Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000742370
Ethics application status
Approved
Date submitted
14/05/2017
Date registered
22/05/2017
Date last updated
22/05/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
OPTAmising prevention of delirium and other risks for older people in the ED through use of an assistant workforce: a pre- post study.
Scientific title
OPTAmising prevention of delirium and other risks for older people in the ED through use of an assistant workforce: a pre- post study.
Secondary ID [1] 291940 0
Nil known
Universal Trial Number (UTN)
Trial acronym
OPTA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Delirium 303277 0
Condition category
Condition code
Neurological 302706 302706 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention was four full time equivalent (FTE) Older Person Technical Assistants (OPTAs) will be rostered between 8 am to 8pm in the ED, seven days a week for 12 months in 8 hour shifts. The OPTAs focus on screening and the supportive care of people over the age of 75 years who were not experiencing life threatening situations.

The prerequisites for selection as an OPTA include previous training or experience as a health care assistant or equivalent. On commencement in the ED, over a 5 day period ,the OPTAs will be oriented to the ED and hospital environment, trained and assessed in competency as assistants in nursing, patient privacy and dignity as well as the screening tools. They will be instructed on recording screening findings and supportive care in the electronic patient management system.

Screening undertaken includes:
*Six item screener, a brief cognitive assessment screen designed for EDs
*Confusion Assessment Method Instrument (CAMI) for delirium
*Falls Risk for Hospitalised Older People, a falls screening tool
*Identification of Seniors at Risk, a tool to identify patients at risk for ED representation
*Numerical rating scale for pain
*Waterlow screening tool for pressure injury risk screening
*Mini-Nutritional Assessment for nutrition and
*Modified Care Strain Index to screen for caregiver strain with long-term family caregivers.

In line with Australian clinical practice guidelines for the management of people with delirium, preventative environmental and clinical practice strategies are incorporated into the role. This multicomponent delirium prevention strategy consists of orienting the person to the ED environment, attending to nutrition, hydration and elimination needs, providing sensory and mobility aids, supervising and assisting moving, support when agitated and facilitating carer presence as often as possible. A delirium prevention box is available for OPTAs to use with patients this included daily newspapers, playing cards, games and puzzles, crosswords, a radio with ear phones and a clock. OPTAs also provided support to carers in the ED who are often older people themselves.

The setting is a tertiary referral hospital Emergency Department in New South Wales, Australia. In the year prior to this study, the ED had 67,000 ED presentations, 13 % of which were by patients over 75 years of age.
Intervention code [1] 298060 0
Early detection / Screening
Comparator / control treatment
All patients presenting to the tertiary referral Emergency Department over the age of 75 years.

Patients presenting the year before the OPTA Intervention, 1st July 2010 to 30th June 2011 were compared to patients seen by OPTAs 1st July 2011 to 30th June 2012.

In order to determine the extent to which screening, assessment and care interventions known to prevent delirium and other adverse events in older people were documented as having been undertaken in the ED, the medical records of 63 patients will be randomly selected for a medical record documentation audit, undertaken by members of the research team comparing the same period, 1st March 2010 to 30th June 2010 compared to 1st March 2012 and 30th June 2012.
Control group
Historical

Outcomes
Primary outcome [1] 302107 0
Delirium is assessed using the Confusion Assessment Method (CAM)
Timepoint [1] 302107 0
During hospital stay
Secondary outcome [1] 334796 0
Admission to hospital
Timepoint [1] 334796 0
After Emergency Department visit
Secondary outcome [2] 335015 0
Emergency Department length of stay
Timepoint [2] 335015 0
Minutes in the ED
Secondary outcome [3] 335016 0
Hospital inpatient length of stay
Timepoint [3] 335016 0
Days in hospital
Secondary outcome [4] 335017 0
Quality of medical record documentation of screening in the ED, pain, falls risk, pressure Injury risk, nutrition, cognition
Timepoint [4] 335017 0
Documentation during ED visit. Assessed by pre and post medical record audit.
Secondary outcome [5] 335057 0
Quality of medical record documentation of supportive care in the ED, review of pain, given food or fluids,orientation, toileting, mobilisation, pressure care and family or carers in attendance
Timepoint [5] 335057 0
Documentation during during ED visit. Assessed by pre and post medical record audit.

