A patient decision aid for antidepressant use in pregnancy: Pilot randomized controlled trial

Simone N Vigod; Neesha Hussain-Shamsy; Donna E Stewart; Sophie Grigoriadis; Kelly Metcalfe; Tim F Oberlander; Carrie Schram; Valerie H Taylor; Cindy-Lee Dennis

doi:10.1016/j.jad.2019.01.051

A patient decision aid for antidepressant use in pregnancy: Pilot randomized controlled trial

J Affect Disord. 2019 May 15:251:91-99. doi: 10.1016/j.jad.2019.01.051. Epub 2019 Mar 18.

Authors

Simone N Vigod¹, Neesha Hussain-Shamsy², Donna E Stewart³, Sophie Grigoriadis⁴, Kelly Metcalfe⁵, Tim F Oberlander⁶, Carrie Schram⁷, Valerie H Taylor⁸, Cindy-Lee Dennis⁹

Affiliations

¹ Department of Psychiatry, University of Toronto, Toronto, ON, Canada; Institute for Health Policy, Management and Evaluation, University of Toronto, Toronto, ON, Canada; Women's College Hospital and Research Institute, Toronto, ON, Canada. Electronic address: simone.vigod@wchospital.ca.
² Women's College Hospital and Research Institute, Toronto, ON, Canada.
³ Department of Psychiatry, University of Toronto, Toronto, ON, Canada; University Health Network, Toronto, ON, Canada.
⁴ Department of Psychiatry, University of Toronto, Toronto, ON, Canada; Sunnybrook Health Sciences Centre, Toronto, ON, Canada.
⁵ Lawrence S. Bloomberg Faculty of Nursing, University of Toronto, Toronto, ON, Canada.
⁶ Department of Pediatrics, University of British Columbia, Vancouver, British Columbia, Canada.
⁷ Department of Psychiatry, University of Toronto, Toronto, ON, Canada.
⁸ Department of Psychiatry, University of Toronto, Toronto, ON, Canada; Institute for Health Policy, Management and Evaluation, University of Toronto, Toronto, ON, Canada.
⁹ Department of Psychiatry, University of Toronto, Toronto, ON, Canada; Lawrence S. Bloomberg Faculty of Nursing, University of Toronto, Toronto, ON, Canada; Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto, ON, Canada.

PMID: 30913472
DOI: 10.1016/j.jad.2019.01.051

Abstract

Background: Decisions about antidepressant use in pregnancy are complex. We performed a pilot randomized controlled trial assessing the feasibility of a trial protocol for an online patient decision aid (PDA) for women deciding about antidepressant use in pregnancy.

Methods: 96 preconception and pregnant Canadian women recruited from specialist (n = 51) and non-specialist (n = 45) settings with Decisional Conflict Scale (DCS, range 0-100) score of ≥25 signifying moderate-to-high decisional conflict were randomly allocated to either the PDA or a control condition that guided participants to publicly available resources for advice around antidepressants and pregnancy. Follow-up data were collected at 4 weeks post-randomization.

Results: About 88.9% of eligible participants consented to participate. Women's views of the tool were positive; 88.7% of participants provided follow-up data. At follow-up, mean DCS score had decreased by 19.9 points in the PDA group vs. 13.3 in controls (adjusted mean difference, MD, 7.01, 95% CI -14.3 to 0.30). In the non-specialist setting, DCS scores decreased more for PDA users (25.5 points) than controls (10.5 points; adjusted MD -15.1, 95% CI -25.6 to -4.55); the MD was negligible in the specialist setting.

Limitations: The main limitation is the highly educated, high-income nature of our sample.

Conclusions: Evaluation of an online PDA for antidepressant use in pregnancy with national recruitment is feasible. Pilot results suggest that the tool is acceptable and reduces decisional conflict more than clinical care alone in a non-specialist setting. Evaluation of the PDA's impact on longer-term maternal and child clinical outcomes is a key next step.

Trial registration: ClinicalTrials.gov NCT02308592.

Keywords: Antidepressive agents; Patient decision aid; Pregnancy.

Publication types

Randomized Controlled Trial
Research Support, Non-U.S. Gov't

MeSH terms

Adult
Antidepressive Agents / therapeutic use*
Canada
Conflict, Psychological
Decision Making
Decision Support Techniques*
Depressive Disorder, Major / diagnosis
Depressive Disorder, Major / drug therapy*
Depressive Disorder, Major / psychology
Double-Blind Method
Female
Humans
Patient Participation
Pilot Projects
Pregnancy
Pregnancy Complications / diagnosis
Pregnancy Complications / drug therapy*
Pregnancy Complications / psychology
Young Adult

Substances

Antidepressive Agents

Associated data

ClinicalTrials.gov/NCT02308592

Grants and funding

CIHR/Canada