Design and theory
This is a pragmatic, cluster RCT. The intervention is guided by the Theory of Change [23], which seeks to create a safe and inclusive relationship between health providers and older people (see Figure 1).
Participants and setting
Sites
Subacute hospitals providing inpatient care in New South Wales; South Australia; Victoria; and Western Australia.
Health providers
We aim to recruit inpatient subacute clinical staff providing direct care to older people, including medical, nursing, or allied health. We will exclude staff who do not expect to be working at the site for at least 12 months post-baseline.
Older people
We will include all inpatients at participating sites, aged 65+ (or aged 50+ if Aboriginal or Torres Strait Islander), who are willing to participate and individually capable of providing informed consent.
Exclusion criteria for older people are: i) receiving palliative care, ii) lack of decision-making capacity.
Intervention
This intervention comprises 3 components:
- Training: Health provider participants will be asked to complete training via an online Learning Management System (Acorn) hosted by the National Ageing Research Institute (NARI). The training takes ~60 minutes to complete, is self-paced, and participants will have access to it over a two-month period. It has four modules on: knowledge of abuse; drivers of abuse; screening for abuse (including how to administer the Australian Elder Abuse Screening Instrument [AUSI]) [24]; and management of elder abuse (further details available through the online trial registry anzctr.org.au, registration #ACTRN12623000676617p). This training was co-designed through workshops, interviews and user-testing with health providers, family carers, older people, and elder abuse survivors. Site champions will promote completion of the training, with the aim of at least 60% of eligible health providers on participating wards completing the training over a 2-month period.
- Screening tool: Intervention sites will be provided with the AUSI screening tool, which has content validity [24]; and has been demonstrated to increase staff confidence in screening for abuse, and the proportion of cases of suspected abuse that provoked multidisciplinary responses [25]. Following the training, health providers will be asked to screen all patients for elder abuse, and to manage detected cases as per usual practice, including referrals to outside agencies, but with support from the site champion where required.
- Site champion: Each site will recruit an on-site clinician (senior social worker or other staff with commensurate experience) as a site champion, who will support other hospital staff in screening and managing elder abuse. They will be trained by the research team and work one day per week supporting the intervention. Site champions will encourage uptake of the training and the AUSI, and regularly contact staff to assess concerns and/or challenges encountered with screening. Site champions will be contacted every 2–3 weeks via email/phone by the research team to proactively support them and build a national peer-support network [26].
Control
The control arm will be waitlisted and given access to the training after nine months. Control arm sites will also recruit site champions, who will be trained and support in data collection. They will encourage completion of the outcome measures for health providers, recruit older people and collect data, and collect deidentified site data but will not provide further input beyond their normal clinical role.
Outcome assessments
All health provider participants will complete baseline assessment prior to site randomisation. Outcomes will be assessed at baseline (t0), 4 months follow-up (t1), and 9 months follow-up (t2).
Sites
Site champions will obtain summary statistics routinely collected by hospitals such as general site characteristics (size of workplace, location, subacute services offered), characteristics of patients admitted to participating wards (age, gender, country of birth, English proficiency; reason for subacute stay). They will also ascertain the number of eligible health providers to enable the calculation of the percentage who complete the training. Elder abuse detection and referral data will be collected from the 9 months preceding the trial to the end of the trial (i.e., at completion of 9-month outcomes). Specifically, site champions will screen medical records of all inpatients on participating wards during that time to ascertain i) number of records screened, ii) number of cases that identified elder abuse and the types, iii) referrals made to social work, iv) the frequency of interventions and referrals (e.g., legal referral, safety planning) using a standardised template that will be provided. In the intervention arm, the number of times the AUSI screening tool is administered and not administered will also be collected, however, the responses on the AUSI will not be collected.
Health providers
Health providers will complete a demographic survey (age, gender, profession, years of experience in profession, and whether they have completed elder abuse training prior to the trial). They will also complete the adapted Knowledge and Management of Abuse (KAMA) [27] (primary outcome) adapted for an Australian subacute care setting, the Australian adaptation of the Caregiver Scenario Questionnaire (CSQ) [28, 29], and Carolina Opinions on
Care of Older Adults (COCOA) survey [30] (secondary outcomes) via online survey in REDCap.
