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

Study Overview
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Brief Summary
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This study is being 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 will compare 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 start a new treatment for depression. The investigators hope that using an app to facilitate management of depression symptoms, medication use, and side effects will help patients and their providers understand their response to medications and lead to better response and improvements in depression.

Detailed Description
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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.

Official Title
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Implementation and Evaluation of the Pathway Platform: A Digitally Enabled Care Pathway to Improve Depression Key Performance Indicators and Patient Outcomes in Primary Care Clinics

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Other: Pathway Platform mobile app


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Pathway Platform application use<br>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. | Other: Pathway Platform mobile app<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine if there is a change in adherence to measurement based care practices following the implementation of the Pathway Platform in a primary care setting. | The representative measure will be utilization of the Patient Health Questionnaire [PHQ-9]. The proportion of patients who have at least 2 PHQ-9 scores documented in their medical record over the 6 month study period will be compared between pre- and post- Pathway app implementation. | 6 months prior to and 6 months post-implementation of the Pathway app | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Process Outcome: Measurement-based care. | The proportion of patients reflecting measurement-based care informed major depression disorder treatment adjustments in their charts, defined as at lease one medication dose change, switch or add on medication. | 6 months prior to and 6 months post-implementation of the Pathway Platform app. | 
| Process Outcome: Shared-decision making | The proportion of patients reflecting shared-decision making using the OPTION12 Tool framework. | 6 months prior to and 6 months post-implementation of the Pathway Platform app. | 
| Process Outcome: Referrals to behavioral health | The proportion of patients with at least one referral will be compared. | 6 months prior to and 6 months post-implementation of the Pathway Platform app. | 
| Process Outcome: Follow-up after hospitalization for mental illness | The proportion of hospitalized adults who receive follow-up within 7 days of discharge and within 30 days of discharge. | 6 months prior to and 6 months post-implementation of the Pathway Platform app. | 
| Process Outcome: Follow-up after emergency department visit for mental illness | The proportion of adults who receive follow-up within 7 days of discharge and within 30 days of emergency department visit. | 6 months prior to and 6 months post-implementation of the Pathway Platform app. | 
| Process Outcome: Healthcare resource utilization, hospital admissions | The number of hospital admissions among patients receiving care at a clinic participating in this study. | 6 months prior to and 6 months post-implementation of the Pathway Platform app. | 
| Process Outcome: Healthcare resource utilization, length of stay | The length of stay for hospitalizations among patients receiving care at a clinic participating in this study. | 6 months prior to and 6 months post-implementation of the Pathway Platform app. | 
| Process Outcome: Healthcare resource utilization, emergency room admissions | The number of emergency room admissions among patients receiving care at a clinic participating in this study. | 6 months prior to and 6 months post-implementation of the Pathway Platform app. | 
| Process Outcome: Healthcare resource utilization, outpatient visits | The number of outpatient encounters among patients receiving care at a clinic participating in this study. | 6 months prior to and 6 months post-implementation of the Pathway Platform app. | 
| Process Outcome: Healthcare resource utilization, financials | The costs associated with health care services among patients receiving care at a clinic participating in this study. Costs will be calculated using USA national average costs for inpatient and outpatient visits. | 6 months prior to and 6 months post-implementation of the Pathway Platform app. | 
| Patient Clinical Outcomes: remission of major depressive disorder | The proportion of patients with Patient Health Questionnaire-9 [PHQ-9] scores <=5 at the end of the study period. Scores from this nine item questionnaire can range from 0 - 27. Higher scores indicate greater severity of depression. The last measurement available will be used to calculate remission. | 6 months prior to and 6 months post-implementation of the Pathway Platform app. | 
| Patient Clinical Outcomes: response to treatment for major depressive disorder | The proportion of patients with a 50 percent or greater reduction in PHQ-9 scores. Scores from this nine item questionnaire can range from 0 - 27. Higher scores indicate greater severity of depression. A 50 percent reduction in score reflects significant improvement in depression. The first and last scores available during the study period will be used to calculate response. | 6 months prior to and 6 months post-implementation of the Pathway Platform app. |