The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12614000957695
Ethics application status
Approved
Date submitted
18/08/2014
Date registered
8/09/2014
Date last updated
6/12/2019
Date data sharing statement initially provided
6/12/2019
Date results information initially provided
6/12/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The PULSAR project (specialist care trial): does providing recovery-oriented training to staff in specialist community-based mental health services improve the personal recovery of adult consumers?
Scientific title
The PULSAR project (specialist care trial): a two stepped-wedge cluster randomised controlled trial to test whether training mental health staff in recovery-oriented practice using the PULSAR (Principles Unite Local Services Assisting Recovery) intervention improves the personal recovery in adult consumers of specialist community-based mental health services.
Secondary ID [1] 284916 0
none
Universal Trial Number (UTN)
U1111-1156-6385
Trial acronym
PULSAR (Specialist Care Trial)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psychotic disorders
292386 0
Any other mental health condition 292901 0
Condition category
Condition code
Mental Health 292701 292701 0 0
Psychosis and personality disorders
Mental Health 292702 292702 0 0
Depression
Public Health 293190 293190 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The PULSAR intervention is a training intervention that is delivered by the research team to staff in participating specialist community-based mental health services. The intervention focuses on teaching and promoting recovery-based practices to staff. PULSAR stands for "Principles Unite Local Services Assisting Recovery". Recovery-oriented practice involves supporting a process of change through which individuals improve their health and wellness, live a self-directed life, and strive to reach their full potential. A package of interventions, developed and trialled by the Refocus Team, Institute of Psychiatry, King's College London UK, promotes recovery-oriented practice in mental health teams. In the PULSAR project these materials are adapted for Australian specialist community-based mental health services. The content and process of training are sensitive to the needs of the Victorian mental health system and the local cultural and legal contexts.

The training has been developed either as a two-day spaced program, or as four ½ day spaced sessions, or a two-day session for staff from involved services. In round two, the delivery of the intervention was modified to account for previously unknown restrictions on the ability of services to release staff for two days of training. In response to this the training was re-designed so that all material is covered in the first day of training, with more in-depth exploration and practice of the knowledge and skill on day two. The training is delivered by mental health clinicians, including experienced trainers from the study team or host organisations, with co-delivery by consumer trainers for at least half the time and carer involvement for at least one hour of training. A schedule of training is provided to trainers along with standardised training packs including use of videos to provide standardised content. Trainers are asked to keep a record of training and asked to record any deviations from the schedule and use of materials.

The intervention focuses on promoting recovery-based practices to staff that are in addition to standard care, and is comprised of two core components: Recovery-Promoting Relationships and Working Practices.

Recovery-Promoting Relationships: According to a recovery-oriented framework, the working relationship between staff and consumers is crucial to the process of recovery. The intervention develops and supports this relationship by: assisting teams to develop a shared understanding of personal recovery; exploring existing values held by individual workers and the team; developing skills in coaching; and raising the expectations held by consumers that their values, strengths and goals will be prioritised in their relationships with staff members.

Working Practices: The intervention is centered around three main working practices that form the specific behaviours and recovery supports necessary for building positive, recovery-promoting relationships in mental health care: 1) Understanding values, treatment and support preferences; 2) Assessing and working with strengths; and 3) Supporting goal-striving. Staff are trained to ensure that care planning is based on the consumer’s values, preferences, strengths, and personally valued goals.

The intervention is supported by four implementation strategies: 1) Personal recovery training; 2) Coaching and working practice training; 3) Team manager reflection group; and 4) Team reflection sessions, as well as a set of training materials and compatible working tools.

After receiving the intervention, staff are invited to take part in monthly hour long PULSAR Active Learning Sessions (PALS) with an experienced PULSAR facilitator to discuss and reflect upon their experiences of delivering recovery-oriented practice in the service setting. PALS are available for 12-24 months following the intervention (depending on whether trained in the first or second year) and are delivered via face to face in a group setting.

These interventions are delivered and evaluated in a stepped-wedge cluster randomised controlled trial. Seven specialist mental health services (clusters) were randomised to receive the PULSAR intervention in year 1 and seven specialist mental health services in year 2. To account for potential contamination of the intervention ‘dosage’ to be received within each cluster (i.e. the number of staff who had undergone the PULSAR training), a dosage variable will be included into the modelling. This variable will be based on estimates of staff changes, which will be collected via the site coordinator every three months including the number and EFT of 1) new staff taking up employment from outside the service 2) staff that had moved to another team but remain within the service and 3) staff leaving the service.
Intervention code [1] 289736 0
Rehabilitation
Comparator / control treatment
Standard treatment, which is defined as follows:
a) For Monash Health: routine care as governed by the policies and procedures applicable to Monash Health, and which are consistent with the National Services for Mental Health Services 2010 & Directives as issued from time to time by Chief Psychiatrist and concordant with Mental Health Act 2014.

b) For the Psychiatric Disability Rehabilitation Support sector: a non-clinical module of care which already has a number of elements concordant with recovery-oriented practice, and which we will be exploring whether can be further improved by the PULSAR intervention.

