Trial Review

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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] 280282 0
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 286240 0
Allied Health professional skill sharing 286271 0
Condition category
Condition code
Physical Medicine / Rehabilitation 286455 286455 0 0
Other physical medicine / rehabilitation
Public Health 286495 286495 0 0
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] 284634 0
Rehabilitation
Intervention code [2] 284664 0
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] 286899 0
Functional independence measured via the WHODAS. This is a questionnaire which will be administered by a research project staff member.
Timepoint [1] 286899 0
Baseline, 1 and 4 months
Secondary outcome [1] 296941 0
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] 296941 0
Baseline, 1 and 4 months
Secondary outcome [2] 296942 0
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] 296942 0
Baseline, 1 and 4 months
Secondary outcome [3] 296943 0
Modified Barthel a questionnaire which can be self or proxy administered. It is a valid and reliable measure of functional independence
Timepoint [3] 296943 0
Baseline, 1 and 4 months
Secondary outcome [4] 296944 0
Timed up and Go which is an objective measure of functinal mobility and can be used to calculate falls risk
Timepoint [4] 296944 0
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?
No
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] 285048 0
Government body
Name [1] 285048 0
Queensland Health
Country [1] 285048 0
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] 283912 0
Government body
Name [1] 283912 0
AHWACU
Address [1] 283912 0
147-163 Charlotte Street
Brisbane
Queensland 4000
Country [1] 283912 0
Australia
Other collaborator category [1] 260714 0
University
Name [1] 260714 0
James Cook University
Address [1] 260714 0
1 James Cook Drive
Townsville
Queensland 4811
Country [1] 260714 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287052 0
Townsville Ethics Committee
Ethics committee address [1] 287052 0
Townsville Hospital
PO Box 670
Townsville Mail Centre
Queensland 4810
Ethics committee country [1] 287052 0
Australia
Date submitted for ethics approval [1] 287052 0
Approval date [1] 287052 0
14/03/2012
Ethics approval number [1] 287052 0
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 34029 0
A/Prof Alison Pighills
Address 34029 0
Mackay Institute of Research and Innovation
Mackay Base Hospital
PO Box 5580
Mackay
Qld 4741
Country 34029 0
Australia
Phone 34029 0
+610748857081
Fax 34029 0
Email 34029 0
[email protected]
Contact person for public queries
Name 17276 0
A/Prof Dr Alison Pighills
Address 17276 0
Education and Research Centre
Mackay Base Hospital
PO Box 5580
Mackay Mail Centre
Mackay
Queensland 4740
Country 17276 0
Australia
Phone 17276 0
061 7 4885 6131
Fax 17276 0
Email 17276 0
[email protected]
Contact person for scientific queries
Name 8204 0
A/Prof Dr Alison Pighills
Address 8204 0
Education and Research Centre
Mackay Base Hospital
PO Box 5580
Mackay Mail Centre
Mackay
Queensland 4740
Country 8204 0
Australia
Phone 8204 0
061 7 4885 6131
Fax 8204 0
Email 8204 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
No additional documents have been identified.