Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12620001173987
Ethics application status
Approved
Date submitted
5/10/2020
Date registered
9/11/2020
Date last updated
18/05/2022
Date data sharing statement initially provided
9/11/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Optimising outcomes for frail hospitalised older adults – nurse led volunteer support and pain assessment interventions: A cluster randomised control trial
Scientific title
Optimising outcomes for frail hospitalised older adults – nurse led volunteer support and pain assessment interventions: A cluster randomised control trial
Secondary ID [1] 302457 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Frailty 319287 0
Condition category
Condition code
Physical Medicine / Rehabilitation 317259 317259 0 0
Other physical medicine / rehabilitation
Public Health 317536 317536 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will utilise a cluster randomised control trial to evaluate the effectiveness of nurse led volunteer support interventions and technology driven pain assessment (PainChek Universal®) compared with standard care, on changes in frailty and specific clinical outcomes of older adults during hospitalisation, at discharge and at 30 days after discharge. A stakeholder evaluation (stakeholders include patient-participants, family, staff and volunteers) and cost effectiveness analysis will also be conducted.

Potential participants will be screened for frailty using the modified-Reported Edmonton Frail Scale (mod-REFS) and demographic and clinical information will be collected from their patient file. Patients meeting the frailty criteria (mod-REFS score of 8 or greater) will be invited to participate in the intervention study. All participants will be assessed on admission and discharge by the project nurse using the InterRAI Acute Care assessment battery.

All participants will have their level of pain, scale used, whether assessment was at rest or on movement, and any action taken in response (e.g., medication, repositioning, heat pack) recorded for all pain assessments as part of usual care while in hospital. This information will be recorded by ward staff. For groups receiving PainChek Universal® this information will be recorded in the app. For the other groups, this information will be recorded on the Pain Record Sheet which will be kept in the patient’s room.

There will be three intervention groups:
1) Standard care plus nurse led volunteer support
For participants allocated nurse led volunteer support, the project nurse will develop an individual volunteer support care plan in consultation with the patient and ward staff to provide up to two one-hour session with a volunteer per weekday for the duration of their hospitalisation. Volunteer support may include:
Orientation - Volunteers will utilise strategies aimed at time, place, and situation to reorient patients if required. This may include orienting patients to the ward areas by taking them for a walk showing the layout of the ward; using a room calendar and or clock to orientate to date and time; and discussing about being in hospital as part of situational reorientation.
Cognitive Stimulation - Volunteers will engage in activities with patients to support cognition. This may include reading newspapers, discussing current events, or discussing areas of interest.
Mobility support - Volunteers will utilise strategies to promote physical activity such as accompanying patients on walks around the ward or encouraging them in their bed or chair exercises.
Nutrition - Volunteers will use strategies to improving patients’ nutrition such as assisting patients with cutting food and positioning utensils and drinks, so they are accessible and also encourage the patient to eat and drink.
Sensory Support - Volunteers will provide sensory support for patients’ vision and hearing such as checking if patients require glasses and hearing aids and if they are accessible and in place.

Volunteer support provided to the participant will be recorded by the volunteers on the Volunteer Support Care Plan Record.

2) Standard care plus technology driven pain assessment (PainChek Universal®)
During their hospital stay participants in this group will have any pain assessments conducted as part of usual care and any actions taken in response recorded for this project in the PainChek Universal® application by ward staff. For participants unable to report pain (e.g., due to cognitive impairment), the application based-tool utilises the in-built cameras and processors of smart devices to assess the presence of pain associated facial muscle movements (action units) using a 3-second video analysis of the individual’s face. The application then guides the assessor through checklists of pain behaviours, which include items related to changes in vocalisations, movement, and behaviours enacted by individuals during the experience of pain. The total of these behaviours informs the pain intensity according to the following categories: no pain (0-6), mild (7-11), moderate (12-15) and severe (greater than or equal to 16). For participants able to verbally report pain, their standard pain assessments (e.g., numerical ratings) will be recorded in PainChek Universal®.

All pain assessments will be recorded in the PainChek Universal application and stored in a repository within the PainChek Universal® secure cloud database.

