Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615001016527
Ethics application status
Approved
Date submitted
15/09/2015
Date registered
29/09/2015
Date last updated
3/04/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Improving access for community health and sub-acute outpatient services.
Scientific title
Does the STAT(Specific Timely appointments and Triage) model reduce waiting times for sub-acute outpatient services compared to a traditional wait list and triage model?
Secondary ID [1] 287510 0
Nil
Universal Trial Number (UTN)
Trial acronym
The STAT Project
Linked study record

Health condition
Health condition(s) or problem(s) studied:
waiting times for admission to sub-acute outpatient services 296038 0
Paediatric Allied Health Services (Occupational therapy, physiotherapy and speech pathology)
 296039 0
Adult Allied Health Services (Occupational Therapy and Physiotherapy) 296093 0
Specialist Clinics (Continence and Lymphoedema clinics) 296094 0
Condition category
Condition code
Public Health 296308 296308 0 0
Health service research
Physical Medicine / Rehabilitation 296538 296538 0 0
Physiotherapy
Physical Medicine / Rehabilitation 296539 296539 0 0
Speech therapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The STAT model is a new approach to access and triage for ambulatory services. Clinicians schedule a specified number of appointments for triage and assessment of new referrals in their weekly schedule, based on analysis of supply and demand. All patients are assessed in the first available time slot, and the clinician then prioritises the patient within the context of his/her caseload. Unlike traditional triage systems, clinicians are able to consider the relative priority of both new patients and those already under their care, and the system drives clinicians to seek efficiencies in patient management and make decisions in response to demand.

Each site will have a 12 week period in which to implement the new model, before post intervention data collection commences. Sites will be supported to make the change through 2 x 90 minute workshops, occurring within the first 4 weeks of the intervention period, approximately 1 week apart. Additional meetings will be held with key personal at the sites and project staff during the implementation period as required. The initial workshop will involve group training in the theory behind the model and how it works in practice, as well as an interactive component in which participants anticipate potential barriers, challenges and other issues that may arise in applying the model to the specific service in question. The second workshop is entirely interactive, and provides an opportunity to work through all the issues raised in the first workshop and develop strategies and contingency plans for each one, as well as a detailed implementation plan specific to the needs of the service.

A small allocation of funds will be available to contribute to reduction in the backlog of patients waiting prior to introducing the new model, but no ongoing additional resources will be available to the services.

Project staff will meet with key clinicians and managers in the service approximately monthly to monitor adherence to the model throughout the post intervention period.
Intervention code [1] 292743 0
Other interventions
Comparator / control treatment
Traditional wait list and triage approach to managing demand, whereby new patients are given a triage category and placed on a waiting list, and selected from the waiting list when existing patients are discharged.
Control group
Active

Outcomes
Primary outcome [1] 295959 0
Time from referral to first face to face appointment ('waiting time'). Referral date and dates of all appointments are routinely collected on health service databases at all sites. Waiting time will be calculated by subtracting the date of first appointment from the date of referral.

Collected for all patients who have their first face to face appointment during the pre or post data collection periods.
Timepoint [1] 295959 0
At admission to the service, defined as the date of the client's first face to face appointment with the service.
Secondary outcome [1] 317049 0
Number of face to face appointments during the first 12 weeks following admission (defined as first face to face appointment). Referral date and dates of all appointments are routinely collected on health service databases at all sites.

Collected for all patients who have their first face to face appointment during the pre or post data collection periods.
Timepoint [1] 317049 0
12 weeks following the first face to face appointment
Secondary outcome [2] 317050 0
Health related quality of life, measured using the AQOL - 8D.

This information will be collected from a subgroup of 40 consecutive patients in each data collection period (pre and post intervention) at each site.
Timepoint [2] 317050 0
At the time of the first face to face appointment, and repeated 12 weeks following the first face to face appointment.
Secondary outcome [3] 317052 0
Admission to any of the 6 inpatient facilities (acute/subaucte hospitals) within the Eastern Health network within 6 months of the first face to face appointment. This information will be sought from Health Information Services at Eastern Health.

Collected for all patients who have their first face to face appointment during the pre or post data collection periods.
Timepoint [3] 317052 0
Collected retrospectively 6 months after the first face to face appointment.
Secondary outcome [4] 317053 0
Patient /carer satisfaction with the services. Patient satisfaction will be measured using a 12 item questionnaire with responses recorded on a 5 point Likert scale adapted from the Physical Therapy Outpatient Satisfaction questionnaire developed by Goldstein et al, 2000. Two additional open ended questions will be asked to provide further opportunity to explore sources of satisfaction and dissatisfaction with the service, as well as the Net Promotor Score, which asks the participant to rate the lkelihood of recommending the service to others on a 5 point Likert scale.

