Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614001312639
Ethics application status
Approved
Date submitted
26/11/2014
Date registered
16/12/2014
Date last updated
28/11/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
The PULSAR project (primary care trial): does providing recovery-oriented training to general practitioners delivering primary mental health care improve the personal recovery of their patients?
Scientific title
The PULSAR project: a two stepped-wedge cluster randomised controlled trial to test whether training general practitioners in recovery-oriented practice using the PULSAR (Principles Unite Local Services Assisting Recovery) intervention improves personal recovery in adult consumers of mental health services in primary care settings.
Secondary ID [1] 284570 0
none
Universal Trial Number (UTN)
U1111-1164-3141
Trial acronym
PULSAR (Primary Care Trial)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psychotic disorders
 291846 0
Any other mental health condition 293667 0
Condition category
Condition code
Mental Health 292207 292207 0 0
Psychosis and personality disorders
Mental Health 292208 292208 0 0
Depression
Public Health 293814 293814 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The PULSAR intervention is a training intervention that will be delivered by the research team to participating general practitioners in primary care. The intervention focuses on teaching and promoting recovery-oriented practice 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, we will adapt these materials for the Australian primary care sector including privately-owned GP practices and government-funded Community Health Services. The content and process of training will be sensitive to the needs of the Victorian mental health and primary care systems and the local cultural and legal contexts.

PULSAR training involves attendance at a 4.5 hour interactive workshop. The training has been reviewed and accredited as a Category 1 activity by the Royal Australian College of General Practitioners and the Australian College of Rural and Remote Medicine. It is also recognised by General Practice Mental Health Standards Collaboration towards Mental Health Skills Training. The training will be delivered by mental health clinicians, including experienced trainers from the study team with co-delivery by consumer trainers for at least half the time and carer involvement for at least one hour of training. Also to be offered are optional monthly one hour follow up sessions. The training and follow up sessions will aim to train and support GPs to adopt recovery-oriented practices. A schedule of training will be provided to trainers along with standardised training packs including use of videos to provide standardised content. Trainers will be asked to keep a record of training and to record any deviations from the schedule and use of materials.

We will deliver these interventions and evaluate the process in a stepped-wedge cluster study design, together with an embedded qualitative study to identify the contextual enablers and challenges to implementing recovery-oriented practice. Half the primary care sites (clusters) will be randomised to receive the PULSAR intervention in year 1 and the other half in year 2. Data collection consists of cross-sectional surveys collected from patients of study GPs at baseline and again at the end of 9 months and 18 months, and semi-structured qualitative interviews with GPs and patients at 3 and 9 months following the GP training. To account for potential contamination of the intervention 'dosage' to be received within each cluster (i.e., the GP who had the PULSAR training), a dosage variable will be included in the modelling. This variable will be based on staff movements, which will be collected every three months. Specifically, the site GP(s) will be contacted every three months and it will be recorded if a site GP leaves the service, thereby decreasing the ‘dosage’ at the centre.
Intervention code [1] 289341 0
Rehabilitation
Comparator / control treatment
Standard treatment. In primary care, standard treatment typically involves a primary mental health care assessment conducted by the GP in line with the key requirements of the GP Mental Health Treatment Plan under the Better Access to Mental Health Care initiative. The assessment will usually involve diagnostic review as well as problem identification. There will be possible consideration of referral to other mental health professionals such as a psychiatrist or psychologist but often the GP will be the main treatment provider. Where indicated, pharmacological treatment is provided according to diagnosis, for example the presence of a depressive or anxiety disorder may involve treatment with antidepressant medication while the presence of a psychotic disorder would commonly involve antipsychotic medication. A typical GP would provide supportive psychotherapy with basic cognitive behavioural therapy content and medication.

