An interventional study of Pathway Platform mobile app in Major Depressive Disorder, sponsored by Wake Forest University Health Sciences. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-24.
Sponsored by Wake Forest University Health Sciences · Not applicable, Interventional, and Health services research
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.
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.
4,845 studies on the registry are indexed under Depressive Disorder; 514 are open to participants now.
This study's enrollment of 89 is above the median of 80 across 3,999 interventional studies indexed under Depressive Disorder.
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Exclusion Criteria:
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.
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.
Time frame: Baseline to 6 months post-implementation of the Pathway app
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline to 6 months post-implementation of the Pathway app
Process Outcome: Number of Behavioral Related Hospitalizations
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline to 6 months post-implementation of the Pathway app
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: throughout 6-month of Pathway app use
Pathway platform was implemented with interested PCPs from 8 primary care sites. Pre- implementation control cohort was created by identifying potentially eligible patients retrospectively from EHR. Post-implementation Pathway Cohort - The first participant was enrolled in on 7/21/21 and last participant was enrolled on 7/2/22.
| Milestone | Pre-Implementation Cohort | Pathway Participants |
|---|---|---|
| Started | 90 | 89 |
| Completed | 90 | 89 |
| Not completed | 0 | 0 |
| Milestone | Pre-Implementation Cohort | Pathway Participants |
|---|---|---|
| Started | 90 | 89 |
| Completed | 90 | 89 |
| Not completed | 0 | 0 |
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.
| participants | Pre-Implementation Cohort | Pathway Participants |
|---|---|---|
| Proportion of Patients Who Completed Patient Health Questionnaire | 35 | 49 |
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.
| participants | Pre-Implementation Cohort (N=90) | Pathway Participants (N=89) |
|---|---|---|
| Process Outcome: Measurement-based Care | 38 | 40 |
The proportion of patients reflecting shared-decision making using the OPTION12 Tool framework.
No measurements were reported for this outcome.
The proportion of patients with at least one referral will be compared.
| participants | Pre-Implementation Cohort (N=90) | Pathway Participants (N=89) |
|---|---|---|
| Process Outcome: Referrals to Behavioral Health | 21 | 8 |
The number who receive follow-up within 7 days of discharge and within 30 days of discharge.
| Participants | Pre-Implementation Cohort (N=90) | Pathway Participants (N=89) |
|---|---|---|
| Process Outcome: Total Number of Hospitalized Participants During Follow up Period | 19 | 23 |
The proportion of adults who receive follow-up within 7 days of discharge and within 30 days of emergency department visit.
| Participants | Pre-Implementation Cohort (N=90) | Pathway Participants (N=89) |
|---|---|---|
| Process Outcome: Follow-up After Emergency Department Visit for Mental Illness | 3 | 0 |
The number of hospital admissions among patients receiving care at a clinic participating in this study.
| participants | Pre-Implementation Cohort (N=90) | Pathway Participants (N=89) |
|---|---|---|
| Hospitalizations | 19 | 23 |
| Behavioral health related hospitalization | 4 | 0 |
| Participants | Pre-Implementation Cohort (N=90) | Pathway Participants (N=89) |
|---|---|---|
| Process Outcome: Number of Behavioral Related Hospitalizations | 4 | 0 |
The number of emergency room admissions among patients receiving care at a clinic participating in this study.
| Participants | Pre-Implementation Cohort (N=90) | Pathway Participants (N=89) |
|---|---|---|
| Process Outcome: Healthcare Resource Utilization, Emergency Room Admissions | 11 | 5 |
The number of outpatient encounters among patients receiving care at a clinic participating in this study.
| number of units | Pre-Implementation Cohort (N=90) | Pathway Participants (N=89) |
|---|---|---|
| Number of ED Visits | 11 | 5 |
| Number of Behavioral Health-Related ED Visits | 11 | 5 |
| Number of Outpatient Visits | 216 | 243 |
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.
No measurements were reported for this outcome.
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.
| median PHQ-9 total score | Pre-Implementation Cohort | Pathway Participants |
|---|---|---|
| PHQ-9 Median Score: Baseline | 14.5 (11.0 to 27.0) | 12 (9.0 to 17.0) |
| 3-months | 11.0 (8.5 to 12.5) | 8.5 (3.0 to 15.0) |
| 6-months | 17.0 (14.5 to 20.0) | 6.5 (3.0 to 12.5) |
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.
| participants | Pre-Implementation Cohort (N=90) | Pathway Participants (N=89) |
|---|---|---|
| Patient Health Questionnaire-9 [PHQ-9] Score Reduction | 2 | 7 |
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.
| score on a scale | Pathway Participants (N=89) |
|---|---|
| Patient Reported Outcomes: Patient Activation Measure-13 [PAM-13] | 4 (-5 to 13) |
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.
No measurements were reported for this outcome.
