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Trial registered on ANZCTR


Registration number
ACTRN12619001341112
Ethics application status
Approved
Date submitted
31/08/2019
Date registered
30/09/2019
Date last updated
30/09/2019
Date data sharing statement initially provided
30/09/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Stepped care to support trauma recovery: A feasibility study
Scientific title
A parallel randomised controlled trial of stepped care case management compared with enhanced usual care to reduce posttraumatic stress and pain-related disability after major trauma: A feasibility study
Secondary ID [1] 297977 0
None
Universal Trial Number (UTN)
U1111-1232-2652
Trial acronym
N/A
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Posttraumatic stress disorder 312534 0
pain 312535 0
Condition category
Condition code
Mental Health 311065 311065 0 0
Other mental health disorders
Injuries and Accidents 311066 311066 0 0
Other injuries and accidents
Public Health 312714 312714 0 0
Health service research
Musculoskeletal 312715 312715 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 312716 312716 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
BRIEF NAME: Stepped Collaborative Care

WHY: Participants in the intervention group will receive stepped care case management, adapted from the Trauma Survivor Outcome Support (TSOS) model, which provides timely referrals for medication and psychotherapeutic treatment for pain and mental health, depending on the participant's individual risk profile and treatment needs. The case management aims to reduce care fragmentation and enhance care coordination, particularly with primary care providers.

WHAT:
Materials: Participants may receive information and resources to support their recovery needs based on their individual needs, and will include existing publicly available fact sheets, booklets, and information on support groups. Examples include: “PTSD and Recovery” by Phoenix Australia, “Grief following road trauma” by Road Trauma Support Services, and “Self-managing chronic pain” by Pain Australia. Participants may also receive a trauma recovery booklet focused on in-hospital and early post-discharge expectations and planning, which was developed as part of another project by researchers at Monash University and is currently being evaluated at Alfred Health.
Procedures: Participants will receive stepped collaborative care in addition to the enhanced usual care provided to the control condition as summarised below.

Enhanced usual care:
1. The participant will be informed that they may need further treatment for their pain or mental health, and they will be given information on a range of recommendations relevant to their risk profile.
2. If the participant has not been discharged the study team will inform the treating team in the hospital of the patient’s risk profile, their enrolment in the study, and that they may require ongoing care.
3. The participant’s primary care provider in the community, if they have one, will be informed of the participant’s risk profile, their enrolment in the study, and recommendations on how to support their patient’s ongoing care.

Stepped collaborative care involves first informing the participant that they will receive support from a case manager who is based at Alfred Health for the next six months. If participants have been discharged to rehabilitation, the case manager will maintain contact with the participant, but will not provide additional treatment or referrals until they are discharged home. While in hospital, and after discharge, the care coordination team will:
1. Make regular contact with participants via telephone, or face to face during inpatient or outpatient admissions at The Alfred, to help support their pain or mental health treatment needs and risk behaviours. Participants will be encouraged to contact the case manager via a dedicated mobile phone number for ongoing assistance. Contact frequency will be approximately weekly in the first 2-4 months, but will vary with each participant’s level of need and engagement.
2. Liaise with the primary care provider regarding potential ongoing medication needs in accordance with recommendations from the study doctors. If the participant does not have a primary care provider the case manager will help them to find one.
3. Liaise with any additional case managers (e.g., with the TAC or WSV) involved with their ongoing care to ensure that the participant receives coordinated care.
4. Use motivational interviewing (MI) techniques and basic cognitive behavioural therapy (CBT) principles during case coordination to address high risk behaviours, to improve readiness for therapy, and encourage behaviour change, or medication adherence.
5. Assess pain and mental health symptoms during case management encounters using validated screening tools to support case management decision making. The tools used during case management symptom assessment differ to those in the outcome assessment battery, with the exception of the NM-ASSIST, and may include:
a. Brief Pain Inventory to collect ratings of pain severity (four items) and pain interference (7 items);
b. PTSD Symptom Scale – Interview Version for DSM-5 (PSSI-5), or the five item Primary care PTSD screen for DSM-5 (PC-PTSD-5) to assess PTSD symptoms;
c. Hospital Anxiety and Depression Scale to measure anxiety and depression symptoms.
6. Arrange referrals via the study doctors for appropriate treatment in the community, through hospital outpatient or telehealth services, or in collaboration with the participant’s primary care provider who may be asked to make referrals (e.g., via a mental health care plan).
7. Provide recommendations for smartphone applications or web-based treatment programs (e.g., AfterTrauma recovery app, PTSD coach, Manage My Pain) that may support recovery through self-management of pain and mental health symptoms if the participant has a smart phone with internet connection and want to try those resources.

