Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000539730
Ethics application status
Approved
Date submitted
24/03/2022
Date registered
6/04/2022
Date last updated
13/10/2022
Date data sharing statement initially provided
6/04/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Web-based shared care for GPs and mental health services in Sydney
Scientific title
Trial of a web-based shared care tool on access to health care for people living with mental illness attending mental health services in a Sydney local health district
Secondary ID [1] 306505 0
None
Universal Trial Number (UTN)
U1111-1276-2491
Trial acronym
SHAReD (Shared Health Arrangements Research & Development)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular diseases 325368 0
Metabolic disorders 325756 0
Cancer 325863 0
Severe mental illness 325864 0
Condition category
Condition code
Cardiovascular 322750 322750 0 0
Diseases of the vasculature and circulation including the lymphatic system
Metabolic and Endocrine 322751 322751 0 0
Diabetes
Diet and Nutrition 322753 322753 0 0
Obesity
Mental Health 323095 323095 0 0
Psychosis and personality disorders
Mental Health 323096 323096 0 0
Schizophrenia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is an electronic version of a shared care plan (e-shared plan) using Inca from the Precedence Software Company. Inca is commercially available software that integrates with most general practice medical record software in Australia (e.g.: Best Practice, Medical Director) to create electronic shared care plans (“e-care plans”) that can be shared with other clinicians and consumers.
An Inca template for an e-care plan for consumers of adult community mental health services (MHSs) in Sydney Local Health District (SLHD) was developed to replace the shared care checklist used by SLHD. This is a static document that has been installed in the GP’s electronic medical record system by the primary health network. It can be viewed onscreen or printed and used as a paper form. This checklist was slightly revised for the trial to qualify as a shared care plan so the e-shared plan and shared care document are identical apart from the mode (electronic and interactive or static document).
Both the electronic (intervention) and the document (comparison) versions of the care plan specify goals and tasks for the GP, mental health service and consumers, their frequency, and who is responsible for their completion. The care plan tracks the tasks and provides prompts for overdue tasks. Tasks for the GP could be “review blood tests”; for the MHS could be “arrange for consumer to have a blood test”; for consumer could be “reduce smoking ”.
The study is a pragmatic cluster randomised trial with the unit of randomisation being four of the five Adult Community Mental Health 'Core' Teams in Sydney Local Health District (SLHD). Pairs of teams (matched by service type and consumer population) randomised to early or late intervention over 12 months.
Training will be provided by the research team and an Inca specialist from Precedence Software Company to mental health service clinicians and GPs.
- Mental health service clinicians: 1-hour online workshop on shared care and the use of the shared care tool will be provided to 4 groups 2-4 weeks prior to the commencement of the intervention. A recorded training session will be available for new staff or staff who missed the training. A certificate of attendance will be provided.
- GPs in the intervention group: a one-on-one, 1 hour online or face-to-face training session will be provided on the use of the e-shared plan, including how to support consumers to use the tool immediately after the GPs consent to the study. Screenshots of how to use the e-shared care plan will be available as part of a training package.
- Ongoing support for all clinicians in using the Inca e-shared plan will be provided by Precedence via telephone, live chat or email.

Recruitment and establishment of the care plan involves the following steps:
- MHS clinicians enrol consumers in shared care and organise an appointment (face-face or telehealth) with the consumer’s GP to initiate shared care.
- Precedence will install Inca software on the GPs’ computers remotely. The installation could take 10 -30 minutes.
- Precedence and a research team member will show the GP how to create a care plan template and how to add new care team members including MHS clinicians.
- The MHS clinician and consumer (with carer or support worker if applicable) attend an appointment with the GP to set up the e-shared plan. It is anticipated that the initial appointment to establish the e-shared care plan in general practice will take 30 minutes.
- After initiating the care plan, the GP will be alerted to the care plan each time the patient’s medical record is opened. The GP will then click on the link to take them into the care plan.
- After the care plan is initiated by the GP, the MHS will receive an email notifying them of the care plan and providing log in information for them to access and edit the care plan as appropriate.
- Consumers will receive log-in information to access the online version of Inca to view their own shared care plan and if accessing a computer is an issue, a printed copy of the care plan will be provided by the GP or/and MHS clinician.
- Participants will continue to see their GP or mental health provider separately or together as necessary.
- Appointments for shared care with the GP will be determined from the frequency that tasks are to be performed. These will be at least annually for the GP.
Mental health services have equipment to use Inca enable video conferences / telehealth with GPs and consumers.
GPs can tailor the e-shared plan for each patient. For example, a patient task could be added, the smoking section could be deleted if the patient does not smoke.
Measures of intervention fidelity include:
- the proportion of consumers whose e-care plan is accessed by the GP and mental health team
- consistency of use of the e-care plans across sites.
Intervention code [1] 322930 0
Prevention
Comparator / control treatment
The comparator is 'usual care', which is shared care using a shared care checklist that is installed as a document in the GPs (EMR). This is applied to those patients associated with the two mental health teams allocated to the control group. Participants in the control group will receive a delayed intervention after follow-up data is collected.
Control group
Active