The control group will be given the intervention after 12 months, as required in a two stepped-wedge cluster randomised controlled trial design. The purpose of the stepped-wedge design is to ensure everyone gets the intervention, to improve acceptability and to increase the power of the study.

Control group
Active

Outcomes
Primary outcome [1] 292544 0
Improved personal recovery: Process of Recovery Questionnaire (QPR)
Timepoint [1] 292544 0
12 and 24 months. The overarching study design is a two stepped-wedge cluster randomised controlled trial, and primary timepoints for this design are at 12 and 24 months. This is because the QPR data collection (cross-sectional) points for all sites are at baseline, 12 months and 24 months with the intervention commencing in the first quarter of year 1 for the cluster sites randomised to receive the intervention first (A sites) and in the first quarter of year 2 for the remaining cluster sites (B sites). This study also has two planned nested designs, for which the primary timepoint is 12 months. 1) a conventional cluster randomised controlled trial (complete stepped-wedge design for QPR data) in which data collection points are at baseline and after 12 months. The intervention is delivered in the first quarter of the year. 2) a longitudinal study involving participation at 2 timepoints that are one year apart for a subgroup of participants (design: pre-post intervention or incomplete stepped-wedge for QPR data).
Secondary outcome [1] 309193 0
Recovery in mental health: INSPIRE
Timepoint [1] 309193 0
The secondary timepoint is at 12 months following the PULSAR intervention.

Data collection for secondary measures occurs in face-to-face interviews. Interviews are planned to occur only pre and post the intervention i.e. baseline and 12 months (A sites) and 12 months and 24 months (B sites).
Secondary outcome [2] 309194 0
Mental well-being: Warwick and Edinburgh Wellbeing Scale (WEMWBS)
Timepoint [2] 309194 0
The secondary timepoint is at 12 months following the PULSAR intervention. Data collection for secondary measures occurs in face-to-face interviews. Interviews are planned to occur only pre and post the intervention i.e. baseline and 12 months (A sites) and 12 months and 24 months (B sites).
Secondary outcome [3] 335212 0
Other outcome: Health Economics and Perceived Need for Care Questionnaire (HE&PNCQ)
Timepoint [3] 335212 0
12 months following the PULSAR intervention
Secondary outcome [4] 335213 0
Other outcome: Client Satisfaction Survey (CSQ)
Timepoint [4] 335213 0
12 months following the PULSAR intervention
Secondary outcome [5] 335214 0
Mind Australia Satisfaction Survey (MASS)
Timepoint [5] 335214 0
12 months following the PULSAR intervention
Secondary outcome [6] 335215 0
Other outcome: The Coercion Ladder
Timepoint [6] 335215 0
12 months following the PULSAR intervention.
Secondary outcome [7] 335216 0
Other outcome: Global Assessment of Functioning (GAF)
Timepoint [7] 335216 0
12 months following the PULSAR intervention.
Secondary outcome [8] 335217 0
The Social and Occupational Functioning Assessment Scale (SOFAS)
Timepoint [8] 335217 0
12 months following the PULSAR intervention.

Eligibility
Key inclusion criteria
1..Aged 18 years or over
2. Aged less than 75 years
3. Have English proficiency
4. Are able to provide informed consent
5. Have accessed a study cluster mental health service in the 3 months prior to data collection.

Additional inclusion criteria for participation in the nested longitudinal study:

6. Primary diagnosis of psychosis, e.g., schizophrenia, schizoaffective disorder, bipolar disorder.
Minimum age
18 Years
Maximum age
74 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
People who cannot give informed consent
People who are unable to speak or read English
People who are in prison

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
ALLOCATING TO TREATMENT
There are fourteen cluster sites in this study all of which are specialist care mental health sites located in the catchment of Monash Health. This is a cluster randomised control trial (cRCT) which utilises a stepped-wedge (2-step) design: study steps are twelve months apart. Clusters will be randomised to receive the PULSAR intervention at either year 1 or year 2. To ensure that cluster types are balanced in step periods, stratified randomisation will be applied. An offsite researcher who is independent from the research team performed the stratified randomisation during the third quarter of 2014, when involvement of sites was confirmed and sites were notified of randomisation status when necessary for arrangement of delivery of the training intervention. Research assistants collecting data from consumers in face-to-face interview are not be informed of the intervention status of cluster sites and staff from each site are asked not to divulge intervention status to research assistants. The blindness of research assistants is monitored.

