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Trial registered on ANZCTR


Registration number
ACTRN12618001139268
Ethics application status
Approved
Date submitted
3/07/2018
Date registered
11/07/2018
Date last updated
11/07/2019
Date data sharing statement initially provided
11/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
General Practitioner (GP) education and screening feedback for improving depression outcomes among primary care patients
Scientific title
Reducing depression in primary care patients via General Practitioner education and screening feedback: A cluster RCT
Secondary ID [1] 294733 0
Nil known
Universal Trial Number (UTN)
U1111-1213-0171
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 307616 0
Condition category
Condition code
Mental Health 306672 306672 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Eligible general practice patients will complete a brief (approximately 10 minutes) touchscreen computer survey on a tablet device while in the waiting room prior to their appointment. The survey will screen patients for depression using the Patient Health Questionnaire (PHQ-9).
The intervention will comprise both GP and patient directed interventions:
Step 1: GP education. Consenting GPs will undertake an online quality improvement activity by completing a clinical e-audit "Depression: Achieve remission, prevent relapse (92162)." The online audit will take approximately 15 hours to complete and will involve the following activities: identifying patients who may benefit from additional or alternative treatments; accessing tools and information on what works in treatment of depression; considering recommending a combination of non-pharmacological approaches as part of a broader management plan; and reviewing response to treatment by routinely assessing mood, thoughts and function and modifying treatment/management accordingly. GPs will be requested to finish the online audit before patient data collection is initiated to earn 40 Category 1 CPD points, subject to approval of the RACGP. GPs will also be provided with a list of established mental health support services as well as mental health emergency phone numbers.
Step 2: Pre-GP consultation. Consenting patients will complete the baseline assessment via touchscreen computer prior to their consultation with the GP. Upon survey completion, the web-based software will automatically calculate PHQ-9 scores and summarise information regarding preferences for type of help for depressive symptoms. For those patients who score 10 or more on the PHQ-9, or greater than 0 on item 9, tailored feedback of the patient's survey results will be provided to GPs.
Step 3: GP consultation. The feedback will provide GPs with summarised information about the patient’s severity of depressive symptoms (i.e. PHQ-9 score), willingness to discuss help for depression with their GP and their preferred type of help. Together with the GP’s knowledge of the patient’s personal and medical history, this information can be used by the GP to guide secondary screening to determine whether some other cause (e.g. recent bereavement, illness, medication) is contributing to the patient’s symptoms, or some action to treat depression is needed. If the GP deems further action necessary, they can use the information provided to explore preferences for care and barriers to acceptance of particular treatment approaches.
Step 4: Patient self-management strategies. GPs will also be provided with printed brochures on self-management strategies that can be offered to patients at the GPs discretion. For example, they may be offered to patients who indicate a preference for self-management strategies; or to those for whom self-management strategies are likely to be a useful adjunct to the agreed treatment approach. The brochures will comprise of the publicly available "beyondblue Connect toolkit." The toolkit consists of six worksheets with information and general advice for improving wellbeing through activities such as simple cognitive behavioural strategies. The toolkit also includes telephone and web contact details for beyondblue mental health support services.
Intervention code [1] 301028 0
Early detection / Screening
Intervention code [2] 301029 0
Treatment: Other
Intervention code [3] 301033 0
Behaviour
Comparator / control treatment
GPs in the control group will not be offered the GP education online clinical audit. Patients attending appointments with GPs in the control group will receive the touchscreen computer survey. However, no feedback on survey results will be provided to either patients or GPs. As an exception, the following interventions will be offered in order to minimise risks for patients who may have severe depressive symptoms. GPs in the control condition will be provided with feedback for patients who score 20 or more on the PHQ9 (indicative of severe depression) or who score 2 or 3 on item 9 of the PHQ9 at baseline (indicative of potential self-harm). At follow-up, patients who score 20 on the PHQ9 or who score 2 or 3 on item 9 of the PHQ9 will be sent a letter by the research team. The letter will include information about potential sources of help, including their GP and a mental health helpline LifeLine Australia.