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.
| score on a scale | Pathway Participants (N=89) |
|---|---|
| Patient Reported Outcomes: Work and Social Adjustment Scale (WSAS) | -4 (-14 to 6) |
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.
| score on a scale | Pre-Implementation Cohort (N=90) | Pathway Participants (N=89) |
|---|---|---|
| Exploratory - Patient Clinical and Reported Outcomes: Patient Health Questionnaire [PHQ-9] | 2 (1 to 3) | 4 (2.5 to 4.5) |
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.
| score on a scale | Pathway Participants (N=89) |
|---|---|
| Exploratory - Patient Clinical and Reported Outcomes: World Health Organization- Five Well Being Index [WHO-5] | 3 (-1 to 7) |
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.
| score on a scale | Pathway Participants (N=89) |
|---|---|
| Exploratory - Patient Clinical and Reported Outcomes: Perceived Deficits Questionnaire-Depression [PDQ-D5] | 4 (0 to 8) |
This Patient Clinical and reported outcome summarizes patient self-reported adherence to antidepressant medication plan as prescribed will be described.
| participants | Pathway Participants (N=89) |
|---|---|
| Exploratory - Patient Clinical and Reported Outcomes: Patient Reported Therapeutic Response to Antidepressant Medication Plan. | 87 |
Collected over Baseline through week 75. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pathway Platform Application Use | 0/89 (0%) | 5/89 (5.6%) | 10/89 (11.2%) |
| Pre-Implementation Cohort Retrospective Control Group Identified From Study Sites. | — | — | — |
| Event | Pathway Platform Application Use | Pre-Implementation Cohort Retrospective Control Group Identified From Study Sites. |
|---|---|---|
| Attempted Overdose hospitalizationPsychiatric disorders | 1/89 | — |
| Hospitalization for CholecystectomyGastrointestinal disorders | 1/89 | — |
| D & C procedurePregnancy, puerperium and perinatal conditions | 1/89 | — |
| Mitral Valve repairCardiac disorders | 1/89 | — |
| DizzinessEar and labyrinth disorders | 1/89 | — |
| Event | Pathway Platform Application Use | Pre-Implementation Cohort Retrospective Control Group Identified From Study Sites. |
|---|---|---|
| Carpel tunnel surgeryMusculoskeletal and connective tissue disorders | 2/89 | — |
| Scar RepairSurgical and medical procedures | 1/89 | — |
| L sided chest pain, ED visitInvestigations | 1/89 | — |
| Abdominal pain/Ovarian cyst ruptureNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/89 | — |
| Observational hospitalization for abnormal vaginal bleedingReproductive system and breast disorders | 1/89 | — |
| L Breast Mass ExcisionReproductive system and breast disorders | 1/89 | — |
| Laparoscopic Lysis of Adhesions (renal)Surgical and medical procedures | 1/89 | — |
| ED visit AnxietyGeneral disorders | 1/89 | — |
| ED Visit Cellulitis R handSkin and subcutaneous tissue disorders | 1/89 | — |
| Age, Continuous(years) | Pre-Implementation Cohort (N=90) | Pathway Participants (N=89) | Total |
|---|---|---|---|
| Median | 39 (28 to 57) | 35 (28 to 46) | 37 (37 to 51) |
| Sex: Female, Male(Participants) | Pre-Implementation Cohort (N=90) | Pathway Participants (N=89) | Total |
|---|---|---|---|
| Female | 52 | 71 | 123 |
| Male | 38 | 18 | 56 |
| Race/Ethnicity, Customized(Participants) | Pre-Implementation Cohort (N=90) | Pathway Participants (N=89) | Total |
|---|---|---|---|
| Race/Ethnicity , N (%) — White | 50 | 41 | 91 |
| Race/Ethnicity , N (%) — Hispanic / Latino | 16 | 16 | 32 |
| Race/Ethnicity , N (%) — Black | 14 | 29 | 43 |
| Race/Ethnicity , N (%) — Other | 10 | 3 | 13 |
| Type of Insurance(Participants) | Pre-Implementation Cohort (N=90) | Pathway Participants (N=89) | Total |
|---|---|---|---|
| Medicare | 14 | 6 | 20 |
| Commercial | 59 | 68 | 127 |
| Medicaid | 17 | 15 | 32 |
| Qualifying PHQ Score(units on a scale) | Pre-Implementation Cohort (N=90) | Pathway Participants (N=89) | Total |
|---|---|---|---|
| Median | 14 (11 to 17) | 15 (12 to 18) | 15 (10 to 18) |
| Medications at the qualifying visit(Participants) | Pre-Implementation Cohort (N=90) | Pathway Participants (N=89) | Total |
|---|---|---|---|
| Selective Serotonin Reuptake Inhibitors (SSRIs) | 69 | 67 | 136 |
| Serotonin-Norepinephrine Reuptake Inhibitors (SNRIs) | 7 | 3 | 10 |
| Alpha-2 Receptor Antagonists (Tetracyclics ) - Mirtazapine | 2 | 1 | 3 |
| Tricyclic Agents | 0 | 1 | 1 |
| Serotonin Modulators | 1 | 0 | 1 |
| Trintellix | 0 | 0 | 0 |
| Bupropion | 11 | 17 | 28 |
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Wake Forest University Health Sciences