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Trial registered on ANZCTR


Registration number
ACTRN12617000198325
Ethics application status
Approved
Date submitted
25/01/2017
Date registered
6/02/2017
Date last updated
31/01/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy and cost-effectiveness of a community based model of care for older patients with complex needs: a study protocol for a multicentre randomized controlled trial using a stepped wedge cluster design
Scientific title
Efficacy and cost-effectiveness of a community based model of care for older patients with complex needs: a study protocol for a multicentre randomised controlled trial using a stepped wedge cluster design
Secondary ID [1] 291007 0
Nil known
Universal Trial Number (UTN)
U1111-1191-9535
Trial acronym
The OPEN ARCH Project
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Older person community based care 301776 0
Geriatric assessment with care coordination 301777 0
Chronic disease 301778 0
Transitions of care 301779 0
Condition category
Condition code
Public Health 301470 301470 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Older Persons ENablement And Rehabilitation for Complex Health conditions (OPEN ARCH) model of care intervention extends the Geriatric Evaluation and Management (GEM) model of care and enables a direct path from General Practitioners (GP) to a community based geriatrician for comprehensive interdisciplinary assessment and care management. OPEN ARCH then facilitates timely access to the most appropriate care in the community that if provided early, could enable the older person’s health to be supported such that they can remain living in the community and not require hospital attendance or admission.

The OPEN ARCH intervention have two components:
1) fast track specialist geriatric assessment via a community based referral to a geriatrician in local GP practices; and,
2) an enablement service offering the coordination and implementation of health and social care services customised to patient need in the community.

The OPEN ARCH intervention will be delivered within primary health care. Patients who are deemed eligible by GP screening evaluation and meet inclusion criteria will be requested to provide informed consent. Those who agree to participate will be fast-tracked, within 1-2 weeks, for a consultation with a specialist geriatrician. It is worth noting that participants will have access to this assessment via their GP, this will avoid the expected wait-times associated with standard access via hospital ‘out-patients’. A CGA will be conducted with their GP within the first phase of the intervention period. Alternatively, if a participant is unable to attend the assessment at the practice, a geriatrician will offer a home visit.
During the first interview and assessment, the geriatrician will provide an in-depth, standardised CGA, a multi-dimensional, interdisciplinary process used to quantify an older individual's medical, psychosocial and functional capabilities, including diagnosis, identification of problems, goal setting, and forming an individualised comprehensive management plan for holistic treatment, rehabilitation, support and follow up. The type and number of referrals to primary allied health care professionals and community support services will be determined by individual clinical needs and delivered in the community (GP, allied health practice or community health centre) or at home. Examples of allied health services that will be offered include: occupational therapy, physiotherapy, dietetics and social work. Community social support services such as personal care assistance, meals and domestic assistance will be arranged through My Aged Care and community health providers.

Based on recommendations from the CGA, the enablement officer will meet with participants to develop individual care plans. The enablement officer, who is an advanced health professional specialising in aged care, will further coordinate participant’s community care by linking them with existing services. Although a registered clinician, their role is not to provide discipline specific services, but rather draw on existing public, private and non-government allied health, nursing and social support services available in the community to facilitate care coordination goals. All participants will continue to consult with their GP for usual medical care.

Location
The study will be conducted at three sites in Far North Queensland (Australia): Cairns, Kuranda and Weipa. Twelve GPs will be recruited and randomised as ‘clusters’ at baseline using simple randomization. Each GP cluster will then recruit 10-12 participants.

Recruitment of GPs
The OPEN ARCH intervention builds on a successful collaboration between Cairns and Hinterland and Hospital and Health Service clinicians with local GP practices. Ten GPs within the Cairns area (urban) and the Cairns Hinterland region (rural) and Weipa (remote) will be approached to participate in the study. The project manager will conduct informed consent for the GP to participate in the study.

