Proactive, Personalized Postpartum Mental Healthcare

NCT ID: NCT03803189

Last Updated: 2021-10-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-14
• Study Completion Date: 2021-04-24

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.

Conditions

Postpartum Depression; Postpartum Blues; Postpartum Anxiety; Postpartum Mood Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: DOUBLE

Study Groups

Personalized eToolkit

The intervention arm will receive a personalized eToolkit with community and electronic supports each time they complete a survey, and their PCP will receive supports in the EMR to facilitate postpartum mental healthcare.

Group Type: EXPERIMENTAL

Usual care plus eToolkit

Intervention Type: BEHAVIORAL

The intervention arm will receive repeated e-surveys via email to collect the Edinburgh Postpartum Depression Scale (EPDS) score at baseline and 2, 4, 6, 8, and 12 weeks. Those with EPDS\<10 will be triaged as low risk. Those with EPDS 10-18 (without suicidality) will be triaged as symptomatic for non-urgent clinical assessment with a message delivered via the EMR. Those with EPDS≥19 or suicidality will be triaged as requiring immediate follow-up, with an urgent message to their PCP via EMR, phone (if suicidal) and fax. Prompts in the EMR will enable evidence-based clinical care for PPD and PPA, highlight treatment preferences to support shared decision making, and identify appropriate referrals. Intervention arm participants will receive a personalized eToolkit after the completion of each survey. Patients in the intervention group with symptoms will be invited to a telephone interview at 12 weeks postpartum to describe their experience with the intervention.

Usual care

The control arm will not receive intervention materials, unless they express suicidality, in which case they will receive a message with supports for suicidality including local emergency departments and crisis lines and an urgent message via EMR and fax will be sent to their PCP. Control arm participants will be asked to complete a baseline e-survey in their third trimester, and a follow-up e-survey 24-weeks after their baby is born.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Usual care plus eToolkit

The intervention arm will receive repeated e-surveys via email to collect the Edinburgh Postpartum Depression Scale (EPDS) score at baseline and 2, 4, 6, 8, and 12 weeks. Those with EPDS\<10 will be triaged as low risk. Those with EPDS 10-18 (without suicidality) will be triaged as symptomatic for non-urgent clinical assessment with a message delivered via the EMR. Those with EPDS≥19 or suicidality will be triaged as requiring immediate follow-up, with an urgent message to their PCP via EMR, phone (if suicidal) and fax. Prompts in the EMR will enable evidence-based clinical care for PPD and PPA, highlight treatment preferences to support shared decision making, and identify appropriate referrals. Intervention arm participants will receive a personalized eToolkit after the completion of each survey. Patients in the intervention group with symptoms will be invited to a telephone interview at 12 weeks postpartum to describe their experience with the intervention.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

Michael Garron Hospital

OTHER

Sponsor Role: collaborator

Women's College Hospital

OTHER

Sponsor Role: lead

Responsible Party

Noah Ivers

Family Physician and Scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Noah Ivers, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Women's College Hospital

Locations

South East Toronto Family Health Team

Toronto, Ontario, Canada

Women's College Hospital Family Practice Health Centre

Toronto, Ontario, Canada

Countries

Canada

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Other Identifiers

PCG-155463

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2018-0099-B

Identifier Type: -

Identifier Source: org_study_id