WHO PROVIDED: The case manager must have strong interpersonal and empathic skills in building rapport, and prior knowledge, experience and training in supporting people with complex treatment needs for pain, mental health and substance abuse conditions, as defined in the TSOS treatment manual. The case manager needs to be able to interface with numerous and diverse individuals including participants and their families, surgical and primary care providers, staff in hospital and community agencies, mental health professionals, and other members of the clinical and investigative team. They must therefore have sufficient skills and experience in liaising with those providers and agencies in order to co-ordinate each participant’s care. The case manager could be a social worker, registered nurse or a non-healthcare professional who possesses the attributes required for the role (e.g., an allied health assistant who has worked in a related field).
The case manager will receive training, coaching and supervision by the clinical and academic investigators.
Training for the case manager comprises an initial interactive workshop, via zoom, led by TSOS investigators at Harbourview Medical Centre, which will provide an overview of the core elements of providing the modified trauma survivors outcomes and support program. This includes understanding posttraumatic stress disorder, pain, case management, the role of study doctors in identifying and recommending suitable medications, MI and CBT principles, and community linkage for referral and treatment provision.
During the trial, the case manager will have access to coaching from psychologists and study doctors in the study team and their collaborative network. Remote coaching for the case manager(s) will be provided by the Harborview team, and may include discussion about concern elicitation, providing motivational interviewing or cognitive behavioural therapy-based guidance, as well as problem-solving barriers to screening and intervention implementation to manage and treat PTSD and pain symptoms. The case manager will be able to contact a clinical member of the study team to discuss any urgent issues as needed, and all other queries will be discussed at team case conferencing meetings every 1-2 weeks. The case conferencing meetings will provide an opportunity for the collaborative care team to review patient symptoms and concerns, and to identify additional strategies that the case manager could use to help the patient to manage their symptoms and improve their recovery.

HOW: While in hospital, and after discharge, the care co-ordination team will make regular contact with participants via telephone or face to face at hospital during inpatient admissions or outpatient appointments to identify and address pain and mental health treatment needs. Participants will be encouraged to contact the case manager via a dedicated mobile phone number for ongoing assistance.

WHERE: Case management will be provided from within a single major trauma service (The Alfred) in metropolitan Melbourne, and refer patients for evidence based treatment either in the hospital, in the community or via e-health (e.g., telehealth, web or application-based treatments), according to the participants needs and preferences. The case manager will be located at the hospital, and will use resources within REDCap to facilitate participant screening, referrals and communication between the care coordination team and primary care providers.

WHEN and HOW MUCH: Participants will be recruited within 28 days post-injury, or within 28 days of becoming medically stable and conscious post-injury. The case manager will maintain regular contact with participants in the intervention group up to six months after recruitment. Overall it is expected that case management will spend between 10 to 15 hours supporting each participant.

TAILORING: Treatments offered will be stratified and tailored for each participant based on their risk profile, their treatment readiness and preferences, and will be arranged in accordance with national and international evidence based guidelines for post-traumatic mental health and pain management.

HOW WELL: Planned: To enable assessment of adherence, all case manager initiated referrals and recommendations for treatment will be recorded in the REDCap database. Adherence with referred treatments and medications in the intervention group will be recorded by cross referencing referrals and recommendations made by the case management team with attendance reported by participants in follow-up interviews or case management meetings, and via linkage with administrative treatment records (i.e., via Medicare Benefits Schedule, Pharmaceutical Benefits Scheme, Victorian Admitted Episodes Dataset and the Transport Accident Commission).
Additional insights regarding the acceptability of the intervention will be explored in qualitative interviews with participants from both groups at 3-6 months post-injury.
Intervention code [1] 314283 0
Early detection / Screening
Intervention code [2] 314284 0
Treatment: Other
Comparator / control treatment
BRIEF NAME: Enhanced Usual Care

WHY: Participants in the control group will receive enhanced usual care, which is the most ethically appropriate way of ensuring that other care providers have been informed of the participant’s potential ongoing care needs, without actively coordinating their care needs over time.