Randomisation of GPs
All GPs (n=12) will be randomised as ‘clusters’ at baseline using simple randomisation. Such cluster randomisation allows control for the ‘between GPs variance’. Two clusters will be commencing the intervention at each step, as per recommendations of Barker et al, 2017, to ensure that the intervention effect estimator maintains the nominal 5% significance level and is reasonably unbiased. All clusters will ultimately receive the intervention for the same length of time.

Participants recruitment
The treating GP, enrolled in the study, will select patients based on set eligibility criteria. The GP will discuss the study with individual patients and invite them to provide verbal consent to be contacted by the project manager to further discuss the project. The project team will arrange a time to meet with interested participants to discuss the OPEN ARCH intervention and study requirements, inviting them to provide informed consent for inclusion in the study. Participants who do not wish to provide consent for inclusion in the OPEN ARCH intervention may still access specialist geriatric assessment via the existing Cairns Hospital Outpatient referral pathway, but they will not be offered access the OPEN ARCH community care coordination offered by the enablement officers, or a geriatric assessment at their GP clinic.

Participation in this study is voluntary. Patient participants will be informed that they can withdraw at any time without giving a reason and that refusal to participate will not have any impact on current or future access to geriatric or GP services. If requested by the participant any information they may have provided will be withdrawn from the study. We do not anticipate that GPs will withdraw their consent to participate in the study. However, should a GP move their practice or retire, then their patient participants will also be withdrawn from the study and they will not be invited to participate in any further data collection. Routine geriatric assessments will still be available to all patients via the usual outpatient referral system and any links with services initiated by the enablement officer may continue independently of the OPEN ARCH intervention.

Staffing
For the purposes of this study the following staffing will be recruited: 1) a program manager, who will facilitate GP engagement, patient recruitment and consent, data collection, data management and reporting. 2) A community embedded specialist in geriatric medicine to provide comprehensive geriatric assessments and management plans at the GPs rooms. 3) Two community based care coordinators (enablement officers), who will facilitate access to health care services, social supports and self-management options. These positions are solely community embedded, designed to coordinate hospital based specialist geriatric and other primary care services, such as social care services, allied health and rehabilitation services.

Frequency of analyses
All data will be collected at Baseline ‘0’ with retrospective collection for three months to ‘-1’, following every three months data collection, at the time points ‘1’, ‘2’, and ‘3’, except for participant’ experiences which will be collected at the end on the study period.
Intervention code [1] 296972 0
Treatment: Other
Intervention code [2] 296974 0
Prevention
Comparator / control treatment
Standard care for the control group will comprise an assessment by GPs with normal clinical care. This group will also be offered the intervention after 12 months.
Control group
Active

Outcomes
Primary outcome [1] 300864 0
Emergency Department (ED) presentations assessed by review of ED records
Timepoint [1] 300864 0
3 months prior to commencing intervention, and 3, 6, and 9 months post intervention commencement
Primary outcome [2] 300866 0
Hospital admissions visits assessed by review of hospital records
Timepoint [2] 300866 0
3 months prior to commencing intervention, and 3, 6, and 9 months post intervention commencement
Primary outcome [3] 300867 0
Use of health services. Number of referrals/appointments with primary and allied health care professionals via Medicare records
Timepoint [3] 300867 0
3 months prior to commencing intervention, and 3, 6, and 9 months post intervention commencement
Secondary outcome [1] 331074 0
Functional status as measured by Functional Independence Measure and Seniors at Risk (ISAR) screening tool
Timepoint [1] 331074 0
3 months prior to commencing intervention, and 3, 6, and 9 months post intervention commencement
Secondary outcome [2] 331075 0
Quality of Life (QoL) as measured by EQ-5D-5L and AQOL-8D
Timepoint [2] 331075 0
3 months prior to commencing intervention, and 3, 6, and 9 months post intervention commencement
Secondary outcome [3] 331109 0
Participants’ satisfaction collected via the PSQ-18 questionnaire
Timepoint [3] 331109 0
9 months post intervention commencement
Secondary outcome [4] 331110 0
In-patient length of stay assessed by review of hospital records
Timepoint [4] 331110 0
3 months prior to commencing intervention, and 3, 6, and 9 months post intervention commencement
Secondary outcome [5] 342607 0
Cost effectiveness of the intervention will be assessed as a change to cost outcomes, including the cost of implementing the intervention and subsequent use of health services; and, the change to health benefits, represented by quality adjusted life years (QALYs)
Timepoint [5] 342607 0
9 months post intervention commencement

