ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12614000457640

Ethics application status

Approved

Date submitted

3/03/2014

Date registered

1/05/2014

Date last updated

14/05/2018

Type of registration

Prospectively registered

Titles & IDs

Public title

Getting to the CORE: testing a co-design technique to optimise psychosocial recovery outcomes for people affected by mental illness in the community mental health setting.

Scientific title

The CORE Study: a stepped wedge cluster randomised controlled trial to test a co-design technique to optimise psychosocial recovery outcomes for people affected by mental illness in the community mental health setting.

Secondary ID [1]

Nil

Universal Trial Number (UTN)

U1111-1153-2605

Trial acronym

CORE

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Bipolar Disorder

Anxiety Disorders

Major Depressive Disorders

Psychotic Disorders

Schizophrenia

Personality Disorders

Panic Disorders

Condition category

Condition code

Mental Health

Depression

Mental Health

Schizophrenia

Mental Health

Psychosis and personality disorders

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Mental Health Experience Co-design (MH ECO) is a structured process for service users (consumers), carers and mental health staff to come together to identify improvements to service planning and delivery and co-design the solutions to these improvements. The process is facilitated by trained researchers experienced in the use of co-design methods.

The intervention will be implemented over nine months from 2014-2017 at up to eleven participating mental health teams (clusters). There are two main stages to MH ECO. Stage one is information gathering through an open ended computer assisted telephone interview (CATI) and focus groups and face to face interviews. Stage two is a facilitated co-design process where collaboration and co-design groups are established and meet over five months..

The telephone interview is undertaken over six weeks with consumers and carers at each mental health team to identify the positive and negative experiences of services. Interviews take up to one hour to complete. Each team will have up to 30 consumers and 30 carers recruited. All 30 consumers and 30 carers who express interest will be invited to complete the CATI. Up to three positive and three negative touch points (experiences) are discussed in consumer, carer and staff focus groups to gain better understanding. Focus groups are held separately, for up to two hours, with 8-10 people participating in these.

The second stage involves the co-design process. Consumers, carers and staff who express interest in the co-design process receive two training sessions over two weeks to build skills and confidence for working in group settings. Training sessions are up to two hours each. Following the completion of training sessions, a collaboration group (8-10 people in each cluster) is established comprised of consumers, carers and staff members.. The collaboration group meets first (for up to two hours) to set objectives for achieving some changes around the identified negative touch points.

This is followed by the establishment of up to three co-design groups (8-10 people in each cluster - there is one co-design group for each of the negative touch points). Co-design groups meet three times for up to two hours. Session one explores the negative touch point to brainstorm ideas for change, session two focuses in on what will change and session three is the development of an action plan for implementation.

The action plan is returned to the second collaboration group meeting for implementation in month six. A month one implementation period is scheduled where there is no contact with any clusters.

Intervention code [1]

Other interventions

Comparator / control treatment

The stepped wedge design means that the clusters not in receipt of the intervention act as the control group for the study.

The usual care delivered to consumers comprises a comprehensive needs assessment and individual recovery plan developed, individualised support through focus on improving daily living skills, capacity for mental health self–management and social connectedness, and support to access health and human services required through partnership and coordination delivered by key worker.

Control group

Active

Outcomes

Primary outcome [1]

Primary Outcome = improved psychosocial recovery (Recovery Assessment Scale - Revised 24 Item RAS-R).

Timepoint [1]

9, 18, 27 months after intervention commencement.

Secondary outcome [1]

Secondary Outcome = improved mental health and well-being for consumers and carers (EUROHIS - Quality of Life 8 Item Scale).

Timepoint [1]

9, 18, 27 months after intervention commencement

Secondary outcome [2]

Secondary Outcome = change in staff attitudes to recovery (RSA, Recovery Self Assessment Scale - Provider Version and STARS Staff Attitudes to Recovery Scale).

Timepoint [2]

9, 18, 27 months following baseline data collection from staff.

