Trial Outcomes & Findings for Use of a Digitally Enabled App With Clinical Team Interface in the Management of Depression (NCT NCT04891224)
NCT ID: NCT04891224
Last Updated: 2025-03-24
Results Overview
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.
COMPLETED
NA
89 participants
Baseline to 6 months post-implementation of the Pathway app
2025-03-24
Participant Flow
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.
Participant milestones
| Measure |
Pre-Implementation Cohort
Retrospective control group identified from study sites.
|
Pathway Participants
Consented and activated Pathway app.
|
|---|---|---|
|
Screening
STARTED
|
90
|
89
|
|
Screening
COMPLETED
|
90
|
89
|
|
Screening
NOT COMPLETED
|
0
|
0
|
|
Enrollment
STARTED
|
90
|
89
|
|
Enrollment
COMPLETED
|
90
|
89
|
|
Enrollment
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Use of a Digitally Enabled App With Clinical Team Interface in the Management of Depression
Baseline characteristics by cohort
| Measure |
Pre-Implementation Cohort (N=90)
n=90 Participants
Retrospective control group identified from study sites.
|
Pathway Participants (N=89)
n=89 Participants
Consented and activated Pathway app.
|
Total
n=179 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
39 years
n=5 Participants
|
35 years
n=7 Participants
|
37 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
52 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
123 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
38 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity , N (%) · White
|
50 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
91 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity , N (%) · Hispanic / Latino
|
16 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity , N (%) · Black
|
14 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity , N (%) · Other
|
10 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Type of Insurance
Medicare
|
14 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Type of Insurance
Commercial
|
59 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
127 Participants
n=5 Participants
|
|
Type of Insurance
Medicaid
|
17 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Qualifying PHQ Score
|
14 units on a scale
n=5 Participants
|
15 units on a scale
n=7 Participants
|
15 units on a scale
n=5 Participants
|
|
Medications at the qualifying visit
Selective Serotonin Reuptake Inhibitors (SSRIs)
|
69 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
136 Participants
n=5 Participants
|
|
Medications at the qualifying visit
Serotonin-Norepinephrine Reuptake Inhibitors (SNRIs)
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Medications at the qualifying visit
Alpha-2 Receptor Antagonists (Tetracyclics ) - Mirtazapine
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Medications at the qualifying visit
Tricyclic Agents
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Medications at the qualifying visit
Serotonin Modulators
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Medications at the qualifying visit
Trintellix
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Medications at the qualifying visit
Bupropion
|
11 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 6 months post-implementation of the Pathway appProportion 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.
Outcome measures
| Measure |
Pathway Participants (N=89)
n=89 Participants
Consented and activated Pathway app.
|
Pathway Participants (N=89)
n=90 Participants
Consented and activated Pathway app.
|
|---|---|---|
|
Proportion of Patients Who Completed Patient Health Questionnaire
|
49 participants
|
35 participants
|
SECONDARY outcome
Timeframe: Baseline to 6 months post-implementation of the Pathway appThe 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.
Outcome measures
| Measure |
Pathway Participants (N=89)
n=89 Participants
Consented and activated Pathway app.
|
Pathway Participants (N=89)
n=90 Participants
Consented and activated Pathway app.
|
|---|---|---|
|
Process Outcome: Measurement-based Care
|
40 participants
|
38 participants
|
SECONDARY outcome
Timeframe: 6 months prior to and 6 months post-implementation of the Pathway Platform appPopulation: 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.
The proportion of patients reflecting shared-decision making using the OPTION12 Tool framework.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to 6 months post-implementation of the Pathway appThe proportion of patients with at least one referral will be compared.