3) Standard care plus nurse led volunteer support and technology driven pain assessment (PainChek Universal®)
Participants in this group will receive both nurse led volunteer support (as described for intervention 1) and technology driven pain assessment (as described for intervention 2)
Intervention code [1] 318756 0
Prevention
Intervention code [2] 318757 0
Rehabilitation
Intervention code [3] 318758 0
Treatment: Other
Comparator / control treatment
The control group will receive standard care during their hospital stay
Control group
Active

Outcomes
Primary outcome [1] 325320 0
Frailty as measured by the InterRAI-Acute Care Frailty Index
Timepoint [1] 325320 0
Admission and discharge
Primary outcome [2] 325321 0
Frailty as measured by the modified-Reported Edmonton Frail Scale (mod-REFS)
Timepoint [2] 325321 0
Admission and 30 days post-discharge
Secondary outcome [1] 387492 0
Length of hospital determined from admission and discharge dates entered into InterRAI AC during admission and discharge assessments
Timepoint [1] 387492 0
discharge
Secondary outcome [2] 387493 0
Hospital readmissions as reported by the participant or proxy
Timepoint [2] 387493 0
30 days post-discharge
Secondary outcome [3] 387519 0
Activities of daily living as measured by InterRAI AC
Timepoint [3] 387519 0
admission and discharge
Secondary outcome [4] 387520 0
cognitive assessment as measured by InterRAI AC
Timepoint [4] 387520 0
admission and discharge
Secondary outcome [5] 387522 0
continence as measured by InterRAI AC
Timepoint [5] 387522 0
admission and discharge
Secondary outcome [6] 387523 0
Falls risk as measured by InterRAI AC
Timepoint [6] 387523 0
admission and discharge
Secondary outcome [7] 387524 0
Functional independence as measured by InterRAI AC
Timepoint [7] 387524 0
admission and discharge
Secondary outcome [8] 387525 0
nutrition as measured by InterRAI AC
Timepoint [8] 387525 0
admission and discharge
Secondary outcome [9] 387526 0
Pressure injury risk as measured by InterRAI AC
Timepoint [9] 387526 0
admission and discharge
Secondary outcome [10] 387527 0
Quality of Life as measured by InterRAI AC
Timepoint [10] 387527 0
admission and discharge
Secondary outcome [11] 387528 0
Quality of Life as measured by Australian Quality of Life questionnaire (AQoL)
Timepoint [11] 387528 0
30 days post discharge
Secondary outcome [12] 387529 0
Number of medication recorded in InterRAI AC
Timepoint [12] 387529 0
admission and discharge
Secondary outcome [13] 387530 0
Mobility as measured by timed up and go
Timepoint [13] 387530 0
admission and discharge
Secondary outcome [14] 387531 0
Number of adverse events during hospitalisation (e.g., falls, death, delirium) recorded from patient file
Timepoint [14] 387531 0
discharge
Secondary outcome [15] 387532 0
Discharge destination recorded in InterRAI AC
Timepoint [15] 387532 0
discharge
Secondary outcome [16] 387533 0
Depression as measured in InterRAI AC
Timepoint [16] 387533 0
admission and discharge
Secondary outcome [17] 387534 0
Mean pain level. Pain assessments during usual care can be conducted using different pain scales including 0-10 numerical ratings, painchek app, painad scale, wong-baker scale. Mean scores on these scales will be calculated and converted to a pain level (ie no pain, mild pain, moderate pain, severe pain)
Timepoint [17] 387534 0
all pain assessments conducted as part of usual care during hospitalisation will be recorded on a data collection form or in the painchek app
Secondary outcome [18] 387535 0
Pain management interventions recorded by ward staff - type (e.g., analgesics, repositioning, heat pack)
Timepoint [18] 387535 0
all pain assessments conducted as part of usual care during hospitalisation will be recorded on a data collection form or in the painchek app
Secondary outcome [19] 387536 0
Pain management interventions recorded by ward staff - frequency
Timepoint [19] 387536 0
all pain assessments conducted as part of usual care during hospitalisation will be recorded on a data collection form or in the painchek app

Eligibility
Key inclusion criteria
Patients aged 65 years and over admitted to participating wards
Anticipated length of hospital stay 48 hours or longer
Score greater than or equal to 8 on the modified-Reported Edmonton Frail Scale (mod-REFS)
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Non-medical patient
Severe intellectual disability
Patients who requires isolation due to infection control precautions

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Cluster randomisation at the level of the ward will be performed by the project bio-statistician using simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Factorial
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The lack of literature on interventions for frail hospitalised older adults precludes the calculation of a required sample size based on previous effect sizes. Based on an admission rate of 5 patients over 65 years per medical ward per weekday, 80% consent rate for screening, 50% frailty rate and 50% consent rate for the intervention, a sample size of 180 participants per intervention group, and 720 participants total, is feasible over the 9 month recruitment phase. With this sample size the study will have 95% power to detect an effect size of d=.027 or greater at an alpha level .05 for the comparison of frailty between admission and discharge in each group.