Eligibility

Key inclusion criteria

Consumers: understands and speaks English, is over 16 years of age, attends a program that is part of the Mental Health Community Support Service at the participating service provider, has received a diagnosis of mental illness.

Carers: understands and speaks English, is over 18 years of age, supports someone who attends a program that is part of the Mental Health Community Support Service at the participating service provider.

Staff: work at the mental health service (any time fraction)and are involved in planning and/or the delivery of services related to the Mental Health Community Support Services.

Minimum age

16 Years

Maximum age

64 Years

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

Consumers: does not attend a Community Mental Health Support Service attached to the participating Community Health Centre and does not have a mental illness. Does not speak and understand English. Is exhibiting signs of being unwell and unable to provide consent.

Carers: does not care for someone with a mental illness who attends a Community Mental Health Support Service at participating Centre. Is unwell or unable to provide 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)

Three clusters stratified by service provider will be allocated to each wave. Initially, the 12 possible combinations of the pair-wise clusters from the three different services were created to ensure that clusters from the same service provider are not allocated to the same wave. Using these pairs, 24 possible sequence allocation combinations of the paired clusters to the three waves were identified (8 combinations of three sets of paired clusters by three different possible starting times). One of the 24 possible sequence allocation combinations will be randomly selected by allocating a random number from the uniform distribution using Stata Statistical Software Packaging to each of the 24 sequence allocation combinations and selecting the sequence allocation with the smallest random number. The random selection of the sequence allocation will be conducted by a statistician blinded to the identity of the clusters and not involved in the assessment or intervention delivery. The pair of clusters and order in which they receive the intervention will be communicated to the trial coordinators. The two clusters allocated to the first wave will be notified of intervention commencement after the initial baseline period is completed. The remaining four clusters will be notified of the intervention commencement at the start of their allocated step/wave. Staff, consumers and carers are not blinded to the intervention but they are blinded to the wave during which they receive it. Research interviewers collecting outcome data will remain blinded to who is in receipt of the intervention.

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people assessing the outcomes
The people analysing the results/data

Intervention assignment

Other

Other design features

Stepped wedge design cluster randomised controlled trial. Clusters receive the intervention three at a time (in steps) over three waves. Clusters awaiting intervention act as controls.

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Sample Size Calculation:
Overall, 1008 measurements from 252 consumers (42 per site) at each of the four waves (one for baseline and at each follow up time) from the six clusters will be sufficient to detect an effect size of 0.35 of 1 standard deviation for psycho-social recovery between the intervention and usual care waves with at least 80% power.. Sample size was based on the primary outcome of psycho-social recovery score with the following assumptions: intra-cluster correlation for the outcome of 0.1 and significance level of 5% for a two-sided test, probability that each individual will remain at the site at each wave (0, 0.2 and 0.6) and within-subject correlation of individuals that contributed to at least two consecutive waves (0.2 and 0.7).

The study power was calculated as the proportion among all 2000 simulation runs of two-sided p-values for the estimated fixed treatment effect that reached a nominal value of less than 0.05. Two thousand replications for each set of parameter combinations were sufficient to estimate the power with a margin of error of 1.75%, assuming that the true power was 80%. The simulations were run using R version 3.1.1. Given a fixed sample cluster size, power was the smallest when it was assumed that samples at each time point were independent (that is, probability of remaining at the next wave was zero) and that the study power increased as the probability of remaining at the site and within cluster subject correlation increased. Note the power calculations using the simulation study provided more conservative estimates of the power than the sample size calculations based on the formula provided by Hussey and Hughes. These differences may be due to different derivations of the estimated test statistic. Within the simulation procedure, a t-distribution with Satterthwaite’s approximation for degrees of freedom was employed, whereas the analytical approach suggested by Hussey and Hughes assumes a standard normal distribution for the test statistic which yields less conservative results.

