518 0
6021 - Stirling
Recruitment postcode(s) [7] 41519 0
3931 - Mornington
Recruitment postcode(s) [8] 42335 0
3215 - North Geelong
Recruitment postcode(s) [9] 42336 0
2010 - Darlinghurst
Recruitment postcode(s) [10] 42337 0
6102 - Bentley

Funding & Sponsors
Funding source category [1] 313561 0
Government body
Name [1] 313561 0
Department of Health and Aged Care, Medical Research Future Fund (MRFF) Dementia Ageing and Aged Care Mission
Country [1] 313561 0
Australia
Primary sponsor type
Other
Name
National Ageing Research Institute Ltd.
Address
PO Box 2127, Royal Melbourne Hospital VIC 3050
Country
Australia
Secondary sponsor category [1] 315589 0
None
Name [1] 315589 0
Address [1] 315589 0
Country [1] 315589 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312740 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 312740 0
Ethics committee country [1] 312740 0
Australia
Date submitted for ethics approval [1] 312740 0
09/03/2023
Approval date [1] 312740 0
17/08/2023
Ethics approval number [1] 312740 0

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

Contacts
Principal investigator
Name 125738 0
Prof Bianca Brijnath
Address 125738 0
National Ageing Research Institute
PO Box 2127
Royal Melbourne Hospital VIC 3050
Country 125738 0
Australia
Phone 125738 0
+613 8387 2294
Fax 125738 0
Email 125738 0
[email protected]
Contact person for public queries
Name 125739 0
Marina Cavuoto
Address 125739 0
National Ageing Research Institute
PO Box 2127
Royal Melbourne Hospital VIC 3050
Country 125739 0
Australia
Phone 125739 0
+613 8387 2314
Fax 125739 0
Email 125739 0
[email protected]
Contact person for scientific queries
Name 125740 0
Marina Cavuoto
Address 125740 0
National Ageing Research Institute
PO Box 2127
Royal Melbourne Hospital VIC 3050
Country 125740 0
Australia
Phone 125740 0
+613 8387 2314
Fax 125740 0
Email 125740 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


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.