Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000757516
Ethics application status
Approved
Date submitted
9/05/2024
Date registered
20/06/2024
Date last updated
20/06/2024
Date data sharing statement initially provided
20/06/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating the Preventative Integrated Care Service for adults living with chronic disease
Scientific title
Assessing programme development, effectiveness, and sustainability of the Preventative Integrated Care Service for adults living with chronic respiratory disease, chronic cardiovascular disease, and diabetes
Secondary ID [1] 312070 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular diseases 333518 0
Chronic lung diseases 333519 0
Diabetes 333520 0
Condition category
Condition code
Cardiovascular 330200 330200 0 0
Coronary heart disease
Respiratory 330201 330201 0 0
Chronic obstructive pulmonary disease
Metabolic and Endocrine 330202 330202 0 0
Diabetes
Cardiovascular 330424 330424 0 0
Hypertension
Cardiovascular 330425 330425 0 0
Other cardiovascular diseases
Respiratory 330491 330491 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The Preventative Integrated Care Service (PICS) is a rapid access, specialised, multidisciplinary, outpatient care model that was recently established in South-East Queensland, Australia. It provides a 14-day, rapid assessment and medical stabilisation service offering intensive specialised medical management of adults living with chronic respiratory diseases, chronic cardiovascular diseases, and/or diabetes. PICS is delivered by a specialist-led, multidisciplinary care team, and is delivered through multimodalities (e.g., in clinic, telephone, remote biometric monitoring, home visit). This programme was rolled out in South-East Queensland, Australia, was rolled out without implementation evaluation planning at its inception.
This research will be conducted over three, six-month phases:
- Phase 1: Context assessment (t1, August-September 2024). The primary outcomes of core components, programme determinants, and patient experiences, and secondary outcome of barriers and enablers will be identified and measured.
- Phase 2: Process evaluation (t2, February-March 2025). The primary outcomes of fidelity and adoption, and secondary outcome of clinical effectiveness will be measured.
- Phase 3: Service iteration and adaption for quality improvement (t3, August-September 2025). The primary outcome of service iteration and adaption will be measured.
There are four groups of participants that will be engaged in the research:
- Adopters (Consumers): Patients who have received PICS. Consumers will be recruited to participate in 45-60min semi-structured interviews (one baseline, and a six-month follow-up) on their perspectives and experience of receiving the PICS. Patients will not be required to undertake additional physical or psychometric assessments. Patients will receive reciprocity for their time. Engagement of patients is only during Phase 1 Context assessment. Further detail is provided in Section 7 Recruitment. Deidentified, clinical patient information will be utilised for secondary outcome measurement (Phase 2 secondary outcome - clinical effectiveness) for data between t1 (01 August 2024) and t3 (01 August 2025). A waiver for consent has been approved by the Human Research Ethics Committee.
- Adopters & implementers (PICS service delivery staff): Participants will be recruited at all three phases of research. Participation will involve semi-structured interviews (Phase 1 and 2), with the opportunity to provide feedback on interview summary notes to the researcher. A subsample of participants will be recruited to Phase 3, to participate in collaborative workshops for service iteration and adaption. Following the completion of their semi-structured interview, participants will be offered to the opportunity to nominate to participate in the collaborative workshop, A representative sample cross disciplines and professional delegation (i.e., clinician, team leader, executive) will be determined by the research team. The collaborative workshop will involve two x four-hour face-to-face workshops, facilitated by the research team. Active participation in responding to researcher queries and participating in conversation with colleagues will be required. The workforce profile for the PICS includes Nurse Practitioners, Registered Nurses, Senior Medical Officers, Dietitian, Pharmacist, Physiotherapists, Occupational Therapists, and Social Workers.
- Implementation leaders and decision makers: Participants will be recruited at all three phases of research. Participation will involve semi-structured interviews (Phase 1 and 2), with the opportunity to provide feedback on interview summary notes to the researcher. A subsample of participants will be recruited to Phase 3, to participate in collaborative workshops for service iteration and adaption. Following the completion of their semi-structured interview, participants will be offered to the opportunity to nominate to participate in the collaborative workshop, A representative sample cross disciplines and professional delegation (i.e., clinician, team leader, executive) will be determined by the research team.
- Wider system referrers: Participants will be recruited at Phase 3, with the opportunity to provide feedback on interview summary notes to the researcher.
Intervention code [1] 328437 0
Not applicable
Comparator / control treatment
There is no control or comparator group. This is a quasi-experimental, observational study examining the implementation effectiveness of a model of care that has already been rolled out by the Queensland Government.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 338011 0
Core components (operationally defined as compulsory service elements for this model of care) is a primary outcome for Phase 1.
Timepoint [1] 338011 0
Phase one - context assessment (t1): Assessment of core components will occur in August & September 2024.
Primary outcome [2] 338012 0
Programme determinants (operationally defined as characteristics that influence implementation effectiveness of this model of care) is a primary outcome for Phase 1.
Timepoint [2] 338012 0
Phase one - context assessment (t1): Assessment of programme determinants will occur in August & September 2024.
Primary outcome [3] 338013 0
Consumer experiences is a primary outcome for Phase 1.
Timepoint [3] 338013 0
Phase one - context assessment (t1): Assessment of consumer experiences will occur in August & September 2024.
Secondary outcome [1] 434122 0
Fidelity (primary outcome for Phase 2) will examine protocol adherence as prescribed by the PICS Model of Care across all service areas.
Timepoint [1] 434122 0
Phase two - process evaluation (t2): Assessment of fidelity will occur in February & March 2025.
Secondary outcome [2] 434850 0
Adoption (primary outcome for Phase 2) will be examined through service utilisation (measured through occasions of service) and number of referrals to service.
Timepoint [2] 434850 0
Phase two - process evaluation (t2): Assessment of adoption will occur in February & March 2025.
Secondary outcome [3] 435314 0
Service adaption (primary outcome for Phase 3) will be assessed using a theory-driven, prioritisation workshop.
Timepoint [3] 435314 0
Phase three - service iteration and adaption for quality improvement (t3): Assessment of service adaption will occur in August & September 2025.
Secondary outcome [4] 435315 0
Phase one (context assessment) will have one secondary outcome - barriers and enablers.
Timepoint [4] 435315 0
This will be conducted at two timepoints - Phase one (t1) and Phase two (t2). The same method will be used at both timepoints.
Secondary outcome [5] 435316 0
Phase two (process evaluation) will have one secondary outcome.
effectiveness, will be broadly measured comparing referral rates, hospitalisations, and subjective wellbeing using, where appropriate, pre-post and time-series analysis.
Timepoint [5] 435316 0
All deidentified clinical records between t1 (01 August 2024) and t3 (01 August 2025).

