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Trial registered on ANZCTR


Registration number
ACTRN12616001003460
Ethics application status
Approved
Date submitted
23/07/2016
Date registered
29/07/2016
Date last updated
29/07/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Efficacy, feasibility and usability of a facial recognition technology integrated mobile app for identifying the presence and severity of pain in institutionalised patients with dementia.
Scientific title
FAcial recognition-based and Computerised Evaluation of PAIN in INstitutionalised DEMENTIA residents
Secondary ID [1] 283793 0
Nil Known
Universal Trial Number (UTN)
U1111-1185-6973
Trial acronym
FAcial recognition-based and Computerised Evaluation of PAIN in INstitutionalised DEMENTIA residents (FACE of PAIN IN DEMENTIA) Project
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dementia 290771 0
Pain 290772 0
Behavioural problems 299613 0
Condition category
Condition code
Neurological 291135 291135 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study consists of 3 phases
I. Pre-implementation phase
1) Face to face training of “Pain Champions” (half day)
2) Retrospective clinical audit (8 weeks prior to the commencement of the clinical trial undertaken by a research assistant employed by the project team)
3) Care staff familiarisation period with the use and operation of the ePAT (2 weeks)
4) Baseline data collection (Week 0)
II.Clinical implementation (8 weeks)
1) Commencement of the clinical trial and introduction of the tool (Week 1-Week 8)
III.Post-implementation (8 weeks)
1) Cessation of the clinical trial and return to standard (normal) practice.
2) Data collection points at Week 9

Intervention: Electronic Pain Assessment Tool (ePAT) is a point of care app which uses automated facial recognition technology in real-time to identify facial micro-expressions indicative of the presence of pain. These data are then used in combination with other non-facial pain cues such as vocalisation, movements and behaviours to automatecally calculate a pain severity score.

The ePAT consists of 6 domains, which are derived from American Geriatric Society's Indicators of Persistent Pain in Older Adults. For each pain assessment encounter, staff member videos the resident's face for 10 seconds which is analysed by the app in real-time to identify facial micro-expressions. Then, staff member navigates through other non-facial domains to answer Yes/No questions for a checklist of indicators, using the app, to arrive at a pain intensity score.

Pain Champions
As a strategy of implementation, nurse from each care home will be nominated as “Pain Champion”. Nomination will occur when an expression of interest of an employee nurse is initially raised with the nurse manager of the care home to participate in the project. According to Knowledge for Health (K4Health) initiative, “champions are charismatic opinion leaders who advocate for a particular program, policy or technology”. Champions should be characterised by “passion, persistence and persuasiveness”. The role of “Pain Champions” is to administer the study where they work and train and encourage the rest of the staff within the care home to perform electronic pain assessments. Within each care home, each champion will be finally selected by the general manager based on certain criteria agreed on by both parties.

Face-to-face Training of Pain Champions will be conducted by the researcher. It is comprised of 2 parts:
1) Theoretical session
This session includes lectures, educational videos and case studies and has the following four modules:

Module 1: Background about pain
Definition of pain, subjective nature of pain, pathophysiology of pain, types of pain, causes of pain, consequences of pain (including behavioural change),

Module 2: Pain in dementia and residential care
Prevalence of pain in dementia, pain in mild dementia, pain in moderate-to-severe dementia, pain assessment tools (self-rating instruments e.g. VDS or FPS), (behavioural or observational (proxy) pain assessment tools e.g. Abbey, ePAT), challenges of currently available pain assessment methods

Module 3: Pain management in residential care
Discussion about current recommendations from clinical guidelines, and different therapeutic options available for pain management in residential care such as pharmacotherapy (e.g. opioids or paracetamol) and non-drug therapy (e.g. message or essential oil therapy)

Module 4: Overview of study protocol for ePAT implementation
The study protocol will be worked through step by step and staff members will have the opportunity to complete data collection forms.


2) Practical session
During this session the following will be conducted:

Module 1: Conditions that might affect the operation of the ePAT

Module 2: Live demo of the ePAT

Module 3: Hand-on practice using the ePAT by staff in pairs (i.e. completing facial assessments and questionnaire checklist domains) and on residents (if possible)


Participants will be sampled using non-probability convenience sampling strategy. Participants will be served as own control and will be subjected to the ePAT as an intervention of measuring pain. The ePAT uses the combination of a digital AGS-based checklist and automated facial recognition technology in a smart device to capture micro-facial expressions, behaviours and physical features indicative of pain. Residents’ pain will be assessed by aged care staff for 8 weeks whenever is suspected during rest and on movement (upon receiving routine care activities known to be associated with pain e.g. assisted transfer, repositioning, bathing and toileting or when a resident performing his/her own daily activities e.g. self-transfer or walking within the care home) as per usual practice. There is no independent control group in this study.

