Clinical trial NCT04891224: Use of a Digitally Enabled App With Clinical Team Interface in the Management of Depression
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorder
Keywords: PHQ-9, Shared decision making
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: Takeda
name: Lundbeck LLC
First posted: 2021-05-18
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This study will used 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 are compared before and after implementation. Additional patient outcomes are assessed after implementation among patients using the Pathway Platform.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Proportion of Patients Who Completed Patient Health Questionnaire
timeFrame: Baseline to 6 months post-implementation of the Pathway app
Secondary outcomes:
measure: Process Outcome: Measurement-based Care
timeFrame: Baseline to 6 months post-implementation of the Pathway app
measure: Process Outcome: Shared-decision Making
timeFrame: 6 months prior to and 6 months post-implementation of the Pathway Platform app
measure: Process Outcome: Referrals to Behavioral Health
timeFrame: Baseline to 6 months post-implementation of the Pathway app
measure: Process Outcome: Total Number of Hospitalized Participants During Follow up Period
timeFrame: 6 months prior to and 6 months post-implementation of the Pathway Platform app.
measure: Process Outcome: Follow-up After Emergency Department Visit for Mental Illness
timeFrame: Baseline to 6 months post-implementation of the Pathway app
measure: Process Outcome: Healthcare Resource Utilization, Hospital Admissions
timeFrame: Baseline to 6 months post-implementation of the Pathway app
measure: Process Outcome: Number of Behavioral Related Hospitalizations
timeFrame: 6 months prior to and 6 months post-implementation of the Pathway Platform app.
measure: Process Outcome: Healthcare Resource Utilization, Emergency Room Admissions
timeFrame: Baseline to 6 months post-implementation of the Pathway app
measure: Process Outcome: Healthcare Resource Utilization, Outpatient Visits
timeFrame: 6 months prior to and 6 months post-implementation of the Pathway Platform app.
measure: Process Outcome: Primary Care Physician (PCP) Visits
timeFrame: 6 months prior to and 6 months post-implementation of the Pathway Platform app.
measure: Patient Health Questionnaire-9 [PHQ-9] Score
timeFrame: Baseline to 6 months post-implementation of the Pathway app
measure: Patient Health Questionnaire-9 [PHQ-9] Score Reduction
timeFrame: Baseline to 6 months post-implementation of the Pathway app
Other outcomes:
measure: Patient Reported Outcomes: Patient Activation Measure-13 [PAM-13]
timeFrame: Baseline and 6-month post-Pathway app use
measure: Patient Reported Outcomes: CollaboRATE
timeFrame: Baseline, 3 months and 6 months post-Pathway app use.
measure: Patient Reported Outcomes: Work and Social Adjustment Scale (WSAS)
timeFrame: Baseline and 6-month post-Pathway app use
measure: Exploratory - Patient Clinical and Reported Outcomes: Patient Health Questionnaire [PHQ-9]
timeFrame: 6 months prior to and 6 months post-implementation of the Pathway app
measure: Exploratory - Patient Clinical and Reported Outcomes: World Health Organization- Five Well Being Index [WHO-5]
timeFrame: Baseline to 6-month post-Pathway app use
measure: Exploratory - Patient Clinical and Reported Outcomes: Perceived Deficits Questionnaire-Depression [PDQ-D5]
timeFrame: Baseline to 6-month post-Pathway app use
measure: Exploratory - Patient Clinical and Reported Outcomes: Patient Reported Therapeutic Response to Antidepressant Medication Plan.
timeFrame: throughout 6-month of Pathway app use
Locations:
city: Oak Lawn
country: United States
facility: Advocate Christ Medical Center
state: Illinois
Study officials:
affiliation: Advocate Medical Group
name: David Kemp, MD
role: PRINCIPAL_INVESTIGATOR
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