This information will be collected from a subgroup of 40 consecutive patients in each data collection period (pre and post intervention) at each site.
Timepoint [4] 317053 0
12 weeks following the first face to face appointment with the service.
Secondary outcome [5] 317054 0
Number of patients who are referred to the service but discharged (discontinued) without ever having a face to face appointment.

Collected for all patients who have their first face to face appointment during the pre or post data collection periods.
Timepoint [5] 317054 0
12 weeks following the first face to face appointment with the service.
Secondary outcome [6] 317055 0
Health economics data questionnaire using a questionnaire specifically designed for this study. The questionnaire includes the following areas: paid employment, informal care/support, benefits received, health service utilisation and details of hospital admissions.

This information will be collected from a subgroup of 40 consecutive patients in each data collection period (pre and post intervention) at each site.
Timepoint [6] 317055 0
12 weeks following the first face to face appointment with the service.
Secondary outcome [7] 317669 0
Nature of each face to face appointment during the first 12 weeks following admission (defined as first face to face appointment). This includes group vs individual consultation, and location of consultation (patient's home or clinic setting).

Collected for all patients who have their first face to face appointment during the pre or post data collection periods. This is routinely colelcted data and will be retrieved from health service records.
Timepoint [7] 317669 0
12 weeks following the first face to face appointment with the service.
Secondary outcome [8] 317671 0
Non arrival rates - the number of appointments missed by each patient without cancellation or notification.
Timepoint [8] 317671 0
12 weeks following the first face to face appointment.

Collected for all patients who have their first face to face appointment during the pre or post data collection periods. This is routinely collected data and will be retrieved from health service records.

Eligibility
Key inclusion criteria
Services are eligible for inclusion in the trial if they:
Are under the auspices of Eastern Health, Victoria.
Provide services to outpatients either in the community or at treatment centres.
Provide services that typically take the form of a series of appointments rather than a single occasion of service.
Currently utilise a waiting list and triage system for managing demand.

The service usage data (eg waiting time, number of appointments, non-arrival rates etc) will be included for all clients who have a first face to face appointment with included services during the data period. Potential participants will be invited to participate in consecutive order of arrival at the service until the required sample size is reached.

Clients will be invited to participate in data collection for the subgroup of 40 participants pre and post intervention at each site if they:
-commence services during the inclusion period
-consent to participate
-are accompanied by someone who can consent on their behalf in the case of children or people whose capacity to conesnt is compromised
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Services will be excluded if they are:

Non Eastern Health services.
Services that do not have a waiting list at the time of recruitment.

Clients will be excluded from the inclusion in the subgroup of 40 patients pre/post at each service it they do not consent to participate, or do not have capacity to give consent (eg due to language barriers, age or cognitive impairment) and are not accompanied by someone who can consent on their behalf. Note that interpreters will sought wherever possible.

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)
A Stepped Wedge Cluster Randomised Controlled Trial.
All 8 services will receive the intervention in random order, with services commencing the STAT model at 4 weekly intervals. Random sequence will be determined by an off site researcher not involved in recruitment or data collection, using a computerised randomisation sequence.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation with a single block using a table created by computer software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Other
Other design features
Stepped Wedge Cluster Randomised Controlled Trial.

Intervention is provided to each of 8 sites in random order, with new services beginning at 4 weekly intervals. Sequence of intervention randomised using a computer generated sequence, run by a researcher not involved in the implementation of the new model or collection of data.

Service level data to be collected from all patients attending the services during the trial period.

Patient level data (QOL health utilisation and patient satisfaction data) will be obtained from a subgroup of 40 patients pre and post intervention at each of the 8 sites (n=640 in total). The intervention occurs at the service level, and patients are unaware of the changes or whether they are being asked to participate during a pre or post intervention period.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The targeted sample size for the SWCRT is calculated by taking into account the intra-cluster correlation coefficient, the expected effect size, and the desired power (80%) of the study as well as the number of steps, the number of baseline measurements, and the number of measurements between steps. The calculation suggests that 2,496 participants (approximately 26 admissions per site per 4 week block of data collection, resulting in a minimum of 312 participants per site) are needed to detect a mean difference with small to medium effects size in waiting time at 5% level of significance and power of 80% and an intra-cluster correlation coefficient of rho=0.01 .

We plan to collect individual data on a sub-group of participants at each of the 8 sites pre and post intervention. The sample for these individual secondary outcomes (quality of life measure, health utilisation questionnaire, and patient satisfaction) will need to be large enough to detect any differences if they exist and for the results to be generalisable. Collection of individual data will require written informed consent of each participant (in contrast to the full data set and primary outcome where we are seeking ethics approval to analyse data routinely collected by the health service).

