Use of a Digitally Enabled App With Clinical Team Interface in the Management of Depression
Last updated on July 2021Recruitment
- Recruitment Status
- Enrolling by invitation
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Major Depressive Disorder
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: This study will use a pre- post- study design to assess the impact of implementing the Pathway Platform in the primary care setting. Clinic performance and select patient outcomes will be compared before and after implementation. Additional patient outcomes will be assessed after implementation among patients using the Pathway Platform.Masking: None (Open Label)Primary Purpose: Health Services Research
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
A pre- and post- study design will be 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). Up to 20 pr...
A pre- and post- study design will be 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). Up to 20 primary care sites will be identified to participate in the study. Care team members involved in depression management will receive education on evidence-based clinical practices for depression care, such as measurement-based care practices and shared- decision making. Clinics with behavioral resources will also receive 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 will also be provided. Study outcomes identified in this protocol will be assessed among 200 patients who will be enrolled in the Pathway Platform (post-implementation cohort). Outcomes will also be assessed in another 200 patients from the same participating clinics prior to study implantation (pre-implantation cohort). Implementation success will be evaluated by comparing study outcomes among the two cohorts with a total sample size of 400 patients (of which 200 will receive the intervention and 200 will not). The primary outcome is PHQ-9 utilization over six months and will be compared between the pre- and post- implementation cohorts. Additional process measures will be compared, including shared-decision making, medication adjustments, referrals to behavioral health, primary care follow-up post hospitalizations, and remission and response. Data collected in the Pathway Platform will also be evaluated to explore pre-defined patient outcomes.
Tracking Information
- NCT #
- NCT04891224
- Collaborators
- Takeda
- Lundbeck LLC
- Investigators
- Principal Investigator: David Kemp, MD Advocate Medical Group