Outcome measures
| Measure |
Pathway Participants (N=89)
n=89 Participants
Consented and activated Pathway app.
|
Pathway Participants (N=89)
n=90 Participants
Consented and activated Pathway app.
|
|---|---|---|
|
Process Outcome: Referrals to Behavioral Health
|
8 participants
|
21 participants
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Pathway Participants (N=89)
n=89 Participants
Consented and activated Pathway app.
|
Pathway Participants (N=89)
n=90 Participants
Consented and activated Pathway app.
|
|---|---|---|
|
Process Outcome: Total Number of Hospitalized Participants During Follow up Period
|
23 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: Baseline to 6 months post-implementation of the Pathway appPopulation: Data for emergency department visits (ED) and ED visits related to behavioral health were analyzed for Pre-implementation cohort and Pathway participants.
The proportion of adults who receive follow-up within 7 days of discharge and within 30 days of emergency department visit.
Outcome measures
| Measure |
Pathway Participants (N=89)
n=89 Participants
Consented and activated Pathway app.
|
Pathway Participants (N=89)
n=90 Participants
Consented and activated Pathway app.
|
|---|---|---|
|
Process Outcome: Follow-up After Emergency Department Visit for Mental Illness
|
0 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Baseline to 6 months post-implementation of the Pathway appPopulation: Data were analyzed for hospitalization and behavioral health related hospitalizations for both cohorts.
The number of hospital admissions among patients receiving care at a clinic participating in this study.
Outcome measures
| Measure |
Pathway Participants (N=89)
n=89 Participants
Consented and activated Pathway app.
|
Pathway Participants (N=89)
n=90 Participants
Consented and activated Pathway app.
|
|---|---|---|
|
Process Outcome: Healthcare Resource Utilization, Hospital Admissions
Hospitalizations
|
23 participants
|
19 participants
|
|
Process Outcome: Healthcare Resource Utilization, Hospital Admissions
Behavioral health related hospitalization
|
0 participants
|
4 participants
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Pathway Participants (N=89)
n=89 Participants
Consented and activated Pathway app.
|
Pathway Participants (N=89)
n=90 Participants
Consented and activated Pathway app.
|
|---|---|---|
|
Process Outcome: Number of Behavioral Related Hospitalizations
|
0 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Baseline to 6 months post-implementation of the Pathway appThe number of emergency room admissions among patients receiving care at a clinic participating in this study.
Outcome measures
| Measure |
Pathway Participants (N=89)
n=89 Participants
Consented and activated Pathway app.
|
Pathway Participants (N=89)
n=90 Participants
Consented and activated Pathway app.
|
|---|---|---|
|
Process Outcome: Healthcare Resource Utilization, Emergency Room Admissions
|
5 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: 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.
The number of outpatient encounters among patients receiving care at a clinic participating in this study.
Outcome measures
| Measure |
Pathway Participants (N=89)
n=89 Participants
Consented and activated Pathway app.
|
Pathway Participants (N=89)
n=90 Participants
Consented and activated Pathway app.
|
|---|---|---|
|
Process Outcome: Healthcare Resource Utilization, Outpatient Visits
Number of Outpatient Visits
|
243 number of units
|
216 number of units
|
|
Process Outcome: Healthcare Resource Utilization, Outpatient Visits
Number of ED Visits
|
5 number of units
|
11 number of units
|
|
Process Outcome: Healthcare Resource Utilization, Outpatient Visits
Number of Behavioral Health-Related ED Visits
|
5 number of units
|
11 number of units
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to 6 months post-implementation of the Pathway appMedian 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.
Outcome measures
| Measure |
Pathway Participants (N=89)
n=89 Participants
Consented and activated Pathway app.
|
Pathway Participants (N=89)
n=90 Participants
Consented and activated Pathway app.
|
|---|---|---|
|
Patient Health Questionnaire-9 [PHQ-9] Score
PHQ-9 Median Score: Baseline
|
12 median PHQ-9 total score
Interval 9.0 to 17.0
|
14.5 median PHQ-9 total score
Interval 11.0 to 27.0
|
|
Patient Health Questionnaire-9 [PHQ-9] Score
3-months
|
8.5 median PHQ-9 total score
Interval 3.0 to 15.0
|
11.0 median PHQ-9 total score
Interval 8.5 to 12.5
|
|
Patient Health Questionnaire-9 [PHQ-9] Score
6-months
|
6.5 median PHQ-9 total score
Interval 3.0 to 12.5
|
17.0 median PHQ-9 total score
Interval 14.5 to 20.0
|
SECONDARY outcome
Timeframe: Baseline to 6 months post-implementation of the Pathway appNumber 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.
