New York, New York 10032

  • Depressive Symptoms

Purpose:

The purpose of this study is to examine the effectiveness of a multi-level intervention - centered around a web-application that facilitates depression screening, automated shared decision making (SDM), patient activation, and psychoeducation - on mental health treatment optimization among patients with elevated depressive symptoms with or without co-morbid anxiety receiving care in primary care clinics that offer collaborative care. The objectives of the study include: Leveraging user centered design to refine an electronic SDM (eSDM) tool (aim 1), and assessing the effect of the eSDM tool on provider behavior (aim 2) and on patient enrollment in depression treatment (aim 3).


Study summary:

Collaborative care, a team-based approach to integrating primary and behavioral health, is effective in reducing depressive and anxiety symptoms and improving clinical outcomes. However, attempts to optimize collaborative care in real world settings have been hindered by patient (stigma, low self-efficacy, low perceived treatment efficacy), provider (suboptimal symptom recognition and communication at referral), and system (limited resources, lack of screening) level barriers. Few if any prior studies have focused on assessing the effectiveness of multi-level strategies to optimize treatment engagement in primary care settings in the sustainability phase of collaborative care. Using the behavior change wheel (BCW) framework, we created a multi-level strategy for optimizing treatment in primary care settings with collaborative care programs. The strategy involves patient-level electronic screening, patient activation, and an automated shared decision-making tool in addition to primary care provider-level behavioral health education with automated decisional support. The investigators now aim to test this multifaceted implementation strategy for optimizing treatment amongst patients with elevated depressive symptoms (with or without co-morbid anxiety) in the ambulatory care network (ACN) clinics of New York Presbyterian Hospital (NYPH) with established/mature collaborative care programs that predominantly care for socioeconomically disadvantaged and minority patients. We will randomize providers to either the multicomponent strategy or enhanced usual care. The investigators aim to assess the effectiveness of this intervention on patient engagement in mental health treatment (primary outcome) as well as on provider action to optimize/manage treatment (secondary outcome).


Criteria:

Inclusion Criteria: - English or Spanish Speaking - ≥ 18 years of age - Elevated depressive symptoms Elevated Patient Health Questionnaire (PHQ)-9 >=10 Elevated PHQ-9 >=5 and Generalized Anxiety Disorder (GAD)-7 >= 10 Exclusion Criteria: - Under the care of a psychiatrist or depression collaborative care manager in the prior 3 months - Diagnosis of psychosis or schizophrenia - Diagnosis of bipolar disorder - Dementia or severe cognitive impairment - History of coronary heart disease - Pregnancy - Dementia or severe cognitive impairment


NCT ID:

NCT05085886


Primary Contact:

Principal Investigator
Nathalie Moise, MD, MS
Florence Assistant Professor of Medicine

Jennifer Mizhquiri Barbecho
Phone: 917-985-1926
Email: cbch_depcarestudy@cumc.columbia.edu


Backup Contact:

Email: nm2562@cumc.columbia.edu
Nathalie Moise, MD, MS
Phone: 2123422889


Location Contact:

New York, New York 10032
United States

Nathalie Moise, MD, MS
Phone: 212-342-2889
Email: nm2562@cumc.columbia.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: June 28, 2022

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