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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] 309401 0
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 329634 0
Condition category
Condition code
Public Health 326557 326557 0 0
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] 325836 0
Treatment: Devices
Intervention code [2] 326072 0
Early detection / Screening
Intervention code [3] 326073 0
Prevention
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 334398 0
Number of pharmacist interventions provided (assessed through pharmacist log book).
Timepoint [1] 334398 0
4-, 8- and 12-weeks post-baseline period completion.
Primary outcome [2] 334399 0
Cost analysis of staff time spent during study implementation period (assessed through staff log books).
Timepoint [2] 334399 0
4-, 8- and 12-weeks post-baseline period completion.
Secondary outcome [1] 420515 0
Proportion of all pharmacists' recommendations to GPs and aged care staff that are implemented (assessed through pharmacist log book).
Timepoint [1] 420515 0
4-, 8- and 12-weeks post-baseline period completion.
Secondary outcome [2] 435297 0
Change in resident symptom score (Edmonton Symptom Assessment Score)
Timepoint [2] 435297 0
Secondary outcome [3] 435298 0
Change in resident symptom score (Edmonton Symptom Assessment Score)
Timepoint [3] 435298 0
4-, 8- and 12-weeks post-baseline period completion.
Secondary outcome [4] 435299 0
Change in sleep as measured using Emfit sleep sensor
Timepoint [4] 435299 0
4-, 8- and 12-weeks post-baseline period completion.
Secondary outcome [5] 435300 0
Change in sleep as measured using Emfit sleep sensor
Timepoint [5] 435300 0
4-, 8- and 12-weeks post-baseline period completion.
Secondary outcome [6] 435301 0
Change in physical activity as measured using Fibion SENS
Timepoint [6] 435301 0
4-, 8- and 12-weeks post-baseline period completion.
Secondary outcome [7] 435302 0
Change in physical activity as measured using Fibion SENS
Timepoint [7] 435302 0
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?
No
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
30
Accrual to date
Final
29
Recruitment in Australia
Recruitment state(s)
SA
Recruitment postcode(s) [1] 40078 0
5352 - Tanunda

Funding & Sponsors
Funding source category [1] 313595 0
Commercial sector/Industry
Name [1] 313595 0
Aged Care Research & Industry Innovation Australia (ARIIA)
Country [1] 313595 0
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] 315381 0
None
Name [1] 315381 0
Address [1] 315381 0
Country [1] 315381 0
Other collaborator category [1] 282619 0
Individual
Name [1] 282619 0
Dr Tahlia Meola
Address [1] 282619 0
Level 6, Playford Building, Frome Road, University of South Australia, Adelaide SA 5000
Country [1] 282619 0
Australia
Other collaborator category [2] 282620 0
Individual
Name [2] 282620 0
Dr Peter Brown
Address [2] 282620 0
University of New South Wales Tyree Foundation Institute of Health Engineering, High St, Kensington NSW 2052
Country [2] 282620 0
Australia
Other collaborator category [3] 282621 0
Individual
Name [3] 282621 0
Dr Dorothea Dumid
Address [3] 282621 0
Level 7, Centenary Building, Frome Road, University of South Australia, Adelaide SA 5000
Country [3] 282621 0
Australia
Other collaborator category [4] 282622 0
Individual
Name [4] 282622 0
Dr Rachel Milte
Address [4] 282622 0
College of Nursing and Health Sciences, Flinders University, Sturt North Sturt Rd, Bedford Park SA 5042
Country [4] 282622 0
Australia
Other collaborator category [5] 282623 0
Individual
Name [5] 282623 0
Dr Monique Boord
Address [5] 282623 0
Level 6, Playford Building, Frome Road, University of South Australia, Adelaide SA 5000
Country [5] 282623 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312772 0
University of South Australia Human Research Ethics Committee
Ethics committee address [1] 312772 0
Ethics committee country [1] 312772 0
Australia
Date submitted for ethics approval [1] 312772 0
22/11/2022
Approval date [1] 312772 0
22/12/2022
Ethics approval number [1] 312772 0
HREC205098

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

Contacts
Principal investigator
Name 125858 0
Dr Renly Lim
Address 125858 0
Level 6, Playford Building, Frome Road, University of South Australia, Adelaide SA 5000
Country 125858 0
Australia
Phone 125858 0
+61 883022307
Fax 125858 0
Email 125858 0
[email protected]
Contact person for public queries
Name 125859 0
Renly Lim
Address 125859 0
Level 6, Playford Building, Frome Road, University of South Australia, Adelaide SA 5000
Country 125859 0
Australia
Phone 125859 0
+61 883022307
Fax 125859 0
Email 125859 0
[email protected]
Contact person for scientific queries
Name 125860 0
Renly Lim
Address 125860 0
Level 6, Playford Building, Frome Road, University of South Australia, Adelaide SA 5000
Country 125860 0
Australia
Phone 125860 0
+61 883022307
Fax 125860 0
Email 125860 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
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.TypeCitationLinkEmailOther DetailsAttachment
18818Study 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
SourceTitleYear of PublicationDOI
Dimensions AIA Digitally Enabled, Pharmacist service to detecT medicine harms in residential aged care (nursing home) (ADEPT): protocol for a feasibility study2024https://doi.org/10.1136/bmjopen-2023-080148
N.B. These documents automatically identified may not have been verified by the study sponsor.