The control group will be given the intervention after 9 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] 292080 0
Improved personal recovery as indicated by Process of Recovery Questionnaire (QPR)
Timepoint [1] 292080 0
9 and 18 months. The overarching study design is a two stepped-wedge cluster randomised controlled trial, and the primary timepoints for this design are at 9 and 18 months. This is because the QPR data collection points for all sites are at baseline, 9 months and 18 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 last quarter of year 1 for the remaining cluster sites (B sites).
Secondary outcome [1] 308174 0
Recovery in mental health using the INSPIRE Recovery in mental health: INSPIRE
Timepoint [1] 308174 0
The secondary timepoint is at 9 months following the PULSAR intervention.
Secondary outcome [2] 308175 0
Improvements in mental well-being using the Warwick and Edinburgh Wellbeing Scale (WEMWBS)
Timepoint [2] 308175 0
9 months following the PULSAR intervention.
Secondary outcome [3] 308176 0
Psychological distress as measured by the Kessler-10 (K-10)
Timepoint [3] 308176 0
9 months following the PULSAR intervention.

Eligibility
Key inclusion criteria
CONSUMERS
1. Aged 18 years or over
2. Aged less than 75 years
3. Have English proficiency
4. Are able to provide informed consent
5. Are patients of the participating general practitioners (GPs) i.e., consulting with the participating GP in at least 50% of their visits to the clinic or is identified by the GP as a patient.

In addition:
6. Seven of the 10 patients recruited per cluster, in the previous 3-months prior to data collection, must have either
6.1 a mental health plan made or reviewed and/or
6.2 received any class of antidepressant medication on a continuing basis (prescribed for a least a month) to provide treatment for a mental illness.

If insufficient numbers are identified the time frame will be moved out to 6 months.

7. Three of the 10 patients recruited from each cluster must have
7.1 a clinical diagnosis of psychosis, e.g. schizophrenia, schizoaffective disorder, bipolar disorder and/or
7.2 been prescribed antipsychotic medication in the previous 6 months.

STAFF
1. Work within a community health service or accredited primary care site located in the catchment of Monash Health. Depending on response to initial recruitment, this may be extended to any GP practice that is within Medicare Local regions that overlap with the Monash Health catchment.
2. Have worked at this practice for a least 12 months.
3. The participating site is the principal site of their clinical practice and the majority of their services are devoted to generalist primary care.
4. Commit to participating in PULSAR training.
5. Commit to identifying eligible patients and sending study invitation letters and study surveys to potential patient participants for the study.
Minimum age
18 Years
Maximum age
74 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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 TREATMENT
Currently there are around 300 accredited primary care service and community health services in the Monash Health catchment area. Of these, we will aim to recruit up to 30 services to participate (see Recruitment Procedure, below). For example, we will aim to recruit GPs from the following organisational structures:
* 26-28 GPs from privately owned practices,
* 2-4 GPs from government funded Community Health Services offering consultation-based services.

Once cluster sites have been identified and recruited into the study they 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 performs the stratified randomisation during the fourth quarter of 2014-first quarter of 2015, when involvement of the sites is confirmed and sites will be notified of randomisation status when necessary for arrangements of delivery of the training intervention. The number of participating Primary Care sites is anticipated to be low (20-30) therefore a dynamic minimisation routine will be applied in order to balance intervention allocations across four strata. These strata are: private practice or community health centre; geographical location (Monash Medical Centre Catchment, Dandenong service catchment, Casey catchment or other); size of facility categorised by the equivalent full time (EFT) of General Practitioners employed (<=2 EFT, 3-5 EFT or >5 EFT); and general care or special focus practices (special focus classified if the targeted focus has patients >10% of the practice patient population).

ENROLLING A PARTICIPANT
This study involves two sample groups consisting of: (1) GP participants and (2) patients of the participating GPs.

(1) GPs: We will aim to recruit a total of 30 GPs, at least one per cluster, recruited into this study. The same GP participant will be enrolled in the study for the entire study period.

(2) PATIENTS FROM PARTICIPATING PRIMARY CARE CLUSTERS: There will be up to 300 patients, where possible ten per participating GP, recruited into this study in each of the three waves of data collection (total of up to 900). The participating GP will oversee a mail out of an invitation Letter to Participate to eligible candidates, and may also hand out study packs to eligible patients during consultations.