Outcome measures
| Measure |
Pathway Participants (N=89)
n=20 Participants
Consented and activated Pathway app.
|
Pathway Participants (N=89)
n=7 Participants
Consented and activated Pathway app.
|
|---|---|---|
|
Patient Health Questionnaire-9 [PHQ-9] Score Reduction
|
7 participants
|
2 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 6-month post-Pathway app usePopulation: Only 54 patients out of the 89 Pathway participants completed a baseline and 6-month Patient Activation Measure-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.
Outcome measures
| Measure |
Pathway Participants (N=89)
Consented and activated Pathway app.
|
Pathway Participants (N=89)
n=54 Participants
Consented and activated Pathway app.
|
|---|---|---|
|
Patient Reported Outcomes: Patient Activation Measure-13 [PAM-13]
|
—
|
4 score on a scale
Interval -5.0 to 13.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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.
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.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 6-month post-Pathway app useThis 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.
Outcome measures
| Measure |
Pathway Participants (N=89)
Consented and activated Pathway app.
|
Pathway Participants (N=89)
n=54 Participants
Consented and activated Pathway app.
|
|---|---|---|
|
Patient Reported Outcomes: Work and Social Adjustment Scale (WSAS)
|
—
|
-4 score on a scale
Interval -14.0 to 6.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 months prior to and 6 months post-implementation of the Pathway appThe 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.
Outcome measures
| Measure |
Pathway Participants (N=89)
n=14 Participants
Consented and activated Pathway app.
|
Pathway Participants (N=89)
n=7 Participants
Consented and activated Pathway app.
|
|---|---|---|
|
Exploratory - Patient Clinical and Reported Outcomes: Patient Health Questionnaire [PHQ-9]
|
4 score on a scale
Interval 2.5 to 4.5
|
2 score on a scale
Interval 1.0 to 3.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to 6-month post-Pathway app usePopulation: Pre-implementation cohort did not complete these assessments.
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.
Outcome measures
| Measure |
Pathway Participants (N=89)
Consented and activated Pathway app.
|
Pathway Participants (N=89)
n=89 Participants
Consented and activated Pathway app.
|
|---|---|---|
|
Exploratory - Patient Clinical and Reported Outcomes: World Health Organization- Five Well Being Index [WHO-5]
|
—
|
3 score on a scale
Interval -1.0 to 7.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to 6-month post-Pathway app usePopulation: Pre-implementation cohort did not complete these assessments.
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.
Outcome measures
| Measure |
Pathway Participants (N=89)
Consented and activated Pathway app.
|
Pathway Participants (N=89)
n=89 Participants
Consented and activated Pathway app.
|
|---|---|---|
|
Exploratory - Patient Clinical and Reported Outcomes: Perceived Deficits Questionnaire-Depression [PDQ-D5]
|
—
|
4 score on a scale
Interval 0.0 to 8.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: throughout 6-month of Pathway app usePopulation: Pre-implementation cohort did not complete these assessments.
This Patient Clinical and reported outcome summarizes patient self-reported adherence to antidepressant medication plan as prescribed will be described.
Outcome measures
| Measure |
Pathway Participants (N=89)
Consented and activated Pathway app.
|
Pathway Participants (N=89)
n=89 Participants
Consented and activated Pathway app.
|
|---|---|---|
|
Exploratory - Patient Clinical and Reported Outcomes: Patient Reported Therapeutic Response to Antidepressant Medication Plan.
|
—
|
87 participants
|
Adverse Events
Pathway Platform Application Use
Pre-Implementation Cohort Retrospective Control Group Identified From Study Sites.
Serious adverse events
| Measure |
Pathway Platform Application Use
n=89 participants at risk
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.
