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Completed

NCT Number: NCT04891224

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Advocate Christ Medical Center

Oak Lawn, Illinois, 60453, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Pathway Platform mobile app

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.

Primary outcomes

  1. Proportion of Patients Who Completed Patient Health Questionnaire

    Time frame: 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 outcomes

  1. Process Outcome: Measurement-based Care

    Time frame: 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.

  2. Process Outcome: Shared-decision Making

    Time frame: 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.

  3. Process Outcome: Referrals to Behavioral Health

    Time frame: Baseline to 6 months post-implementation of the Pathway app

    The proportion of patients with at least one referral will be compared.

  4. Process Outcome: Total Number of Hospitalized Participants During Follow up Period

    Time frame: 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.

  5. Process Outcome: Follow-up After Emergency Department Visit for Mental Illness

    Time frame: 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.

  6. Process Outcome: Healthcare Resource Utilization, Hospital Admissions

    Time frame: 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.

  7. Process Outcome: Number of Behavioral Related Hospitalizations

    Time frame: 6 months prior to and 6 months post-implementation of the Pathway Platform app.

  8. Process Outcome: Healthcare Resource Utilization, Emergency Room Admissions

    Time frame: 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.

  9. Process Outcome: Healthcare Resource Utilization, Outpatient Visits

    Time frame: 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.

  10. Process Outcome: Primary Care Physician (PCP) Visits

    Time frame: 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.

  11. Patient Health Questionnaire-9 [PHQ-9] Score

    Time frame: 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.

  12. Patient Health Questionnaire-9 [PHQ-9] Score Reduction

    Time frame: 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.

Other outcomes

  1. Patient Reported Outcomes: Patient Activation Measure-13 [PAM-13]

    Time frame: Baseline and 6-month post-Pathway app use

    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.

  2. Patient Reported Outcomes: CollaboRATE

    Time frame: Baseline, 3 months and 6 months post-Pathway app use.

    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.

  3. Patient Reported Outcomes: Work and Social Adjustment Scale (WSAS)

    Time frame: Baseline and 6-month post-Pathway app use

    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.

  4. Exploratory - Patient Clinical and Reported Outcomes: Patient Health Questionnaire [PHQ-9]

    Time frame: 6 months prior to and 6 months post-implementation of the Pathway app

    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.

  5. Exploratory - Patient Clinical and Reported Outcomes: World Health Organization- Five Well Being Index [WHO-5]

    Time frame: Baseline to 6-month post-Pathway app use

    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.

  6. Exploratory - Patient Clinical and Reported Outcomes: Perceived Deficits Questionnaire-Depression [PDQ-D5]

    Time frame: Baseline to 6-month post-Pathway app use

    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.

  7. Exploratory - Patient Clinical and Reported Outcomes: Patient Reported Therapeutic Response to Antidepressant Medication Plan.

    Time frame: throughout 6-month of Pathway app use

    This Patient Clinical and reported outcome summarizes patient self-reported adherence to antidepressant medication plan as prescribed will be described.

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • Lundbeck LLC
  • Takeda

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
May 18, 2021
Registry last updated
Mar 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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