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Trial registered on ANZCTR

Registration number

ACTRN12623000506695

Ethics application status

Approved

Date submitted

6/04/2023

Date registered

17/05/2023

Date last updated

20/05/2024

Date data sharing statement initially provided

17/05/2023

Type of registration

Prospectively registered

Titles & IDs

Public title

A Digitally Enabled, Pharmacist service to detecT medicine harms in residential aged care: the ADEPT project

Scientific title

A Digitally Enabled, Pharmacist service to detecT medicine harms in residential aged care: the ADEPT project

Secondary ID [1]

ARIIA (GO000039)

Universal Trial Number (UTN)

U1111-1290-7973

Trial acronym

ADEPT project

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Public Health

Condition category

Condition code

Public Health

Health service research

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

The project will be conducted in two phases over 12 months.

Phase one will involve extraction of data from digital technologies and integration of the TeleClinical Care platform (TCC) into existing aged care software systems. Phase two will involve a pre-post feasibility study conducted over 12-weeks. Thirty participants residing in residential aged care will be recruited. Baseline data will be collected including demographic details, comorbidities, medicine use, cognition, falls history, and care provided within the aged care facility. Digital technologies will be installed in consenting residents rooms and two weeks baseline data will be collected to serve as a reference point. Sleep data (e.g. total sleep time, sleep efficiency) will be extracted from sleep sensors and activity levels (e.g. sedentary time, light intensity physical activity) from an accelerometer. Data will be uploaded daily to the TCC dashboard where clinically significant changes are detected and the resident is triaged for appropriate action.

Number of adverse events will be collected monthly and current medication and medication changes will be collected over the 12-week study period. Outcome data will be collected from participants at 4-, 8-, and 12-weeks and the Edmonton Symptom Assessment Scale (ESAS) will be collected at 4-, 8-, and 12-weeks to validate the digital technologies.

If and when residents’ health declines beyond a certain threshold compared to baseline levels, the system will automatically flag residents that will alert the pharmacist to take appropriate action (e.g., continue monitoring, perform a review, or initiate multidisciplinary review).

The number and types of pharmacist intervention or recommendations following use of the TCC system will be assessed. The pharmacist will be asked to log their recommendations in a pharmacist log.

Intervention code [1]

Treatment: Devices

Intervention code [2]

Early detection / Screening

Intervention code [3]

Prevention

Comparator / control treatment

No control group.

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Number of pharmacist interventions provided (assessed through pharmacist log book).

Timepoint [1]

4-, 8- and 12-weeks post-baseline period completion.

Primary outcome [2]

Cost analysis of staff time spent during study implementation period (assessed through staff log books).

Timepoint [2]

4-, 8- and 12-weeks post-baseline period completion.

Secondary outcome [1]

Proportion of all pharmacists' recommendations to GPs and aged care staff that are implemented (assessed through pharmacist log book).

Timepoint [1]

4-, 8- and 12-weeks post-baseline period completion.

Secondary outcome [2]

Change in resident symptom score (Edmonton Symptom Assessment Score)

Timepoint [2]

Secondary outcome [3]

Change in resident symptom score (Edmonton Symptom Assessment Score)

Timepoint [3]

4-, 8- and 12-weeks post-baseline period completion.

Secondary outcome [4]

Change in sleep as measured using Emfit sleep sensor

Timepoint [4]

4-, 8- and 12-weeks post-baseline period completion.

Secondary outcome [5]

Change in sleep as measured using Emfit sleep sensor

Timepoint [5]

4-, 8- and 12-weeks post-baseline period completion.

Secondary outcome [6]

Change in physical activity as measured using Fibion SENS

Timepoint [6]

4-, 8- and 12-weeks post-baseline period completion.

Secondary outcome [7]

Change in physical activity as measured using Fibion SENS

Timepoint [7]

4-, 8- and 12-weeks post-baseline period completion.

Eligibility

Key inclusion criteria

Permanent residents living in Tanunda Lutheran Home will be invited to participate.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Key exclusion criteria include receiving palliative care, receiving respite care, or being involved in another research project. Participants will be withdrawn from the study if they receive palliative care after the beginning of the study.