WHAT:
Materials: Participants and/or their primary care provider will receive a summary of their potential ongoing treatment needs tailored to their baseline risk profile.

Procedures: Participants allocated to the control condition will receive enhanced usual care, but will not receive stepped collaborative care (case management and ongoing support from the study team).

Enhanced usual care will involve:
1. The participant will be informed that they may need further treatment for their pain or mental health, and they will be given information on a range of options relevant to their risk profile.
2. If the participant has not been discharged then the study team will inform the treating team in the hospital of the patient’s risk profile, their enrolment in the study, and that they may require ongoing care.
3. The participant’s primary care provider in the community, if they have one, will be informed of the participant’s risk profile, their enrolment in the study, and recommendations on how they can support their patient’s ongoing care.
4. Participants may receive a trauma recovery booklet focused on in-hospital and early post-discharge expectations and planning. The booklet allows patients to document details about their injury and treatments received during their inpatient stay, and provides information about common tests to expect while in hospital, and how to begin setting recovery goals, managing pain and discomfort, emotional recovery, reducing smoking, drug and alcohol use, and services that may be available to support recovery. The booklet was not developed for this stepped care trial, but is being implemented and evaluated at the same time as the present trial as part of a separate project by researchers at Monash University and therefore may be received by patients in this study.

HOW: The letter summarising the participant's risk profile will be provided at baseline only.

WHERE, WHEN and HOW MUCH: Initial engagement with participants in the control group will be during their hospital stay and/or within 28 days of their injury. For patients who had a period during which they were acutely medically unstable, the 28-day reference point will commence from when the patient was medically stable and conscious post-injury. Participants in the enhanced usual care group will remain in the study for 6-months, during which time if they disclose suicidal ideation during follow up interviews a suicide risk response protocol will be followed; however, all other aspects of the enhanced component of their usual care is limited to the period immediately following their recruitment.

TAILORING: The initial letter summarising the participant's enrolment in the study will be tailored to their individual risk profile from the baseline screening and assessment measures.

HOW WELL: Planned: the same data and intervention monitoring procedures outlined for the intervention group will also be used for the control group.
Control group
Active