All analyses will be conducted on an intention-to-treat basis. Descriptive statistics will be conducted using mean with standard deviation, median and interquartile range and frequency for baseline characteristics. The primary outcome, change in frailty during hospital admission, will be analysed using Generalised Linear Mixed Models, comparing the intervention wards with the control wards, adjusting the standard errors for clustering. Models will be adjusted for age, gender, Charlson co-morbidity score and for clustering by ward. All analysis will be conducted in STATA. All analysis will be conducted independently by researchers.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
15/03/2021
Actual
22/03/2021
Date of last participant enrolment
Anticipated
25/02/2022
Actual
25/02/2022
Date of last data collection
Anticipated
1/07/2022
Actual
Sample size
Target
720
Accrual to date
Final
421
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 17735 0
Hollywood Private Hospital - Nedlands
Recruitment postcode(s) [1] 31590 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 306884 0
Charities/Societies/Foundations
Name [1] 306884 0
Ramsay Hospital Research Foundation
Country [1] 306884 0
Australia
Funding source category [2] 306889 0
University
Name [2] 306889 0
Edith Cowan University
Country [2] 306889 0
Australia
Funding source category [3] 306890 0
Hospital
Name [3] 306890 0
Hollywood Private Hospital
Country [3] 306890 0
Australia
Primary sponsor type
University
Name
Edith Cowan University
Address
270 Joondalup Drive
Joondalup WA 6027
Country
Australia
Secondary sponsor category [1] 307442 0
Hospital
Name [1] 307442 0
Hollywood Private Hospital
Address [1] 307442 0
101 Monash Ave,
Nedlands WA 6009
Country [1] 307442 0
Australia
Other collaborator category [1] 281500 0
Commercial sector/Industry
Name [1] 281500 0
PainChek
Address [1] 281500 0
35 Lime St
Sydney NSW 2000
Country [1] 281500 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307040 0
Ramsay Health Care Human Research Ethics Committee (SA/WA)
Ethics committee address [1] 307040 0
Ethics committee country [1] 307040 0
Australia
Date submitted for ethics approval [1] 307040 0
01/10/2020
Approval date [1] 307040 0
25/01/2021
Ethics approval number [1] 307040 0
2057
Ethics committee name [2] 307042 0
Edith Cowan University Human Research Ethics Committee
Ethics committee address [2] 307042 0
Ethics committee country [2] 307042 0
Australia
Date submitted for ethics approval [2] 307042 0
03/02/2021
Approval date [2] 307042 0
18/02/2021
Ethics approval number [2] 307042 0
2021-02210-SAUNDERS

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

Contacts
Principal investigator
Name 105818 0
Dr Rosemary Saunders
Address 105818 0
School of Nursing and Midwifery, Edith Cowan University, 270 Joondalup Drive, Joondalup, WA, 6027
Country 105818 0
Australia
Phone 105818 0
+61 8 63043513
Fax 105818 0
Email 105818 0
[email protected]
Contact person for public queries
Name 105819 0
Rosemary Saunders
Address 105819 0
School of Nursing and Midwifery, Edith Cowan University, 270 Joondalup Drive, Joondalup, WA, 6027
Country 105819 0
Australia
Phone 105819 0
+61 8 63043513
Fax 105819 0
Email 105819 0
[email protected]
Contact person for scientific queries
Name 105820 0
Rosemary Saunders
Address 105820 0
School of Nursing and Midwifery, Edith Cowan University, 270 Joondalup Drive, Joondalup, WA, 6027
Country 105820 0
Australia
Phone 105820 0
+61 8 63043513
Fax 105820 0
Email 105820 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
SourceTitleYear of PublicationDOI
EmbaseEffectiveness of nurse-led volunteer support and technology-driven pain assessment in improving the outcomes of hospitalised older adults: protocol for a cluster randomised controlled trial.2022https://dx.doi.org/10.1136/bmjopen-2021-059388
N.B. These documents automatically identified may not have been verified by the study sponsor.