Use of a Digitally Enabled App With Clinical Team Interface in the Management of Depression

NCT ID: NCT04891224

Last Updated: 2025-03-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 89 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-19
• Study Completion Date: 2023-01-30

Brief Summary

This study was conducted to understand the use of a mobile app (titled Pathway) to help patients track depression symptoms, medications, side effects, and goals in addition to the usual care with their doctor. Investigators compared the effect of the app over 6 months and examine whether the app can increase engagement between patients and their doctor and help in the management of illnesses as patients started a new treatment for depression. The investigators hoped that using an app to facilitate management of depression symptoms, medication use, and side effects help patients and their providers understand their response to medications and lead to better response and improvements in depression.

Detailed Description

A pre- and post- study design was utilized to assess the impact of implementing the Pathway Platform in the primary care setting. The Pathway Platform consists of a mobile app for patients and a care team interface that can be accessed through Epic (electronic medical record system). Eight primary care sites were identified to participate in the study. Care team members involved in depression management received education on evidence-based clinical practices for depression care, such as measurement-based care practices and shared- decision making. Clinics with behavioral resources also received additional education on behavioral health integration. Training on how to onboard patients to use the Pathway Platform and utilize electronic medical records to view data collected in the Pathway Platform was also provided. Study outcomes identified in this protocol are described among patients enrolled in the Pathway Platform (post-implementation cohort) as well as a similar group of patients from the same participating clinics prior to study implantation (pre-implantation cohort). Implementation success was evaluated by comparing study outcomes among these two cohorts. The primary outcome is PHQ-9 utilization over six months are compared between the pre- and post- implementation cohorts. Additional process measures compared include; shared-decision making, medication adjustments, referrals to behavioral health, primary care follow-up post hospitalizations, and depression remission and response. Data collected in the Pathway Platform is also used to explore pre-defined patient outcomes.

Conditions

Major Depressive Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Pathway Platform application use

Study participants will download the Pathway app to their mobile device. This app will gather patient health data, present standardized questionnaires and research data collection tools. Subject responses will be visible to their provider via interface with the electronic medical record.

Group Type: OTHER

Pathway Platform mobile app

Intervention Type: OTHER

The pathway platform intervention involves 3 components: 1. The patient facing app which will: a) Gather health information related to depression management and patient-Provider engagement. b) Clinical data collection; PHQ-9, WHO-5, PDQ-D-5, medication adherence and side effects, goal setting and goal tracking. c) Research data; Patient Activation Measure -13\[PAM-13\], CollaboRATE, and Work and Social Adjustment Scale \[WSAS\]. 2. Electronic Medical Record Integration - a) Data collected in the app is accessible to care team in real time. b) Provide a longitudinal summary to assist in decision making and depression management. 3. Educational Scaffolding - a) Training program describing how the Pathway Platform can support care team members in clinical processes related to measurement-based care and shared-decision making. b) Includes ongoing feedback with up to three audit cycles.

Interventions

Pathway Platform mobile app

The pathway platform intervention involves 3 components: 1. The patient facing app which will: a) Gather health information related to depression management and patient-Provider engagement. b) Clinical data collection; PHQ-9, WHO-5, PDQ-D-5, medication adherence and side effects, goal setting and goal tracking. c) Research data; Patient Activation Measure -13\[PAM-13\], CollaboRATE, and Work and Social Adjustment Scale \[WSAS\]. 2. Electronic Medical Record Integration - a) Data collected in the app is accessible to care team in real time. b) Provide a longitudinal summary to assist in decision making and depression management. 3. Educational Scaffolding - a) Training program describing how the Pathway Platform can support care team members in clinical processes related to measurement-based care and shared-decision making. b) Includes ongoing feedback with up to three audit cycles.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Diagnosis with major depressive disorder or reference to "clinical depression" in patient charts.
• Recently prescribed monotherapy antidepressant medication (defined as new start, medication switch, or dose change in the past 3 months.)
• Patients with inadequate response or tolerability concerns determined based on A PHQ-2 score of 3 or greater or a PHQ-9 score of 5 or more, recorded in medical records in the past 6 weeks or during screening,
• Able and willing to provide informed consent
• Able to use the Pathway Platform based on clinician's judgment, e.g. owns an iPhone version 5 or later or smartphones with Android operating systems, have an active data plan or regular WiFi access

Exclusion Criteria

• Missing PHQ-2 score in the past 6 weeks and/or unable to perform PHQ-2 at index visit
• Diagnosis with bipolar depression, schizophrenia, and/or schizoaffective disorder
• Patient no longer under primary care for depression and has transitioned to a psychiatric care team (i.e., Psychiatrist, Advance Practice Psychiatric Nurse, Psychiatric Nurse Practitioner, Psychiatric Physician Assistant).
• Lack of functional English literacy (indicated by primary language in electronic medical record).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Takeda

INDUSTRY

Sponsor Role: collaborator

Lundbeck LLC

INDUSTRY

Sponsor Role: collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Kemp, MD

Role: PRINCIPAL_INVESTIGATOR

Advocate Medical Group

Locations

Advocate Christ Medical Center

Oak Lawn, Illinois, United States

Countries

United States

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Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

9050020

Identifier Type: -

Identifier Source: org_study_id