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Trial registered on ANZCTR


Registration number
ACTRN12619001433190
Ethics application status
Approved
Date submitted
24/09/2019
Date registered
16/10/2019
Date last updated
16/10/2019
Date data sharing statement initially provided
16/10/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Perinatal Identification, Referral and Integrated Management for Improving Depression: The PIRIMID Study
Scientific title
Perinatal Identification, Referral and Integrated Management for Improving Depression: The PIRIMID Study
Secondary ID [1] 297747 0
Nil known
Universal Trial Number (UTN)
Trial acronym
PIRIMID
Linked study record
This is a follow up study to the pilot trial registered under ACTRN12616001217493

Health condition
Health condition(s) or problem(s) studied:
Postnatal depression 312080 0
Postnatal anxiety 312081 0
Condition category
Condition code
Mental Health 310640 310640 0 0
Depression
Reproductive Health and Childbirth 310641 310641 0 0
Childbirth and postnatal care
Mental Health 310642 310642 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
PIRIMID. Maternal and child health nurses (MCHNs) in this condition will use the integrated electronic screening and clinical decision support system (CDSS) to screen woman as part of their emotional health assessment during her 8-week Key Ages and Stages (KAS) visit at the Maternal and Child Health Centre.
The PIRIMID system is a tablet-based electronic screening system for carrying out perinatal depression screening and providing clinical decision support to health professionals. In the PIRIMID system, the Edinburgh Postnatal Depression Scale (EPDS) score and other psychosocial information collected via e-screening are automatically collated and made available on the clinician's desktop in the form of an interactive dashboard. PIRIMID then provides clear, best-practice prompts to encourage clinicians to develop a management plan. PIRIMID guides the clinician with clear, step-by-step guidance, supporting information and prompts for structuring a management plan with referral decisions tailored to each woman's data.
Screening will take approx 10 minutes, this includes 2-5 minutes of the woman answering questions by herself, and 5 minute of the clinician reviewing and discussing these responses with the woman. Women will then complete a study questionnaire which will take approx 10 minutes.
Intervention code [1] 313986 0
Early detection / Screening
Comparator / control treatment
Current best-practice. Current best practice guidelines for screening include the Edinburgh Postnatal Depression Scale (EPDS) and psychosocial risk questions during the postnatal period. MCHNs in this condition will continue to follow their usual practice when completing each woman’s emotional health assessment during her 8-week KAS visit at the Maternal and Child Health Centre. In this municipality, e-screening will be used to ask the woman EPDS and psychosocial questions.
Control group
Active

Outcomes
Primary outcome [1] 319493 0
Treatment uptake. Proportion of women who have received help for their mental heath from GP, psychologist or psychiatrist as measured by questionnaire. This question is designed specifically for this study.
Timepoint [1] 319493 0
baseline, 4 and 6 (primary endpoint) months postnatal
Primary outcome [2] 319494 0
Acceptability and Satisfaction of experience with PIRIMID or current best-practice for women and nurses as measured by 10 point Likert-type scale,
Timepoint [2] 319494 0
8-week KAS visit
Secondary outcome [1] 368425 0
Uptake of secondary services and other sources of help and social support accessed. As measured by questionnaires. This questionnaire is designed specifically for this study.
Timepoint [1] 368425 0
Baseline (8-week KAS visit), 4 and 6 months postnatal
Secondary outcome [2] 368426 0
Anxiety and Stress symptoms as measured by the Depression, Anxiety and Stress Scales (DASS-21)
Timepoint [2] 368426 0
4 and 6 months postnatal
Secondary outcome [3] 368428 0
Health Economic Measures.
Health-related Quality of life - measured by EQoL-5D-5L,
Productivity costs - measured by iMTA Productivity Cost Questionnaire: iPCQ,
Health care costs - estimated based on health care resource utilization obtained from patient-reported resource/service use and Medicare Benefits Schedule (MBS) and Pharmaceutical Benefits Scheme (PBS).
Timepoint [3] 368428 0
Baseline (8-week KAS visit), 4 and 6 months postnatal

Eligibility
Key inclusion criteria
Ability to understand spoken and written English language
Baby aged 6-10 weeks
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Nil

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is concealed from researchers and MCHNs. Sealed opaque envelopes are used to allocate MCHNs to the two conditions.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer-generated, permuted blocks, randomized allocation schedule will be generated and operated by an independent researcher and used to assign MCHNs to the two conditions. To help ensure baseline comparability of the MCHNs in each condition, the randomized allocation schedule will be stratified according to years of MCHN experience.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample size for this c-RCT is based on detecting an absolute difference of 4.8% in the primary outcome - the proportion of women taking up treatment from baseline to 6 months postnatal. Data from published studies shows that, on average, only 24% of affected women will receive any treatment at all. From our pilot work (ACTRN12616001217493), the new system is expected to double this rate. Taking these percentages, we expect 0.1*0.24=2.4% treatment uptake in the current best-practice condition and 0.15*0.48=7.2% in the PIRIMID condition. We calculated that with a total of 50 clusters, and average of 29 women per nurse are needed to detect a different of this size with 90% power at the 5% significance level. Allowing for a 12% non-return of data (in line with 11% seen in previous studies), this gives a total of n=1650, an average of 33 women per nurse (cluster).
All analyses will be conducted following the intention-to-treat principle, according to the cluster’s randomised allocation. We will use generalised linear models that account for clustering using the generalised estimating equation (GEE) approach with robust standard errors. For the primary outcome (treatment from a GP, psychiatrist or psychologist), we will fit the model with an identity link function and binomial distribution to obtain the treatment effect as an absolute difference in help-seeking. In cases of non-convergence, the logarithmic or logit link function will be used instead and we will report the treatment effect as relative risk or odds ratio. The same approach will be applied to secondary referrals and supports accessed (help from family, mothers’ groups, social services etc.) For other secondary outcomes including the DASS-21 subscales (anxiety, depression and stress) and acceptability and satisfaction, we will use the identity link function and normal distribution. The GEE approach handles missing data under the missing completely at random assumption and we will undertake multiple imputation as a sensitivity analysis under the missing at random assumption. We will fit unadjusted models, accounting only for baseline values and the stratification factor (MCHN experience) as the initial analyses, and multivariable models to additionally control for any imbalances in cluster-level baseline covariates and potential individual-level confounding factors (e.g., age) as secondary analyses. The difference between intervention and control will be estimated at 4 and 6 months including 95% confidence intervals and p-values.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2020
Actual
Date of last participant enrolment
Anticipated
30/06/2021
Actual
Date of last data collection
Anticipated
31/10/2021
Actual
Sample size
Target
1650
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 13450 0
Austin Health - Heidelberg Repatriation Hospital - Heidelberg West
Recruitment postcode(s) [1] 26055 0
3081 - Heidelberg West

Funding & Sponsors
Funding source category [1] 302272 0
Government body
Name [1] 302272 0
National Health and Medical Research Council
Country [1] 302272 0
Australia
Primary sponsor type
Individual
Name
Professor Jeannette Milgrom
Address
Parent-Infant Research Institute (PIRI)
Austin Health
Level 1, Centaur Building
Heidelberg Repatriation Hospital
300 Waterdale Road
Heidelberg Heights VIC 3081
Country
Australia
Secondary sponsor category [1] 302143 0
None
Name [1] 302143 0
Address [1] 302143 0
Country [1] 302143 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302949 0
Austin Health Human Research Ethics Commitee
Ethics committee address [1] 302949 0
Ethics committee country [1] 302949 0
Australia
Date submitted for ethics approval [1] 302949 0
27/02/2019
Approval date [1] 302949 0
06/08/2019
Ethics approval number [1] 302949 0
HREC/50164/Austin-2019

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 91946 0
Prof Jeannette Milgrom
Address 91946 0
Parent-Infant Research Institute (PIRI)
Austin Health
Level 1, Centaur Building
Heidelberg Repatriation Hospital
300 Waterdale Rd
Heidelberg Heights VIC 3081
Country 91946 0
Australia
Phone 91946 0
+61 3 9496 4496
Fax 91946 0
+61 3 9496 4148
Email 91946 0
jeannette.milgrom@austin.org.au
Contact person for public queries
Name 91947 0
Alan Gemmill
Address 91947 0
Austin Health
Level 1, Centaur Building
Heidelberg Repatriation Hospital
300 Waterdale Rd
Heidelberg Heights VIC 3081
Country 91947 0
Australia
Phone 91947 0
+61 3 9496 4496
Fax 91947 0
+61 3 9496 4148
Email 91947 0
alan.gemmill@austin.org.au
Contact person for scientific queries
Name 91948 0
Alan Gemmill
Address 91948 0
Austin Health
Level 1, Centaur Building
Heidelberg Repatriation Hospital
300 Waterdale Rd
Heidelberg Heights VIC 3081
Country 91948 0
Australia
Phone 91948 0
+61 3 9496 4496
Fax 91948 0
+61 3 9496 4148
Email 91948 0
alan.gemmill@austin.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Our ethics approval specifies that results of this research project will be published and/or presented in a variety of forums. Information will always be presented in such a way that an individual research participants cannot be identified. Only collated group data will be presented.


What supporting documents are/will be available?

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
No additional documents have been identified.