Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000904976
Ethics application status
Approved
Date submitted
23/07/2020
Date registered
14/09/2020
Date last updated
2/03/2022
Date data sharing statement initially provided
14/09/2020
Date results provided
2/03/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Prevalence of frailty and pain in hospitalised adult patients in an acute hospital
Scientific title
Prevalence of frailty and pain in hospitalised adult patients in an acute hospital
Secondary ID [1] 301862 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Frailty 318359 0
Pain 318360 0
Condition category
Condition code
Public Health 316370 316370 0 0
Epidemiology
Public Health 316371 316371 0 0
Other public health

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
A prospective single-day point prevalence survey of the frailty and pain levels of inpatients at an acute care private hospital will be undertaken. All inpatients, excluding day surgery and critical care units, will be invited to participate. Frailty assessment will be performed using the modified Reported Edmonton Frail Scale. Current pain levels will be assessed using the PainChek® smartphone application. Patients will also provide a rating of the intensity of their current pain and the worst pain experienced in the last 24 hours using the Numerical Rating Scale (0-10). Demographic and clinical information will be collected from the patient’s hospital file. All data will be collected on one single day with approximately 15 minutes interaction with each participant.
Intervention code [1] 318156 0
Early Detection / Screening
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 324531 0
% participants classified as frail (scoring 8 or above on the modified Reported Edmonton Frail Scale)
Timepoint [1] 324531 0
day of data collection
Primary outcome [2] 324532 0
% participants experiencing pain at time of assessment as determined by a PainChek® score of 7 and above
Timepoint [2] 324532 0
day of data collection
Primary outcome [3] 324810 0
% of participants experiencing pain at time of assessment as determined by a numerical rating of 1 or greater
Timepoint [3] 324810 0
day of data collection
Secondary outcome [1] 385808 0
severity of worst pain in the last 24 hours: proportion of participants reporting no pain (numerical rating 0), mild pain (numerical rating 1-4), moderate pain (numerical rating 5-6) and severe pain (numerical rating 7-10)
Timepoint [1] 385808 0
day of data collection

Eligibility
Key inclusion criteria
All acute care inpatients hospitalised at or before 0800 on the day of data collection willing and able to provide informed verbal consent

If patient is unable to consent due to cognitive impairment or inability to verbally communicate, verbal consent provided by collateral source

Aged 18 years or over
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Admitted to day procedures unit

Admitted to high dependency areas (ICU, CCU)

Hospitalised after 0800

Severe hearing impairment

Severe intellectual disability

Too unwell to participate

Refuse consent

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
All inpatients meeting inclusion criteria will be invited to participate (518 eligible beds). We will aim to meet guidelines for prevalence studies which suggest >300 participants represents an adequate sample size and >70% is an adequate response rate.

The overall response rate of the survey will be reported as the percentage of eligible patients present in the hospital included in the final sample. Reasons for exclusion and the associated percentages will also be reported. The demographics of the final sample will be fully described.

The percentage prevalence of frailty in the sample will be calculated, demographic and clinical characteristics of frail versus not frail patients will be reported and explored. Percentage prevalence will also be calculated in terms of the severity of frailty for the classifications: not frail (0-5), apparently vulnerable (6-7), mild frailty (8-9), moderate frailty (10-11) and severe frailty (12-18).

Percentage prevalence of pain will be calculated separately for PainChek® scores and numerical ratings of pain. Demographic and clinical characteristics of the patients reporting pain versus no pain will be described and explored. Prevalence will also be explored in terms of intensity of pain for PainChek® (0-6 no pain, 7-11 mild, 12-15 moderate and 16-42 severe) and the numerical ratings at assessment and worst pain in the last 24 hours (1-4 mild, 5-6 moderate, 7-10 severe).

Further modelling will be conducted comparing frailty scores with pain scores and adjusting for covariates including age, gender, ward type and reason for admission.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
26/11/2020
Actual
26/11/2020
Date of last participant enrolment
Anticipated
26/11/2020
Actual
26/11/2020
Date of last data collection
Anticipated
26/11/2020
Actual
26/11/2020
Sample size
Target
363
Accrual to date
Final
253
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 17142 0
Hollywood Private Hospital - Nedlands
Recruitment postcode(s) [1] 30821 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 306284 0
Charities/Societies/Foundations
Name [1] 306284 0
Ramsay Hospital Research Foundation
Country [1] 306284 0
Australia
Funding source category [2] 306286 0
University
Name [2] 306286 0
Edith Cowan University
Country [2] 306286 0
Australia
Funding source category [3] 306287 0
Hospital
Name [3] 306287 0
Hollywood Private Hospital
Country [3] 306287 0
Australia
Primary sponsor type
University
Name
Edith Cowan University
Address
270 Joondalup Drive
Joondalup, WA 6027
Country
Australia
Secondary sponsor category [1] 306776 0
Hospital
Name [1] 306776 0
Hollywood Private Hospital
Address [1] 306776 0
101 Monash Ave,
Nedlands WA 6009
Country [1] 306776 0
Australia
Other collaborator category [1] 281400 0
Commercial sector/Industry
Name [1] 281400 0
PainChek
Address [1] 281400 0
35 Lime St
Sydney NSW 2000
Country [1] 281400 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306500 0
Ramsay Health Care Human Research Ethics Committee (SA/WA)
Ethics committee address [1] 306500 0
Ethics committee country [1] 306500 0
Australia
Date submitted for ethics approval [1] 306500 0
10/07/2020
Approval date [1] 306500 0
20/10/2020
Ethics approval number [1] 306500 0
2038
Ethics committee name [2] 306504 0
Edith Cowan University Human Research Ethics Committee
Ethics committee address [2] 306504 0
Ethics committee country [2] 306504 0
Australia
Date submitted for ethics approval [2] 306504 0
22/10/2020
Approval date [2] 306504 0
28/10/2020
Ethics approval number [2] 306504 0
2020-02008-SAUNDERS

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

Contacts
Principal investigator
Name 104082 0
Dr Rosemary Saunders
Address 104082 0
School of Nursing and Midwifery
Edith Cowan University
270 Joondalup Drive
Joondalup, WA, 6027
Country 104082 0
Australia
Phone 104082 0
+61 8 63043513
Fax 104082 0
Email 104082 0
[email protected]
Contact person for public queries
Name 104083 0
Rosemary Saunders
Address 104083 0
School of Nursing and Midwifery
Edith Cowan University
270 Joondalup Drive
Joondalup, WA, 6027
Country 104083 0
Australia
Phone 104083 0
+61 8 63043513
Fax 104083 0
Email 104083 0
[email protected]
Contact person for scientific queries
Name 104084 0
Rosemary Saunders
Address 104084 0
School of Nursing and Midwifery
Edith Cowan University
270 Joondalup Drive
Joondalup, WA, 6027
Country 104084 0
Australia
Phone 104084 0
+61 8 63043513
Fax 104084 0
Email 104084 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
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Saunders, R., Crookes, K., Seaman, K., Ang, S. G. ... [More Details] 380256-(Uploaded-20-04-2023-16-41-56)-Journal results publication.pdf

Documents added automatically
SourceTitleYear of PublicationDOI
EmbasePrevalence of frailty and pain in hospitalised adult patients in an acute hospital: A protocol for a point prevalence observational study.2021https://dx.doi.org/10.1136/bmjopen-2020-046138
N.B. These documents automatically identified may not have been verified by the study sponsor.