Eligibility
Key inclusion criteria
There are four categories of participants for this research.
a) Adopters - PICS Consumers: Consumers who have received PICS within the past six months. Service eligibility is defined as:
i) Any patient that has a confirmed diagnosis of heart failure, and/or cardiovascular disease; and/or
ii) Any patient with type 2 diabetes mellitus and HbA1c >8% or unstable diabetes requiring insulin or recent or current hospital admission related to diabetes, diabetic complications, or high risk foot; and/or
iii) any patient with type 1 diabetes; and/or
iv) any patient with a confirmed diagnosis of asthma, chronic obstructive pulmonary disease, bronchiectasis, interstitial lung disease, and/or pulmonary fibrosis; AND has/will experience(d) at least one of the following:
v) Intensive care unit requirement during most recent admission;
vi) Post discharge from complex respiratory/cardiac/diabetes disease related hospital admission;
vii) At high risk of admission/readmission to hospital with a potentially preventable hospitalisation caused by their chronic condition;
viii) Complex new diagnosis of chronic condition and social determinants;
ix) Patient discharged on new home oxygen.

b) Adopters and Implementers - PICS Staff who are delivering the service protocol: Staff who are current employees of the PICS.

c) Implementation decision makers - Health service directors & executive directors: Hospital and Health Service staff who have professional and/or operational leadership delegation over one or more professional, clinical, or operational components of the PICS (e.g., Executive, Team Leader, Allied Health Directors, Informatics Managers) within the study period.

d) Wider system referrers – general practitioners and other specialists within the catchment area: Primary care providers and referring Hospital and Health Service staff to the PICS.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
a) Adopters - PICS Consumers: PICS consumers who have not received PICS services in the past six months, Consumers who:
i) Reside outside of service catchment;
ii) Require high acuity care. e.g., Hospital in the Home, Emergency Department, or for Direct Admission to an inpatient unit.
iii) Do not have one of the listed chronic conditions or who do not meet the inclusion criteria.
iv) Are currently residing in an Residential Aged Care Facility.

b) Adopters and Implementers - Staff who are not current employees of the PICS.

c) Implementation decision makers - Health service directors & executive directors: Hospital and Health Service staff who do not have professional and/or operational leadership delegation over one or more professional, clinical, or operational components of the PICS (e.g., Executive, Team Leader, Allied Health Directors, Informatics Managers) within the study period.

d) Wider system referrers – general practitioners and other specialists operating outside of the catchment area, health professionals who have not yet referred to the PICS.