Eligibility
Key inclusion criteria
To be eligible to enter the study, patients will have to be aged 70 years or older for non-Indigenous and 50 years or older for Indigenous, live within the geographical catchment (Cairns area), have frequent presentations to the ED and have complex social, psychological or mental health needs as determined by the Identification of Seniors at Risk (ISAR) screening tool for functional decline.
Minimum age
70 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
People younger than 70 years who do not have complex social, psychological or mental health needs as determined by the Identification of Seniors at Risk (ISAR) screening tool for functional decline

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
All GPs (n=12) will be randomised as ‘clusters’ at baseline using simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation). Such cluster randomisation allows control for the ‘between GPs variance’. Two clusters will be commencing the intervention at each step, as per recommendations of Barker et al, 2017, to ensure that the intervention effect estimator maintains the nominal 5% significance level and is reasonably unbiased. All clusters will ultimately receive the intervention for the same length of time.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
A multicentre, randomised controlled trial using a stepped wedge cluster design with repeated cross-sectional samples will be utilised in this study. The stepped wedge design allows all participants to receive the intervention, which is the preferred methodology for studies where the intervention is predicted to do more good than harm. It allows patients to act as their own controls and detect trends and changes associated with time.
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
The primary outcome measures, including Emergency Department (ED) presentations, acute hospital admissions, in-patient bed days, allied health and support services utilization, will be analysed as panels between each cross sectional time point of the stepped wedge design, comparing primary outcomes within and between clusters. Each cross section will include participants undertaking the intervention as well as those receiving standard care (pre-intervention component). In addition to assessing intervention effects, the stepped wedge design can also model the effects of time to determine whether time of intervention (intervening early versus intervening late) impacts the effectiveness of the intervention. Secondary outcome measures, including functional status, ISAR, and QoL measures will compared pre versus post intervention periods, for each participant, thus they will act as their own control. Participants’ experience of the OPEN ARCH intervention as measured by the Likert scale responses will be analysed using descriptive statistics.

We aim to examine within and between cluster variance, treatment outcomes for intervention versus control, across time, by applying a Generalised Linear mixed Model (GLMM), as recommended for small cluster designed stepped wedge studies. These models can each adjust for unequal numbers within clusters and cope with non-parametric data distributions. Within the GLMM, primary and secondary outcomes will be assessed against time and intervention status, represented as Fixed Effects, while study clusters and clients will be represented in the model as Random effects. Secondary outcome analyses will include t-tests (for continuous data), chi square (for proportions) and GLMMs where applicable, to control for demographic differences. All statistical tests will be two-sided and performed using a 5% significance level with no adjustment for multiplicity. Data analysis will be performed using STATA version 15.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2018
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 15183 0
4870 - Cairns
Recruitment postcode(s) [2] 18723 0
4874 - Weipa
Recruitment postcode(s) [3] 18722 0
4881 - Kuranda

