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A novel approach to partnering with family carers in the prevention of delirium.

A novel approach to partnering with family carers in the prevention of delirium: The Prevention & Early Delirium Identification Carer Toolkit (PREDICT)

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12625000705482
Acronym
PREDICT
Enrollment
5418
Registered
2025-07-03
Start date
2025-12-01
Completion date
2026-08-30
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Delirium is a sudden and serious change in thinking and awareness that can affect older people in hospital. Delirium is the most common hospital acquired complication in older adults, it is preventable and comes at a significant health and social care cost. Carers are key to recognising cognitive deterioration associated with delirium in their family members. The Prevention & Early Delirium Identification Carer Toolkit (PREDICT) model of care is designed to inform carers about delirium risk factors and preventive strategies and empower and assist them to be actively involved in the care of their family member. PREDICT was developed through an extensive scoping literature review and a pilot study that was codesigned and validated with carers using the eDelphi technique. The pilot demonstrated both the acceptability of PREDICT and its potential for impact on outcomes at a larger scale. This study evaluates the implementation of PREDICT. It provides carers with information, tools, and support so they can: • Understand delirium and how to prevent it, • Complete a simple 7-question checklist each day to detect early signs, • Access educational videos and printed resources, • Receive support during the hospital stay, and • Help plan for a safe and personalised discharge. We believe that involving carers in this way will improve care for older patients, reduce delirium, and support carer wellbeing. The study is being tested in four hospitals across NSW using a phased approach.

Interventions

Brief name: PREDICT model of care This study evaluates an evidence-based intervention, PREDICT (Prevention & Early Delirium Identification Carer Toolkit) (Aggar, et al.2023). PREDICT is a scalable, low risk model of care supporting partnerships with carers in the prevention of delirium for hospitalised older Australians. PREDICT offers a practical but transformative person-centred approach to delirium prevention and risk assessment, in addition to supporting carer wellbeing. It supports carer-he