Older people
Older people will complete a demographic survey (age, gender, education, postcode, country of birth, language/s spoken, English language skills, First Nations status, reason for admission and underlying health risk factors for elder abuse (e.g., dementia, mobility)), the Adult Social Care Outcomes Toolkit (ASCOT)[31] (primary outcome), the Short Form Survey-12 (SF-12v2)[32], and an adapted Resource Utilisation in Dementia lite (a-RUD-lite) (secondary outcomes) via online/paper/telephone survey. Site champions will support older people where required, and record the older person’s length of admission once discharged.
Process evaluation
We will conduct a multi-method process evaluation on how the intervention works in practice. Training completion rates will be monitored using the NARI Learning Management System. In addition to monitoring uptake of the screening tool, a researcher will visit each intervention site for 2-3 days approximately 3 months after implementation of the screening tool. We will observe how the screening and referrals are conducted, interview site champions, and 20-25 health providers across the sites. This evaluation will mobilise WHO guidance for scaling up health service innovations [33] as we seek to understand: intervention uptake, potential facilitators/barriers and solutions; whether the essential features of the intervention are being adhered to in practice (and if not, what remedial action can or should be taken); and whether the intervention improved elder abuse detection and response, impacted practice, and provider satisfaction.
Table 1. Trial Registration Data Set
Data category
|
Information
|
Primary registry and trial identifying number
|
ANZCTR
ACTRN12623000676617
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Date of registration in primary registry
|
22 June 2023
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Secondary identifying numbers
|
MRFF Application ID: 2015995
|
Source(s) of monetary or material support
|
Department of Health and Aged Care, Medical Research Future Fund (MRFF) Dementia Ageing and Aged Care Mission
|
Primary sponsor
|
Department of Health and Aged Care, Medical Research Future Fund (MRFF) Dementia Ageing and Aged Care Mission
Email: [email protected].
Mail:
Department of Health and Aged Care
GPO Box 9848
Canberra ACT 2601
Australia
|
Secondary sponsor(s)
|
None
|
Contact for public queries
|
BB [email protected]
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Contact for scientific queries
|
BB [email protected]
|
Public title
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No More Shame: Investigating the effect of changing health providers recognition and response to elder abuse on associated stigma
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Scientific title
|
No More Shame: Investigating the effect of changing health providers recognition and response to elder abuse on associated stigma
|
Countries of recruitment
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Australia
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Health condition(s) or problem(s) studied
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Elder abuse, Public Health, Health promotion/education
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Intervention(s)
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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.
|
Key inclusion and exclusion criteria
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Ages eligible for study: ≥18 years
Sexes eligible for study: Both
Accepts healthy volunteers: No
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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.
|
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.
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Study type
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Interventional
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Allocation: Randomised controlled trial. Randomisation using minimisation, stratifying by state.
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Primary purpose: Educational / counselling / training
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Phase not applicable
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Date of first enrolment
|
n/a
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Target sample size
|
709
|
Recruitment status
|
Not yet recruiting
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Primary outcome(s)
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Primary outcome [1] 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] Baseline, 4 months (primary timepoint) and 9 months after baseline.
Primary outcome [2] 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] Baseline, 4 months (primary timepoint) and 9 months after baseline.
Primary outcome [3] 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] Baseline, 4 months (primary timepoint) and 9 months after baseline.
|
Key secondary outcomes
|
Secondary outcome [1] Change in sub-acute health providers recognition and response to elder abuse, as measured by scores on the Caregiver Scenario Questionnaire (CSQ).
Timepoint [1] Baseline, 4 months and 9 months after baseline.
Secondary outcome [2] Change in sub-acute health providers ageist attitudes, as measured by scores on the Carolina Opinions on Care of Older Adults (COCOA). Timepoint [2] Baseline, 4 months and 9 months after baseline.
