Clinical trial NCT03803189: Proactive, Personalized Postpartum Mental Healthcare
Official title: Proactive, Personalized Postpartum Mental Healthcare (P3MH): Designing and Testing an eHealth Intervention to Deliver Proactive, Personalized Postpartum Mental Healthcare for New Parents in Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postpartum Depression
Postpartum Blues
Postpartum Anxiety
Postpartum Mood Disorder
Lead sponsor: Women's College Hospital
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: Michael Garron Hospital
First posted: 2019-01-14
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: An independent statistician following a 2:1 ratio to increase opportunities to learn about the intervention processes during this pilot trial will randomly allocate consenting patients at each site following the completion of their baseline survey to intervention or usual care using a computer-generated sequence.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Mental health symptoms - especially depression and anxiety - are very common in new parents, affecting close to 20% of mothers and at least 10% of fathers. When such symptoms progress to severe levels, they can be more difficult to treat. Early identification of symptoms and prompt treatment are ideal. Despite broad awareness that mental health symptoms in new parents are common, few systems are in place to automatically assess and monitor such symptoms. Evidence-based symptom surveys that can identify parents at risk for postpartum mental health disorders exist, and effective medication and non-medication treatment options are available. Yet, most primary care settings do not have systems in place to ensure that parents with mental health problems (and especially fathers) are identified and treated. This study will use a digital application with a customized website, electronic medical record and email integration to engage parents in assessing their mental health symptoms within weeks of the birth of their new baby. Electronic symptom surveys, sent on behalf of the family doctor, will be used to support proactive, personalized postpartum mental healthcare (P3MH). Responses will be used to enable a tailored care plan for the patient, including advice about options for referrals, treatment, and local community-based psycho-educational and/or social supports. This eHealth intervention includes a web-based application for parents and seamless integration in the EMR, so that when the family doctor sees the patient in clinic, relevant information is ready to be discussed. In this study, a co-design process will be carried with patients and health professionals to refine this eHealth intervention, and determine the usability, user experience, and perceived value of this process in terms of whether it enables mental health symptoms to be caught early and managed in the best way possible for each parent. The procedures will also be piloted for a future large-scale evaluation.

Detailed description: This pilot randomized trial seeks to determine the usability and perceived value of a primary care-based eHealth application that: (1) uses a validated tool (EPDS), to identify and monitor depression and anxiety symptoms in new parents; and (2) collects data on contextual factors and treatment preferences that inform the provision of tailored resources to patients and support the PCP to initiate a tailored treatment pathway. The trial will take place at two sites in the Greater Toronto Area: Women's College Hospital Family Practice Health Centre, and South-East Toronto Family Health Team.

Potential participants (e.g. pregnant women and their partners) will be identified and recruited during pregnancy. Participants will be randomized with an allocation ratio of 2:1 to increase opportunities to learn about the intervention processes. Participants in the intervention arm will complete e-surveys to monitor for symptoms at 2, 4, 6, 8 and 12 weeks postpartum. When symptoms are identified, participants will additionally complete information about contextual factors and treatment preferences. A personalized eToolkit for the patient and clinical decision supports for their primary care provider (PCP) will be produced based on responses to the e-surveys at each time-point. The personalized eToolkit with recommendations for each parent will be generated that includes information about online resources, treatment options, and local, community-based psycho-educational and/or social supports. Participants will be emailed a link to their customized set of resources. The application seamlessly integrates into the primary care electronic medical record (EMR) to provide decision support for the primary care provider, and facilitate shared decision making during the clinical encounter regarding treatment and referral options. Participants will also use the eHealth application to monitor their symptoms over time, alert the primary care team regarding changes, and facilitate timely treatment changes as needs evolve. Participants in the control arm will receive usual care from their primary care provider. If they are flagged as symptomatic at baseline (EPDS\>15, PHQ-9 and/or GAD-7 \> 10) they will be removed from the study, and provided with electronic resources immediately. A message via EMR will be sent to their PCP, and if suicidality is flagged, their PCP will also receive a message via fax and phone.

Eligibility criteria: Inclusion Criteria:

* Biological and non-biological new parents of all sex and gender identities
* Must be able to interact with an eHealth intervention (i.e., have a smartphone, and an active email address)
* Must be rostered to a participating primary care provider who works \>1 day per week in the participating clinics and provides comprehensive primary care

Exclusion Criteria:

* History of severe mental illness (e.g. schizophrenia, bipolar disorder), active alcohol or substance use disorder, and/or symptomatic at time of recruitment (i.e., EPDS\>15. PHQ-9 and/or GAD-7 \>10 or suicidality)
* Pregnant women with active mental illness

Primary outcomes:
measure: Change in Edinburgh Postpartum Depression Scale (EPDS) Score
timeFrame: Baseline, 12 weeks and 24 weeks postpartum
Secondary outcomes:
measure: Time to treatment initiation
timeFrame: 24 weeks postpartum
Other outcomes:
measure: Perceived value of personalized eToolkit
timeFrame: 12 weeks postpartum
Locations:
city: Toronto
country: Canada
facility: South East Toronto Family Health Team
state: Ontario
city: Toronto
country: Canada
facility: Women's College Hospital Family Practice Health Centre
state: Ontario
Study officials:
affiliation: Women's College Hospital
name: Noah Ivers, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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