RECRUITMENT PROCEDURES
GP PARTICIPANTS
Primary care sites will be identified by the research team directly using the National Health Services Directory and White Pages. Existing contacts within Monash Health, South East Health Providers Associations and Medicare Locals within the catchment of Monash Health will also be utilised. We will mail all identified primary care sites an Invitation Letter to Participate. Simultaneously we will advertise the study and invite GP participation using multiple Newsletter and websites. Recruitment will be guided somewhat pragmatically depending on response to initial recruitment efforts. For example, if necessary to achieve adequate numbers, recruitment will be extended to include all GP practices within Medicare Local regions that overlap with the Monash Health catchment, including Bayside, South Eastern Melbourne, Inner East Melbourne and Eastern Melbourne.

The invitation letter will outline the study and request participation. A member of the research team will aim to make a follow up telephone call to explore interest, and if appropriate, request a meeting with senior site staff to further explain the study, detail the study plan, explain data collection activities and provide a study information package. If a GP decides to participate then she or he will be required to sign the GP Participant Information and Consent Sheet (Attachment G). At least one GP per site will be recruited. The participant GP is responsible, with assistance from the PULSAR project team, to organise details of patient recruitment within the site.

PATIENT PARTICIPANTS
At each of the primary care sites recruited we will aim to recruit at least 10 patients of each participating GP. We define this as individuals who consult the same GP in 50% of their visits to the clinic. Seven of these will be GROUP 1 participants and three will be GROUP 2 participants. Anticipating a 20% response rate, the initial number of letters mailed to eligible patients will be 35 in GROUP 1 and 15 in GROUP 2. Contact with patients will be made with a mail out by the primary care sites, on behalf of the researchers, and will explain to patients that they are being invited to participate in research conducted by Monash Health and Monash University which is supported by the respective organisation. Subject to negotiation with the individual primary care sites, measures will be used to promote patient response. This might include, for example, members of the research team making themselves available to assist patients to complete survey measures and the placement of promotional material in waiting rooms.

Efforts will be made to minimise the burden on primary care sites. Each primary care sites will receive a base remuneration of $500 for committing resources to help offset practice administration costs involved in recruitment and an additional $25 for the successful recruitment of each eligible patient. The team will provide each participating site with pre-filled envelopes (which will then require administration staff to forward to eligible patients by mail). In the envelopes patients will receive an invitation Letter to Participate, a patient Participant Information and Consent Form, the study measures, and two reply paid envelopes to the PULSAR team at Southern Synergy.

Recruitment will be coordinated by the participating GP using the following recommended processes below. This method has been adopted to ensure recruitment is independent from the researchers, to maintain privacy of participants, and to minimise the research-related administrative burden placed on primary care site staff.

IDENTIFYING GROUP 1 PATIENT PARTICIPANTS:
1. Practice billing and clinical software will be used to identify patients seen by the participating GP in the previous three months who had either:
*a mental health plan made or a review of a mental health plan
and/or
*prescribed any class of antidepressant medication on a continuing basis (prescribed for at least a month) as treatment for a mental illness.
If insufficient numbers are identified, the time frame will be extended to six months.

2. At least 35 potentially eligible participants will be identified.
3. The participating GP will screen this list of potential participants using clinical notes to confirm patients’ clinical status and eligibility to participate.
4. At least 35 patient invitation letters will be mailed to eligible participants in the primary care site, using stamped envelopes provided by the research team.
5. The researchers will contact the primary care site if less than seven surveys are returned in the initial wave of recruitment. In this case, the site will be required to identify and mail further invitation letters to potentially eligible participants. The number required in second round depends on the number recruited from round one.