Outcomes
Primary outcome [1] 330852 0
Change in the number of risk factors recorded as being screened in the GPs medical record over the past nine months.
Timepoint [1] 330852 0
Nine months prior to intervention commencement and nine months after
Primary outcome [2] 330861 0
Change in the frequency of recorded care plans (GP Management Plans and/or Team Care Arrangements) with community mental health services in the GPs medical record over the past nine months
Timepoint [2] 330861 0
Nine months prior to intervention commencement and nine months after
Primary outcome [3] 330960 0
Change in rate of GP advice/referral for smoking cessation, diet and physical activity in last nine months as reported via consumer survey. Composite score from questions developed for this study. 0 no advice or referral 1 advice or referral for one behaviour 2 advice or referral for 2 behaviours 3 advice or referral for all 3 behaviours
Timepoint [3] 330960 0
Baseline and nine months post intervention commencement
Secondary outcome [1] 407837 0
Change in patient assessment of extent to which providers (MH & GP) are working to a common care plan in last nine months as reported via consumer survey. Questions developed for this study.
Timepoint [1] 407837 0
Baseline and nine months post intervention commencement
Secondary outcome [2] 407838 0
Change in provider-reported quality of communication between MHS and GPs in last nine months as reported via provider survey. Questions developed for this study.
Timepoint [2] 407838 0
Baseline and nine months post intervention commencement
Secondary outcome [3] 407860 0
Change in frequency of telehealth communication between patient, GP, and mental health service for shared care in last nine months as recorded in SLHD reporting system ("STARS": Community Ambulatory Mental Health Report).
Timepoint [3] 407860 0
Nine months prior to intervention commencement and nine months after
Secondary outcome [4] 407861 0
Change in ED use for primary care preventable conditions in last nine months from SLHD electronic medical record (eMR): Integrated Care Outcomes Database (ICOD)
Timepoint [4] 407861 0
Nine months prior to intervention commencement and nine months after
Secondary outcome [5] 407862 0
Change in number of GP visits in last nine months from GP medical records and Commonwealth Medical Benefit scheme (MBS) records
Timepoint [5] 407862 0
Nine months prior to intervention commencement and nine months after
Secondary outcome [6] 407863 0
Change in percent of MHS consumers engaged in Mental Health Shared Care arrangements as recorded in SLHD EMR reports
Timepoint [6] 407863 0
Baseline and nine months post intervention commencement
Secondary outcome [7] 407864 0
Change in consumer ratings of how well their GP and mental health service are working together plan their care in last nine months. Question developed for this study as part of the consumer survey interview
Timepoint [7] 407864 0
Baseline and nine months post intervention commencement
Secondary outcome [8] 407865 0
Change in consumer health literacy score: Domain 1 (Feeling understood and supported by healthcare providers) of the Health Literacy Questionnaire
Timepoint [8] 407865 0
Baseline and nine months post intervention commencement
Secondary outcome [9] 407866 0
Change in consumer-reported health risk behaviours (composite score). Questions developed for this study for one-on-one survey interview (carer or other support person can be present if the consumer prefers this).
Timepoint [9] 407866 0
Baseline and nine months post intervention commencement
Secondary outcome [10] 407867 0
Change in consumer Absolute Cardiovascular Disease Risk score based on information provided in the consumer survey. Questions developed for this study
Timepoint [10] 407867 0
Baseline and nine months post intervention commencement
Secondary outcome [11] 407868 0