Communication with GPs
GPs will be formally consented to be part of the study as they will be making decisions regarding ePAT scores. Each GP will be briefed about a previous validation study and the objectives and implementation of current trial. Participating GPs will be regularly consulted about ePAT pain scores as per standard practice, with particular focus on those residents with behavioural issues. The outcome of consultation together with respective reasons for selecting therapeutic actions (if any) will also be documented on the Pain Management Record Form. Treating GPs will be under no pressure to recommend anything under the umbrella of the trial but rather will do so when necessary as part of standard care. Feedback about the clinical utility of the tool will be gathered using focus group interview.

Responding to Pain Rating in Patients with Cognitive Impairment during the Clinical Trial
During implementation phase, each pain assessment is to be documented on a Pain Management Record designed for the purpose of this study. Resident’s pain will be reviewed using electronic Pain Assessment Tool (ePAT) unless the Assessor wishes to validate the result obtained against a standard tool such Abbey Pain Scale (APS). Following the ePAT assessment, the standard practice will be followed. Weekly outcome review for pain management for each resident will also be documented

Total number of ePAT assessments for resident sample, number of ePAT assessments per resident, number of ePAT assessments at rest, number of ePAT assessments after a movement or activity will also be recorded.

Ease of use and staff satisfaction are expressed in percentages. Responses (scores of entire tool and subscales) of Clinical Utility Attribute Questionnaire (CUAQ) and Mobile Application Rating Scales (MARS) will be presented as percentages, mean +/-SD and median with interquartile ranges.
Intervention code [1] 288478 0
Treatment: Devices
Comparator / control treatment
Participants will be served as own control and will be subjected to the ePAT as an intervention of measuring pain. Pain assessments will be conducted during rest (no activity) as a reference point, and upon movements (activity) during the implementation trial. In addition, overall improvement in pain management and secondary outcomes will be compared before, during and subsequent to the introduction of the ePAT as an interventional method of measuring pain.

Abbey Pain Scale (APS) may be used (as a comparator for validation) sometimes by staff during some ePAT data collection points to validate the ePAT score. The use of APS is carried out at the discretion of care staff, when they feel that the ePAT score may not be accurate.

Each pain assessment is to be documented on a Pain Management Record Form designed for the purpose of this study. Resident’s pain will be reviewed using electronic Pain Assessment Tool (ePAT) unless the Assessor wishes to validate the result obtained against a standard tool such Abbey Pain Scale (APS). Following the ePAT assessment, the standard practice will be followed.
Control group
Active

