Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000773730
Ethics application status
Approved
Date submitted
18/05/2022
Date registered
31/05/2022
Date last updated
4/07/2022
Date data sharing statement initially provided
31/05/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Nurse led volunteer support interventions and a technology driven pain assessment
for older adults in hospital
Scientific title
Effectiveness of nurse led volunteer support interventions and a technology driven pain assessment for older adults in hospital
Secondary ID [1] 305104 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Extended hospital admission 323325 0
Pain 323326 0
Clinical incidents 326378 0
Condition category
Condition code
Physical Medicine / Rehabilitation 320888 320888 0 0
Other physical medicine / rehabilitation
Public Health 320889 320889 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All patients will have their pain assessed by nurses utilizing the PainChek® Universal and all patients will be offered one-to-one volunteer support across morning and afternoon shifts from Monday to Friday during their inpatient admission on the study wards at Joondalup Health Campus.
Volunteer support consists of assisting patients with activities related to orientation, cognition, sensory, mobility (encouraging and walking with ambulant patients; encouraging the patient to complete exercises), nutrition ( encouraging the patient to eat, and assisting with the set-up of meals), and wellbeing support (such as providing hand and foot massage, hair brushing) the nurse The duration of the volunteer support will be recorded on the volunteer Support Care plan.
For patients who are able to report their pain using the Numerical Rating Scale 0-10, nurses will assess the pain and record the outcome in PainChek® Universal application. For patients who are unable to report their pain using NRS the nurse will assess the patients pain using the PainChek application within PainChek Universal. Using AI, facial recognition and smartphone technology, PainChek® intelligently automates the pain assessment process at the point of care.
Intervention code [1] 323489 0
Treatment: Other
Comparator / control treatment
A historical control group comprising patients admitted to the same two wards at Joondalup Health Campus in the same period one year prior to the practice change (1 April 2021- 1 April 2022) will be used as the comparator group
Control group
Historical

Outcomes
Primary outcome [1] 331232 0
Length of stay obtained from hospital administrative data from hospital medical records
Timepoint [1] 331232 0
Discharge
Secondary outcome [1] 409260 0
Falls incidence obtained from hospital administrative data from hospital clinical incidence management system.
Timepoint [1] 409260 0
Data collected after final day during hospitalisation
Secondary outcome [2] 409261 0
Incidence of delirium obtained from hospital administrative data from hospital clinical incidence management system.
Timepoint [2] 409261 0
Data collected after final day during hospitalisation
Secondary outcome [3] 409262 0
Incidence of behavioural incidents obtained from hospital administrative data from hospital clinical incidence management system.
Timepoint [3] 409262 0
Data collected after final day during hospitalisation
Secondary outcome [4] 409263 0
Incidence of death obtained from hospital administrative data from hospital medical records
Timepoint [4] 409263 0
Data collected after final day during hospitalisation
Secondary outcome [5] 409264 0
Incidence of pressure injuries obtained from hospital administrative data from hospital clinical incidence management system.
Timepoint [5] 409264 0

Data collected after final day during hospitalisation
Secondary outcome [6] 409265 0
Incidence of analgesic use obtained from hospital pharmacy management system.
Timepoint [6] 409265 0


Data collected after final day during hospitalisation

Eligibility
Key inclusion criteria
Patients admitted to two geriatric medical wards at an acute metropolitan tertiary hospital in Perth, Western Australia.
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Nil

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The study sample has been calculated based on the approximate number of patient admissions during the study period.
Descriptive statistics will be presented with means and standard deviations for parametric data, median and interquartile range for non-parametric data, and frequency for baseline characteristics. The clinical outcomes will be analysed using t-tests.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
2/02/2022
Date of last participant enrolment
Anticipated
3/10/2022
Actual
Date of last data collection
Anticipated
3/10/2022
Actual
Sample size
Target
200
Accrual to date
20
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 22401 0
Joondalup Health Campus - Joondalup
Recruitment postcode(s) [1] 37566 0
6027 - Joondalup