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)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Who is / are masked / blinded?

Intervention assignment

Other design features

Phase

Not Applicable

Type of endpoint/s

Statistical methods / analysis

A mixed-methods process evaluation, applying the RE-AIM framework, will be used to assess the level of medicine harm detection and implementation of the service. Pre-post paired t-test or Wilcoxon tests will be utilised for continuous data and Chi-square tests for categorical variables. A cost-analysis will be undertaken to measure costs associated with the pharmacist service. The resource use associated with the development and implementation of the service, including staff (aged care and health professionals) time, equipment, and resources will be measured and valued using appropriate unit costs.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

1/07/2023

Actual

2/08/2023

Date of last participant enrolment

Anticipated

Actual

26/10/2023

Date of last data collection

Anticipated

30/11/2023

Actual

15/01/2024

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment postcode(s) [1]

5352 - Tanunda

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Aged Care Research & Industry Innovation Australia (ARIIA)

Address [1]

Level 2, Tonsley Hub, 1284 South Road, TONSLEY SA 5042

Country [1]

Australia

Primary sponsor type

Individual

Name

Dr Renly Lim

Address

Level 6, Playford Building, Frome Road, University of South Australia, Adelaide SA 5000

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Other collaborator category [1]

Individual

Name [1]

Dr Tahlia Meola

Address [1]

Level 6, Playford Building, Frome Road, University of South Australia, Adelaide SA 5000

Country [1]

Australia

Other collaborator category [2]

Individual

Name [2]

Dr Peter Brown

Address [2]

University of New South Wales Tyree Foundation Institute of Health Engineering, High St, Kensington NSW 2052

Country [2]

Australia

Other collaborator category [3]

Individual

Name [3]

Dr Dorothea Dumid

Address [3]

Level 7, Centenary Building, Frome Road, University of South Australia, Adelaide SA 5000

Country [3]

Australia

Other collaborator category [4]

Individual

Name [4]

Dr Rachel Milte

Address [4]

College of Nursing and Health Sciences, Flinders University, Sturt North Sturt Rd, Bedford Park SA 5042

Country [4]

Australia

Other collaborator category [5]

Individual

Name [5]

Dr Monique Boord

Address [5]

Level 6, Playford Building, Frome Road, University of South Australia, Adelaide SA 5000

Country [5]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of South Australia Human Research Ethics Committee

Ethics committee address [1]

University of South Australia, GPO Box 2471, Adelaide, South Australia 5001

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

22/11/2022

Approval date [1]

22/12/2022

Ethics approval number [1]

HREC205098

Summary

Brief summary

Medicine related harms are a national problem, contributing to 250,000 annual hospital admissions and increased health care costs. Medication harms are an even larger issue for residential aged care, with a report showing over 95% of residents experiencing one or more medicine related problems. The ADEPT project is a joint project between the University of South Australia, University of New South Wales, and Flinders University. Our aim is to develop and implement a digitally enabled, evidence-based, pharmacist service to actively detect medicine harms in residential aged care, and to determine the extent to which this model of care reduces medicine induced deterioration.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Renly Lim

Address

Level 6, Playford Building, Frome Road, University of South Australia, Adelaide SA 5000

Country

Australia

Phone

+61 883022307

Fax

[email protected]

Contact person for public queries

Name

Renly Lim

Address

Level 6, Playford Building, Frome Road, University of South Australia, Adelaide SA 5000

Country

Australia

Phone

+61 883022307

Fax

[email protected]

Contact person for scientific queries

Name

Renly Lim

Address

Level 6, Playford Building, Frome Road, University of South Australia, Adelaide SA 5000

Country

Australia

Phone

+61 883022307

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

Data are collected from a small group of aged care residents located at one facility in South Australia, and there is high risk of re-identification of individual participants.

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
18818	Study protocol				The ADEPT project will be made available when the ... [More Details]

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Dimensions AI	A Digitally Enabled, Pharmacist service to detecT medicine harms in residential aged care (nursing home) (ADEPT): protocol for a feasibility study	2024	https://doi.org/10.1136/bmjopen-2023-080148

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically