Major Depressive Disorder
Conditions
Keywords
PHQ-9, Shared decision making
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.
Interventions
OTHERPathway 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.
Sponsors
Takeda
Lundbeck LLC
Wake Forest University Health Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Patients Who Completed Patient Health Questionnaire | 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
| Measure | Time frame | Description |
|---|---|---|
| Process Outcome: Total Number of Hospitalized Participants During Follow up Period | 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. |
| Process Outcome: Healthcare Resource Utilization, Hospital Admissions | 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. |
| 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 | 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. |
| Process Outcome: Healthcare Resource Utilization, Outpatient Visits | 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. |
| Process Outcome: Primary Care Physician (PCP) Visits | 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. |
| Patient Health Questionnaire-9 [PHQ-9] Score | 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. |
| Patient Health Questionnaire-9 [PHQ-9] Score Reduction | 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. |
| Process Outcome: Measurement-based Care | 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. |
| Process Outcome: Shared-decision Making | 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. |
| Process Outcome: Referrals to Behavioral Health | Baseline to 6 months post-implementation of the Pathway app | The proportion of patients with at least one referral will be compared. |
| Process Outcome: Follow-up After Emergency Department Visit for Mental Illness | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Patient Reported Outcomes: Work and Social Adjustment Scale (WSAS) | 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. |
| Exploratory - Patient Clinical and Reported Outcomes: Patient Health Questionnaire [PHQ-9] | 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. |
| Exploratory - Patient Clinical and Reported Outcomes: World Health Organization- Five Well Being Index [WHO-5] | 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. |
| Exploratory - Patient Clinical and Reported Outcomes: Perceived Deficits Questionnaire-Depression [PDQ-D5] | 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. |
| Exploratory - Patient Clinical and Reported Outcomes: Patient Reported Therapeutic Response to Antidepressant Medication Plan. | 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. |
| Patient Reported Outcomes: CollaboRATE | 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. |
| Patient Reported Outcomes: Patient Activation Measure-13 [PAM-13] | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Pre-Implementation Cohort (N=90) Retrospective control group identified from study sites. | 90 |
| Pathway Participants (N=89) Consented and activated Pathway app. | 89 |
| Total | 179 |
Baseline characteristics
| Characteristic | Pre-Implementation Cohort (N=90) | Total | Pathway Participants (N=89) |
|---|---|---|---|
| Age, Continuous | 39 years | 37 years | 35 years |
| Medications at the qualifying visit Alpha-2 Receptor Antagonists (Tetracyclics ) - Mirtazapine | 2 Participants | 3 Participants | 1 Participants |
| Medications at the qualifying visit Bupropion | 11 Participants | 28 Participants | 17 Participants |
| Medications at the qualifying visit Selective Serotonin Reuptake Inhibitors (SSRIs) | 69 Participants | 136 Participants | 67 Participants |
| Medications at the qualifying visit Serotonin Modulators | 1 Participants | 1 Participants | 0 Participants |
| Medications at the qualifying visit Serotonin-Norepinephrine Reuptake Inhibitors (SNRIs) | 7 Participants | 10 Participants | 3 Participants |
| Medications at the qualifying visit Tricyclic Agents | 0 Participants | 1 Participants | 1 Participants |
| Medications at the qualifying visit Trintellix | 0 Participants | 0 Participants | 0 Participants |
| Qualifying PHQ Score | 14 units on a scale | 15 units on a scale | 15 units on a scale |
| Race/Ethnicity, Customized Race/Ethnicity , N (%) Black | 14 Participants | 43 Participants | 29 Participants |
| Race/Ethnicity, Customized Race/Ethnicity , N (%) Hispanic / Latino | 16 Participants | 32 Participants | 16 Participants |
| Race/Ethnicity, Customized Race/Ethnicity , N (%) Other | 10 Participants | 13 Participants | 3 Participants |
| Race/Ethnicity, Customized Race/Ethnicity , N (%) White | 50 Participants | 91 Participants | 41 Participants |
| Sex: Female, Male Female | 52 Participants | 123 Participants | 71 Participants |
| Sex: Female, Male Male | 38 Participants | 56 Participants | 18 Participants |