Brief name: PREDICT model of care This study evaluates an evidence-based intervention, PREDICT (Prevention & Early Delirium Identification Carer Toolkit) (Aggar, et al.2023). PREDICT is a scalable, low risk model of care supporting partnerships with carers in the prevention of delirium for hospitalised older Australians. PREDICT offers a practical but transformative person-centred approach to delirium prevention and risk assessment, in addition to supporting carer wellbeing. It supports carer-healthcare staff partnerships by integrating carers into the care team at admission and ensuring carers: (i) are acquainted with PREDICT and encouraged to engage with its resource during the patient’s hospital stay; (ii) complete a 7-item psychometrically tested screening tool (Shulman, et al. 2016) designed for non-healthcare professionals to identify people at risk of delirium and implement delirium prevention strategies; (iii) access the comprehensive multimedia delirium education package to build awareness and skill development (visually representing a diversity of backgrounds and relational dynamics, inclusive of same-sex partnerships); (iv) access support resources (e.g., counselling, social prescriptions, peer-support) to sustain carer wellbeing; and (v) participate actively in co-designing a patient-specific discharge plan. The intervention involves access to PREDICT (Prevention & Early Delirium Identification Carer Toolkit) website/app and pre intervention education for healthcare staff. PREDICT is designed to engage and support carers in the identification and management of delirium. PREDICT includes an education resource in hard copy or online, application (app) and/or website, detailing preventive strategies, risk factors, and non-pharmacological interventions for older adults who experience delirium, and a screening tool designed to support carers identify delirium symptoms and patients at risk of delirium. PREDICT also provides resources to support carers experiencing caregiving burden and carer psychological distress. PREDICT has been codesigned and validated with academic, clinician, and consumer expertise. It has also been assessed for suitability for delivery to carers from non-English speaking backgrounds and LGBTQ+ carers. Healthcare staff education Education sessions will be provided to healthcare staff in participating wards during regular in-service education. These sessions will be provided at regular scheduled times and locations for in-service at each site. All healthcare staff who usually attend these in-service sessions will be eligible, including RNs, ENs, and allied healthcare staff. Staff do not need to agree to participate in the evaluation to receive education and access the PREDICT. Healthcare staff will attend PREDICT education for 60 minutes (30 minutes face to face and 30 mins online). These education sessions will occur during the control phase for each cluster, as close as possible to the intervention phase. This is necessary to ensure that healthcare staff education can be completed in time for implementation, while restricting risks of contamination of the control phase. The face-to-face education sessions will be held daily in the 2–3-week period leading up to implementation start date. Following the completion of Module 1 , Module 2 , (The Podcast), will be emailed to the participants as a second part of the education for them to complete prior to the implementation start date. Module 1 Education will be face to face and will include the revision of delirium, an introduction to PREDICT and model of care, information about the study and the healthcare workers role in supporting PREDICT. The educational resources used in this study are a combination of peer reviewed resource readily available and have not been newly developed. The materials are based on the following established sources: Australian Delirium Clinical Care Standard (2021)Published by the Australian Commission on Safety and Quality in Health Care, this standard provides evidence-based guidance for the prevention, recognition, and management of delirium across healthcare settings. Source: https://www.safetyandquality.gov.au/standards/clinical-care-standards/delirium-clinical-care-standard. Module 2 Education The Podcast we will review four peer-reviewed articles that explore key aspects of delirium care from the perspectives of nurses, carers, a case study, and the use of the 4AT delirium screening tool. These articles are sourced from reputable academic journals and databases. • Marcantonio, E. R. (2012). Postoperative Delirium: A 76-Year-Old Woman With Delirium Following Surgery. JAMA?: The Journal of the American Medical Association, 308(1), 73–81. https://doi.org/10.1001/jama.2012.6857 • Assa, A. H., Wicks, M. N., & Umberger, R. A. (2021). Family Caregivers' Experience of Patients With Delirium in Critical Care Units: A State-of-the-Science Integrative Review. American journal of critical care : an official publication, American Association of Critical-Care Nurses, 30(6), 471–478. https://doi.org/10.4037/ajcc2021394 • Penfold, R. S., Farrow, L., Hall, A. J., Clement, N. D., Ward, K., Donaldson, L., Johansen, A., Duckworth, A. D., Anand, A., Hall, D. E., Guthrie, B., & MacLullich, A. M. J. (2025). Delirium on presentation with a hip fracture is associated with adverse outcomes : a multicentre observational study of 18,040 patients using national clinical registry data. The bone & joint journal, 107-B(4), 470–478. https://doi.org/10.1302/0301-620X.107B4.BJJ-2024-1164.R1 • Fox, A., Johnston, S., Wyles, K., Patterson, S., Bail, K., Hutt, L., Keogh, S. and Beattie, E. (2025), Perceptions and Practices of Clinicians Undertaking Invasive Procedures With Patients Experiencing Delirium in Hospital: A Sequential Mixed Methods Study. Nurs Health Sci., 27: e70154. https://doi.org/10.1111/nhs.70154 • Australian Commission on Safety and Quality in Health Care. (2021). Delirium clinical care standard. https://www.safetyandquality.gov.au/publications-and-resources/resource-library/delirium-clinical-care-standard-2021 Successful implementation of healthcare staff education will be defined as achievement of 80% of eligible healthcare staff in participating wards completing the education modules; this is the benchmark used in auditing. The CNC/Es providing the education will track attendance and completion. Education sessions will be delivered at each site by the Clinical Nurse Consultants or Clinical Nurse Educators (CNC/Es). Clinical Nurse Consultants (CNCs) are Registered Nurses with a minimum level of post-registration experience and approved post-registration qualifications and are senior members of nursing staff. Clinical Nurse Educators (CNEs) are Registered Nurses who hold relevant clinical or education post registration qualifications or appropriate experience, with their primary role being to deliver and evaluate clinical education programs at the ward/unit level. CNC/Es will be trained prior to delivering these sessions by the Implementation Site Lead (ISL) for the relevant health district. The ISL will be a Registered Nurse at Clinical Nurse Consultant or Clinical Nurse Specialist level of qualifications and experience, employed at 1.0 FTE. This train-the-trainer approach will help to ensure standardised education across sites, while allowing ongoing support for healthcare staff throughout the intervention. Healthcare staff will be provided with access to PREDICT at this initial information session. Access to PREDICT is via QR code or direct weblink, provided to healthcare