ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12612000415808

Ethics application status

Approved

Date submitted

5/04/2012

Date registered

13/04/2012

Date last updated

16/07/2018

Type of registration

Prospectively registered

Titles & IDs

Public title

Shared competencies and delegation practice in the Mackay Health Services District Emergency Department: A Randomised Controlled Trial

Scientific title

Is Allied Health professional skill sharing clinically effective in improving functional independence in older people, as compared to usual care?

Secondary ID [1]

None

Universal Trial Number (UTN)

U1111-1129-8115

Trial acronym

Linked study record

Health condition

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

Functional decline in older people

Allied Health professional skill sharing

Condition category

Condition code

Physical Medicine / Rehabilitation

Other physical medicine / rehabilitation

Public Health

Health service research

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Allied Health professional skill sharing will involve qualified practitioners providing interventions which are considered the domain of other disciplines. An Occupational Therapist (OT) and a Physiotherapist (PT) will provide interventions from these 2 disciplines and additionally from Speech Pathology, Dietetics, Soial Work and Podiatry. Patients randomised to this group will be assessed and followed up by 1 clinician who will provide interventions historically delivered by other disciplines. However, they will refer on to these disciplines if more specialist input is needed. patients will be followed up for up to 4 weeks as frequently as dictated by their condition

Intervention code [1]

Rehabilitation

Intervention code [2]

Treatment: Other

Comparator / control treatment

Usual care control intervention will involve patients being referred to individual Allied health disciplines as the need is identified by medical and nursing staff.

Control group

Active

Outcomes

Primary outcome [1]

Functional independence measured via the WHODAS. This is a questionnaire which will be administered by a research project staff member.

Timepoint [1]

Baseline, 1 and 4 months

Secondary outcome [1]

EQ-5D-3L is a questionnaire which can be self or proxy administered. It is a quality of life measure and will be used to calculate cost utility

Timepoint [1]

Baseline, 1 and 4 months

Secondary outcome [2]

SF12 is a questionnaire which can be self or proxy administered. It is a quality of life measure and can also be used to calculate cost utility

Timepoint [2]

Baseline, 1 and 4 months

Secondary outcome [3]

Modified Barthel a questionnaire which can be self or proxy administered. It is a valid and reliable measure of functional independence

Timepoint [3]

Baseline, 1 and 4 months

Secondary outcome [4]

Timed up and Go which is an objective measure of functinal mobility and can be used to calculate falls risk

Timepoint [4]

Baseline, 1 and 4 months

Eligibility

Key inclusion criteria

Older people, 65 yrs and over, suffering functional decline, Mackay Hospital and Health Service (HHS), within 30 minutes travel of Mackay Base hospital

Minimum age

65 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Anxious, too unwell to consent, cognitive impairment, under 65 yrs age

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Patients attending Mackay HHS who fulfil the inclusion criteria will be enrolled by the clinicians providing the intervention. Once baseline assessments have been completed the clinicians will randomise participants using web based, remote, simple randomisation.
Allocation concealment will be maintained because the clinicians recruiting and carrying out baseline assessment will be blind to group allocation because randonisation will not take place until the recruitment process is complete. Subversion of randomisation process will not be possible because remote web based randomisation is being used

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Simple, web based, remote randomisation via a clinical trials unit in the UK (York Trials Unit)

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

23/04/2012

Actual

23/04/2012

Date of last participant enrolment

Anticipated

Actual

30/01/2013

Date of last data collection

Anticipated

Actual

31/05/2013

Sample size

Target

152

Accrual to date

Final

152

Recruitment in Australia

Recruitment state(s)

QLD

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Queensland Health

Address [1]

147-163 Charlotte Street
Brisbane
Queensland 4000

Country [1]

Australia

Primary sponsor type

Hospital

Name

Mackay Health Service District

Address

Mackay Base Hospital
PO Box 5580
Mackay Mail Centre
Mackay
Queensland 4740

Country

Australia

Secondary sponsor category [1]