| Type of Insurance Commercial | 59 Participants | 127 Participants | 68 Participants |
| Type of Insurance Medicaid | 17 Participants | 32 Participants | 15 Participants |
| Type of Insurance Medicare | 14 Participants | 20 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 89 | 0 / 0 |
| other Total, other adverse events | 10 / 89 | 0 / 0 |
| serious Total, serious adverse events | 5 / 89 | 0 / 0 |
Outcome results
Primary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pre-Implementation Cohort | Proportion of Patients Who Completed Patient Health Questionnaire | 35 participants |
| Pathway Participants | Proportion of Patients Who Completed Patient Health Questionnaire | 49 participants |
Secondary
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
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Pre-Implementation Cohort | Patient Health Questionnaire-9 [PHQ-9] Score | PHQ-9 Median Score: Baseline | 14.5 median PHQ-9 total score |
| Pre-Implementation Cohort | Patient Health Questionnaire-9 [PHQ-9] Score | 3-months | 11.0 median PHQ-9 total score |
| Pre-Implementation Cohort | Patient Health Questionnaire-9 [PHQ-9] Score | 6-months | 17.0 median PHQ-9 total score |
| Pathway Participants | Patient Health Questionnaire-9 [PHQ-9] Score | PHQ-9 Median Score: Baseline | 12 median PHQ-9 total score |
| Pathway Participants | Patient Health Questionnaire-9 [PHQ-9] Score | 3-months | 8.5 median PHQ-9 total score |
| Pathway Participants | Patient Health Questionnaire-9 [PHQ-9] Score | 6-months | 6.5 median PHQ-9 total score |
Secondary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pre-Implementation Cohort | Patient Health Questionnaire-9 [PHQ-9] Score Reduction | 2 participants |
| Pathway Participants | Patient Health Questionnaire-9 [PHQ-9] Score Reduction | 7 participants |
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.
Time frame: Baseline to 6 months post-implementation of the Pathway app
Population: Data for emergency department visits (ED) and ED visits related to behavioral health were analyzed for Pre-implementation cohort and Pathway participants.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pre-Implementation Cohort | Process Outcome: Follow-up After Emergency Department Visit for Mental Illness | 3 Participants |
| Pathway Participants | Process Outcome: Follow-up After Emergency Department Visit for Mental Illness | 0 Participants |
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.
Time frame: Baseline to 6 months post-implementation of the Pathway app
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pre-Implementation Cohort | Process Outcome: Healthcare Resource Utilization, Emergency Room Admissions | 11 Participants |
| Pathway Participants | Process Outcome: Healthcare Resource Utilization, Emergency Room Admissions | 5 Participants |
Secondary
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
Population: Data were analyzed for hospitalization and behavioral health related hospitalizations for both cohorts.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pre-Implementation Cohort | Process Outcome: Healthcare Resource Utilization, Hospital Admissions | Hospitalizations | 19 participants |
| Pre-Implementation Cohort | Process Outcome: Healthcare Resource Utilization, Hospital Admissions | Behavioral health related hospitalization | 4 participants |
| Pathway Participants | Process Outcome: Healthcare Resource Utilization, Hospital Admissions | Hospitalizations | 23 participants |
| Pathway Participants | Process Outcome: Healthcare Resource Utilization, Hospital Admissions | Behavioral health related hospitalization | 0 participants |
Secondary
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.
Population: It was not feasible to accurately gather this information on patients in both cohorts because patients can seek care outside of our healthcare system.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pre-Implementation Cohort | Process Outcome: Healthcare Resource Utilization, Outpatient Visits | Number of ED Visits | 11 number of units |
| Pre-Implementation Cohort | Process Outcome: Healthcare Resource Utilization, Outpatient Visits | Number of Behavioral Health-Related ED Visits | 11 number of units |
| Pre-Implementation Cohort | Process Outcome: Healthcare Resource Utilization, Outpatient Visits | Number of Outpatient Visits | 216 number of units |
| Pathway Participants | Process Outcome: Healthcare Resource Utilization, Outpatient Visits | Number of Behavioral Health-Related ED Visits | 5 number of units |
| Pathway Participants | Process Outcome: Healthcare Resource Utilization, Outpatient Visits | Number of Outpatient Visits | 243 number of units |
| Pathway Participants | Process Outcome: Healthcare Resource Utilization, Outpatient Visits | Number of ED Visits | 5 number of units |
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.