Statistical Data Analysis:

Descriptive statistics will be used to summarise the characteristics of staff, consumers and carers. The participants will be analysed in the group that the cluster was assigned to at each time point. A linear mixed effects model will be used to compare the intervention and usual care periods for continuous outcomes and generalised linear mixed effects model for binary outcomes. The model will include intervention status and time as fixed effects and site and individuals as random effects. Organisational and individual factors strongly correlated with the outcome will also be included as fixed effects in the model. These will include: recovery orientation of services and staff attitudes to recovery at baseline, age, gender, education level, work status, quality of life, medication and hospitalisation. The estimated intervention effect will be reported as mean outcome difference for continuous outcomes and odds ratio for binary outcomes between study groups, with respective 95% confidence intervals and p-values. A secondary analysis will investigate an interaction effect between intervention and time. Costs of the delivery of the intervention will be recorded but no economic evaluation will be undertaken. An intention-to-treat (ITT) analysis strategy will be used. Every effort will be made to minimise missing outcome data at each wave and reasons individuals are lost to follow-up will be recorded. Sensitivity analyses will be conducted to assess the robustness of the missing data assumption made in the primary analysis. Analysis will be conducted using Stata software package 13.

Recruitment

Recruitment status

Active, not recruiting

Date of first participant enrolment

Anticipated

1/10/2014

Actual

1/10/2014

Date of last participant enrolment

Anticipated

31/07/2017

Actual

31/07/2017

Date of last data collection

Anticipated

31/07/2018

Actual

Sample size

Target

270

Accrual to date

Final

287

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment postcode(s) [1]

3689 - Wodonga

Recruitment postcode(s) [2]

3011 - Footscray

Recruitment postcode(s) [3]

3066 - Collingwood

Recruitment postcode(s) [4]

3047 - Broadmeadows

Recruitment postcode(s) [5]

3134 - Ringwood

Recruitment postcode(s) [6]

3030 - Werribee

Recruitment postcode(s) [7]

3337 - Melton

Recruitment postcode(s) [8]

3931 - Mornington

Recruitment postcode(s) [9]

3676 - Wangaratta

Recruitment postcode(s) [10]

3084 - Rosanna

Recruitment postcode(s) [11]

3020 - Sunshine

Recruitment postcode(s) [12]

3128 - Box Hill

Recruitment postcode(s) [13]

3140 - Lilydale

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Mental Illness Research Fund

Address [1]

The Victorian State Government Department of Health
Mental Health, Drugs and Regions Division
50 Lonsdale Street
Melbourne, 3000
Victoria, Australia

Country [1]

Australia

Funding source category [2]

Government body

Name [2]

Psychiatric Illness and Intellectual Disability Donations Trust Fund

Address [2]

State Government of Victoria, Department of Health
50 Lonsdale Street
Melbourne, 3000
Victoria, Australia

Country [2]

Australia

Primary sponsor type

University

Name

The University of Melbourne

Address

The Department of General Practice
Melbourne Medical School
Faculty of Dentistry, Medicine and Health Sciences
200 Berkeley Street
Carlton Vic 3053

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The University of Melbourne

Ethics committee address [1]

Office for Research Ethics & Integrity
The University of Melbourne
Level 1, 780 Elizabeth St
University Building No. 220
MELBOURNE VIC 3010

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

19/02/2014

Approval date [1]

21/03/2014

Ethics approval number [1]

1340299.13

Summary

Brief summary

The aim of CORE is to test if a structured co-design method (Mental Health Experience Co-Design, MH ECO) optimises psychosocial recovery outcomes for people affected by mental illnesses. MH ECO is a purposefully designed process to engage consumers, carers and service providers of adult community mental health services in re-designing aspects of services. MH ECO involves talking with consumers and carers to identify the positive and negative aspects of service and care experiences. Focus groups and interviews are conducted with consumers, carers and service providers to explore these negative aspects of care and experiences in-depth. Collaboration and co-design groups comprised of staff, consumers and carers are formed to identify ways to improve services, develop action plans and implement these. CORE is designed as a stepped wedge cluster randomised controlled trial (SWCRCT). This means that the intervention will be rolled out sequentially to participating mental health teams three clusters at a time over three waves. By the end of the trial though all clusters will have received the intervention.