Outcomes
Primary outcome [1] 321157 0
Acceptability: The total number and proportion of patients who are enrolled and randomized out of those who are screened and identified to be eligible will be measured, in accordance with the following calculation: total number of patients recruited and randomized/total number of patients screened and eligible
Timepoint [1] 321157 0
Measured during active recruitment of patients until recruitment completion, 12-18 months.
Primary outcome [2] 321158 0
Acceptability: Number and proportion of participants who are randomized to each group who complete the six month follow-up interview.
Timepoint [2] 321158 0
Measured at 6-months post-recruitment for each participant.
Secondary outcome [1] 374141 0
Effectiveness: effects on pain severity and pain-related disability using the Pain severity, interference with Enjoyment of life and General activity (PEG) tool
Timepoint [1] 374141 0
At baseline (recruitment), 1 month, 3 months, and 6 months post-recruitment.
Secondary outcome [2] 374142 0
Effectiveness: effects on neuropathic pain symptoms using the Neuropathic Pain Diagnostic Questionnaire (DN4)
Timepoint [2] 374142 0
At baseline (recruitment), 1 month, 3 months, and 6 months post-recruitment.
Secondary outcome [3] 374143 0
Effectiveness: effects on pain-related catastrophising using the Pain Catastrophizing Scale (PCS)
Timepoint [3] 374143 0
At baseline (recruitment), 1 month, 3 months, and 6 months post-recruitment.
Secondary outcome [4] 374408 0
Effectiveness: effects on anxiety-related cognitive, emotional, and behavioural reactions to pain using the Sensitivity to Pain Traumatisation Scale (SPTS)
Timepoint [4] 374408 0
At baseline (recruitment), 1 month, 3 months, and 6 months post-recruitment.
Secondary outcome [5] 374409 0
Effectiveness: effects on PTSD symptoms using the Posttraumatic Checklist (PCL-C), including additional items from the PCL-5 to measure DSM-5 PTSD symptoms.
Timepoint [5] 374409 0
At baseline (recruitment), 1 month, 3 months, and 6 months post-recruitment.
Secondary outcome [6] 374740 0
Effectiveness: effects on Symptoms of anxiety using the 7-item Generalized Anxiety Disorder scale (GAD)
Timepoint [6] 374740 0
At baseline (recruitment), 1 month, 3 months, and 6 months post-recruitment.
Secondary outcome [7] 374741 0
Effectiveness: effects on depression and suicidal ideation using the 9-item Patient Health Questionnaire (PHQ)
Timepoint [7] 374741 0
At baseline (recruitment), 1 month, 3 months, and 6 months post-recruitment.
Secondary outcome [8] 374742 0
Effectiveness: effects on probable drug use disorders using the NIDA modified-ASSIST screening tool.
Timepoint [8] 374742 0
At baseline (recruitment), 1 month, 3 months, and 6 months post-recruitment.
Secondary outcome [9] 374743 0
Effectiveness: effects on probable alcohol use disorders using the Alcohol Use Disorders Identification Test (AUDIT-C)
Timepoint [9] 374743 0
At baseline (recruitment), 1 month, 3 months, and 6 months post-recruitment.
Secondary outcome [10] 374744 0
Effectiveness: effects on general health status using the Euroqol-5 dimensions-5 level (EQ-5D-5L)
Timepoint [10] 374744 0
At baseline (recruitment), 1 month, 3 months, and 6 months post-recruitment.
Secondary outcome [11] 374745 0
Effectiveness: effects on activity limitations using the World Health Organisation (WHO) Disability Assessment Schedule 2.0 (WHO-DAS 2.0)
Timepoint [11] 374745 0
At baseline (recruitment), 1 month, 3 months, and 6 months post-recruitment.
Secondary outcome [12] 374746 0
Effectiveness: The number of participants in each group who have a regular primary care provider by the end of the intervention, measured using structured questions in the 6 month follow up interview.
Timepoint [12] 374746 0
Measured at baseline and 6-months post-recruitment for each participant.
Secondary outcome [13] 374747 0
Implementation: self-reported health care utilisation by participants in each group, measured in structured follow-up interviews. These interviews measure the number and duration of inpatient, outpatient, rehabilitation and other health service encounters, and are based on the interview schedule for Post-Injury Inpatient Hospitalisations and Post-Injury Health Service Use questionnaires from the NIH-funded Trauma Survivor Outcome Support project (ClinicalTrials.gov identifier: NCT02655354; NIH project ID: UH3MH106338-02).
Timepoint [13] 374747 0
At baseline (recruitment), 1 month, 3 months, and 6 months post-recruitment:
Secondary outcome [14] 374748 0
Implementation: administrative records of health service use, measured through linkage with the Medicare Benefit Schedule, Pharmaceutical Benefits Scheme, Transport Accident Commission, Worksafe Victoria and Victorian Admitted Episodes Dataset records of health care services or medications received.
Timepoint [14] 374748 0
Baseline to 6-months post-recruitment, adjusting for pre-injury health-related costs.
Secondary outcome [15] 374749 0
Implementation (acceptability): participant satisfaction after completing the intervention measured using a modified Client Satisfaction Questionnaire in the follow up interview.
Timepoint [15] 374749 0
Measured at 6-months post-recruitment for each participant in the intervention group
Secondary outcome [16] 374750 0
Implementation: The cost of providing the intervention to participants in each group, measured through research staff logs of the time spent in direct communication with participants (e.g., case management interactions), letter writing, sourcing resources, or engaging with healthcare providers.
Timepoint [16] 374750 0
Baseline to 6-months post-recruitment
Secondary outcome [17] 375139 0
Implementation: The cost of healthcare use measured by linkage with the Medicare Benefit Schedule, Pharmaceutical Benefits Scheme, Transport Accident Commission, Worksafe Victoria and Victorian Admitted Episodes Dataset records of health care services or medications received.
Timepoint [17] 375139 0
Baseline to 6-months post-recruitment, adjusting for pre-injury health-related costs.