Government body

Name [1]

AHWACU

Address [1]

147-163 Charlotte Street
Brisbane
Queensland 4000

Country [1]

Australia

Other collaborator category [1]

University

Name [1]

James Cook University

Address [1]

1 James Cook Drive
Townsville
Queensland 4811

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Townsville Ethics Committee

Ethics committee address [1]

Townsville Hospital
PO Box 670
Townsville Mail Centre
Queensland 4810

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

14/03/2012

Ethics approval number [1]

HREC/11/QTHS/185

Summary

Brief summary

Demographic trends resulting in increased longevity and an increasingly aged population, combined with the current economic climate, indicate that there will be rising demand placed on already stretched health resources. This is accentuated by the rural location of the Mackay Health Service District (MHSD) which leads to a disproportionate amount of patient and clinician time being spent on travel, as compared to metropolitan services. 
Within Mackay Base Hospital there are pressures on bed availability (average 96.5% bed occupancy), necessitating innovative early discharge / admission prevention strategies. In addition, patients may be admitted unnecessarily because; they are nearing their emergency department (ED) wait limit target; there are limited and variable Allied Health (AH) services available for ED referrals; or existing ED staff do not have a detailed awareness of community services available to address these patients’ rehabilitation needs. 
Compounding this, anecdote suggests that there are inefficiencies within existing AH service delivery models; that tasks are duplicated by health professionals, that patients are frustrated by repeating information to AH staff involved in their care, that Allied Health Assistants (AHAs) are under utilised and that services are often fragmented. 
Increasing pressures on services, staff shortages and lone working, common in regional areas, has led to clinicians informally skill sharing, albeit in an ad-hoc and unstructured fashion, often without the requisite training and competence to enable them to be effective, or to recognise when they are out of their depth. There is inherent risk in this practice, unless a rigorous process has been followed to identify and risk analyse tasks for their appropriateness to share across professional boundaries or delegate. 
There is subjective information indicating that many tasks are undertaken by qualified practitioners that could be delegated to AHAs, and that there are tasks that can’t be delegated but don’t require highly specialist knowledge and skills to perform, for example routine assessments / interventions. In these instances, it is intuitively sensible to identify which tasks could be delegated / shared across professional boundaries, to use the skill set of the multi-disciplinary team (MDT) more effectively. 
The Calderdale Competency Framework is a systematic approach to identifying tasks carried out in teams, deciding which can be shared across professional boundaries, or delegated, and assessing competence. Following implementation of the Calderdale Framework, AH practitioners share professional skills across AH disciplines and increase delegation of tasks to AHAs, reducing the number of professionals involved in a patient’s care and minimising duplication of interviews, assessments, interventions, documentation and travel. 
The Calderdale Competency Framework has numerous potential benefits for the patients, clinicians and organisations, including:

Patients are able to form a rapport with 1 individual who can meet most needs, reducing the number of visitors to their home or bedside - more rounded, holistic knowledge of the patient 
Access to a wider range if interventions for patients living in rural / remote areas
Reduced repetition of personal details, condition history and assessments - reduced travel costs and duplication of tasks / roles
Closer MDT working - Multi skilled staff - effective team built around the patient
Increased awareness and respect of one another’s roles - more issues are identified and addressed - awareness of when staff need to seek the involvement of their colleagues 
Each discipline’s areas of expertise are identified - guides focus of resources 
Safe skill sharing / transferable skills
Multi skilled workforce using the full scope of  practice and delegating appropriately
Increased job satisfaction – clarified roles and responsibilities - reduction in staff absence
Less ‘hand offs’ - No need for patient handover
Improved service productivity / patient flow
Management of increased demands

Although this framework has been applied in many settings in the UK, it has not been used previously in Australia and the clinical effectiveness of this model of care (MoC) has never been evaluated. In Queensland Health, this model of care is known as shared competencies and delegation practice (SCDP).
The proposed study aims to examine the clinical and cost effectiveness in SCDP in relation to its current implementation in the Mackay Health Service District.


