Using patient engagement in the design and rationale of a trial for women with depression in obstetrics and gynecology practices

Abstract

Introduction: Significant health disparities exist among socioeconomically disadvantaged women, who experience elevated rates of depression and increased risk for poor depression treatment engagement and outcomes. We aimed to use stakeholder input to develop innovative methods for a comparative effectiveness trial to address the needs of socioeconomically disadvantaged women with depression in women's health practices.

Methods: Using a community advisory board, focus groups, and individual patient input, we determined the feasibility and acceptability of an electronic psychosocial screening and referral tool; developed and finalized a prioritization tool for women with depression; and piloted the prioritization tool. Two intervention approaches, enhanced screening and referral using an electronic psychosocial screening, and mentoring using the prioritization tool, were developed as intervention options for socioeconomically disadvantaged women attending women's health practices. We describe the developmental steps and the final design for the comparative effectiveness trial evaluating both intervention approaches.

Conclusions: Stakeholder input allowed us to develop an acceptable clinical trial of two patient-centered interventions with patient-driven outcomes.

Trial registration: ClinicalTrials.gov NCT00895999.

Keywords: Depression; Patient engagement; Patient preference; Quality of life; Socioeconomic disadvantage; Women's health.