Change in consumer diabetes risk score on AUSDRISK based on information provided in the consumer survey. Questions developed for this study
Timepoint [11] 407868 0
Baseline and nine months post intervention commencement
Secondary outcome [12] 407870 0
Change in costs of potentially preventable hospitalisations avoided in last 12 months based on hospital data from SLHD
Timepoint [12] 407870 0
Nine months prior to intervention commencement and nine months after
Secondary outcome [13] 407871 0
Change in consumer quality of life score on EQ5D-5L
Timepoint [13] 407871 0
Baseline and nine months post intervention commencement
Secondary outcome [14] 408257 0
Change in hospitalisations for primary care preventable conditions in last nine months from SLHD electronic medical record (eMR): Integrated Care Outcomes Database (ICOD)
Timepoint [14] 408257 0
Nine months prior to intervention commencement and nine months after
Secondary outcome [15] 408258 0
Change in rate of prescription of antihypertensive medications in past nine months as recorded in GP clinical records
Timepoint [15] 408258 0
Nine months prior to intervention commencement and nine months after
Secondary outcome [16] 408259 0
Change in rate of prescription of lipid lower medications in past nine months as recorded in GP clinical records
Timepoint [16] 408259 0
Nine months prior to intervention commencement and nine months after
Secondary outcome [17] 408260 0
Change in rate of influenza vaccination of consumers in past nine months as recorded in GP clinical records
Timepoint [17] 408260 0
Nine months prior to intervention commencement and nine months after
Secondary outcome [18] 408262 0
Level of GP satisfaction with communication with MHS in the previous nine months. Composite score from questions developed for GP survey in this study.
Timepoint [18] 408262 0
Baseline and nine months post intervention commencement
Secondary outcome [19] 408263 0
GP provision of preventive health of patients engaged with mental health services. Composite score from questions developed for GP survey in this study.
Timepoint [19] 408263 0
Baseline and nine months post intervention commencement
Secondary outcome [20] 408264 0
Provider (GPs and MHS) experience of the impact of the electronic shared care plans on how well patients’ needs are addressed. Qualitative data from semi-structured one-on-one interviews (face-to-face, video or telephone)
Timepoint [20] 408264 0
Nine months after intervention commencement
Secondary outcome [21] 408265 0
Consumer report of changes in how their mental health service and GP have communicated over the past 12 months. Qualitative data from semi-structured one-on-one interviews (face-to-face, video or telephone)
Timepoint [21] 408265 0
Nine months after intervention commencement
Secondary outcome [22] 408266 0
Consumer experience with the electronic shared care system that your GP and mental health service. Qualitative data from semi-structured one-on-one interviews (face-to-face, video or telephone)
Timepoint [22] 408266 0
Nine months after intervention commencement
Secondary outcome [23] 408283 0
Change in systolic blood pressure in past nine months as recorded in GP clinical records
Timepoint [23] 408283 0
Nine months prior to intervention commencement and nine months after
Secondary outcome [24] 408284 0
Change in total cholesterol in past nine months as recorded in GP clinical records
Timepoint [24] 408284 0
Nine months prior to intervention commencement and nine months after
Secondary outcome [25] 408285 0
Change in weight in past nine months as recorded in GP clinical records
Timepoint [25] 408285 0
Nine months prior to intervention commencement and nine months after
Secondary outcome [26] 408286 0
Change in smoking status in past nine months as recorded in GP clinical records
Timepoint [26] 408286 0
Nine months prior to intervention commencement and nine months after