ENROLLING A PARTICIPANT
Context
Data collection consists of cross-sectional surveys collected at baseline and again at the end of years 1 and 2. These involves consumers of the service clusters at the designated time points and will not necessarily involve follow up of the same participants. This will enable assessment of the function of the team/service cluster in delivery of recovery-oriented practice through observation of current clientele. The primary outcome is the Questionnaire about the Process of Recovery collected from 756 consumers (252 each at baseline, step 1, step 2). Secondary and other outcomes measuring well-being, service satisfaction and health economic impact are collected from a subset of 252 consumers (63 at baseline; 126 at step 1; 63 at step 2) via interviews. A nested incomplete step-wedge design involves interview-based longitudinal data collected from a sub-set of 88 participants from specialist care who have a psychotic disorder (44 at baseline, step 1; 44 at step 1, step 2).

PRIMARY RECRUITMENT
The primary mode of recruitment is through letters of invitation sent in mailouts to all eligible consumers of the participating services from each cluster site.

Consent for consumer recruitment
The letter of invitation sent to consumers in the mailouts includes a) a one-page letter of invitation; b) a "participant contact and consent form" and the survey documents including the Process of Recovery Questionnaire (QPR) and a demographic form. The letter of invitation explains to candidates that if they are interested in participating they can express this by completing and returning the QPR and demographic form and if they are happy to provide their contact details they will be mailed a $10 shopping voucher.

Participants are instructed to return the signed consent form and completed QPR/demographic form in separate envelopes to ensure confidentiality of data. The consent form and QPR/demographic form are colour-coded to their respective envelope to facilitate comprehension of participant instructions. The researchers, upon receipt of the consent form and QPR/demographic form, use a unique matching code printed on each for linkage.

Reply-paid envelopes of Southern Synergy are used rather than reply-paid envelopes to patients’ respective clinic/specialist mental health service. The rationale being that this reduces possible breaches of confidentiality because consenting participants will be returning their data directly to the research team who will then securely enter (using password protected files and computers) and store (using lockable filing cabinets for hard copies) all materials.

We have included a statement in the invitation letter that their service has not released any identifying information to the researchers and that it is the individual’s choice to disclose identifying information as indicated by completing and returning the participant contact details form.

Candidates are instructed to also sign the "Consent to future contact" section of the Participant contact and consent form if they wish to participate in other parts of the PULSAR project such as a face-to-face interview. Participants who complete a face-to-face interview are required to provide full written informed consent for both the interview and to the researchers accessing routinely collected data using a revised PICF. At the end of interview, participants are asked whether they would be interested in completing a follow-up interview approximately 12 months later. If participants are willing to be contacted regarding the follow-up interview, they are asked to provide their up-to-date contact details.

SECONDARY RECRUITMENT
Recruitment strategies to promote consumer response to the mailouts will be flexibly employed according to the needs of sites. Strategies may include, for example, having researchers, especially consumer researchers, available at sites to speak about PULSAR, use of publicity materials such as advertisements, posters or PULSAR-branded materials, and direct contact with, and support for, clinicians. Considerable care will be taken to ensure, as far as reasonably possible, that recruitment strategies are consistent across time points at participating clusters.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)
There are fourteen cluster sites in this study all of which are specialist care mental health care sites located in the catchment of Monash Health. Clusters will be randomised to receive the PULSAR intervention at either year 1 or year 2. As per above, the trials will use stratified randomisation to ensure that cluster types (and therefore participants) are balanced in step periods.

The method of sequence generation will be by simple randomisation using an online Research Randomizer for random number generation. Seven randomisation keys will be created that correspond to the 7 strata. The randomisation will be performed offsite by an independent researcher during the third quarter of 2014.

Each stratum contains 2 sites; therefore individual site codes will indicate the stratum and the site, a or b. For example, the sites within strata 5 are called 5a and 5b. This nomenclature was set prior to the generation of the randomisation key. The seven generated random numbers will be assigned consecutively to all ‘a’ sites. A positive number designates a site receiving the intervention in year 1, and a negative number in year 2. The ‘b’ site receives the intervention in the year not designated to the ‘a’ site.