Secondary outcome [3] Change in older people's mental health status, as measured by scores on the 12-item Short-Form Health Survey (SF-12v2). Timepoint [3] Baseline, 4 months and 9 months after baseline.
Secondary outcome [4] 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] Baseline, 4 months and 9 months after baseline.
Secondary outcome [5] 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] Approximately 3 months after implementation of the intervention.
Secondary outcome [6] 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] Baseline, 4 months and 9 months after baseline.
Secondary outcome [7] 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] 9 months prior to the trial until baseline, baseline, 4 months and 9-months after baseline.
Secondary outcome [8] 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] 9 months prior to the trial until baseline, baseline, 4 months and 9-months after baseline.
Secondary outcome [9] 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] 9 months prior to the trial until baseline, baseline, 4 months and 9-months after baseline.
Secondary outcome [10] 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] 9 months prior to the trial until baseline, baseline, 4 months and 9-months after baseline.
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Table 2. Procedure timeline
Procedures
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Assessment/Procedure
|
Screening
|
Baseline
|
4-month Follow-up
|
9-month Follow-up
|
Health Providers
|
|
|
|
|
Informed Consent
|
x
|
|
|
|
Demographic Information
|
|
x
|
|
|
a-KAMA questionnaire
|
|
x
|
x
|
x
|
COCOA questionnaire
|
|
x
|
x
|
x
|
Older Adults
|
|
|
|
|
Informed Consent
|
x
|
|
|
|
Demographic Information
|
|
x
|
|
|
ASCOT questionnaire
|
|
x
|
x
|
x
|
SF-12v2 questionnaire
|
|
x
|
x
|
x
|
a-RUD-lite questionnaire
|
|
x
|
x
|
x
|
Has patient attended another hospital in trial during study period
|
|
x
|
x
|
x
|
Administrative/Site Data
|
9-months prior to Baseline
|
Baseline
|
Baseline to 4-months
|
4-months to 9-months
|
Elder abuse cases
|
x
|
x
|
x
|
x
|
Elder abuse referrals
|
x
|
x
|
x
|
x
|
Nature of referral
|
x
|
x
|
x
|
x
|
|
Number of eligible clinicians (total and by profession)
|
|
x
|
x
|
|
|
Number of clinicians who have completed the training (total and by profession)
|
|
x
|
x
|
|
|
Number of times the screening tool was administered / not administered
|
|
x
|
x
|
x
|
Sample size
As health providers are not anticipated to be systemically different based on location (clusters), we have not accounted for ICC for health providers; therefore, 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%. This difference is similar to that reported by our previous research, and the sample size calculation uses a standard deviation of 4.8 as previously reported [34]. We calculated that we need 10 clusters (5 intervention, 5 control) with 40 older people in each cluster to detect a medium effect on the ASCOT at a power of 80% and a significance level of 5%. As responses to elder abuse vary across jurisdictions, an ICC of 0.1 is assumed for older people with the standard deviation of 0.2 reported by others [35], calculated using the Shiny Calculator for Sample size for Cluster Randomised Trials[36]. Assuming 53% refusal rate to participate/unable to consent as observed in our group’s prior work in the UK [37, 38] the total sample size is 92 health providers and 612 older people (~60 older people/site).
Recruitment
Site champions will recruit health providers and older people in intervention and control arms. They will promote the study to subacute staff, during staff meetings, through posters and emails targeting relevant staff. A QR code will link to further information about the study. For the 4- and 9-month follow-up, site champions will remind staff up to 3 times verbally or by email.
Site champions will prospectively recruit all older patients who meet eligibility criteria, as identified through staff meetings, medical files, and discussion with patients. They will provide each eligible participant with an invitation letter and PICF. Older people can choose to complete paper-based surveys with a reply-paid envelope provided; or a text-message or email link with the necessary information, as we have successfully used in prior research [39]. Older people will be recruited once the health providers in the intervention arm have completed the training and use of the screening tool has been implemented at the site, therefore, the baseline, 4-month, and 9-month time points for older people will be slightly later.