Outcomes
Primary outcome [1] 291122 0
There is a composite primary outcome in this study which is identifying presence and severity of pain using the ePAT or Abbey Pain Scale or Self -rating (Verbal Descriptor Scale). The choice of scale to use is dependent on the self-rating capacity of residents and the on the adherence of staff to use ePAT or Abbey Pain Scale.
Timepoint [1] 291122 0
Time points for clinical data collection
1)From the clinical audit 8 weeks before implementation/introduction of the ePAT
2) At baseline (Day 1,Week 1)
3) During implementation phase at Week 4-6 as comparators for change with the ePAT (i.e. change against baseline data) only for residents who are likely to have an attrition due to hospitalisation or death.
4) At Week 9 post-implementation to compare with previous time points of data collection (i.e. comparative change with Week 4-6)
Overall, these data are collected to review changes that occurred in residents’ outcomes over time as a result of using the ePAT in participating care homes and to establish whether practice improvement (if any) has been maintained after withdrawal of the ePAT. Data collected outside of the normal range of data routinely collected by the home will be the conducted by a research assistant at baseline, 4-6 and 9 week periods.
Secondary outcome [1] 306026 0
Medication (analgesic & psychotropic) use (assessed by Medication Quantification Scale)
Timepoint [1] 306026 0
1)From the clinical audit 8 weeks before implementation/introduction of the ePAT
2) At baseline (Day 1,Week 1)
3) During implementation phase at Week 4-6 as comparators for change with the ePAT (i.e. change against baseline data) only for residents who are likely to have an attrition due to hospitalisation or death.
4) At Week 9 post-implementation to compare with previous time points of data collection (i.e. comparative change with Week 4-6)
Overall, these data are collected to review changes that occurred in residents’ outcomes over time as a result of using the ePAT in participating care homes and to establish whether practice improvement (if any) has been maintained after withdrawal of the ePAT. Data collected outside of the normal range of data routinely collected by the home will be the conducted by a research assistant at baseline, 4-6 and 9 week periods.
Secondary outcome [2] 325939 0
Agitation (measured by Cohen-Mansfield agitation inventory)
Timepoint [2] 325939 0
1)From the clinical audit 8 weeks before implementation/introduction of the ePAT
2) At baseline (Day 1,Week 1)
3) During implementation phase at Week 4-6 as comparators for change with the ePAT (i.e. change against baseline data) only for residents who are likely to have an attrition due to hospitalisation or death.
4) At Week 9 post-implementation to compare with previous time points of data collection (i.e. comparative change with Week 4-6)
Overall, these data are collected to review changes that occurred in residents’ outcomes over time as a result of using the ePAT in participating care homes and to establish whether practice improvement (if any) has been maintained after withdrawal of the ePAT. Data collected outside of the normal range of data routinely collected by the home will be the conducted by a research assistant at baseline, 4-6 and 9 week periods.
Secondary outcome [3] 325940 0
Aggression (rated by neuropsychiatric inventory-nursing home version (NPI-NH))
Timepoint [3] 325940 0
1)From the clinical audit 8 weeks before implementation/introduction of the ePAT
2) At baseline (Day 1,Week 1)
3) During implementation phase at Week 4-6 as comparators for change with the ePAT (i.e. change against baseline data) only for residents who are likely to have an attrition due to hospitalisation or death.
4) At Week 9 post-implementation to compare with previous time points of data collection (i.e. comparative change with Week 4-6)
Overall, these data are collected to review changes that occurred in residents’ outcomes over time as a result of using the ePAT in participating care homes and to establish whether practice improvement (if any) has been maintained after withdrawal of the ePAT. Data collected outside of the normal range of data routinely collected by the home will be the conducted by a research assistant at baseline, 4-6 and 9 week periods.
Secondary outcome [4] 325941 0
Depression (scored by Cornell Scale for Depression in Dementia (CSDD)
Timepoint [4] 325941 0
1)From the clinical audit 8 weeks before implementation/introduction of the ePAT
2) At baseline (Day 1,Week 1)
3) During implementation phase at Week 4-6 as comparators for change with the ePAT (i.e. change against baseline data) only for residents who are likely to have an attrition due to hospitalisation or death.
4) At Week 9 post-implementation to compare with previous time points of data collection (i.e. comparative change with Week 4-6)
Overall, these data are collected to review changes that occurred in residents’ outcomes over time as a result of using the ePAT in participating care homes and to establish whether practice improvement (if any) has been maintained after withdrawal of the ePAT. Data collected outside of the normal range of data routinely collected by the home will be the conducted by a research assistant at baseline, 4-6 and 9 week periods.
Secondary outcome [5] 325942 0
Cognition (as rated by Dementia Rating severity Scale)
Timepoint [5] 325942 0
1)From the clinical audit 8 weeks before implementation/introduction of the ePAT
2) At baseline (Day 1,Week 1)
3) During implementation phase at Week 4-6 as comparators for change with the ePAT (i.e. change against baseline data) only for residents who are likely to have an attrition due to hospitalisation or death.
4) At Week 9 post-implementation to compare with previous time points of data collection (i.e. comparative change with Week 4-6)
Overall, these data are collected to review changes that occurred in residents’ outcomes over time as a result of using the ePAT in participating care homes and to establish whether practice improvement (if any) has been maintained after withdrawal of the ePAT. Data collected outside of the normal range of data routinely collected by the home will be the conducted by a research assistant at baseline, 4-6 and 9 week periods.
Secondary outcome [6] 325943 0
Quality of life (measured by the Quality of Life in Alzheimer’s Disease (QOL-AD)
Timepoint [6] 325943 0
1)From the clinical audit 8 weeks before implementation/introduction of the ePAT
2) At baseline (Day 1,Week 1)
3) During implementation phase at Week 4-6 as comparators for change with the ePAT (i.e. change against baseline data) only for residents who are likely to have an attrition due to hospitalisation or death.
4) At Week 9 post-implementation to compare with previous time points of data collection (i.e. comparative change with Week 4-6)
Overall, these data are collected to review changes that occurred in residents’ outcomes over time as a result of using the ePAT in participating care homes and to establish whether practice improvement (if any) has been maintained after withdrawal of the ePAT. Data collected outside of the normal range of data routinely collected by the home will be the conducted by a research assistant at baseline, 4-6 and 9 week periods.
Secondary outcome [7] 325944 0
Care workers and support staff burden (rated by Care Burden Index).
Timepoint [7] 325944 0
1)From the clinical audit 8 weeks before implementation/introduction of the ePAT
2) At baseline (Day 1,Week 1)
3) During implementation phase at Week 4-6 as comparators for change with the ePAT (i.e. change against baseline data) only for residents who are likely to have an attrition due to hospitalisation or death.
4) At Week 9 post-implementation to compare with previous time points of data collection (i.e. comparative change with Week 4-6)
Overall, these data are collected to review changes that occurred in residents’ outcomes over time as a result of using the ePAT in participating care homes and to establish whether practice improvement (if any) has been maintained after withdrawal of the ePAT. Data collected outside of the normal range of data routinely collected by the home will be the conducted by a research assistant at baseline, 4-6 and 9 week periods.
Secondary outcome [8] 326019 0
Length of training time required, assessed by review of training session logs.
Timepoint [8] 326019 0
Immediately prior to start of implementation phase
Secondary outcome [9] 326020 0
Usability and quality of the software, assessed by staff using Mobile Rating Scale (MARS) questionnaire
Timepoint [9] 326020 0
Post-implementation phase
Secondary outcome [10] 326021 0
Staff acceptability of the ePAT assessment system, assessed by semi-structured interviews with pain champions and using Clinical Utility Attribute Questionnaire (CUAQ ) for all centre staff.
Timepoint [10] 326021 0
Post-implementation phase