Trial website

Trial related presentations / publications

*Publications*

Dimopoulos-Bick, T., Dawda, P., Maher, L., Verma, R., & Palmer, V. (2018). Experience-Based Co-Design: Tackling common challenges. The Journal of Health Design; Vol 3, No 1 (2018): Patients as co-designers to improve the quality of care.

Palmer, V., Gunn, J., Herrman, H., Callander, R., Weavell, W., Furler, J., . . . Chondros, P. (2015). Getting to the CORE of the links between engagement, experience and recovery outcomes. NewParadigm, 41-45.

Palmer, V., Piper, D., Richard, L., Furler, J., Herrman, H., Cameron, J., . . . Iedema, R. (2016). Balancing opposing forces - a nested process evaluation study protocol for a stepped wedge designed cluster randomised controlled trial: the CORE study. International Journal of Qualitative Methods, 15(1).

Palmer, V., & Whitley, R. (2017). Across the spectrum: strategies to improve recognition and treatment of mental disorders in primary care. In A. F. Carvalho & R. S. McIntyre (Eds.), Mental Disorders in Primary Care (pp. 21-33). Oxford: Oxford University Press.

Palmer, V. J., Chondros, P., Piper, D., Callander, R., Weavell, W., Godbee, K., . . . Gunn, J. (2015). The CORE study protocol: a stepped wedge cluster randomised controlled trial to test a co-design technique to optimise psychosocial recovery outcomes for people affected by mental illness in the community mental health setting. BMJ Open, 5(e006688).

Richard, L., Piper, D., Weavell, W., Callander, R., Iedema, R., Furler, J., . . . Palmer, V. J. (2017). Advancing engagement methods for trials: the CORE study relational model of engagement for a stepped wedge cluster randomised controlled trial of experience-based co-design for people living with severe mental illnesses. Trials, 18(1), 169. Retrieved from https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-017-1878-7 doi:10.1186/s13063-017-1878-7

Whitley, R., Palmer, V., & Gunn, J. (2015a). Harnessing primary care to enhance recovery from severe mental illness. British Journal of General Practice, 65(637), 429-430.

Whitley, R., Palmer, V., & Gunn, J. (2015b). Recovery from severe mental illness. Canadian Medical Association Journal, 187(13), 951-952.

*Presentations*

Palmer, V. (2018, 20-22 September). Timeline mapping as a visual method to explore temporality, affectivity and relationality in the life events and stories of people living with severe mental illness. Paper presented at the Qualitative Research on Mental Health Conference, Berlin, Germany.

Palmer, V. (2018, 1st August). The participation paradox re-evaluated: Individual and system value in experience based co-design. AAAPC Most Distinguished Paper, presented at the Primary Health Care Research Conference (PHCRIS), Melbourne, Australia.

Palmer, V. (2018, 2nd May). This week is the same as every week': short diaries as a method to elicit insights into everyday life routines, practices, thoughts and feelings of people living with severe mental illnesses. Paper presented at the Qualitative Methods Conference, Banff, Canada.

Palmer, V., Harvey, C., Gunn, J., & Davidson, S. (2018, 25th February). Developing a primary care response to the physical health crisis for people living with severe mental illnesses. Paper presented at the World Psychiatry Association Thematic Congress, Melbourne, Australia.

Palmer, V. (2017, 7-8 December). Engaging the vulnerable in coproduction of public services international symposium. Invited presentation at the University of Birmingham, UK.

McNamara, J., Davidson, J., Palmer,V., Cameron, D. (2017, 30 November). Creativity, Mental Health, and Co-designed Research. Invited panel discussion at the Melbourne Social Equity Institute, Melbourne, Australia.

Richard, L., Herrman, H., Gunn, J., & Palmer, V. (2017, 18th November). The Experiences of Violence for People Living With Severe Mental Illness: Using a Timeline Visual Mapping Method to Understand Violence and Improve Service Responsiveness in Primary Health Care (The CORE Study). Paper presented at the North American Primary Care Research Group (NAPCRG), Montreal, Quebec.

