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

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

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.

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.

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.

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.

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.

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.

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.

The proportion of hospitalized adults who receive follow-up within 7 days of discharge and within 30 days of discharge.

The proportion of adults who receive follow-up within 7 days of discharge and within 30 days of emergency department visit.

The number of hospital admissions among patients receiving care at a clinic participating in this study.

The length of stay for hospitalizations among patients receiving care at a clinic participating in this study.

The number of emergency room admissions among patients receiving care at a clinic participating in this study.

The number of outpatient encounters among patients receiving care at a clinic participating in this study.

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.

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.

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.

This tool consists of 13 statements used to describe one's health. Patients rate each statement on a likert scale from Disagree Strongly (1) to Agree Strongly (4). Sum scores are categorized into levels of activation with higher scores indicating a patient's readiness to take action. The difference between baseline and 6-month follow up will be compared among patients using the Pathway Platform.

CollaboRATE is a process measure of shared decision making between patients and clinicians. Scores from this questionnaire range from 0 -100 with higher scores reflecting more shared decision making. Scores from this tool will be analyzed across 3 time-points.

This tool consists of 5 questions related to a patient's perception of how his/her current problem impairs his/her ability to carry out normal activities. Items are ranked from 0 (not impairing abilities at all) to 8 (very severely impairing abilities). Resulting scores range from 0-40 with higher scores reflecting more severe psychopathology. Baseline and post-Pathway app use scores will be compared among patients using the Pathway Platform.

The difference in PHQ-9 scores will be compared in all patients who completed this scale at 2 time points. Scores from this nine item questionnaire can range from 0 - 27. Higher scores indicate greater severity of depression. The difference between two scores and the direction of the change will reflect degree of improvement or decline.

Exploratory - Patient Clinical and reported outcomes: World Health Organization- Five Well Being Index [WHO-5]

The WHO-5 asks patients to rate 5 indices of wellbeing on a 5 point likert scale; 0 being the worst, 5 being the best. Resulting scores range from 0-25, the higher the score, the better the perceived quality of life. Changes in scores will be compared in patients who completed this scale at 2 time points.

Exploratory - Patient Clinical and reported outcomes: Perceived Deficits Questionnaire-Depression [PDQ-D5]

The PDQ-5 asks patients to respond to five questions representing four subscales: Attention/Concentration, Retrospective Memory, Prospective Memory, and Planning/Organization. Total PDQ-5 score consists of the sum of the raw scores on these 5 items and could range from 0-20 with higher scores indicating greater perceived deficit.The difference in PDQ-D5 scores will be compared in all patients who completed this scale at 2 time points.

Exploratory - Patient Clinical and reported outcomes: summarize patient reported therapeutic response to antidepressant medication plan.

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).

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