Investigators, site coordinators, participants and all others are unable to change the randomisation key and intervention allocation given to a site.



Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Other
Other design features
This project involves a two stepped-wedge (2-step) cluster randomised controlled trials conducted in specialist mental health care settings. Half the clusters in each setting receive the intervention in step 1 and the other half receive the intervention 12 months later, at step 2. Clusters awaiting intervention act as controls. A longitudinal qualitative study examining staff and consumer perspectives on the PULSAR intervention is also included in the overall PULSAR project.

Participants will be asked to indicate consent to being approached for other research projects. The sample frame this generates, for example, may possibly be used for recruitment of participants in planned qualitative surveys accompanying the quantitative research.

In addition to primary and secondary outcomes measures, other measures administered during the participant interviews include:
1. Participant demographic record
2. Health Economics and Perceived Need for Care Questionnaire (HE&PNCQ)
3. Client Satisfaction Survey (CSQ)
4. Mind Australia Satisfaction Survey (MASS)
5. The Coercion Ladder
6. Global Assessment of Functioning (GAF)
7. The Social and Occupational Functioning Assessment Scale (SOFAS)

Of these additional measures only the demographics, HE&PNCQ, GAF and SOFAS will be administered and scored by the interviewer. All remaining measures are self-report.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Sample size
The primary analysis examines QPR data from consumers in the cRCT (stream 1) and requires a total sample size of 756 consumers from 14 clusters over three years. This will be sufficient to detect a medium effect size representing a change in QPR score by 6.3. Secondary analyses that examine data from a subset of stream 1 consumers who participate in stream 2 of the cRCT, requires a total sample size of 252 consumers over the study period. This will be sufficient to detect medium effect sizes in the QPR and two secondary outcome measures (WEMWBS and INSPIRE). Additional secondary analyses to examine longitudinal data from a subset of stream 2 consumers who participate in stream 3 of the cRCT, requires a total sample size of 88 consumers over the study period. This will be sufficient to detect medium-large effect sizes in the QPR and WEMWBS and INSPIRE, .
Sample size calculations were based on 14 clusters; intracluster correlation coefficient (ICC) of 0.05; significance level set at 0.05; power of 0.80; and available published and unpublished (INSPIRE) data about distribution properties. All sample size calculations were done using Stata statistical software stepped-wedge Version 11, StataCorp. 2009.
The provided power calculations indicate the minimum number of participants we will aim to recruit. Contingent on response rates to the initial recruitment efforts and on project resource availability these numbers may increase.

Main analysis plan
The primary analysis involves evaluating the PULSAR training intervention at the consumer level by examining the QPR data from consumers. The planned data collection schedule has three main periods called T0, T1 and T2. Baseline (T0) data collection occurs in the year prior to and three months after the step 1 intervention is delivered. In the next period called step 1, (T1), data collection occurs during the following 12 months. Then in the next period called step 2, (T2), data collection occurs during the following 12 months. During both T1 and T2 periods, data collection at individual clusters occurs at a minimum of 9 months after the intervention was delivered to ensure embedding of intervention practices and principles.
Descriptive statistics will be used to summarise the characteristics of the clusters at baseline and consumer-level variables at time of data collection. Cluster-level variables are those used in the stratified randomisation, which are seven types of organisational variations, plus the intervention status of the cluster and the time since (or before) the start of the intervention. The ICC will be calculated and reported.
The analysis of data in a stepped-wedge cRCT is most suitably analysed mixed-effects models. The primary analysis examines the effect of PULSAR on the primary outcome (consumer-level QPR scores) using a linear mixed-effects model state ‘on an intention-to-treat basis’. The model will include intervention status and time as fixed effects and clusters and consumers as random effects. Normally step one is just to examine intervention – control group differences controlling for cluster, before including covariates. An a priori model-fitting analysis strategy will involve both univariate and multivariable models to be developed based on baseline consumer and cluster-level variables considered statistically significant (p < 0.10) or clinically important (e.g., age, sex), and included in the model as fixed. Model fit will be examined by comparing AIC values.
Secondary analyses will examine the effect of PULSAR on secondary outcomes (WEMWBS and INSPIRE) using a linear mixed-effects models to compare the intervention and control periods (pre-intervention).
Estimated intervention effects will be reported as the mean outcome difference for continuous outcomes and Odds Ratio for binary outcomes between intervention and control periods. This can be described as a meta-analysis approach as (in the case of continuous data) the mean change in each cluster will be standardised by using the variance of the outcome measure within that cluster. The estimated intervention effects will be reported with 95% Confidence Intervals and p values. Analysis will be conducted using Stata V.14, StataCorp. Stata Statistical Software: Release 14. College Station, TX: StataCorp LP, 2015.

