Proactive, Personalized Postpartum Mental Healthcare (P3MH)
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|ClinicalTrials.gov Identifier: NCT03803189|
Recruitment Status : Recruiting
First Posted : January 14, 2019
Last Update Posted : April 25, 2019
|Condition or disease||Intervention/treatment||Phase|
|Postpartum Depression Postpartum Blues Postpartum Anxiety Postpartum Mood Disorder||Behavioral: Usual care plus eToolkit||Not Applicable|
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 three sites in the Greater Toronto Area: Women's College Hospital Family Practice Health Centre, South-East Toronto Family Health Team, and North York 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|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.|
|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.|
|Primary Purpose:||Health Services Research|
|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|
|Actual Study Start Date :||March 14, 2019|
|Estimated Primary Completion Date :||March 2020|
|Estimated Study Completion Date :||May 2020|
Experimental: 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.
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.
No 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.
- Change in Edinburgh Postpartum Depression Scale (EPDS) Score [ Time Frame: Baseline, 12 weeks and 24 weeks postpartum ]The primary outcome will assess intervention effectiveness in terms of improved patient-reported mental health outcomes at 12 and 24 weeks postpartum. Scale range: 0-30; EPDS<10 without suicidality indicates low-risk for postpartum depression and anxiety; EPDS 10-18 without suicidality indicates medium-risk for postpartum depression and anxiety; EPDS>19 and/or suicidality indicates high-risk for postpartum depression and anxiety
- Time to treatment initiation [ Time Frame: 24 weeks postpartum ]Qualitative self-report questionnaire: what treatments were used by participant
- Perceived value of personalized eToolkit [ Time Frame: 12 weeks postpartum ]Qualitative self-report questionnaire: perceived value of the intervention, including whether it was adequately personalized and whether it meets the perceived care needs of mothers and their partners; and barriers and facilitators to implementation of and engagement with the intervention.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03803189
|Contact: Natasha Kithulegoda, MPH||4163236400 ext firstname.lastname@example.org|
|South East Toronto Family Health Team||Recruiting|
|Toronto, Ontario, Canada, M4C 5T2|
|Contact: Natasha Kithulegoda, MPH|
|Principal Investigator: Jackie Bellaire, MD|
|Women's College Hospital Family Practice Health Centre||Recruiting|
|Toronto, Ontario, Canada, M5S 1B3|
|Contact: Natasha Kithulegoda, MPH|
|Principal Investigator: Noah Ivers, MD PhD|
|Principal Investigator:||Noah Ivers, MD, PhD||Women's College Hospital|