IDENTIFYING GROUP 2 PATIENT PARTICIPANTS (PEOPLE WITH A DIAGNOSIS OF PSYCHOSIS):
1. Practice billing and clinical software will be used to identify patients of the participating GP who have been prescribed antipsychotic medication in the previous six months or have a diagnosis of psychosis, e.g. schizophrenia, schizoaffective disorder, bipolar disorder.
2. We will aim to identify at least 15 potentially eligible participants.
3. The participating GP will screen this list of potential participants, with reference to their clinical notes if necessary to confirm patients’ clinical status and eligibility for the study. NOTE: this step is very important for identifying GROUP 2 patients because anti-psychotic medications are also prescribed for people without psychosis. This screening will be undertaken by the GP, not the research team, and it will require the GP to assess eligibility at this point.
4. The 15 invitation letters will be mailed to eligible participants by staff at the primary care site, using stamped envelopes provided by the research team.
5. The researchers will contact the primary care site if less than three surveys are returned in the initial wave of recruitment. In this case, the site will be required to identify additional potentially eligible participants and mail further invitation letters. The number required in the second round depends on the number recruited from round one.

CONSENT FOR GP PARTICIPANTS
The “Recruitment Procedure” for “GP Participants” has been detailed above.

The invitation letter sent to each primary care site will be signed by the project Principal Investigator and two chief investigators who are general practitioners addressed to the lead physician(s), owner(s) or Manager at each primary care site. Letters of invitation to the community health services will also include the Letter of Support from Monash Health. The letter will outline the study and request participation. A member of the research team will aim to make a follow up telephone call four to seven days later to explore interest, and if appropriate, request a meeting with senior site staff to further explain the study, detail the study plan, explain data collection activities and provide a study information package. If a GP decides to participate then she or he will be required to sign the GP Participant Information and Consent Sheet. At least one GP per site will be recruited.

CONSENT FOR PATIENT PARTICIPANTS
The patient Participant Information Sheet/Consent Form and letter of invitation will explain to candidates that if they are interested in participating they will need to return the signed consent form and complete the surveys. They will be notified that they can complete the surveys online if they prefer.

There are two levels of participation/consent being sought from patient participants, which are as follows:
* Level 1 refers to a participant consenting to participate in the research and returning completed study surveys to the research team in a reply-paid envelope.
* Level 2 refers to a participant providing additional permission so that the researchers can access routinely collected (and relevant) clinical data to be used in the project.
Levels of participation and consent are clearly outlined in the project patient Participant Information and Consent Form.

Patients will receive blue and yellow reply paid envelopes. Participants who only agree to return a completed survey (Level 1 consent) will tick the appropriate box on the consent form (indicating Level 1 consent) and will return the consent form (printed on yellow paper) in the yellow envelope and the completed survey (printed on blue paper) in the blue envelope.

If a participant elects to give additional permission to enable the researchers to access routinely collected (and relevant) clinical data to be used in the project, then they tick the appropriate box on the consent form (indicating Level 2 consent). All participants are asked to tick the appropriate box if they wish to be contacted for future related research (optional). All participants return the survey and consent form in the separate colour-coded envelopes provided. This ensures confidentiality should any unknown party come in possession of the survey. The researchers, once receiving the consent form, will use a unique code printed on each survey for linkage. This unique ID code will also be used to access the online survey.

Reply-paid envelopes of Southern Synergy will be used rather than reply-paid envelopes to patients’ respective clinic/specialist mental health service. The rationale being that this will reduce 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 in the patient Participant Information and Consent Sheet and invitation Letter to Participate that their service has not released any identifying information to the researchers and that it is the individual’s choice to disclose identifying information for the purposes of research participation as indicated by completing and returning the consent form and questionnaire. Participants will receive a $25 shopping voucher for completing the survey if they provide their postal address for this purpose.

Once sufficient numbers of participants have been recruited within each primary care cluster, we will stop recruiting participants from that group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
As per above, the trial will use stratified randomisation to ensure that cluster types (and therefore participants) are balanced in step periods.