Sensitivity analyses
A missing data analysis will investigate any patterns of missingness. For each primary and secondary outcome component with missing data, multiple imputation using multivariate regression with factors of age, gender, time, and intervention status will produce 100 estimates. Sensitivity analyses will be performed using this multiple imputation to account for missing data and then re-running the analyses. Sensitivity analyses will also include the intervention dosage variable described earlier.
Economic evaluation
Overall, costs associated with each participant will follow well established health economic principles, and cover direct medical costs of illness, plus the labour market effects of illness. Direct medical costs are to be calculated for prescription and other medically recommended non-prescription medications, and hospital and health service contacts. Labour market productivity losses will be imputed using the human capital approach by multiplying reported days off work due to mental illness with an individual’s estimated salary using instrumentation devised by this team for a previous health economic evaluation. Using only days off work due to illness to capture labour market costs captures an important aspect of the cost of illness; however, it is noted that the estimates obtained will be conservative and the true cost will be higher than what we obtain because of other effects of illness such as higher rates of non-participation in employment, or underemployment.


Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 289540 0
Government body
Name [1] 289540 0
Mental Illness Research Fund, The Victorian State Government Department of Health
Address [1] 289540 0
The Victorian State Government Department of Health
Mental Health, Drugs and Regions Division
50 Lonsdale St
Melbourne, Vic 3000
Country [1] 289540 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Southern Synergy
Dandenong Hospital
126-128 Cleeland St
Dandenong VIC 3175
Country
Australia
Secondary sponsor category [1] 288226 0
None
Name [1] 288226 0
Address [1] 288226 0
Country [1] 288226 0
Other collaborator category [1] 278029 0
Hospital
Name [1] 278029 0
Monash Health
Address [1] 278029 0
Mental Health Program
Monash Health
Dandenong Hospital
126-128 Cleeland St
Dandenong VIC 3175
Country [1] 278029 0
Australia
Other collaborator category [2] 278030 0
Charities/Societies/Foundations
Name [2] 278030 0
Ermha Inc
Address [2] 278030 0
9 Buckley St
Noble Park
VIC 3174
Country [2] 278030 0
Australia
Other collaborator category [3] 278031 0
University
Name [3] 278031 0
La Trobe University
Address [3] 278031 0
La Trobe University
Melbourne VIC 3086
Country [3] 278031 0
Australia
Other collaborator category [4] 278032 0
Charities/Societies/Foundations
Name [4] 278032 0
Mind Australia
Address [4] 278032 0
86-92 Mount St
Heidelberg VIC 3084
Country [4] 278032 0
Australia
Other collaborator category [5] 278033 0
University
Name [5] 278033 0
Royal Melbourne Institute of Technology (RMIT)
Address [5] 278033 0
124 Little La Trobe St
Melbourne VIC 3000
Country [5] 278033 0
Australia
Other collaborator category [6] 278034 0
Other Collaborative groups
Name [6] 278034 0
Refocus Team
Address [6] 278034 0
Health Service and Population Research Department (Box P029)
Institute of Psychiatry
King's College London
De Crespigny Park
Denmark Hill
London SE5 8AF
Country [6] 278034 0
United Kingdom
Other collaborator category [7] 278035 0
University
Name [7] 278035 0
University of Melbourne
Address [7] 278035 0
1-100 Grattan St
Parkville VIC 3010
Country [7] 278035 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291281 0
Monash Health Human Research Ethics B
Ethics committee address [1] 291281 0
Research Directorate
Monash Health
Monash Medical Centre
246 Clayton Rd
Clayton VIC 3168
Ethics committee country [1] 291281 0
Australia
Date submitted for ethics approval [1] 291281 0
10/04/2014
Approval date [1] 291281 0
22/05/2014
Ethics approval number [1] 291281 0
14102B
Ethics committee name [2] 291533 0
Monash University Human Research Ethics Committee (MUHREC)
Ethics committee address [2] 291533 0
Monash University
Victoria 3800
Ethics committee country [2] 291533 0
Australia
Date submitted for ethics approval [2] 291533 0
Approval date [2] 291533 0
28/05/2014
Ethics approval number [2] 291533 0
CF14/1600 - 2014000773