Eligibility
Key inclusion criteria
All patients presenting to the Emergency Department
Minimum age
75 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who are critically unwell, requiring resuscitation and patients who are have low complexity presentations and most likely discharged from hospital

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
OPTA screening scores were compared with Aged Services Emergency Team (ASET) RNs. These advanced clinical RNs target care for older patients with chronic and complex care needs in the ED. The scores obtained by OPTAs and those obtained by RNs for each screening tool were compared using weighted Kappa; 95% Confidence Intervals were calculated using the Jackknife variance estimation method. In order to calculate correlation, a smaller group of patients was screened independently by one of the five OPTAs as well as one of the six RNs. To account for possible correlations between patients with the same OPTA/RN screening, a variable with the OPTA/RN identifier was added as a clustering variable.

In order to determine the extent to which screening, assessment and care interventions known to prevent delirium and other adverse events in older people were documented as having been undertaken in the ED, the medical records of 63 patients were randomly selected for the medical record documentation audit, undertaken by members of the research team comparing the same period, 1st March 2010 to 30th June 2010 compared to 1st March 2012 and 30th June 2012. The medical record audit reviewed evidence of documentation for assessment of delirium risk factors, including pain, falls, pressure injury care, nutrition and cognition as well as evidence for support care provided in the ED that prevents or assists with the management of delirium including ongoing pain review, provision of food or fluids, orientation, toileting, mobilization, pressure care and family or carers in attendance with the patient. Results were compared using student t-test.
Focus group interviews were recorded and transcribed verbatim. Focus group data were analysed thematically. Significant statements were highlighted and clustered around the goals of the model of care.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/07/2011
Date of last participant enrolment
Anticipated
Actual
1/07/2012
Date of last data collection
Anticipated
Actual
5/05/2017
Sample size
Target
3000
Accrual to date
Final
3542
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 8021 0
John Hunter Hospital - New Lambton
Recruitment postcode(s) [1] 16003 0
2305 - New Lambton

Funding & Sponsors
Funding source category [1] 296452 0
Hospital
Name [1] 296452 0
John Hunter Hospital
Country [1] 296452 0
Australia
Primary sponsor type
Hospital
Name
John Hunter Hospital
Address
Locked Bag 1
Newcastle Regional Mail Centre
New Lambton Heights New South Wales 2305
Australia
Country
Australia
Secondary sponsor category [1] 295405 0
None
Name [1] 295405 0
None
Address [1] 295405 0
Country [1] 295405 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297677 0
Hunter New England Local Health Districy
Ethics committee address [1] 297677 0
Ethics committee country [1] 297677 0
Australia
Date submitted for ethics approval [1] 297677 0
16/02/2011
Approval date [1] 297677 0
16/02/2011
Ethics approval number [1] 297677 0
11/02/16.5.01; HREC/10/HNE/402; SSA/10/HNE/402)

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

Contacts
Principal investigator
Name 74786 0
Dr Carolyn Hullick
Address 74786 0
Emergency Department
John Hunter Hospital
Lookout Road
New Lambton Heights NSW 2305
Australia
Country 74786 0
Australia
Phone 74786 0
+61249213533
Fax 74786 0
Email 74786 0
[email protected]
Contact person for public queries
Name 74787 0
Carolyn Hullick
Address 74787 0
Emergency Department
John Hunter Hospital
Lookout Road
New Lambton Heights NSW 2305
Australia
Country 74787 0
Australia
Phone 74787 0
+61249213533
Fax 74787 0
Email 74787 0
[email protected]
Contact person for scientific queries
Name 74788 0
Carolyn Hullick
Address 74788 0
Emergency Department
John Hunter Hospital
Lookout Road
New Lambton Heights NSW 2305
Australia
Country 74788 0
Australia
Phone 74788 0
+61249213533
Fax 74788 0
Email 74788 0
[email protected]

No information has been provided regarding IPD availability


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
EmbaseAn assistant workforce to improve screening rates and quality of care for older patients in the emergency department: findings of a pre- post, mixed methods study.2018https://dx.doi.org/10.1186/s12877-018-0811-6
N.B. These documents automatically identified may not have been verified by the study sponsor.