Eligibility
Key inclusion criteria
The recruiting study team will consult regularly with the trauma team to identify recent trauma admissions, and will review Electronic Medical Records (EMR) to identify cases who meet the following inclusion criteria:
• Aged >16 years old at the time of injury
• Survive to hospital discharge
• Speak English

Major trauma defined by trauma admission with one or more of the following criteria following injury admission:
• Provisional ISS>12
• Urgent Surgery for intracranial, intrathoracic or intra-abdominal injury, or for fixation of pelvic or spinal fractures
• ICU admission for more than 24 hours with mechanical ventilation

Patients will be eligible for interview screening if they meet the following risk criteria for PTSD AND/OR Persistent Pain.

RISK CRITERIA for PTSD (3 or more of the following criteria are indicated (clinical and socioeconomic):
Clinical PTSD risk criteria:
1. Pre-existing PTSD diagnosis at admission
2. Any other psychiatric diagnosis at admission
3. Any substance use disorder diagnosis or positive BAC or illicit drug test on admission
4. Current or prior tobacco use
5. Intentional injury
6. Intensive care unit (ICU) admission with mechanical ventilation
7. One or more prior trauma hospital admissions
8. A death occurred in the injury event

Socioeconomic risk criteria:
1. Funding source: Transport Accident Commission or WorkSafe Victoria
2. Non-male gender
3. Non-white ethnicity
4. Middle aged (35 to 65 years)
5. Socioeconomic disadvantage (e.g., unemployed, living in a disadvantaged neighbourhood (IRSAD state decile ranking < 5), unemployed, report being at risk of job loss)

PAIN RISK CRITERIA (one or more of the following clinical criteria are indicated):
1. Neuropathic injury
2. Prior psychiatric or substance use condition
a. Pre-existing PTSD diagnosis at admission
b. Any other psychiatric diagnosis at admission
c. Any substance use disorder diagnosis or positive BAC or illicit drug test on admission
3. Prior chronic pain
4. Prior treatment for opioid-addiction disorder
a. Methadone or buprenorphine treatment pre-injury
5. Intense post-injury or post-surgical pain:
a. Persistent intense pain requiring breakthrough analgesia beyond expected level for injury
b. Acute pain consultations at or after discharge for severe pain
c. Patient is medically stable but discharge is delayed due to complex pain
6. High post-injury opioid consumption
a. >= 90 mg/day of oral morphine equivalence post-discharge
b. Prescription for a long acting opioid medication at or post-discharge
c. Referral for interventional postsurgical procedures for pain (e.g., stump catheters for post-amputation)
7. Patient displays or reports high levels of distress

Patients who meet the above criteria will then undergo an interview screen, Any one of the following criteria warrant enrollment:
1. Severe and/or disabling pain (PEG>=4)
2. Post-injury pain has neuropathic qualities (DN4>=3)
3. Clinically elevated psychological symptoms
a. PTSD (PCL-C>=35)
b. Depression (PHQ>14)
c. Suicidality: (PHQ item 9>=1)
d. Drug/alcohol (NM-ASSIST>4)
e. Prior/current opioid misuse (COMM>=1)
4. Catastrophizing (PCS>30)
Minimum age
16 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Potential participants will be excluded if they:
• Have recorded that they do not want to be contacted about research projects at Alfred Health
• Do not have a Medicare number
• Have no capacity to give consent due to:
• Sustained moderate to severe brain injury (i.e., GCS 3 – 12 and head AIS>2)
• Temporary incapacity (e.g., due to intoxication, delirium or medication side-effects)
• Permanent cognitive impairment (e.g., dementia or Alzheimer’s Disease)
• Moderate to severe cognitive impairment (i.e., a score of >=5 on the SPMSQ)
• Were injured during an episode of suicidal or non-suicidal self-harm
• Were injured during an episode of acute psychosis, while committing a crime, or while incarcerated
• Have a history of violence (as a perpetrator of violent crime or harm to others) or behave violently during the hospital admission.
• Have no usual place of residence or no regular means for contact at baseline (e.g., no mobile or landline telephone).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified randomisation sequences for compensable and non-compensable cases generated as follows:

• Blocks of randomisation sequences will be generated separately for participants with a transport injury who are eligible for a compensation claim with the Transport Accident Commission (TAC), and those with other injury causes, anticipating a ratio of 60% TAC cases and 40% non-TAC cases.