staff at the first education session. The PREDICT website is protected by a password to prevent it being accessed by sites during the control period; healthcare staff will be provided with the password at the first education session. Although there is a small possibility of individual healthcare staff being exposed to the intervention or related information through cross-institutional employment or involvement in communities of practice, this will be controlled using cluster randomisation at the district, rather than hospital, level. Therefore, the likelihood of contamination of the control phase in this way is considered very small and its likely impact on results negligible. During the intervention period, healthcare staff will have ongoing weekly support relating to PREDICT through their regular in-service education and stand-up meetings at commencement of shifts. They will also be encouraged to discuss any questions and concerns with the CNC/E at their site. This regular communication will ensure that the healthcare staff are equipped to answer questions the carer may have regarding PREDICT, including the delirium screening tool and the study questionnaire. Carer engagement and access to PREDICT a) Total Duration of the Intervention for Carers: Carers will have access to the PREDICT online platform for a total duration of 6 month intervention. b) Frequency of the Intervention: There is no fixed frequency for the intervention. Carers will be introduced to the platform during admission and orientation, after which they may freely access the website at any time based on their individual needs and preferences. c) Summary of the Content of the Training/Modules for Carers:Carers will not receive formal training. Instead, they will be oriented to the online platform, which contains educational materials designed to support their understanding of delirium care prevention and management. Carers will be provided with access to PREDICT as part of the admissions process, within 24 hours of arrival, by the healthcare staff completing admission. Healthcare staff will log dissemination of PREDICT to eligible carers using the project register. As with healthcare staff, carers will be able to access PREDICT and project materials in hard copy but will be encouraged to access materials and complete the trial measures online. The online version of PREDICT will be accessed using a QR code or direct weblink, provided to carers on admission. The PREDICT website is protected by a password to prevent it being accessed by sites during their control period; carers will be provided with the password on admission. Carers do not need to agree to participate in the evaluation to receive access to or use PREDICT. While carers may have some exposure to PREDICT prior to completing the baseline measures, through access to the hard copy or online materials, this will be negligible compared with the intensive exposure expected during the admission event. Whilst the patient is in hospital, carers will be encouraged daily or as necessary (by healthcare staff) to complete the delirium screening tool (Shulman et al., 2016). The delirium screening tool is a 7-item psychometrically tested tool (Shulman et al., 2016) suitable to be completed by informal or untrained carer observation for delirium in older adults, including those with dementia. The delirium screening tool addresses features of delirium, including altered awareness and attention, fluctuation of mood, disordered thinking and behaviour, impaired eating or drinking, and difficulties with mobility (Shulman et al., 2016). A maximum score of 18, with a cut-off score of 4 or greater indicates delirium. Carers will be asked to advise healthcare staff on the unit if a score of 4 or more is obtained, or if they are concerned about their loved one. Face to face adherence reminders will be provided to healthcare staff in weekly in-service education sessions and stand-up meetings (known to most healthcare staff as “huddles”) by the CNC/Es. Healthcare staff will have the regular and ongoing opportunity to ask questions and seek clarifications around the intervention and the study and key messages from the education sessions will be reviewed as needed. Healthcare staff education will be provided during usual Continuing Professional Development/ healthcare staff education times and in the usual manner/s to minimise additional load. Provision of PREDICT will be integrated into usual procedures, with ward champions supporting dissemination of PREDICT and logging in the project register. An experienced nurse will be employed at each site (health district/ cluster) to liaise, audit, monitor, provide feedback, ensure clinical research credibility, and enforce the intervention for 2 months pre, 6 months during and 4 months post intervention. This level of support will help to ensure high levels of uptake of the intervention and embedding in routine clinical care. The embedded process evaluation uses the Re-AIM framework and includes outcome measures relating to adherence. This includes carer referral to PREDICT by the healthcare staff completing admission and staff and carers accessing the Toolkit. A stepped wedge cluster randomised controlled trial, consisting of a cohort study and healthcare service evaluation, complemented by an integrated process evaluation. The study is to take place in four Australian Healthcare Services across New South Wales, Queensland, and the Australian Capital Territory and involve a range of acute wards (n=34) across 8 hospitals. Participating wards will be nominated by the hospitals. These can include any wards providing acute or subacute inpatient care to adults, including general medical and surgical wards, but excluding Emergency Departments (ED) and Intensive Care Units (ICU). These wards are excluded from the main component of this study because the intensity and pace of these environments requires adaptations to implementation that are not feasible within the scope of this study. Carers for older adults and healthcare staff providing direct care to older adults in participating hospital wards will be recruited. Older adults receiving care in hospital will not be individual participants receiving the intervention; however, health service outcomes will be measured using patient data from standard medical records. Randomisation will be at the level of the health district. The SW-cRCT design involves a sequential rollover of the intervention at four health district clusters that begin in the control condition (baseline data collection) and sequentially receive the intervention at 1-month intervals. Each cluster will experience a 6-month control, a 6-month active intervention, and 2-month post-intervention follow-up period. The four health district clusters will be randomised to one of the four dates to cross-over from control phase to implementation phase until all healthcare services have been exposed to the intervention. This SW-cRCT will be implemented in all participating healthcare services within 18 months. References Aggar, C., Craswell, A., Bail, K., Compton, R., Hughes, M., Sorwar, G., Baker, J., Shinners, L., & Greenhill, J. (2023). Partnering with carers in the management of delirium in general acute care settings: An integrative review. Australas J Ageing, 42(4), 638-648. https://doi.org/10.1111/ajag.13229 Shulman RW, Kalra S, Jiang JZ. Validation of the Sour Seven Questionnaire for screening delirium in hospitalized seniors by informal caregivers and untrained nurses (2016); BMC Geriatrics. 16(43):44-.