Funding & Sponsors
Funding source category [1] 295434 0
Government body
Name [1] 295434 0
Queensland Health Integrated Care Innovation Fund
Country [1] 295434 0
Australia
Primary sponsor type
Hospital
Name
Cairns and Hinterland Hospital and Health Service
Address
165 The Esplanade,
Cairns Qld 4870
Country
Australia
Secondary sponsor category [1] 294295 0
Government body
Name [1] 294295 0
Northern Queensland Primary Health Network
Address [1] 294295 0
Level 2- 3
36 Shields Street,
Cairns, QLD 4870
Country [1] 294295 0
Australia
Secondary sponsor category [2] 294296 0
Hospital
Name [2] 294296 0
Torres and Cape Hospital and Health Service
Address [2] 294296 0
Level 9, CITI Central,
45-48 Sheridan Street,
Cairns QLD 4870
Country [2] 294296 0
Australia
Other collaborator category [1] 279414 0
University
Name [1] 279414 0
CQUniversity
Address [1] 279414 0
160 Ann Street, Brisbane Qld 4000
Country [1] 279414 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296767 0
Cairns and Hinterland Hospital and Health Service
Ethics committee address [1] 296767 0
165 The Esplanade,
Cairns Qld 4870
Ethics committee country [1] 296767 0
Australia
Date submitted for ethics approval [1] 296767 0
14/03/2017
Approval date [1] 296767 0
10/10/2017
Ethics approval number [1] 296767 0

Summary
Brief summary
Background: Community dwelling older persons with complex care needs may deteriorate rapidly and require hospitalisation if they receive inadequate support for their conditions in the community. This trial aims to assess the acceptability, impact and cost-effectiveness of a comprehensive, multidimensional geriatric assessment with care coordination (the OPEN ARCH intervention) in a community setting.

Methods/Design: This multicentre randomised controlled trial uses a stepped wedge cluster design with repeated cross sectional samples. General Practitioners (GPs; n=12) will be randomised as ‘clusters’ at baseline using simple randomisation. Each GP cluster will then recruit 10-12 participants. Data will be collected on each participant at three-month interval (-3, 0, 3, 6 and 9 months). The primary clinical outcomes are Emergency Department (ED) presentations, acute hospital admissions, in-patient bed days, health service (including allied health) and community support service utilization. Secondary outcomes include functional status, Quality of Life (QoL) and participants’ satisfaction. Cost effectiveness of the intervention will be assessed as a change to cost outcomes, including the cost of implementing the intervention and subsequent use of health services; and, the change to health benefits, represented by quality adjusted life years (QALYs).

Discussion: The results will have direct implications for the design and wider implementation of this new model of care for community dwelling older persons with complex care needs. Additionally, it will contribute to the evidence base on acceptability, efficacy, and cost-effectiveness of the intervention for this high-risk group of older people.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 71998 0
A/Prof Edward Strivens
Address 71998 0
OPSAR, Division 2- Integrated Medicine
Cairns and Hinterland Hospital and Health Service
PO Box 902, CAIRNS QLD 4870
Country 71998 0
Australia
Phone 71998 0
+61 7 42266197
Fax 71998 0
Email 71998 0
Edward.Strivens@health.qld.gov.au
Contact person for public queries
Name 71999 0
Ms Jennifer Mann
Address 71999 0
OPSAR, Division 2- Integrated Medicine
Cairns and Hinterland Hospital and Health Service
PO Box 902, CAIRNS QLD 4870
Country 71999 0
Australia
Phone 71999 0
+61 7 4226 0179
Fax 71999 0
Email 71999 0
jennifer.mann3@health.qld.gov.au
Contact person for scientific queries
Name 72000 0
Ms Jennifer Mann
Address 72000 0
OPSAR, Division 2- Integrated Medicine Cairns and Hinterland Hospital and Health Service PO Box 902, CAIRNS QLD 4870
Country 72000 0
Australia
Phone 72000 0
+61 7 4226 0179
Fax 72000 0
Email 72000 0
i.kinchin@cqu.edu.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
SourceTitleYear of PublicationDOI
EmbaseBeyond multimorbidity: Primary care and the older person with complex needs.2021https://dx.doi.org/10.1071/PY20125
EmbaseEfficacy and cost-effectiveness of a community-based model of care for older patients with complex needs: A study protocol for a multicentre randomised controlled trial using a stepped wedge cluster design.2018https://dx.doi.org/10.1186/s13063-018-3038-0
N.B. These documents automatically identified may not have been verified by the study sponsor.