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

Proactive, Personalized Postpartum Mental Healthcare

Sponsors

Lead sponsor: Women's College Hospital

Collaborator: Canadian Institutes of Health Research (CIHR)
Michael Garron Hospital

Source Women's College Hospital
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.

Overall Status Recruiting
Start Date March 14, 2019
Completion Date March 2021
Primary Completion Date January 2021
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Change in Edinburgh Postpartum Depression Scale (EPDS) Score Baseline, 12 weeks and 24 weeks postpartum
Secondary Outcome
Measure Time Frame
Time to treatment initiation 24 weeks postpartum
Enrollment 120
Condition
Intervention

Intervention type: Behavioral

Intervention name: Usual care plus eToolkit

Description: 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.

Arm group label: Personalized eToolkit

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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Noah Ivers, MD, PhD Principal Investigator Women's College Hospital
Overall Contact

Last name: Natasha Kithulegoda, MPH

Phone: 4163236400

Phone ext: 8356

Email: [email protected]

Location
facility status contact investigator
South East Toronto Family Health Team | Toronto, Ontario, M4C 5T2, Canada Recruiting Natasha Kithulegoda, MPH Jackie Bellaire, MD Principal Investigator
Women's College Hospital Family Practice Health Centre | Toronto, Ontario, M5S 1B3, Canada Recruiting Natasha Kithulegoda, MPH Noah Ivers, MD PhD Principal Investigator
Location Countries

Canada

Verification Date

May 2020

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Women's College Hospital

Investigator full name: Noah Ivers

Investigator title: Family Physician and Scientist

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: Personalized eToolkit

Arm group type: Experimental

Description: 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.

Arm group label: Usual care

Arm group type: No Intervention

Description: 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.

Acronym P3MH
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

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

Masking: Double (Investigator, Outcomes Assessor)

Masking description: The sequence will be concealed to primary care providers and study staff other than the research coordinator who will apply the allocation. Study staff, including analysts, will also be blind to treatment allocation. Patients and healthcare professionals who may interact with study participants cannot be blinded due to the nature of the intervention, but outcome assessment will be blind.

Source: ClinicalTrials.gov