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 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.

Study Overview

• Status: Completed
• Conditions: Major Depressive Disorder
• Intervention / Treatment: Other: Pathway Platform mobile app

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.

• Study Type: Interventional
• Enrollment (Actual): 89
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Oak Lawn, Illinois, United States, 60453
      • Advocate Christ Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Pathway Platform application use; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Patients Who Completed Patient Health Questionnaire	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.	Baseline to 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.	Baseline to 6 months post-implementation of the Pathway 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.	Baseline to 6 months post-implementation of the Pathway app
Process Outcome: Total Number of Hospitalized Participants During Follow up Period	The number 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.	Baseline to 6 months post-implementation of the Pathway app
Process Outcome: Healthcare Resource Utilization, Hospital Admissions	The number of hospital admissions among patients receiving care at a clinic participating in this study.	Baseline to 6 months post-implementation of the Pathway app
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	The number of emergency room admissions among patients receiving care at a clinic participating in this study.	Baseline to 6 months post-implementation of the Pathway 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: Primary Care Physician (PCP) Visits	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 Health Questionnaire-9 [PHQ-9] Score	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.	Baseline to 6 months post-implementation of the Pathway app
Patient Health Questionnaire-9 [PHQ-9] Score Reduction	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.	Baseline to 6 months post-implementation of the Pathway app

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Reported Outcomes: Patient Activation Measure-13 [PAM-13]	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.	Baseline and 6-month post-Pathway app use
Patient Reported Outcomes: CollaboRATE	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.	Baseline, 3 months and 6 months post-Pathway app use.
Patient Reported Outcomes: Work and Social Adjustment Scale (WSAS)	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.	Baseline and 6-month post-Pathway app use
Exploratory - Patient Clinical and Reported Outcomes: Patient Health Questionnaire [PHQ-9]	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.	6 months prior to and 6 months post-implementation of the Pathway app
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.	Baseline to 6-month post-Pathway app use
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.	Baseline to 6-month post-Pathway app use
Exploratory - Patient Clinical and Reported Outcomes: Patient Reported Therapeutic Response to Antidepressant Medication Plan.	This Patient Clinical and reported outcome summarizes patient self-reported adherence to antidepressant medication plan as prescribed will be described.	throughout 6-month of Pathway app use

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Collaborators: Takeda; Lundbeck LLC
• Investigators: Principal Investigator: David Kemp, MD, Advocate Medical Group

Publications and helpful links

General Publications

• Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
• Hibbard JH, Mahoney ER, Stockard J, Tusler M. Development and testing of a short form of the patient activation measure. Health Serv Res. 2005 Dec;40(6 Pt 1):1918-30. doi: 10.1111/j.1475-6773.2005.00438.x.
• Mundt JC, Marks IM, Shear MK, Greist JH. The Work and Social Adjustment Scale: a simple measure of impairment in functioning. Br J Psychiatry. 2002 May;180:461-4. doi: 10.1192/bjp.180.5.461.
• Buysse DJ, Yu L, Moul DE, Germain A, Stover A, Dodds NE, Johnston KL, Shablesky-Cade MA, Pilkonis PA. Development and validation of patient-reported outcome measures for sleep disturbance and sleep-related impairments. Sleep. 2010 Jun;33(6):781-92. doi: 10.1093/sleep/33.6.781.
• Forcino RC, Barr PJ, O'Malley AJ, Arend R, Castaldo MG, Ozanne EM, Percac-Lima S, Stults CD, Tai-Seale M, Thompson R, Elwyn G. Using CollaboRATE, a brief patient-reported measure of shared decision making: Results from three clinical settings in the United States. Health Expect. 2018 Feb;21(1):82-89. doi: 10.1111/hex.12588. Epub 2017 Jul 5.
• Lam RW, Lamy FX, Danchenko N, Yarlas A, White MK, Rive B, Saragoussi D. Psychometric validation of the Perceived Deficits Questionnaire-Depression (PDQ-D) instrument in US and UK respondents with major depressive disorder. Neuropsychiatr Dis Treat. 2018 Oct 29;14:2861-2877. doi: 10.2147/NDT.S175188. eCollection 2018.
• Krieger T, Zimmermann J, Huffziger S, Ubl B, Diener C, Kuehner C, Grosse Holtforth M. Measuring depression with a well-being index: further evidence for the validity of the WHO Well-Being Index (WHO-5) as a measure of the severity of depression. J Affect Disord. 2014 Mar;156:240-4. doi: 10.1016/j.jad.2013.12.015. Epub 2013 Dec 25.
• Chen X, Hu N, Wang Y, Gao X. Validation of a brain-computer interface version of the digit symbol substitution test in healthy subjects. Comput Biol Med. 2020 May;120:103729. doi: 10.1016/j.compbiomed.2020.103729. Epub 2020 Mar 25.
• McGahuey CA, Gelenberg AJ, Laukes CA, Moreno FA, Delgado PL, McKnight KM, Manber R. The Arizona Sexual Experience Scale (ASEX): reliability and validity. J Sex Marital Ther. 2000 Jan-Mar;26(1):25-40. doi: 10.1080/009262300278623.
• Vortel MA, Adam S, Port-Thompson AV, Friedman JM, Grande SW, Birch PH. Comparing the ability of OPTION(12) and OPTION(5) to assess shared decision-making in genetic counselling. Patient Educ Couns. 2016 Oct;99(10):1717-23. doi: 10.1016/j.pec.2016.03.024. Epub 2016 Mar 24.

Study record dates

Study Major Dates

• Study Start (Actual): February 19, 2021
• Primary Completion (Actual): January 30, 2023
• Study Completion (Actual): January 30, 2023

Study Registration Dates

• First Submitted: March 9, 2021
• First Submitted That Met QC Criteria: May 13, 2021
• First Posted (Actual): May 18, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 4, 2025
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: PHQ-9, Shared decision making
• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: 9050020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No