Eligibility
Key inclusion criteria
(1) are 60 years or older; (2) have been diagnosed with moderate-to-severe dementia with a current MMSE score equals 9 or PAS equals 10 and/or HDS less than 160; (3) are living in a high-level care designated dementia unit; (4) are dwelling greater than 3 months in the care home; and (5) possess a documented history of any of the followings: (a) chronic pain conditions such as, but not limited to, joints pain (osteo- and rheumatoid arthritis), osteoporosis, chronic back pain, compression fracture, neuropathic and post-herpetic pain; (b) have had a recent or history of falls; (c) presence of skin infections e.g. shingles, active or chronic wounds e.g. pressure sores and skin tears; and/or (d) have a long-lasting infection(s) such as cellulitis and osteomyelitis.
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
If the resident is clinically unwell, deemed ineligible or if it is inappropriate to include as decided by clinical or aged care staff.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
A quasi-experimental, interrupted time series design
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Test-retest analysis pain scores are based on the Pain app during Familiarisation Phase. The Cohen’s Kappa statistic will be used to assess the level of agreement between measurements based on a categorical scale. If the measures are on a continuous scale, then the Intra-class Correlation Coefficient (ICC) will be used. The ICC can also be used to assess agreement between more than 2 raters. The ICC returns a value between zero and 1, with values near 1 indicating good agreement.

Non-probability purposive and convenience sampling will be used to recruit subjects. A target sample of 20-30 subjects per aged care home is aimed for during this study. A subject-to variable ratio of 5:1 appears to be the most reported approach of sample size in the literature. Using this approach (i.e. 5 subjects per one item) and bearing in mind that the ePAT is composed of 42 items, a sample size of at least (5 subjects x 42 items) 210 residents is the target. This number is the minimum value needed before reaching an adequate power of 80% and subsequent statistical significance of less than 0.05. However, failing to retain a subject due to attrition associated reasons (e.g. delirium, hospitalisations, and/or other clinically unstable conditions as well as death) is anticipated during the course of this study. To account for these unforeseen circumstances which may contribute to the reduction of sample size, we have made the choice to recruit an additional number (n=40) of subjects to arrive at a final sample size of 250.

All analyses will be performed by a statistician using the Statistical Package for the Social Sciences (SPSS) software (V.17.0, Chicago, Illinois, USA). Descriptive data of central tendencies measures (such as mean, median and standard deviations) and inferential data such as odd ratio (OR), confidence interval (CI) and regression analyses will be reported in the findings. Regression analyses will be calculated to assess the impact of using the ePAT on secondary outcomes (cognition, behaviour, depression, anxiety, medication use and quality of life). Adjusted and unadjusted ORs for the secondary outcomes will also be reported and assessed for significance using 95% CI.

