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

Not Applicable

Completed

Conditions: Major Depressive Disorder

Interventions: Other: Pathway Platform mobile app

Registration Number: NCT04891224

Lead Sponsor: Wake Forest University Health Sciences

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 89

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).

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pathway Platform application use	Pathway Platform mobile app	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.

Primary Outcome Measures

Name	Time	Method
Proportion of Patients Who Completed Patient Health Questionnaire	Baseline to 6 months post-implementation of the Pathway app	Proportion of patients who have at least 2 Patient Health Questionnaire (PHQ) scores documented in their medical record over the 6 month study period will be compared between pre- and post- Pathway app implementation to 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.

Secondary Outcome Measures

Name	Time	Method
Process Outcome: Measurement-based Care	Baseline to 6 months post-implementation of the Pathway app	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.
Process Outcome: Shared-decision Making	6 months prior to and 6 months post-implementation of the Pathway Platform app	The proportion of patients reflecting shared-decision making using the OPTION12 Tool framework.
Process Outcome: Referrals to Behavioral Health	Baseline to 6 months post-implementation of the Pathway app	The proportion of patients with at least one referral will be compared.
Process Outcome: Total Number of Hospitalized Participants During Follow up Period	6 months prior to and 6 months post-implementation of the Pathway Platform app.	The number who receive follow-up within 7 days of discharge and within 30 days of discharge.
Process Outcome: Follow-up After Emergency Department Visit for Mental Illness	Baseline to 6 months post-implementation of the Pathway app	The proportion of adults who receive follow-up within 7 days of discharge and within 30 days of emergency department visit.
Process Outcome: Healthcare Resource Utilization, Hospital Admissions	Baseline to 6 months post-implementation of the Pathway app	The number of hospital admissions among patients receiving care at a clinic participating in this study.
Process Outcome: Number of Behavioral Related Hospitalizations	6 months prior to and 6 months post-implementation of the Pathway Platform app.
Process Outcome: Healthcare Resource Utilization, Emergency Room Admissions	Baseline to 6 months post-implementation of the Pathway app	The number of emergency room admissions among patients receiving care at a clinic participating in this study.
Process Outcome: Healthcare Resource Utilization, Outpatient Visits	6 months prior to and 6 months post-implementation of the Pathway Platform app.	The number of outpatient encounters among patients receiving care at a clinic participating in this study.
Process Outcome: Primary Care Physician (PCP) Visits	6 months prior to and 6 months post-implementation of the Pathway Platform app.	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.
Patient Health Questionnaire-9 [PHQ-9] Score	Baseline to 6 months post-implementation of the Pathway app	Median 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. For participants 'Baseline' refers to the PHQ9 value the patient entered on the day they downloaded the app. For pre-implementation controls 'Baseline' refers to the PHQ value from the EHR on the qualifying visit.
Patient Health Questionnaire-9 [PHQ-9] Score Reduction	Baseline to 6 months post-implementation of the Pathway app	Number 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.