Funding & Sponsors
Funding source category [1] 309498 0
Charities/Societies/Foundations
Name [1] 309498 0
Ramsay Hospital Research Foundation
Country [1] 309498 0
Australia
Primary sponsor type
University
Name
Edith Cowan University
Address
100 Joondalup Drive
Joondalup. WA. 6027.
Country
Australia
Secondary sponsor category [1] 310476 0
None
Name [1] 310476 0
Address [1] 310476 0
Country [1] 310476 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309284 0
Ramsay Health Care WA/SA HREC
Ethics committee address [1] 309284 0

Crn Grant Blvd & Shenton Ave, Joondalup WA 6027
Ethics committee country [1] 309284 0
Australia
Date submitted for ethics approval [1] 309284 0
Approval date [1] 309284 0
25/10/2021
Ethics approval number [1] 309284 0
2134W
Ethics committee name [2] 310983 0
Edith Cowan University HREC
Ethics committee address [2] 310983 0
100 Joondalup drive
Joondalup WA 6027
Ethics committee country [2] 310983 0
Australia
Date submitted for ethics approval [2] 310983 0
01/11/2021
Approval date [2] 310983 0
17/02/2022
Ethics approval number [2] 310983 0
2021-03014-SAUNDERS

Summary
Brief summary
Hospitalisation for older people can result in poor health outcomes, and this is more evident in frail older patients and those with cognitive impairment. Factors such as chronic health conditions, polypharmacy and cognitive and functional decline are associated with increased risk of health care related harm, (such as falls, delirium and poor nutrition) (George, Long, & Vincent, 2013). Pain is also very common in older adults in hospital, however assessment of pain in older patients in hospital can be impacted by the patient’s communication of pain which may be affected by their beliefs about pain as a normal part of ageing, concerns related to use of medications for pain, and cognitive impairment often resulting in under treatment of pain (Schofield et al, 2018). Assessing pain
begins with a person’s self-report using pain assessment tools but this can be challenging in older patients, and technology driven pain assessments have been developed for better pain assessment. One such application is PainChek Universal® that enables better assessment of pain at the point of care for those whose ability to communicate fluctuates. PainChek Universal® contains 2 scales 1. Numerical Rating Scale (NRS) for those who can self-report their pain.2. The PainChek scale for those who cannot self-report their pain (using automated facial recognition and analysis to identify pain-related facial micro-expressions, together with a series of user completed checklists of pain behaviours (Atee et al. 2017; Atee et al. 2018a).To minimise the risk of health care-related harm, volunteer programs to support patient care have been established in many hospitals worldwide. Volunteer programs have shown a positive impact on older patients in hospital and have positively upon patient health outcomes related to nutrition, falls and delirium (Naylor et al. 2013; Saunders et al 2019).

A non-randomized intervention study will evaluate a model of service delivery for older adults in hospital aged 65 years and older through implementation of technology driven pain assessment and a nurse-led volunteer support program.

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 113622 0
A/Prof Rosemary Saunders
Address 113622 0
Edith Cowan University
100 Joondalup Drive
Joondalup WA 6027
Country 113622 0
Australia
Phone 113622 0
+61 08 63043513
Fax 113622 0
Email 113622 0
[email protected]
Contact person for public queries
Name 113623 0
A/Prof Rosemary Saunders
Address 113623 0

Edith Cowan University
100 Joondalup Drive
Joondalup WA 6027
Country 113623 0
Australia
Phone 113623 0
+61 08 63043513
Fax 113623 0
Email 113623 0
[email protected]
Contact person for scientific queries
Name 113624 0
A/Prof Rosemary Saunders
Address 113624 0

Edith Cowan University
100 Joondalup Drive
Joondalup WA 6027
Country 113624 0
Australia
Phone 113624 0
+61 08 63043513
Fax 113624 0
Email 113624 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.