Summary
Brief summary
PULSAR stands for ‘Principles Unite Local Services Assisting Recovery’. The overall aim of the PULSAR project is to imbed recovery-oriented practice in primary care and specialist mental health services throughout the Monash Health catchment. Recovery-oriented practice involves supporting a process of change through which individuals improve their health and wellness, live a self-directed life, and strive to reach their full potential. A package of training interventions has been developed in the United Kingdom that promotes recovery-oriented practice in teams. We adapt these materials for the Australian setting so that the content and processes of training and development are sensitive to needs of the Victorian mental health care system, the local cultural and legal contexts. The PULSAR intervention involves training staff in recovery-oriented practice using these adapted materials.

This trial pertains to the evaluation of the PULSAR intervention within specialist community-based mental health services; the evaluation of PULSAR in primary care services is being evaluated in separate trial, which is separately registered with ANZCTR. In the specialist care trial, we are delivering the PULSAR intervention to staff at 14 specialist community mental health care settings (clusters) and evaluating the effect on adult consumers of these services. Half of the clusters are randomised to receive the PULSAR intervention in year 1, and the other half receive the PULSAR intervention in year 2.

Our key hypotheses are that consumers in the PULSAR intervention clusters will experience significantly greater gains in personal recovery and in health and wellbeing compared to consumers receiving care in control groups.

Data will be collected cross-sectionally from a minimum of 252 volunteer service users at three time points: baseline, end of year 1 and again at the end of year two. The total number of participants will be at least 756 consumers (i.e. minimum of 18 consumers per cluster per time point). Consumers are recruited into the study if they respond to an invitation letter by completing and returning a short recovery-focused survey. A subset of participants who also return a signed "consent to future contact form" are invited to attend a face-to-face interview where more detailed data will be collected assessing recovery, health and well-being, service satisfaction, perceived coercion in accessing services and health economic impact. Longitudinal data are collected from a further subset of participants invited to attend two face-to-face interviews at time points corresponding to the pre and post intervention periods for their particular cluster.

The significance of the work will be to develop, evaluate, and make readily available a set of training materials and organisational change tools that would facilitate participating mental health services working together to successfully deliver recovery-oriented practice.
Trial website
http://www.pulsarrecovery.org.au
Trial related presentations / publications
Publications
1. Meadows, G. Brophy, L, Shawyer, F, Enticott, JC, Fossey, E, Thornton, CD, Weller, PJ, Wilson-Evered, E, Edan, V, Slade, M.. (2019). REFOCUS-PULSAR recovery-oriented practice training in specialist mental health care: a stepped-wedge cluster randomised controlled trial. The Lancet Psychiatry, 6: 103-14.

2. Shawyer, F., Enticott, J.C., Brophy, L., Bruxner, A. Fossey, E., Inder, B., Julian, J., Kakuma, K., Weller, P., Wilson-Evered, E., Edan, V., Slade, M., and Meadows, G. (2017). The PULSAR Specialist Care protocol: a stepped-wedge cluster randomized control trial a training intervention for community mental health teams in recovery-oriented practice. BMC Psychiatry, 17: 172. DOI 10.1186/s12888-017-1321-3.

Conference presentations
1. Meadows G, Brophy L, Shawyer F, Enticott J, Fossey E, Thornton C, Weller P, Wilson-Evered E, Edan V & Slade M. (2019). A stepped wedge cluster RCT of a team-based Recovery Oriented Practice Intervention for secondary care services; methodological considerations and key findings. Poster. International Federation for Psychiatric Epidemiology (IFPE), 8-10 April. Sao Paulo, Brazil.

2. Meadows, G. (2018). Promoting recovery-oriented mental health care practice; the PULSAR project. Paper. WPA thematic conference, 25-28 February. Melbourne, Australia.

3. Shawyer, F., Enticott, J., Brophy, L., Fossey, E., Inder, B., Julian, J., Kakuma, R., Mazza, D., Russell, G., Weller, P., Wilson-Evered, E., Edan, V., Meadows, G. (2017). Taking recovery orientated practice (ROP) to urban south east Melbourne, Australia: a stepped-wedge cluster randomized controlled trial called PULSAR. Poster. International Federation for Psychiatric Epidemiology (IFPE), 17-20 October. Melbourne, Australia.