Sample characteristics (e.g. age, gender, ethnicity, and years of employment in the care home) of Assessors involved in the project will be reported in descriptive statistics: mean, median, mode, standard deviation (SD) and range. Training length, administration time and observation period are expressed in units of time (e.g. minutes, seconds), which will also be reported in descriptive statistics e.g. mean time taken to do ePAT assessment. Other feasibility data such as total number of ePAT assessments for resident sample, number of ePAT assessments per resident, number of ePAT assessments at rest, number of ePAT assessments after a movement or activity will also be presented. Ease of use and staff satisfaction are expressed in percentages. Responses (scores of entire tool and subscales) of Clinical Utility Attribute Questionnaire (CUAQ) and Mobile Application Rating Scale (MARS) will be presented as percentages, mean +/- SD and median with interquartile ranges. A receiver operating characteristic (ROC) analysis will be used to establish cut-off pain severity scores .

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
6/06/2016
Date of last participant enrolment
Anticipated
1/03/2017
Actual
Date of last data collection
Anticipated
1/07/2017
Actual
Sample size
Target
250
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA,VIC
Recruitment postcode(s) [1] 13666 0
6052 - Inglewood
Recruitment postcode(s) [2] 13675 0
3106 - Templestowe
Recruitment postcode(s) [3] 13676 0
3058 - Coburg
Recruitment postcode(s) [4] 13677 0
3088 - Greensborough
Recruitment postcode(s) [5] 13678 0
3550 - Bendigo
Recruitment postcode(s) [6] 13679 0
3564 - Echuca
Recruitment postcode(s) [7] 13680 0
3444 - Kyneton
Recruitment postcode(s) [8] 13681 0
3442 - Woodend
Recruitment postcode(s) [9] 13682 0
3162 - Caulfield
Recruitment postcode(s) [10] 13683 0
3690 - Wodonga
Recruitment postcode(s) [11] 13684 0
6102 - Bentley

Funding & Sponsors
Funding source category [1] 288454 0
Charities/Societies/Foundations
Name [1] 288454 0
Alzheimer's Australia Dementia Research Foundation
Country [1] 288454 0
Australia
Funding source category [2] 294127 0
Commercial sector/Industry
Name [2] 294127 0
EPAT PTY LTD
Country [2] 294127 0
Australia
Funding source category [3] 294128 0
Commercial sector/Industry
Name [3] 294128 0
Brightwater Aged Care Group
Country [3] 294128 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
GPO Box U1987 Perth,
Western Australia 6845
Country
Australia
Secondary sponsor category [1] 292959 0
Commercial sector/Industry
Name [1] 292959 0
EPAT PTY LTD
Address [1] 292959 0
Suite 5, 95 Hay Street, Subiaco WA 6008
Country [1] 292959 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290325 0
Human Research Ethics Committee (HREC), Curtin University
Ethics committee address [1] 290325 0
Ethics committee country [1] 290325 0
Australia
Date submitted for ethics approval [1] 290325 0
07/01/2014
Approval date [1] 290325 0
18/03/2014
Ethics approval number [1] 290325 0
HR 10/2014
Ethics committee name [2] 295533 0
Brightwater Research Centre-Ethics Committee
Ethics committee address [2] 295533 0
Ethics committee country [2] 295533 0
Australia
Date submitted for ethics approval [2] 295533 0
24/04/2016
Approval date [2] 295533 0
02/05/2016
Ethics approval number [2] 295533 0

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

Contacts
Principal investigator
Name 45082 0
Prof Jeff Hughes
Address 45082 0
School of Pharmacy
Curtin University
GPO Box U1987
Perth Western Australia 6845
Country 45082 0
Australia
Phone 45082 0
+618 9266 7367
Fax 45082 0
+618 9266 2769
Email 45082 0
[email protected]
Contact person for public queries
Name 45083 0
Mustafa Atee
Address 45083 0
School of Pharmacy
Curtin University
GPO Box U1987
Perth Western Australia 6845
Country 45083 0
Australia
Phone 45083 0
+618 9266 2527
Fax 45083 0
Email 45083 0
[email protected]
Contact person for scientific queries
Name 45084 0
Mustafa Atee
Address 45084 0
School of Pharmacy
Curtin University
GPO Box U1987
Perth Western Australia 6845
Country 45084 0
Australia
Phone 45084 0
+618 9266 2527
Fax 45084 0
Email 45084 0
[email protected]

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No Supporting Document Provided



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