All AH tasks carried out within the Emergency Department (ED) in the Mackay Health Services District will be identified and, using a risk management decision tool, tasks will be categorised into those that should be delegated to support staff, those that could be professionally skill shared and those which should remain uni-disciplinary. Competencies will be written / sourced and multi-disciplinary team (MDT) staff will teach each other skills, which have historically been considered their role. An Occupational Therapist and a Physiotherapist will then operate Shared Competencies and Delegation Practice within the ED setting. MDT staff will be fully engaged at all stages of the process to ensure sign up. 
The model is likely to enable patients, triaged to ED categories 2/3/4 (n=27,156 July 2010 - February 2011), to be assessed by AH staff quickly and admission avoided or length of stay reduced, as MDT assessments would have already been completed and discharge planning initiated. The nursing and medical input to patients will not be affected by this study.


Aim(s) of project/study 
This study aims to determine the clinical and cost effectiveness in implementing a SCDP MoC with older people presenting to the ED.


Research questions 
Is Shared Competencies and Delegation Practice (SCDP) clinically effective in enhancing patients’ functional independence, in an Emergency Department (ED) setting, as compared to usual care?
Is SCPD cost effective?


A prospective Randomised Controlled Trial design will be used with blinding of participants, outcome assessors and statistical analysts. Data will be collected at baseline, on discharge from Allied Health intervention and at 4 months post randomisation.

The Cost Utility Study will be carried out from a societal perspective with both direct and indirect costs identified. The primary measure of benefit will be quality of life as measured by the Euroqol. 

Clients who attend the ED between the hours of 8am – 6pm Monday to Saturday, meet the study inclusion criteria and provide written informed consent to participate will be randomised to the intervention or control groups. The intervention group will receive AH input from clinicians trained in Shared Competencies and Delegation Practice whilst in ED, with follow-up on the ward or in the community if required. The AH clinicians based in the ED will be an occupational therapists and physiotherapists, by clinical background, but will be additionally trained in occupational therapy / physiotherapy / speech pathology / dietetics / podiatry and social work competencies. Thus, clinicians will be able to complete a more a rounded assessment and target intervention to meet the client’s complex needs. Intervention will aim to maximise functional independence, prevent admission and minimise the number of AH clinicians involved in a client’s care. An intervention protocol will be developed to ensure consistency in this approach.

The control group will receive standard care, which comprises of clients being referred to individual disciplines, as the need is identified by the Community: Hospital Interface Programme (CHIP) nurses in the ED. Individual disciplines will then intervene with the clients using existing uni-disciplinary approaches and refer on to other services as indicated. Standard care will be documented via an audit prior to trial commencement to ensure that it can be clearly defined at the outset.

Trial website

Trial related presentations / publications

Pighills, A. C., Bradford, M., Bell, K., Flynn, L. J., Williams, G., Hornsby, D., . . . Kaltner, M. (2015). Skill-sharing between allied health professionals in a community setting: A randomised controlled trial. International Journal of Therapy and Rehabilitation, 22(11), 524-534.

Public notes

Contacts

Principal investigator

Name

A/Prof Alison Pighills

Address

Mackay Institute of Research and Innovation
Mackay Base Hospital
PO Box 5580
Mackay
Qld 4741

Country

Australia

Phone

+610748857081

Fax

[email protected]

Contact person for public queries

Name

Dr Alison Pighills

Address

Education and Research Centre
Mackay Base Hospital
PO Box 5580
Mackay Mail Centre
Mackay
Queensland 4740

Country

Australia

Phone

061 7 4885 6131

Fax

[email protected]

Contact person for scientific queries

Name

Dr Alison Pighills

Address

Education and Research Centre
Mackay Base Hospital
PO Box 5580
Mackay Mail Centre
Mackay
Queensland 4740

Country

Australia

Phone

061 7 4885 6131

Fax

[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

No additional documents have been identified.

Trial Review

Documents added manually

Documents added automatically