Study design
Purpose
Duration
Selection
Defined population
Timing
Both
Statistical methods / analysis
Participants per phase of research project are noted as follows:
Phase One: Context Assessment (t1)
- Adopters (Consumers): n=30
- Adopters & implementers (Service delivery staff): n=15
- Implementation decision-makers: n=5
Phase Two: Process evaluation (t2)
- Adopters & implementers (Service delivery staff): n=15
- Implementation decision-makers: n=5
Phase Three: Service iteration and adaption (t3)
- Adopters & implementers (Service delivery staff): n=3-5
- Wider system referrers: n=10

Primarily this is a qualitative study; however, there will be some descriptive analyses and where appropriate, binomial logistic regression will be used to understand the relationship between key demographic factors and Phase two secondary outcome - clinical effectiveness (such as appropriate referral or hospitalisation). All patients with clinical data accessing the PICS within the research period (01/07/2024 to 31/12/2025) will be included for assessment of clinical effectiveness.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2024
Actual
Date of last participant enrolment
Anticipated
30/09/2025
Actual
Date of last data collection
Anticipated
31/12/2025
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 316275 0
University
Name [1] 316275 0
Queensland University of Technology
Country [1] 316275 0
Australia
Funding source category [2] 316325 0
Government body
Name [2] 316325 0
West Moreton Hospital & Health Service
Country [2] 316325 0
Australia
Primary sponsor type
University
Name
Queensland University of Technology
Address
Country
Australia
Secondary sponsor category [1] 318465 0
Government body
Name [1] 318465 0
West Moreton Hospital & Health Service
Address [1] 318465 0
Country [1] 318465 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315094 0
West Moreton Hospital and Health Service
Ethics committee address [1] 315094 0
Ethics committee country [1] 315094 0
Australia
Date submitted for ethics approval [1] 315094 0
18/07/2023
Approval date [1] 315094 0
02/08/2023
Ethics approval number [1] 315094 0
HREC/2023/QWMS/99335

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

Contacts
Principal investigator
Name 133658 0
Mrs Ashleigh Earnshaw
Address 133658 0
The Australian Centre for Health Services Innovation, 60 Musk Ave, Kelvin Grove, QLD, 4059
Country 133658 0
Australia
Phone 133658 0
+61433426411
Fax 133658 0
Email 133658 0
[email protected]
Contact person for public queries
Name 133659 0
Ashleigh Earnshaw
Address 133659 0
The Australian Centre for Health Services Innovation, 60 Musk Ave, Kelvin Grove, QLD, 4059
Country 133659 0
Australia
Phone 133659 0
+61 731380310
Fax 133659 0
Email 133659 0
[email protected]
Contact person for scientific queries
Name 133660 0
Sundresan Naicker
Address 133660 0
The Australian Centre for Health Services Innovation, 60 Musk Ave, Kelvin Grove, QLD, 4059
Country 133660 0
Australia
Phone 133660 0
+61 0449876034
Fax 133660 0
Email 133660 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified ieMR data used for measurement of the Phase 2 secondary outcome of Clinical effectiveness.
When will data be available (start and end dates)?
Healthcare service utilisation data will be accessed retrospectively for the time period of 01 July 2024 to 31 December 2025.
Available to whom?
Anonymised record-level data can be made publicly available on request to investigators, who have submitted a publicly available proposal for analysis, and who have received ethical clearance from their host institution.
Available for what types of analyses?
Assessment of clinical effectiveness of similar to that outlined within this proposal.
How or where can data be obtained?
Email request to primary investigator ([email protected]).


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
22360Study protocol  [email protected] A study protocol manuscript will be submitted for ... [More Details]
22361Informed consent form  [email protected] A copy of Participant Information and Consent Form... [More Details]



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically
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