We recruited 31 GPs across 19 service sites and had one withdrawal leaving 30 GPs across 18 service sites located in the Monash Health catchment. This includes community health services and accredited general practice sites. This catchment includes the core community of eight local government areas, namely City of Monash, City of Greater Dandenong, City of Casey, Cardinia Shire, City of Kingston, City of Bayside, City of East Frankston and City of Glen Eira. To achieve required cluster numbers, recruitment was extended to include any GP site within Medical Local regions that overlap with the Monash Health catchment. 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. Stratification will take into account organisational variations in primary care sites. The study statistician performs the stratified randomisation in the fourth quarter of 2014- the first quarter of 2015, and sites will be notified.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
This project involves two stepped-wedge (2-step) cluster randomised controlled trial conducted in primary care settings. Half the clusters 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.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size calculations

The study is a complete, stepped-wedged, cross-sectional survey design and power calculations were done using Stata statistical software stepped wedge. The primary outcome will be QPR scores. Clusters are defined at the level of the General practice setting, and therefore we are aiming to recruit at least one GP from each cluster. Sample size calculations used published QPR mean of 46 with standard deviation of 16, power of 0.80, significance level set at 0.05, intraclass correlation coefficient (ICC) of 0.05, the number of steps (2), number of baseline measurements (10 per cluster) and measurements after each step (10 per cluster).

If the number of number of clusters (primary care sites) recruited reaches 20 then a minimum sample of 200 participants per wave (or overall minimum of 600 patients) is sufficient to detect a medium effect in the primary outcome. This is medium effect is acceptable; however, better study precision will be obtained if we are able to recruit more than 20 primary care sites. For example, if the number of clusters recruited reaches 30 then a minimum sample of 300 patient per wave (or overall minimum of 900 patients) is sufficient to detect a small-medium effect in the primary outcome.

Statistical analysis

An intention-to-treat analysis will be applied and participant data analysed according to their cluster intervention status. To account for clustering, we will apply multilevel modelling using generalised estimating equations with robust (sandwich) standard errors. This modelling was chosen as it can handle many types of unmeasured dependence between outcomes.

To account for potential contamination of the intervention ‘dosage’ to be received within each cluster (i.e., the GP who had the PULSAR training), a dosage variable will be included into the modelling. This variable will be based on staff movements, which will be collected every three months. The site GP will be contacted every three months and it will be recorded if the site GP leaves the service, thereby decreasing the ‘dosage’ at the centre.

The primary analyses will be based on 9-month and 18-month changes in QPR score. Secondary analyses include changes in the secondary measures collected (K-10, WEMWBS and INSPIRE).

The a priori model-fitting analysis strategy will involve investigating covariates for possible inclusion in the model such as: age, gender, and diagnosis. The intervention and ‘intervention × phase’ variables will be fitted last into the model. Model fit will be examined by comparing aic values. We will use statistical software, STATA.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
15/01/2015
Actual
20/03/2015
Date of last participant enrolment
Anticipated
31/08/2017
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
378
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 14698 0
3175 - Dandenong
Recruitment postcode(s) [2] 14699 0
3806 - Berwick
Recruitment postcode(s) [3] 14700 0
3135 - Ringwood East
Recruitment postcode(s) [4] 14701 0
3134 - Ringwood
Recruitment postcode(s) [5] 14702 0
3186 - Brighton
Recruitment postcode(s) [6] 14703 0
3163 - Glen Huntly
Recruitment postcode(s) [7] 14704 0
3803 - Hallam
Recruitment postcode(s) [8] 14705 0
3183 - St Kilda East
Recruitment postcode(s) [9] 14706 0
3172 - Dingley Village
Recruitment postcode(s) [10] 14707 0
3175 - Dandenong North
Recruitment postcode(s) [11] 14708 0
3200 - Frankston North
Recruitment postcode(s) [12] 14709 0
3805 - Narre Warren
Recruitment postcode(s) [13] 14710 0
3181 - Prahran
Recruitment postcode(s) [14] 14711 0
3939 - Rosebud
Recruitment postcode(s) [15] 14712 0
3941 - Rye
Recruitment postcode(s) [16] 14713 0
3182 - St Kilda
Recruitment postcode(s) [17] 14714 0
3777 - Healesville

