Proactive, Personalized Postpartum Mental Healthcare

NCT03803189 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2021-10-05

No results posted yet for this study

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.

Conditions

Interventions

BEHAVIORAL

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.

Sponsors & Collaborators

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV
  • Michael Garron Hospital

    collaborator OTHER
  • Women's College Hospital

    lead OTHER

Principal Investigators

  • Noah Ivers, MD, PhD · Women's College Hospital

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-14
Primary Completion
2021-04-24
Completion
2021-04-24

Countries

  • Canada

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03803189 on ClinicalTrials.gov