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

Major Depressive Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04891224
• Other study ID #: 9050020
• Status: Completed
• Phase: N/A
• Start date: February 19, 2021
• Est. completion date: January 30, 2023

Study information

• Verified date: March 2023
• Source: Advocate Health Care
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: January 30, 2023
• Est. primary completion date: January 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

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.

Locations

Country	Name	City	State
United States	Advocate Christ Medical Center	Oak Lawn	Illinois

Sponsors (3)

Lead Sponsor	Collaborator
Advocate Health Care	Lundbeck LLC, Takeda

Country where clinical trial is conducted

United States, 

References & Publications (10)

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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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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.
Other	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
Other	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.	Baseline to 6-month post-Pathway app use
Other	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
Other	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
Other	Exploratory - Patient Clinical and reported outcomes: summarize patient reported therapeutic response to antidepressant medication plan.	Patient self-reported adherence to antidepressant medication plan as prescribed will be described.	throughout 6-month of Pathway app use
Primary	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.	6 months prior to and 6 months post-implementation of the Pathway app
Secondary	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.	6 months prior to and 6 months post-implementation of the Pathway Platform app.
Secondary	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.
Secondary	Process Outcome: Referrals to behavioral health	The proportion of patients with at least one referral will be compared.	6 months prior to and 6 months post-implementation of the Pathway Platform app.
Secondary	Process Outcome: Follow-up after hospitalization for mental illness	The proportion of hospitalized adults 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.
Secondary	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.	6 months prior to and 6 months post-implementation of the Pathway Platform app.
Secondary	Process Outcome: Healthcare resource utilization, hospital admissions	The number of hospital admissions 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.
Secondary	Process Outcome: Healthcare resource utilization, length of stay	The length of stay for hospitalizations 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.
Secondary	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.	6 months prior to and 6 months post-implementation of the Pathway Platform app.
Secondary	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.
Secondary	Process Outcome: Healthcare resource utilization, financials	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.
Secondary	Patient Clinical Outcomes: remission of major depressive disorder	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.	6 months prior to and 6 months post-implementation of the Pathway Platform app.
Secondary	Patient Clinical Outcomes: response to treatment for major depressive disorder	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.	6 months prior to and 6 months post-implementation of the Pathway Platform app.