4-7. Meadows, G., Edan, V., Fossey, E., Weller, P., Brophy, L. (2017). Re-situating Recovery symposium. Chair: Graham Meadows. Symposium with 4 papers:
• Graham Meadows: Principles Unite Local Services And Recovery (PULSAR): Introduction and overview
• Vrinda Edan: PULSAR Recovery orientated practice, the intervention
• Penny Weller: Implementing PULSAR
• Lisa Brophy: PULSAR: Preliminary data
Refocus on Recovery conference, 18-20 September. Nottingham, UK.

8-9. Edan, V., Meadows, G., Enticott, J., Fossey, E., Brophy, L., Weller, P. (2017). PULSAR: Researching Recovery Oriented Practice - symposium. 2 papers:
• Meadows, G., Brophy, L., Weller, P., Edan, V. PULSAR: Overview, implementation and the intervention
• Meadows, G., Brophy, L., Enticott, J., Fossey, E., Edan, V. PULSAR: Preliminary data
TheMHS conference, 29 August - 1 September. Sydney, Australia.

10. Mayberry, D., Goodyear, M., Meadows, G. (2017). Improving service supports and models-the Let's Talk About Children Program and Principles Unite Local Services Assisting Recovery. Paper. RANZCP Congress, 30 April - 4 May, Adelaide, Australia.

11. Palmer, V., Alvarez, M., Thomas, N., Mayberry, D., Meadows, G. (2017). Building the evidence base for recovery-oriented mental health: lessons from developing and implementing treatments and services. Symposium with paper by Meadows, G. The PULSAR project. Working together with shared values towards recovery-oriented practice - a stepped-care stepped-wedge study. RANZCP Congress, 30 April - 4 May, Adelaide, Australia.

12. Fossey, E., Brophy, L., Edan, V., Kehoe, M. (2016). PULSAR: researching recovery orientated practice in primary, secondary and community care - symposium. One paper by L. Brophy on secondary care. TheMHS conference, 23-26 August. Auckland, New Zealand.

13. Edan, V., Fossey, E., Brophy, L., Meadows, G. (2016). Coproduction, collaboration, cooperation…To everything there is a season. Paper. 6th Consumer Workforce Conference hosted by VMIAC, 21-22 March. Melbourne, Australia.

14. Edan, V., Meadows, G., Fossey, E., Brophy, L. (2015). Coproduction, collaboration, cooperation…To everything there is a season. Paper. Paper. Service User Academia Symposium, 30 November – 1 December. Auckland, New Zealand.

15. Edan, V. (2015). PULSAR – Principles Unite Local Services Assisting Recovery. Evaluation of personal recovery training to clinical, community and primary care sectors. Paper. 11th ENMESH International Conference, 1-3 October. Malaga, Spain.

16. Meadows, G., Brophy, L., Edan, V. (2015). PULSAR - bringing the opportunities and challenges of culture change in recovery practice to light. Paper. TheMHS Conference, 25-28 August 2015. Canberra, Australia.
Public notes