Sponsors

Southern Cross University
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Prevention
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

Participating wards Nominated by the hospitals. These can include any wards providing acute or subacute inpatient care to adults, including general medical and surgical wards. Carers: included if they • Are aged 18 years or older • Are providing care or support for someone 65 years or over, or 45 years and over for an Aboriginal or Torres Strait Islander person, who is receiving care in hospital • Can report on and identify changes in the patient’s mental and physical abilities and • Can maintain regular contact (in-person, virtually, or by telephone) with the patient during hospitalisation. Nominated carers may include any key personal contact such as partners, family members, friends and neighbours who are nominated as “Next of Kin” or listed/ nominated contact at admission. This approach ensures that while patient-carer dyads are not recruited, the carers involved have been nominated by or with the knowledge of the patients concerned. Carers of patients admitted with delirium (i.e. having developed delirium prior to admission) will be eligible to participate, as the Toolkit supports early management strategies and future prevention as well as identification. Carers involved in other trials, or carers of patients involved in other trials, will be eligible to participate if the other trial/s in which they are involved do not have delirium as a major focus. Plans at discharge (i.e. discharge to home, RACF, etc) do not affect eligibility. Healthcare staff: included if they are routinely involved in patient care on participating wards, such as physiotherapists, nurses and medical officers. Hospital staff who are not routinely involved in direct patient care will be excluded from the study.

Exclusion criteria

Carer: will not be eligible to participate if • the older adult they support is receiving end-of-life care • they, or the patient they are supporting, are involved in another trial which has delirium as a major focus. Healthcare staff: will be included if they are routinely involved in patient care on participating wards, such as nurses, care workers, allied health and medical officers. Hospital staff who are not routinely involved in direct patient care will be excluded from the study. Wards: excluding Emergency Departments (ED) and Intensive Care Units (ICU). These wards are excluded from the main component of this study because the intensity and pace of these environments requires unique adaptations to implementation that are not feasible within the scope of this study.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026