Funding & Sponsors
Funding source category [1] 289202 0
Government body
Name [1] 289202 0
Mental Illness Research Fund, The Victorian State Government Department of Health
Country [1] 289202 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] 288209 0
None
Name [1] 288209 0
Address [1] 288209 0
Country [1] 288209 0
Other collaborator category [1] 277934 0
Hospital
Name [1] 277934 0
Monash Health
Address [1] 277934 0
Mental Health Program
Monash Health
Dandenong Hospital
126-128 Cleeland St
Dandenong VIC 3175
Country [1] 277934 0
Australia
Other collaborator category [2] 277935 0
Charities/Societies/Foundations
Name [2] 277935 0
Ermha Inc
Address [2] 277935 0
9 Buckley St
Noble Park
VIC 3174
Country [2] 277935 0
Australia
Other collaborator category [3] 277936 0
University
Name [3] 277936 0
La Trobe University
Address [3] 277936 0
La Trobe University
Melbourne VIC 3086
Country [3] 277936 0
Australia
Other collaborator category [4] 277937 0
Charities/Societies/Foundations
Name [4] 277937 0
Mind Australia
Address [4] 277937 0
86-92 Mount St
Heidelberg VIC 3084
Country [4] 277937 0
Australia
Other collaborator category [5] 277938 0
University
Name [5] 277938 0
Royal Melbourne Institute of Technology (RMIT)
Address [5] 277938 0
124 Little La Trobe St
Melbourne VIC 3000
Country [5] 277938 0
Australia
Other collaborator category [6] 277939 0
Other Collaborative groups
Name [6] 277939 0
Refocus Team
Address [6] 277939 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] 277939 0
United Kingdom
Other collaborator category [7] 277940 0
University
Name [7] 277940 0
University of Melbourne
Address [7] 277940 0
1-100 Grattan St
Parkville VIC 3010
Country [7] 277940 0
Australia
Other collaborator category [8] 277941 0
University
Name [8] 277941 0
Victoria University
Address [8] 277941 0
Ballarat Rd
Footscray VIC 3011
Country [8] 277941 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290978 0
Monash Health Human Research Ethics B
Ethics committee address [1] 290978 0
Research Directorate
Monash Health
Monash Medical Centre
246 Clayton Rd
Clayton VIC 3168
Ethics committee country [1] 290978 0
Australia
Date submitted for ethics approval [1] 290978 0
30/04/2014
Approval date [1] 290978 0
11/06/2014
Ethics approval number [1] 290978 0
13401L
Ethics committee name [2] 291953 0
Monash University Human Research Ethics Committee (MUHREC)
Ethics committee address [2] 291953 0
Monash University
Victoria 3800
Ethics committee country [2] 291953 0
Australia
Date submitted for ethics approval [2] 291953 0
01/08/2014
Approval date [2] 291953 0
12/08/2014
Ethics approval number [2] 291953 0
Ethics committee name [3] 296406 0
Monash Health Human Research Ethics B
Ethics committee address [3] 296406 0
Research Directorate Monash Health Monash Medical Centre, 246 Clayton Rd Clayton VIC 3168
Ethics committee country [3] 296406 0
Australia
Date submitted for ethics approval [3] 296406 0
14/11/2014
Approval date [3] 296406 0
15/01/2015
Ethics approval number [3] 296406 0
14427B
Ethics committee name [4] 296407 0
Monash University Human Research Ethics Committee (MUHREC)
Ethics committee address [4] 296407 0
Monash University VIC 3800
Ethics committee country [4] 296407 0
Australia
Date submitted for ethics approval [4] 296407 0
05/11/2014
Approval date [4] 296407 0
29/01/2015
Ethics approval number [4] 296407 0
CF15/266 - 2015000120

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 will 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.