If patients with elevated depressive symptoms less than 20 on PHQ-9 are recognised as depressed by their GP, the GPs in the usual care arm are likely to provide one or more of the following: prescription of anti-depressant medication, monitoring of symptoms/ response to treatment, and referral for psychological treatments.
Control group
Active

Outcomes
Primary outcome [1] 305683 0
The proportion of patients scoring 10 or more on the Patient Health Questionnaire (PHQ-9)
Timepoint [1] 305683 0
Baseline, 3, 6 and 12 (primary timepoint) month follow up
Secondary outcome [1] 346163 0
Delivery of mental health services will be assessed via data linkage to Medicare Benefits Schedule (MBS) claims information for the following MBS items: GP mental health treatment items (2700-2717); Provision of Focused Psychological Strategies (2721-2727); Provision of Psychological Therapy Services by a Clinical Psychologist (80000-80020); and Consultant Psychiatrist Referred Patient Assessment and Management Plan (296, 299, 361, 291, 293, 359). For each service, the following details will be provided: Data of service, medicare item number; item description; provider charge; schedule fee; benefit paid; patient out of pocket; bill type; scrambled rendering provider number; date of referral; rendering provider postcode; ordering provider postcode; hospital indicator.
Timepoint [1] 346163 0
Baseline data will encompass MBS data for the 12 months prior to recruitment. Follow up data will encompass MBS data for the 12 months following recruitment. Participants will have 2 years of MBS data collected in total.
Secondary outcome [2] 346164 0
Supply of prescribed of psychotropic medications. For each consenting eligible patient, the following details regarding prescription of psychotropic medications will be obtained via data linkage to Pharmaceutical Benefits Scheme (PBS) claims information for the following PBS items: medication type; date of supply; date of prescription; PBS item code; item description; patient category; patient contribution; net benefit; scrambled prescriber number; pharmacy postcode.
Timepoint [2] 346164 0
Baseline data will encompass PBS data for the 12 months prior to recruitment. Follow up data will encompass PBS data for the 12 months following recruitment. That is, participants will have 2 years of MBS data collected in total.

Eligibility
Key inclusion criteria
Patients attending a participating practice must be aged 18 years or older, and have sufficient English to complete a survey independently.

Eligible GPs will have completed Royal Australian College of General Practitioners (RACGP) accredited GP Mental Health Skills Training (i.e. GPs who are eligible to bill using items 2715 and 2717 for mental health treatment plans).

Eligible practices must have at least 1 eligible GP who works at least 0.4 full time equivalent (or four sessions) a week who agrees to participate.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Patients judged by practice staff to be physically or cognitively unable to complete the survey or provide independent informed consent.

GPs who have previously completed the clinical e-audit: Depression: Achieve remission, prevent relapse (92162) will not be eligible to participate. This is because this e-audit will be offered as part of the intervention.

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)
Allocation is by practice and allocation of practices is concealed. When a practice consents to participate in the trial, the researcher liaising with the practice will obtain the practice allocation from a central administrator who will hold the computer generated allocation sequence. All patients recruited within a practice will be in the same condition. For example, if the practice is allocated to the intervention then all patients recruited within that practice will be in the intervention group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Baseline data will be summarized as the number of observations, means, standard deviations, medians, minimums and maximums where the data are continuous and as number of observations and frequencies where the data are categorical. The data will be presented separately by treatment group.
Aim 1. For the primary outcome, a PHQ-9 score of less than 10 at 12 months, we will test for group differences using a generalised linear mixed effects regression model, with a log link and a binomial distribution. The dichotomous outcome at each follow-up (baseline, 3 months, 6 months and 12 months) is the dependent variable. The model will include fixed effect for baseline history of depression, treatment group (intervention vs usual care), time, and treatment*time interaction. Treatment group comparisons at post-baseline each visit will be estimated by differences in LS means from the treatment*visit interaction and will be presented as risk ratios with accompanying p-values and 95% confidence intervals, with the primary comparison being that at 12 months. We will investigate various variance-covariance structures for the within-subject repeated measures (such as autoregressive, unstructured, and compound symmetric) and choose the model with the best fit according to the smallest Akaike Information Criteria. As a sensitivity analysis we will perform analyses under a variety of plausible assumptions regarding the missing data mechanism to investigate the impact of departures from the missing data assumptions.
Aim 2. The proportion of newly identified cases at baseline who receive appropriate care at follow-up will be compared between groups using a generalised linear mixed model as described above, but the cohort will be restricted to the individuals that are identified as new cases at baseline, and the outcome will be whether or not they received appropriate care at each follow-up time point.
Characteristics of consenting and non-consenting practices will be compared to identify any consent bias using the chi-square test for categorical variables and the t-test or a non-parametric equivalent for continuous variables. Examination of the demographic characteristics of consenting and non-consisting patients will also be tested. Data will be analysed using the intent to treat principal.

