ANZCTR - Registration

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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]

Nil known

Universal Trial Number (UTN)

Trial acronym

OPTA

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Delirium

Condition category

Condition code

Neurological

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]

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]

Delirium is assessed using the Confusion Assessment Method (CAM)

Timepoint [1]

During hospital stay

Secondary outcome [1]

Admission to hospital

Timepoint [1]

After Emergency Department visit

Secondary outcome [2]

Emergency Department length of stay

Timepoint [2]

Minutes in the ED

Secondary outcome [3]

Hospital inpatient length of stay

Timepoint [3]

Days in hospital

Secondary outcome [4]

Quality of medical record documentation of screening in the ED, pain, falls risk, pressure Injury risk, nutrition, cognition

Timepoint [4]

Documentation during ED visit. Assessed by pre and post medical record audit.

Secondary outcome [5]

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]

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?

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]

John Hunter Hospital - New Lambton

Recruitment postcode(s) [1]

2305 - New Lambton

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

John Hunter Hospital

Address [1]

Locked Bag 1
Newcastle Regional Mail Centre
New Lambton Heights New South Wales 2305
Australia

Country [1]

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]

None

Name [1]

None

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Hunter New England Local Health Districy

Ethics committee address [1]

C/O Dr Nicole Gerrand
Manager, Research Ethics and Governance
Research Ethics and Governance Office
Locked bag 1, New Lambton, NSW, 2305

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

16/02/2011

Approval date [1]

16/02/2011

Ethics approval number [1]

11/02/16.5.01; HREC/10/HNE/402; SSA/10/HNE/402)

Summary

Brief summary

Background: 
Older people who present to the Emergency Department experience high rates of prevalent and incident delirium. This study aimed to determine whether an assistant workforce in the Emergency Department could effectively conduct screening to inform assessment and care planning of older persons as well as provide supportive care activities for prevention of delirium. 
Methods: 
This study used a pre-post design. Data was collected before and after the introduction of Older Person Technical Assistants (OPTAs) in the ED and included: recording of OPTA activity during the intervention period; a medical record audit undertaken prior to the implementation and 9 months after implementation; and focus group interviews with Emergency Department Staff. 
The data was analysed using descriptive statistics to describe the activity of the OPTAs. Weighted Kappa scores were calculated to compare the concordance between OPTA screening scores with Aged Services Emergency Team (ASET) Nurses; changes in the rates of documented screening and supportive care that is recommended in the prevention and care of people with or at risk of developing delirium. Qualitative descriptive analysis was used to examine focus group data. 
Results: 
3542 people were seen on 4563 visits by OPTAs between 1st July 2011 and 2012. The reproducibility of all screening tools were found to be very high between the OPTAs and the RNs, with Kappas and ICCs generally all above 0.9. 
The medical record audit showed significant improvement in the rates of documented screening, including cognition from 1.5% to 38% (p<0.001) and review of pain from 29% to 75% (p<0.001). Supportive care related to delirium prevention also improved with patients being given fluids or food increasing from 13% to 49% (p< 0.001) and pressure care from 4.8% to 30% (p,0.001).
Focus group interviews describe mixed response and support of the OPTA role in the ED. 
Conclusions: 
An assistant workforce deployed in an ED setting was found to provide comparable screening results and improve the rates of documented screening and supportive care provided to older people with or at risk of developing delirium in the ED. Implementation of such a model of care requires dedicated staff, robust screening, and comprehensive and systematic assessment and management of care and ongoing treatment.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Carolyn Hullick

Address

Emergency Department
John Hunter Hospital
Lookout Road
New Lambton Heights NSW 2305
Australia

Country

Australia

Phone

+61249213533

Fax

carolyn.hullick@hnehealth.nsw.gov.au

Contact person for public queries

Name

Carolyn Hullick

Address

Emergency Department
John Hunter Hospital
Lookout Road
New Lambton Heights NSW 2305
Australia

Country

Australia

Phone

+61249213533

Fax

carolyn.hullick@hnehealth.nsw.gov.au

Contact person for scientific queries

Name

Carolyn Hullick

Address

Emergency Department
John Hunter Hospital
Lookout Road
New Lambton Heights NSW 2305
Australia

Country

Australia

Phone

+61249213533

Fax

carolyn.hullick@hnehealth.nsw.gov.au

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

Source	Title	Year of Publication	DOI
Embase	An 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.	2018	https://dx.doi.org/10.1186/s12877-018-0811-6

N.B. These documents automatically identified may not have been verified by the study sponsor.

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