ANZCTR - Registration

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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]

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

Metabolic disorders

Cancer

Severe mental illness

Condition category

Condition code

Cardiovascular

Diseases of the vasculature and circulation including the lymphatic system

Metabolic and Endocrine

Diabetes

Diet and Nutrition

Obesity

Mental Health

Psychosis and personality disorders

Mental Health

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]

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]

Change in the number of risk factors recorded as being screened in the GPs medical record over the past nine months.

Timepoint [1]

Nine months prior to intervention commencement and nine months after

Primary outcome [2]

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]

Nine months prior to intervention commencement and nine months after

Primary outcome [3]

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]

Baseline and nine months post intervention commencement

Secondary outcome [1]

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]

Baseline and nine months post intervention commencement

Secondary outcome [2]

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]

Baseline and nine months post intervention commencement

Secondary outcome [3]

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]

Nine months prior to intervention commencement and nine months after

Secondary outcome [4]

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]

Nine months prior to intervention commencement and nine months after

Secondary outcome [5]

Change in number of GP visits in last nine months from GP medical records and Commonwealth Medical Benefit scheme (MBS) records

Timepoint [5]

Nine months prior to intervention commencement and nine months after

Secondary outcome [6]

Change in percent of MHS consumers engaged in Mental Health Shared Care arrangements as recorded in SLHD EMR reports

Timepoint [6]

Baseline and nine months post intervention commencement

Secondary outcome [7]

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]

Baseline and nine months post intervention commencement

Secondary outcome [8]

Change in consumer health literacy score: Domain 1 (Feeling understood and supported by healthcare providers) of the Health Literacy Questionnaire

Timepoint [8]

Baseline and nine months post intervention commencement

Secondary outcome [9]

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]

Baseline and nine months post intervention commencement

Secondary outcome [10]

Change in consumer Absolute Cardiovascular Disease Risk score based on information provided in the consumer survey. Questions developed for this study

Timepoint [10]

Baseline and nine months post intervention commencement

Secondary outcome [11]

Change in consumer diabetes risk score on AUSDRISK based on information provided in the consumer survey. Questions developed for this study

Timepoint [11]

Baseline and nine months post intervention commencement

Secondary outcome [12]

Change in costs of potentially preventable hospitalisations avoided in last 12 months based on hospital data from SLHD

Timepoint [12]

Nine months prior to intervention commencement and nine months after

Secondary outcome [13]

Change in consumer quality of life score on EQ5D-5L

Timepoint [13]

Baseline and nine months post intervention commencement

Secondary outcome [14]

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]

Nine months prior to intervention commencement and nine months after

Secondary outcome [15]

Change in rate of prescription of antihypertensive medications in past nine months as recorded in GP clinical records

Timepoint [15]

Nine months prior to intervention commencement and nine months after

Secondary outcome [16]

Change in rate of prescription of lipid lower medications in past nine months as recorded in GP clinical records

Timepoint [16]

Nine months prior to intervention commencement and nine months after

Secondary outcome [17]

Change in rate of influenza vaccination of consumers in past nine months as recorded in GP clinical records

Timepoint [17]

Nine months prior to intervention commencement and nine months after

Secondary outcome [18]

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]

Baseline and nine months post intervention commencement

Secondary outcome [19]

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]

Baseline and nine months post intervention commencement

Secondary outcome [20]

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]

Nine months after intervention commencement

Secondary outcome [21]

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]

Nine months after intervention commencement

Secondary outcome [22]

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]

Nine months after intervention commencement

Secondary outcome [23]

Change in systolic blood pressure in past nine months as recorded in GP clinical records

Timepoint [23]

Nine months prior to intervention commencement and nine months after

Secondary outcome [24]

Change in total cholesterol in past nine months as recorded in GP clinical records

Timepoint [24]

Nine months prior to intervention commencement and nine months after

Secondary outcome [25]

Change in weight in past nine months as recorded in GP clinical records

Timepoint [25]

Nine months prior to intervention commencement and nine months after

Secondary outcome [26]

Change in smoking status in past nine months as recorded in GP clinical records

Timepoint [26]

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?

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

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment postcode(s) [1]

2050 - Camperdown

Recruitment postcode(s) [2]

2132 - Croydon

Recruitment postcode(s) [3]

2204 - Marrickville

Recruitment postcode(s) [4]

2194 - Campsie

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

NSW Health (Translational Research Grants Scheme)

Address [1]

1 Reserve Road, St Leonards NSW 2065

Country [1]

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]

University

Name [1]

Centre for Primary Health Care and Equity, UNSW Sydney

Address [1]

Kensington Campus
UNSW Sydney
High St
Kensington, NSW 2052
Australia

Postal Address:
UNSW Sydney, NSW 2052
Australia

Country [1]

Australia

Other collaborator category [1]

University

Name [1]

University of Sydney

Address [1]

Street Address:
The University of Sydney
City Road
Camperdown/Darlington NSW 2006

Postal Address:
The University of Sydney NSW 2006

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Research Ethics and Governance Office Royal Prince Alfred Hospital

Ethics committee address [1]

Missenden Road, CAMPERDOWN NSW 2050

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

25/05/2021

Approval date [1]

23/07/2021

Ethics approval number [1]

2021/ETH01006

Ethics committee name [2]

UNSW Human Ethics Research Committee

Ethics committee address [2]

Research Ethics & Compliance Support
UNSW Sydney
Sydney NSW 2052

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

30/09/2021

Approval date [2]

08/10/2021

Ethics approval number [2]

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

Dr Andrew McDonald

Address

Sydney Local Health District
Concord Centre for Mental Health,
Admin Building 109,Concord Hospital,
Hospital Road Concord NSW 2139

Country

Australia

Phone

+61 2 9767 8683

Fax

[email protected]

Contact person for public queries

Name

Catherine Spooner

Address

Centre for Primary Health Care and Equity
UNSW Sydney
Sydney NSW 2052

Country

Australia

Phone

+61 2 93851505

Fax

[email protected]

Contact person for scientific queries

Name

Catherine Spooner

Address

Centre for Primary Health Care and Equity
UNSW Sydney
Sydney NSW 2052

Country

Australia

Phone

+61 2 93851505

Fax

[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?

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. [email protected]

What supporting documents are/will be available?

Doc. No.	Type	Email
15514	Study protocol	[email protected]
15515	Informed consent form	[email protected]
15516	Ethical approval	[email protected]

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.

Trial Review

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