Therefore, it is proposed to collect individual data from a total of 640 patients (40 at pre intervention and another sample of 40 at post intervention for each of the 8 participating sites). This will be approximately 25% of the total sample. Based on available data of comparable quality of life scales evaluated across 11 studies with a mean standardised response mean (SRM) of 0.39 for a comparable quality of life scale, a sample of 640 patients would have greater than 0.95 power to detect a difference if it existed.
The primary outcome (waiting time) will be analysed with a multiple multi-level random-effect regression model which allows for cluster effects. It will allow all identified factors (including patient characteristics such as age, sex and primary diagnosis) to be entered into the model simultaneously as covariates. The secondary outcomes will be also analysed with a similar approach to determine whether implementation of STAT was achieved at the expense of patient care. All analyses will be based on the intention to treat principle.

Costing analysis will be undertaken from two perspectives, (1) that of the health system, and (2) from the patient perspective. Costing of each service will be undertaken over the trial period and will include the cost of practitioners, capital and overhead costs and administrative costs, the additional costs of implementing the STAT model. Costing at the service level will enable cost per output unit to be measured, for example the average cost of a single service, the average cost of an outpatient episode by clinic type, and comparative efficiency measures such as the ratio of inputs to service output to be determined. Cost analysis from the patient perspective will include the cost per patient visit (including clinic waiting time), the cost per episode and the costs of any additional health services utilised during the episode of care.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/09/2015
Actual
30/09/2015
Date of last participant enrolment
Anticipated
Actual
3/03/2017
Date of last data collection
Anticipated
Actual
26/05/2017
Sample size
Target
2496
Accrual to date
Final
3116
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 291922 0
Government body
Name [1] 291922 0
NHMRC
Country [1] 291922 0
Australia
Funding source category [2] 291924 0
Hospital
Name [2] 291924 0
Eastern Health
Country [2] 291924 0
Australia
Funding source category [3] 291956 0
Government body
Name [3] 291956 0
Victorian Department of Health
Country [3] 291956 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
La Trobe University
Plenty Road
Bundoora, Victoria 3086
Country
Australia
Secondary sponsor category [1] 290622 0
Hospital
Name [1] 290622 0
Eastern Health
Address [1] 290622 0
5 Arnold Street,
Box Hill,
Melbourne,
Victoria 3128.
Country [1] 290622 0
Australia
Other collaborator category [1] 278628 0
University
Name [1] 278628 0
Deakin University
Address [1] 278628 0
221 Burwood Hwy,
Burwood,
VIC 3125
Country [1] 278628 0
Australia
Other collaborator category [2] 278629 0
University
Name [2] 278629 0
Plymouth University
Address [2] 278629 0
Drake Circus,
Plymouth,
Devon PL4 8AA UK
Country [2] 278629 0
United Kingdom

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293427 0
Eastern Health
Ethics committee address [1] 293427 0
Ethics committee country [1] 293427 0
Australia
Date submitted for ethics approval [1] 293427 0
Approval date [1] 293427 0
29/10/2014
Ethics approval number [1] 293427 0
E06 - 2014
Ethics committee name [2] 293428 0
La Trobe University
Ethics committee address [2] 293428 0
Ethics committee country [2] 293428 0
Australia
Date submitted for ethics approval [2] 293428 0
Approval date [2] 293428 0
04/11/2014
Ethics approval number [2] 293428 0
E06 - 2014

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

Contacts
Principal investigator
Name 59886 0
Prof Nicholas Taylor
Address 59886 0
Allied Health Clinical Research Office
Eastern Health
Level 2, 5 Arnold Street.
Box Hill,
Victoria 3128.
Country 59886 0
Australia
Phone 59886 0
+61 3 90918874
Fax 59886 0
Email 59886 0
[email protected]
Contact person for public queries
Name 59887 0
Katherine Harding
Address 59887 0
Allied Health Clinical Research Office
Eastern Health
Level 2, 5 Arnold Street,
Box Hill,
Victoria 3128.
Country 59887 0
Australia
Phone 59887 0
+1 3 90918880
Fax 59887 0
Email 59887 0
katherine.harding@easternhealth .org.au
Contact person for scientific queries
Name 59888 0
Katherine Harding
Address 59888 0
Allied Health Clinical Research Office
Eastern Health
Level 2, 5 Arnold Street,
Box Hill,
Victoria 3128.
Country 59888 0
Australia
Phone 59888 0
+1 3 90918880
Fax 59888 0
Email 59888 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
EmbaseReturn on investment of a model of access combining triage with initial management: An economic analysis.2021https://dx.doi.org/10.1136/bmjopen-2020-045096
N.B. These documents automatically identified may not have been verified by the study sponsor.