Time frame: Baseline to 6 months post-implementation of the Pathway app
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pre-Implementation Cohort | Process Outcome: Measurement-based Care | 38 participants |
| Pathway Participants | Process Outcome: Measurement-based Care | 40 participants |
Secondary
Process Outcome: Number of Behavioral Related Hospitalizations
Time frame: 6 months prior to and 6 months post-implementation of the Pathway Platform app.
Population: The data on length of stay for hospitalizations among patients receiving care at a clinic participating in this study was not analyzed because the analytics team was unable to accurately determine and report length of stay (los) for patients in both cohorts. Dates of service were not extracted, unable to provide LOS or time to follow up with primary care physician.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pre-Implementation Cohort | Process Outcome: Number of Behavioral Related Hospitalizations | 4 Participants |
| Pathway Participants | Process Outcome: Number of Behavioral Related Hospitalizations | 0 Participants |
Secondary
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.
Population: The costs associated with health care services among patients receiving care at a clinic participating in this study was not collected because the study team was not able to obtain financial data. We did not have resources to determine this information or analyze the data as study timeline did not allow. Data will not ever be collected for this outcome.
Secondary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pre-Implementation Cohort | Process Outcome: Referrals to Behavioral Health | 21 participants |
| Pathway Participants | Process Outcome: Referrals to Behavioral Health | 8 participants |
Secondary
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
Population: Option 12 tool was not utilized in the study because it would have required observation of patient/provider interaction and scoring of the tool by a 3rd party which took place during the pilot study, however was not feasible for this project. Use of this tool required additional research staff to observe in the clinic which we did not have adequate budget to support.
Secondary
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pre-Implementation Cohort | Process Outcome: Total Number of Hospitalized Participants During Follow up Period | 19 Participants |
| Pathway Participants | Process Outcome: Total Number of Hospitalized Participants During Follow up Period | 23 Participants |
Other Pre-specified
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pre-Implementation Cohort | Exploratory - Patient Clinical and Reported Outcomes: Patient Health Questionnaire [PHQ-9] | 2 score on a scale |
| Pathway Participants | Exploratory - Patient Clinical and Reported Outcomes: Patient Health Questionnaire [PHQ-9] | 4 score on a scale |
Other Pre-specified
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
Population: Pre-implementation cohort did not complete these assessments.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pre-Implementation Cohort | Exploratory - Patient Clinical and Reported Outcomes: Patient Reported Therapeutic Response to Antidepressant Medication Plan. | 87 participants |
Other Pre-specified
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
Population: Pre-implementation cohort did not complete these assessments.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pre-Implementation Cohort | Exploratory - Patient Clinical and Reported Outcomes: Perceived Deficits Questionnaire-Depression [PDQ-D5] | 4 score on a scale |
Other Pre-specified
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
Population: Pre-implementation cohort did not complete these assessments.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pre-Implementation Cohort | Exploratory - Patient Clinical and Reported Outcomes: World Health Organization- Five Well Being Index [WHO-5] | 3 score on a scale |
Other Pre-specified
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.
Population: This tool is intended to be calculated when 3 items have been completed for at least 25 clinical encounters for one particular clinician None of the participants completed this tool at all 3 time-points making the tool invaluable. This outcome only applies to pathway arm.
Other Pre-specified
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
Population: Only 54 patients out of the 89 Pathway participants completed a baseline and 6-month Patient Activation Measure-13.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pre-Implementation Cohort | Patient Reported Outcomes: Patient Activation Measure-13 [PAM-13] | 4 score on a scale |
Other Pre-specified
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Pre-Implementation Cohort | Patient Reported Outcomes: Work and Social Adjustment Scale (WSAS) | -4 score on a scale |