The current trial pertains to the evaluation of the PULSAR intervention within primary mental health care services; the evaluation of PULSAR in specialist care services is being evaluated in separate trial, which is separately registered with ANZCTR. In the primary care trial, we will deliver the PULSAR intervention to staff at up to 30 primary care sites (clusters) across the Monash Health catchment area and adjoining Medicare Local regions and evaluate the effect on adult mental health patients of these services. Half of the clusters will be randomised to receive the PULSAR intervention in year one, and the other half will receive the PULSAR intervention in year two. Clusters will be separated into similar types of services (privately owned general practices and community health services) before randomisation to ensure cluster types are balanced across treatment and control conditions.

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 126 volunteer service users at three time points: baseline, end of 9 months and again at the end of 18 months. The total number of participants will be a minimum of 378 consumers. Consumers will be recruited into the study if they respond to an invitation letter by completing and returning a signed consent form and the project questionnaires mailed by their current service on behalf of the researchers. The questionnaires can also be completed online. Am embedded qualitative study will explore GP and patient perspectives of recovery-oriented practice .

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
Presentations:
Invited industry sponsored symposium, Meadows, G. Psychiatry and the recovery movement – friends or foes? RANZCP Annual Congress, 11-15 May 2014, Perth, Australia.

Oral presentation, Meadows, G. Recovery oriented practice in emergency psychiatry. Alfred & L.A.M.P.S Diversity Conference, 12 August 2015, Melbourne, Australia.

Oral presentation, Meadows, G., Brophy, L., Edan, V. PULSAR - bringing the opportunities and challenges of culture change in recovery practice to light. The MHS (Mental Health Services) Conference, 25-28 August 2015, Canberra, Australia.

Poster presentation, Vasi, S., Enticott, J., Mazza, D., Russell, G., Edan, V., Julian, J., Meadows, G. Recovery oriented mental health in primary care: two steps forward. GP15, 21-23 September 2015, Melbourne, Australia.

Oral presentation, Meadows, G., Edan, V., Russell, G., Brophy, L. Bruxner, A. PULSAR – Principles Unite Local Services Assisting Recovery. Evaluation of personal recovery training to clinical, community and primary care sectors. ENMESH, 1-3 October 2015, Málaga, Spain.

Oral presentation, Edan, V. Collaboration, cooperation, coproduction…To everything there is a season. Service User Academia Symposium, 30 Nov - 1 Dec 2015, Auckland, New Zealand.
Public notes

Contacts
Principal investigator
Name 48226 0
Prof Graham Meadows
Address 48226 0
Southern Synergy
Administration, Research and Training (ART) Building
Dandenong Hospital
126-128 Cleeland St
Dandenong VIC 3175
Country 48226 0
Australia
Phone 48226 0
+613 99029696
Fax 48226 0
+613 99029900
Email 48226 0
[email protected]
Contact person for public queries
Name 48227 0
Dr Frances Shawyer
Address 48227 0
Southern Synergy
Administration, Research and Training (ART) Building
Dandenong Hospital
126-128 Cleeland St
Dandenong VIC 3175
Country 48227 0
Australia
Phone 48227 0
+613 99029461
Fax 48227 0
+613 99029900
Email 48227 0
[email protected]
Contact person for scientific queries
Name 48228 0
Prof Graham Meadows
Address 48228 0
Southern Synergy
Administration, Research and Training (ART) Building
Dandenong Hospital
126-128 Cleeland St
Dandenong VIC 3175
Country 48228 0
Australia
Phone 48228 0
+613 99029696
Fax 48228 0
+613 99029900
Email 48228 0
[email protected]

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseREFOCUS-PULSAR Recovery-Oriented Practice Training in Adult Primary Mental Health Care: Exploratory Findings Including From a Pretest-Posttest Evaluation.2021https://dx.doi.org/10.3389/fpsyt.2021.625408
N.B. These documents automatically identified may not have been verified by the study sponsor.