Contacts
Principal investigator
Name 49678 0
Prof Graham Meadows
Address 49678 0
Southern Synergy
Administration, Research and Training (ART) Building
Dandenong Hospital
126-128 Cleeland St
Dandenong VIC 3175
Country 49678 0
Australia
Phone 49678 0
+613 99029696
Fax 49678 0
+613 99029900
Email 49678 0
graham.meadows@monash.edu
Contact person for public queries
Name 49679 0
Dr Frances Shawyer
Address 49679 0
Southern Synergy
Administration, Research and Training (ART) Building
Dandenong Hospital
126-128 Cleeland St
Dandenong VIC 3175
Country 49679 0
Australia
Phone 49679 0
+613 99029461
Fax 49679 0
+613 99029900
Email 49679 0
frances.shawyer@monash.edu
Contact person for scientific queries
Name 49680 0
Prof Graham Meadows
Address 49680 0
Southern Synergy
Administration, Research and Training (ART) Building
Dandenong Hospital
126-128 Cleeland St
Dandenong VIC 3175
Country 49680 0
Australia
Phone 49680 0
+613 99029696
Fax 49680 0
+613 99029900
Email 49680 0
graham.meadows@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
In compliance with the requirements of the Monash Health Human Research Ethics Committee individual participant data will not be shared because we did not obtain participant consent to do so.
What supporting documents are/will be available?
Study protocol
Statistical analysis plan
Informed consent form
Ethical approval
How or where can supporting documents be obtained?
Type [1] 6066 0
Study protocol
Citation [1] 6066 0
Shawyer, F., Enticott, J.C., Brophy, L., Bruxner, A. Fossey, E., Inder, B., Julian, J., Kakuma, K., Weller, P., Wilson-Evered, E., Edan, V., Slade, M., and Meadows, G. (2017). The PULSAR Specialist Care protocol: a stepped-wedge cluster randomized control trial a training intervention for community mental health teams in recovery-oriented practice. BMC Psychiatry, 17: 172. DOI 10.1186/s12888-017-1321-3.
Email [1] 6066 0
Other [1] 6066 0
Attachment [1] 6066 0
Type [2] 6067 0
Statistical analysis plan
Citation [2] 6067 0
Shawyer, F., Enticott, J.C., Brophy, L., Bruxner, A. Fossey, E., Inder, B., Julian, J., Kakuma, K., Weller, P., Wilson-Evered, E., Edan, V., Slade, M., and Meadows, G. (2017). The PULSAR Specialist Care protocol: a stepped-wedge cluster randomized control trial a training intervention for community mental health teams in recovery-oriented practice. BMC Psychiatry, 17: 172. DOI 10.1186/s12888-017-1321-3.
Email [2] 6067 0
Other [2] 6067 0
Attachment [2] 6067 0
Type [3] 6068 0
Informed consent form
Citation [3] 6068 0
Link [3] 6068 0
Email [3] 6068 0
frances.shawyer@monash.edu
Other [3] 6068 0
Attachment [3] 6068 0
Type [4] 6069 0
Ethical approval
Citation [4] 6069 0
Link [4] 6069 0
Email [4] 6069 0
frances.shawyer@monash.edu
Other [4] 6069 0
Attachment [4] 6069 0
Summary results
Have study results been published in a peer-reviewed journal?
Yes
Journal publication details
Publication date and citation/details [1] 6070 0
Meadows, G. Brophy, L, Shawyer, F, Enticott, JC, Fossey, E, Thornton, CD, Weller, PJ, Wilson-Evered, E, Edan, V, Slade, M.. (2019). REFOCUS-PULSAR recovery-0riented practice training in specialist mental health care: a stepped-wedge cluster randomised controlled trial. The Lancet Psychiatry, 6: 103-14.
Attachments [1] 6070 0
Other publications
Have study results been made publicly available in another format?
Yes
Other publication details
Citation type [1] 6071 0
Conference poster
Citation/DOI/link/details [1] 6071 0
Meadows G, Brophy L, Shawyer F, Enticott J, Fossey E, Thornton C, Weller P, Wilson-Evered E, Edan V & Slade M. (2019). A stepped wedge cluster RCT of a team-based Recovery Oriented Practice Intervention for secondary care services; methodological considerations and key findings. Poster. International Federation for Psychiatric Epidemiology (IFPE), 8-10 April. Sao Paulo, Brazil.
Citation type [2] 6072 0
Presentation
Citation/DOI/link/details [2] 6072 0
Meadows, G. (2018). Promoting recovery-oriented mental health care practice; the PULSAR project. Paper. WPA thematic conference, 25-28 February. Melbourne, Australia.
Attachments [2] 6072 0
Citation type [3] 6073 0
Conference poster
Citation/DOI/link/details [3] 6073 0
Shawyer, F., Enticott, J., Brophy, L., Fossey, E., Inder, B., Julian, J., Kakuma, R., Mazza, D., Russell, G., Weller, P., Wilson-Evered, E., Edan, V., Meadows, G. (2017). Taking recovery orientated practice (ROP) to urban south east Melbourne, Australia: a stepped-wedge cluster randomized controlled trial called PULSAR. Poster. International Federation for Psychiatric Epidemiology (IFPE), 17-20 October. Melbourne, Australia.
Attachments [3] 6073 0
Citation type [4] 6074 0
Presentation
Citation/DOI/link/details [4] 6074 0
Meadows, G., Edan, V., Fossey, E., Weller, P., Brophy, L. (2017). Re-situating Recovery symposium. Chair: Graham Meadows. Symposium with 1 paper presented by L. Brophy with preliminary data. Refocus on Recovery conference, 18-20 September. Nottingham, UK.
Attachments [4] 6074 0
Citation type [5] 6075 0
Citation/DOI/link/details [5] 6075 0
Edan, V., Meadows, G., Enticott, J., Fossey, E., Brophy, L., Weller, P. (2017). PULSAR: Researching Recovery Oriented Practice - symposium with 1 paper by Meadows, G., Brophy, L., Enticott, J., Fossey, E., Edan, V. with preliminary data. TheMHS conference, 29 August - 1 September. Sydney, Australia.
Attachments [5] 6075 0
Results – basic reporting
Results – plain English summary