Palmer, V. (2017, 7-9 August). Experiences of violence for people living with severe mental illnesses: a timeline visual mapping method to understand violence and improve service responsiveness (The CORE Study). Paper presented at the Primary Health Care Research Conference (PHCRIS), Brisbane.

Palmer, V. (2017, 12th June). Embedding experience co-design and co-production in primary care for mental health systems reform – the CORE study. Paper presented at the Health Services Management Centre, University of Birmingham, UK.

Alvarez, M., Thomas, N., Maybery, D., Meadows, G., & Palmer, V. (2017, 2nd May). Building the Evidence Base for Recovery-Oriented Mental Health: Lessons from Developing and Implementing Treatments, Service Models and System Co-Design for People Living with Severe Mental Illnesses in Victoria, Australia. Paper presented at the The Royal Australian and New Zealand College of Psychiatrists Congress, Adelaide, Australia.

Palmer, V. (2017, 2nd May). The Engagement and Psychosocial Recovery Nexus: Testing an Experience-Based Co-Design Methodology in Community Mental Health Services. Paper presented at the The Royal Australian and New Zealand College of Psychiatrists Congress, Adelaide, Australia.

Palmer, V. (2016, 8th June). A silent crisis: a primary care response to the physical health needs for people with severe mental illness. Paper presented at the Primary Health Care Research Conference, Canberra, Australia.

Palmer, V., & Godbee, K. (2016, 5th May). Then and Now: temporality and narrative representation in timeline data collected with people living with severe mental illnesses. Paper presented at the International Qualitative Methods Conference, Glasgow, Scotland.

Palmer, V., Godbee, K., Weavell, W., Callander, R., & Gunn, J. (2016, 3rd May). Can you tell me about...? The pros and cons of telephone interviews and Leximancer analysis for experiential data collected with people living with severe mental illness. Paper presented at the International Qualitative Methods Conference, Glasgow, Scotland.

Palmer, V., Godbee, K., Richard, L., Weavell, W., Callander, R., Furler, J., . . . Iedema, R. (2015, 31st July). A relational model of engagement: recruitment and retention of people with serious mental illnesses, their carers and staff to complex interventions in the community mental health setting. Paper presented at the Primary Health Care Research and Information Service Conference, Adelaide.

Palmer, V. (2015, 22nd July). The engagement nexus and psychosocial recovery. Paper presented at the Mind Colloquium Series, Melbourne.

Palmer, V., Weavell, W., & Callander, R. (2015). Translating experience based co-design into a best practice reality for mental health service design and planning. Paper presented at the TheMHS conference, Canberra.

Robert, G., & Parr, J. (2015). Workshop: Improving Care Using Experience Based Co-design. Republic of Ireland: Waterford Institute of Technology.

Furler, J. (2014). Getting to the CORE: Testing a co-design technique to optimise psychosocial recovery outcomes for people affected by mental illness. Paper presented at the Mental Illness Research Fund Project Launch, Melbourne, Victoria.

Palmer, V. (2014). Getting to the CORE – the journey so far. Paper presented at the Experience Based Co-Design in Mental Health UK network, South Bank University, South Bank, London.

Palmer, V. J. (2014). The CORE Study – a stepped wedge cluster randomised controlled trial to test a codesign technique to optimise psychosocial recovery outcomes for people affected by mental illness in the community mental health setting. Paper presented at the Health Experiences Research Institute, Nuffield Department of Primary Health Care Sciences, The University of Oxford, Oxford.

Ban, L., Palmer, V., Weavell, W., Callander, R., & Fairhurst, K. (2013). Getting to the CORE: Testing a co-design technique to optimise psychosocial recovery outcomes for people affected by mental illness. Paper presented at the Mental Health Services Conference, Melbourne.

Callander, R., Weavell, W., & Fairhurst, K. (2013). MH ECO. Paper presented at the Mental Health Services Conference, Melbourne.

Chondros, P. (2013). Testing the effectiveness of a co-design technique to optimise psychosocial recovery: a stepped wedge cluster randomised trial. Paper presented at the Centre for Primary Care and Public Health, Blizard Institute, Barts and The London School of Medicine and Dentistry, London, England.