• A total of 80 randomisation allocations will be generated for 60 participants (this will allow for some error in the actual proportion of cases who are TAC compensable, but only the first 60 envelopes will be opened).
o 48 TAC randomisations
o 32 non-TAC randomisations

• The two randomisation sequences will be generated for consecutive groups of two to four participants in Stata by a biostatistician independent to the project team.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Descriptive statistics for the primary outcome measures and most secondary outcome measures. Mixed effects regression for secondary outcome 1 (pain and mental health symptoms, and disability).

Recruitment
Recruitment status
Not yet recruiting
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
Recruitment hospital [1] 13652 0
The Alfred - Prahran
Recruitment postcode(s) [1] 26335 0
3004 - Prahran

Funding & Sponsors
Funding source category [1] 302501 0
Charities/Societies/Foundations
Name [1] 302501 0
Rebecca L Cooper Medical Research Foundation Ltd
Address [1] 302501 0
PO Box 1021, Edgecliff, NSW, 2027
Country [1] 302501 0
Australia
Primary sponsor type
University
Name
Monash University
Address
School of Public Health and Preventive Medicine
Monash University
553 St Kilda Road
Melbourne VIC 3004
Country
Australia
Secondary sponsor category [1] 303742 0
None
Name [1] 303742 0
Address [1] 303742 0
Country [1] 303742 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303157 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 303157 0
55 Commercial Road PRAHRAN VIC 3004
Ethics committee country [1] 303157 0
Australia
Date submitted for ethics approval [1] 303157 0
29/04/2019
Approval date [1] 303157 0
30/08/2019
Ethics approval number [1] 303157 0
274/19

Summary
Brief summary
Pain and mental health conditions, especially posttraumatic stress disorder (PTSD), are common and disabling after injury. This study is evaluating an adaptation of the Trauma Survivor Outcome Support (TSOS) model that was developed in Seattle, USA. The intervention that we are evaluating will provide tailored psychological support and coordinated care through a case manager, and aims to reduce the prevalence and impact of persistent pain and symptoms of mental health conditions after major trauma. The control group receives enhanced usual care in which the participant's primary care provider receives a letter summarising the participants potential ongoing treatment needs when they enter the study. The study hypothesis is that the TSOS model of care will be acceptable to patients after major trauma, and that it will reduce the severity of pain and mental health symptoms compared with enhanced usual care.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 92678 0
Dr Melita Giummarra
Address 92678 0
School of Public Health and Preventive Medicine
Monash University
553 St Kilda Road
MELBOURNE VIC 3004
Country 92678 0
Australia
Phone 92678 0
+61399030365
Fax 92678 0
Email 92678 0
melita.giummarra@monash.edu
Contact person for public queries
Name 92679 0
Dr Melita Giummarra
Address 92679 0
School of Public Health and Preventive Medicine
Monash University
553 St Kilda Road
MELBOURNE VIC 3004
Country 92679 0
Australia
Phone 92679 0
+61399030365
Fax 92679 0
Email 92679 0
melita.giummarra@monash.edu
Contact person for scientific queries
Name 92680 0
Dr Melita Giummarra
Address 92680 0
School of Public Health and Preventive Medicine
Monash University
553 St Kilda Road
MELBOURNE VIC 3004
Country 92680 0
Australia
Phone 92680 0
+61399030365
Fax 92680 0
Email 92680 0
melita.giummarra@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
The project does not plan to share or re-use data collected in the study for other purposes, unless required by law. If any external parties request access to the data those parties will require independent ethics approval for that specific purpose. A data dictionary will be available, and will be published via protocols.io.
What supporting documents are/will be available?
Study protocol
Informed consent form
Ethical approval
How or where can supporting documents be obtained?
Type [1] 4704 0
Study protocol
Citation [1] 4704 0
Link [1] 4704 0
Email [1] 4704 0
Other [1] 4704 0
Type [2] 4705 0
Informed consent form
Citation [2] 4705 0
Link [2] 4705 0
Email [2] 4705 0
melita.giummarra@monash.edu
Other [2] 4705 0
Attachment [2] 4705 0
Type [3] 4706 0
Ethical approval
Citation [3] 4706 0
Link [3] 4706 0
Email [3] 4706 0
Other [3] 4706 0
Summary results
No Results