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)
NSW,VIC

Funding & Sponsors
Funding source category [1] 299341 0
Government body
Name [1] 299341 0
National Health and Medical Research Council (NHMRC)
Address [1] 299341 0
Level 1
16 Marcus Clarke Street
Canberra ACT 2601
Country [1] 299341 0
Australia
Primary sponsor type
University
Name
The University of Newcastle
Address
University Drive, Callaghan
NSW 2308, Australia
Country
Australia
Secondary sponsor category [1] 298609 0
None
Name [1] 298609 0
Address [1] 298609 0
Country [1] 298609 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300247 0
The University of Newcastle. Human Research Ethics Committee (HREC) [ECOO144]
Ethics committee address [1] 300247 0
University Drive, Callaghan
NSW 2308
Ethics committee country [1] 300247 0
Australia
Date submitted for ethics approval [1] 300247 0
01/09/2017
Approval date [1] 300247 0
01/03/2018
Ethics approval number [1] 300247 0
H-2017-0291

Summary
Brief summary
About 1 million Australian adults will experience depression each year. GPs play an important role in helping people manage depression. But without assistance, GPs miss about 50% of cases of depression.

This study will examine an intervention designed to assist GPs in 1) identifying patients with depression and 2) providing these patients with appropriate care. The study will take place in 24 general practices across NSW and Victoria, with general practices randomly allocated to one of two groups (intervention or control). At each practice, consenting patients will complete a touchscreen computer survey in the waiting room prior to their GP appointment. The survey will focus on assessing if patients might be experiencing signs of depression.

GPs in the intervention group will receive: 1) education in mental health care; 2) summarised feedback of patient depression scores as measured by the survey; 3) printed patient self-management brochures to distribute to patients; and 4) access to expert advice on depression management. GPs in the control group will not be offered these intervention strategies, but will continue to provide usual care to their patients. Eligible patients who complete the touchscreen survey will undergo follow up surveys at 3, 6 and 12 months.

The study will create new knowledge to inform best practice depression care, with the potential for broad adoption across Australian general practices.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 83038 0
A/Prof Mariko Carey
Address 83038 0
Health Behaviour Research Collaborative
School of Medicine and Public Health, University of Newcastle
HMRI W4
University Drive, Callaghan
NSW 2308
Country 83038 0
Australia
Phone 83038 0
+61 2 4042 0702
Fax 83038 0
Email 83038 0
mariko.carey@newcastle.edu.au
Contact person for public queries
Name 83039 0
A/Prof Mariko Carey
Address 83039 0
Health Behaviour Research Collaborative
School of Medicine and Public Health, University of Newcastle
HMRI W4
University Drive, Callaghan
NSW 2308
Country 83039 0
Australia
Phone 83039 0
+61 2 4042 0702
Fax 83039 0
Email 83039 0
mariko.carey@newcastle.edu.au
Contact person for scientific queries
Name 83040 0
A/Prof Mariko Carey
Address 83040 0
Health Behaviour Research Collaborative
School of Medicine and Public Health, University of Newcastle
HMRI W4
University Drive, Callaghan
NSW 2308
Country 83040 0
Australia
Phone 83040 0
+61 2 4042 0702
Fax 83040 0
Email 83040 0
mariko.carey@newcastle.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
We are seeking advice from the Ethics Committees which have approved our study regarding whether raw line by line data can be shared or whether only processed data (e.g. age category rather than age; ARIA+ classification rather than postcode; PHQ9 total score) can be shared. Processed data may be deemed to pose less risk of identifying individuals than raw data, but still enables the analyses to be replicated. Depending upon advice from the Ethics Committee, either raw line by line or processed data will be made available via NOVA which is the University of Newcastle's data repository.
What supporting documents are/will be available?
Study protocol
Statistical analysis plan
How or where can supporting documents be obtained?
Type [1] 2833 0
Study protocol
Citation [1] 2833 0
Link [1] 2833 0
Email [1] 2833 0
Other [1] 2833 0
The protocol is under review. A citation will be provided when available.
Attachment [1] 2833 0
Type [2] 2834 0
Statistical analysis plan
Citation [2] 2834 0
Link [2] 2834 0
Email [2] 2834 0
Other [2] 2834 0
The statistical analysis plan is contained within the protocol paper. A citation will be provided once the paper has been accepted.
Attachment [2] 2834 0
Summary results
No Results