Gunn, J. (2012, 1-5 December). Getting to the CORE: Testing a co-design technique to optimise psychosocial recovery outcomes for people affected by mental illness. Paper presented at the International Collaborative Research Initiative to Design Interventions for Patients With Multimorbidity In Primary Health Care, North American Primary Care Research Group meeting, New Orleans, USA.

*Posters*

Palmer, V. J., Godbee, K., Richard, L., Piper, D., Callander, R., Weavell, W., . . . Gunn, J. (28 - 30 April, 2015). A relational model of engagement to recruit participants with severe mental illness and their carers to a cluster randomised controlled trial (The CORE Study) Poster presentation at the 15th International Mental Health Conference. Melbourne.

Palmer, V. J., Chondros, P., Piper, D., Callander, R., Weavell, W., Godbee, K., . . . Gunn, J. (21-25 November, 2014). The CORE Study: A stepped wedge cluster randomised controlled trial to test a co-design technique to optimise psychosocial recovery outcomes for people affected by mental illness in the community mental health setting Poster presentation at the 42nd Annual Meeting of the North American Primary Care Research Group (NAPCRG). New York.

Palmer, V. J., Chondros, P., Piper, D., Callander, R., Weavell, W., Godbee, K., . . . Gunn, J. (25-27 August, 2014). The CORE Study Protocol: A stepped wedge cluster randomised controlled trial to test a co-design technique to optimise psychosocial recovery outcomes for people affected by mental illness in the community mental health setting Poster presentation at the 15th International Mental Health Conference. Surfers Paradise.

*Engagement event*

Palmer, V. J., Godbee, K., Richard, L., Piper, D., Callander, R., Weavell, W., . . . Gunn, J. (16 February, 2018). The CORE Forum: Sharing lessons and findings with study participants and partners. The University of Melbourne, Australia.

Public notes

Attachments [1]

/AnzctrAttachments/365787-CORE data analysis plan.pdf (Supplementary information)

Contacts

Principal investigator

Name

Dr Victoria Jane Palmer

Address

The Department of General Practice, Melbourne Medical School, Faculty of Medicine Dentistry and Health Sciences, 200 Berkeley Street, Carlton Victoria 3053

Country

Australia

Phone

+61 3 83 44 4987

Fax

[email protected]

Contact person for public queries

Name

Ms Kali Godbee

Address

The Department of General Practice, Melbourne Medical School, Faculty of Medicine, Dentistry and Health Sciences, The University of Melbourne, 200 Berkeley Street Carlton, Victoria 3053

Country

Australia

Phone

+61 3 9035 7480

Fax

[email protected]

Contact person for scientific queries

Name

Dr Victoria Palmer

Address

The Department of General Practice, Melbourne Medical School, Faculty of Medicine, Dentistry and Health Sciences, The University of Melbourne, 200 Berkeley Street, Carlton Victoria 3053.

Country

Australia

Phone

+61 3 83 44 4987

Fax

[email protected]

No information has been provided regarding IPD availability

What supporting documents are/will be available?

Current supporting documents:

Updated to:

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
23318	Study protocol	-999999
23319	Statistical analysis plan	-999999

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Doc. No.	Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
3964	Plain language summary	No		Trial outcomes currently unavailable while outcome... [More Details]
4457	Other files	No		Currently unavailable until peer review is complet... [More Details]

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Source	Title	Year of Publication	DOI
Embase	Advancing engagement methods for trials: The CORE study relational model of engagement for a stepped wedge cluster randomised controlled trial of experience-based co-design for people living with severe mental illnesses.	2017	https://dx.doi.org/10.1186/s13063-017-1878-7
Embase	The CORE study protocol: A stepped wedge cluster randomised controlled trial to test a co-design technique to optimise psychosocial recovery outcomes for people affected by mental illness in the community mental health setting.	2015	https://dx.doi.org/10.1136/bmjopen-2014-006688

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