Eligibility
Key inclusion criteria
1. Consumers from SLHD Adult Community Mental Health 'Core' Teams in Canterbury, Croydon, Camperdown and Marrickville.
2. Age: 18+ years
3. Engaged in shared care or willing to commence a shared care arrangement before the study commences.
4. Has a GP engaged in shared care who consents to participate and, if the intervention group, to have the electronic care plan installed
5. Willing to provide informed consent and willingness to participate and comply with the study requirements.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unable to give informed consent

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)
Stratified random allocation using a randomisation table created by computer software. Strata based on LHD sector (eastern or western).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The aim is to recruit 500 consumers, expecting that 400 consumers will remain in the study at nine-month follow-up (consistent with 20% lost to follow-up). Power calculation: Assuming a 20% change, a sample size of 91 consumers per group is required to detect a change from 30 to 50% in primary outcomes based on a = 0.05, 1-ß= 0.8. Assuming a design effect due to clustering of 2, a total sample of 360 is required (180 in each group).
For quantitative analyses of differences between treatments, linear or generalised multi-level mixed models will be employed depending on the outcome in question. Intra-class correlations will be calculated to compare the amount of variance associated with design features before selecting random effects for these models. The reason for this is that individual participants will be nested within care coordinators who are nested within community mental health teams, and those same participants are also nested within GPs who may be nested within medical centres. The effects of baseline predictors and features of the care model on the outcomes will be explored using the multi-level models. In addition to an analysis of the sample who completed the entire SHAReD intervention, defined as those consumer, care coordinator & GP triads that complete an online shared care plan, an intention to treat (ITT) analysis will be conducted. Those who were lost to follow-up will be considered by undertaking a range of sensitivity analyses.
An in-built cost-effectiveness study will be conducted from the perspective of the health system. The main health effects consist of satisfactory completion of the online shared care plan, reduction in consumer cardiometabolic risk, avoiding unplanned hospitalisations, and gains in quality-adjusted life years. All the necessary health effects and resources used (direct medical costs, consumers’ out-of-pocket costs for medical care, and indirect costs) will be classified, counted, and valued using established methods. Incremental cost-effectiveness ratios will be calculated; sensitivity analyses undertaken.
Qualitative analyses (predominantly deductive but inductive coding will also be applied to detect new and emerging themes) will also be undertaken.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
7/04/2022
Actual
5/05/2022
Date of last participant enrolment
Anticipated
28/10/2022
Actual
Date of last data collection
Anticipated
30/06/2023
Actual
Sample size
Target
500
Accrual to date
4
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 37116 0
2050 - Camperdown
Recruitment postcode(s) [2] 37117 0
2132 - Croydon
Recruitment postcode(s) [3] 37119 0
2194 - Campsie
Recruitment postcode(s) [4] 37118 0
2204 - Marrickville

Funding & Sponsors
Funding source category [1] 310848 0
Government body
Name [1] 310848 0
NSW Health (Translational Research Grants Scheme)
Country [1] 310848 0
Australia
Primary sponsor type
Government body
Name
Sydney Local Health District
Address
Level 11, KGV Building
Missenden Road
CAMPERDOWN NSW 2050
Country
Australia
Secondary sponsor category [1] 312103 0
University
Name [1] 312103 0
Centre for Primary Health Care and Equity, UNSW Sydney
Address [1] 312103 0
Kensington Campus
UNSW Sydney
High St
Kensington, NSW 2052
Australia

Postal Address:
UNSW Sydney, NSW 2052
Australia
Country [1] 312103 0
Australia
Other collaborator category [1] 282227 0
University
Name [1] 282227 0
University of Sydney
Address [1] 282227 0
Street Address:
The University of Sydney
City Road
Camperdown/Darlington NSW 2006

Postal Address:
The University of Sydney NSW 2006
Country [1] 282227 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310414 0
Research Ethics and Governance Office Royal Prince Alfred Hospital
Ethics committee address [1] 310414 0
Missenden Road, CAMPERDOWN NSW 2050
Ethics committee country [1] 310414 0
Australia
Date submitted for ethics approval [1] 310414 0
25/05/2021
Approval date [1] 310414 0
23/07/2021
Ethics approval number [1] 310414 0
2021/ETH01006
Ethics committee name [2] 310618 0
UNSW Human Ethics Research Committee
Ethics committee address [2] 310618 0
Research Ethics & Compliance Support
UNSW Sydney
Sydney NSW 2052
Ethics committee country [2] 310618 0
Australia
Date submitted for ethics approval [2] 310618 0
30/09/2021
Approval date [2] 310618 0
08/10/2021
Ethics approval number [2] 310618 0
2021/ETH01006