Based on stakeholder consensus, we aim for 60% of eligible staff to complete the training prior to commencing the implementation of the screening tool to maximise patient exposure. It is possible that an older adult participant in the intervention arm will receive clinical care from someone who has not completed the training. Thus, we will also capture the “dose” for each site as a percentage of eligible staff who have completed the training.
Group allocation
Stratified randomisation will allocate clusters (subacute sites) to either intervention or wait-list control using a minimisation procedure. State (VIC, NSW, SA, WA) is a stratification factor. This is a single-blinded study where the statistician and outcome assessors will be blinded to allocation. It is not possible to blind participants to group allocation when collecting the post-intervention scores. During the assessment period, we will ask health provider participants not to discuss the study outside their site.
Data collection and management
For health providers, outcome questionnaires will take approximately 30-40 minutes to complete through the NARI-hosted REDCap database. For older people, questionnaires will take approximately 40 minutes. Outcomes will be entered into an electronic database by the research team and stored on a secure server. Participants will not be identifiable from any data that is published or otherwise publicly released.
Promoting retention and follow-up
Intervention and control sites will receive a gift hamper at each timepoint to encourage survey completion. Survey reminder notices will be posted at all sites’ staffrooms with a QR code for survey completion; at each of the three assessment points those completing the survey will enter a draw for a $250 gift card. A poster benchmarking the site’s progress in survey completion against other sites (de-identified) and study promotion materials will also be placed in staff lunchrooms.
Analysis
Primary and secondary RCT outcomes
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. Cluster site will also be added as a random effect. Due to the likelihood of differences across sites, a number of baseline covariates will be controlled for in the analyses (as listed in Table 3).
Table 3. List of covariates to be used in analysis and source.
|
Health Provider Outcomes
|
Older Adult Outcomes
|
Self-reported
|
profession, age, gender, years in the role
|
age, sex, ethnicity, location, educational and economic attainments, country of birth, English proficiency, reason for subacute stay, and admission to any other hospital in the trial
|
Reported by Site Champion based on data routinely collected by hospitals, or case records
|
general characteristics of the site (size of workplace, location, subacute services offered), average characteristics of older patient cohorts admitted to the participating wards (age, gender, country of birth, English proficiency; reason for subacute stay), and elder abuse cases (number of suspected elder abuse cases p/month, number, and sources of referral) to enable the evaluation and statistical control of differences between sites
|
length of hospital admission, length of admission on participating ward; number of eligible clinicians (total and by profession), and number of clinicians who have completed the training (total and by profession) to provide a measure of “dose”
|
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. Per protocol analyses will also be performed, omitting participants with predefined protocol deviations (e.g., allocated intervention not received, violated inclusion/exclusion criteria). The trial results will be reported in line with the CONSORT extension for cluster trials.
Fidelity and acceptability
Fidelity/adherence data will be derived from training completion rates and the process evaluation. Acceptability of the intervention is pre-specified as >70% of health provider participants rating the intervention ‘completely acceptable’ at 9 months [40].
Process analysis
Qualitative data collected during the process analysis interviews and observations will be thematically analysed using an inductive and reflexive coding approach to iteratively revise and define semantic themes [41] and managed through NVivo. 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.
Economic analysis
We will undertake a trial-based analysis to describe the additional costs (savings) and consequences arising from our intervention as compared to our usual care control condition. 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 RUD-lite [42] plus supplementary self-report at baseline, 4 months and 9 months; 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 [31, 43] 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 [44] at baseline, 4-month and 9-month data. Following recent recommendations [45], 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 [46].
Oversight and monitoring
A 6 monthly project Stakeholder Advisory Group will provide oversight and advice of the project. This will include those with lived experience of elder abuse, older people, family carers, and clinicians, service providers, educators, and advocacy groups experienced in elder abuse responses.
This project has been ethically reviewed and approved by Austin Health Human Research through the National Mutual Acceptance Scheme with governance approval to be provided by each hospital site.