Summary
Brief summary
This trial is exploring if an online shared care plan and telehealth improve the frequency and quality of primary and preventive care for people with a lived experience of severe mental illness.
It aims to improve the health of people living with mental illness by facilitating their engagement with primary care. It also aims identify more effective and time efficient shared care processes, which are essential given the multiple competing demands on primary care and mental health clinicians.
The online shared care plan outlines the preventive care tasks that GPs and SLHD Mental Health Care Coordinators will share. This includes, for example, physical health checks, metabolic blood tests, lifestyle assessment and advice, preventive screening, medication management and referrals to allied health.
This pragmatic trial will invite clients of the Sydney Local Health District Community Mental Health Teams and their usual GPs to participate. Participants will be followed for 12 months.
Trial website
https://cphce.unsw.edu.au/research/shared-shared-health-arrangements-research-development
Trial related presentations / publications
Public notes
This is a cluster randomised trial of electronic care plans comparing preventive care received by patients affiliated with two adult mental health teams (intervention group) with those affiliated with two other mental health teams in Sydney Local Health District (usual care group).
The primary objective is to improve the frequency and quality of primary and preventive care received by consumers of community mental health services (MHSs) in Sydney LHD (“consumers”). Secondary objectives are to better integrate care between mental health services and general practice; improve consumer health risks and service use; and to identify the cost-effectiveness of the intervention compared with usual care.
A sample of participants from the intervention group will be asked to participate in semi-structured qualitative interviews. This will include consumers and their carers (n=20-30), health care providers (n=20) (including MHS staff and GPs). The study enrolment numbers of the consumers who express interest in the survey will be entered into a list randomiser (https://www.random.org/lists/) and the top 30 numbers will be used to create a sample. The sample will be checked to ensure there is representation across:
• Mental Health Teams
• Gender of consumers
• Age groups (younger half, older half of the study sample)
• GPs (no more than one per practice).
The research team will contact the selected consumers and any carers who were nominated by consumers to recruit them to the qualitative interviews.
GPs will be invited to express interest in being interviewed for the study via an invitation within the GP survey. A similar process to that for consumers will be used to randomly select 12 GPs for interview, ensuring representation across MHT, gender of GP, age group of GP (younger half, older half of the study sample) and practice size (less than 3, 4 or more GPs).
Mental health service care coordinators who have facilitated consumer recruitment to the study will be invited to express interest in being interviewed via a letter of invitation sent to them by the Principal Investigator.
These interviews will be conducted by telephone or video conferencing and will take 20-40 minutes.

Contacts
Principal investigator
Name 117578 0
Dr Andrew McDonald
Address 117578 0
Sydney Local Health District
Concord Centre for Mental Health,
Admin Building 109,Concord Hospital,
Hospital Road Concord NSW 2139
Country 117578 0
Australia
Phone 117578 0
+61 2 9767 8683
Fax 117578 0
Email 117578 0
Andrew.McDonald2@health.nsw.gov.au
Contact person for public queries
Name 117579 0
Dr Catherine Spooner
Address 117579 0
Centre for Primary Health Care and Equity
UNSW Sydney
Sydney NSW 2052
Country 117579 0
Australia
Phone 117579 0
+61 2 93851505
Fax 117579 0
Email 117579 0
c.spooner@unsw.edu.au
Contact person for scientific queries
Name 117580 0
Dr Catherine Spooner
Address 117580 0
Centre for Primary Health Care and Equity
UNSW Sydney
Sydney NSW 2052
Country 117580 0
Australia
Phone 117580 0
+61 2 93851505
Fax 117580 0
Email 117580 0
c.spooner@unsw.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant data collected during the trial, after de-identification
When will data be available (start and end dates)?
For verification of published results: immediately following publication
For new analyses: 12 months after the trial has concluded
Data will be available for 5 years after the conclusion of the trial
Available to whom?
Researchers employed by universities or government health organisations who have obtained ethical consent from Sydney LHD ethics committee
Available for what types of analyses?
Any research that is for the benefit of people living with severe mental illness and is approved by Sydney LHD ethics committee
How or where can data be obtained?
Initial enquiries can be made to the Chief Investigator, Dr Andrew McDonald, Sydney LHD. Andrew.McDonald2@health.nsw.gov.au


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
15514Study protocol  c.spooner@unsw.edu.au
15515Informed consent form  c.spooner@unsw.edu.au
15516Ethical approval  c.spooner@unsw.edu.au



Results publications and other study-related documents

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