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.
|
Pre-Implementation Cohort Retrospective Control Group Identified From Study Sites.
Retrospective control group identified from study sites.
|
|---|---|---|
|
Psychiatric disorders
Attempted Overdose hospitalization
|
1.1%
1/89 • Baseline through week 75
Only data collected prospectively on Pathway cohort is reported here. All spontaneously reported SAEs collected. Causality to study procedures for all SAEs = related/not related to the intervention. AE/SAE/mortality data not collected for retrospective Pre-Implementation Cohort, so it cannot be reported.
|
—
0/0 • Baseline through week 75
Only data collected prospectively on Pathway cohort is reported here. All spontaneously reported SAEs collected. Causality to study procedures for all SAEs = related/not related to the intervention. AE/SAE/mortality data not collected for retrospective Pre-Implementation Cohort, so it cannot be reported.
|
|
Gastrointestinal disorders
Hospitalization for Cholecystectomy
|
1.1%
1/89 • Baseline through week 75
Only data collected prospectively on Pathway cohort is reported here. All spontaneously reported SAEs collected. Causality to study procedures for all SAEs = related/not related to the intervention. AE/SAE/mortality data not collected for retrospective Pre-Implementation Cohort, so it cannot be reported.
|
—
0/0 • Baseline through week 75
Only data collected prospectively on Pathway cohort is reported here. All spontaneously reported SAEs collected. Causality to study procedures for all SAEs = related/not related to the intervention. AE/SAE/mortality data not collected for retrospective Pre-Implementation Cohort, so it cannot be reported.
|
|
Pregnancy, puerperium and perinatal conditions
D & C procedure
|
1.1%
1/89 • Baseline through week 75
Only data collected prospectively on Pathway cohort is reported here. All spontaneously reported SAEs collected. Causality to study procedures for all SAEs = related/not related to the intervention. AE/SAE/mortality data not collected for retrospective Pre-Implementation Cohort, so it cannot be reported.
|
—
0/0 • Baseline through week 75
Only data collected prospectively on Pathway cohort is reported here. All spontaneously reported SAEs collected. Causality to study procedures for all SAEs = related/not related to the intervention. AE/SAE/mortality data not collected for retrospective Pre-Implementation Cohort, so it cannot be reported.
|
|
Cardiac disorders
Mitral Valve repair
|
1.1%
1/89 • Baseline through week 75
Only data collected prospectively on Pathway cohort is reported here. All spontaneously reported SAEs collected. Causality to study procedures for all SAEs = related/not related to the intervention. AE/SAE/mortality data not collected for retrospective Pre-Implementation Cohort, so it cannot be reported.
|
—
0/0 • Baseline through week 75
Only data collected prospectively on Pathway cohort is reported here. All spontaneously reported SAEs collected. Causality to study procedures for all SAEs = related/not related to the intervention. AE/SAE/mortality data not collected for retrospective Pre-Implementation Cohort, so it cannot be reported.
|
|
Ear and labyrinth disorders
Dizziness
|
1.1%
1/89 • Baseline through week 75
Only data collected prospectively on Pathway cohort is reported here. All spontaneously reported SAEs collected. Causality to study procedures for all SAEs = related/not related to the intervention. AE/SAE/mortality data not collected for retrospective Pre-Implementation Cohort, so it cannot be reported.
|
—
0/0 • Baseline through week 75
Only data collected prospectively on Pathway cohort is reported here. All spontaneously reported SAEs collected. Causality to study procedures for all SAEs = related/not related to the intervention. AE/SAE/mortality data not collected for retrospective Pre-Implementation Cohort, so it cannot be reported.
|
Other adverse events
| Measure |
Pathway Platform Application Use
n=89 participants at risk
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.
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.
|
Pre-Implementation Cohort Retrospective Control Group Identified From Study Sites.
Retrospective control group identified from study sites.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Carpel tunnel surgery
|
2.2%
2/89 • Baseline through week 75
Only data collected prospectively on Pathway cohort is reported here. All spontaneously reported SAEs collected. Causality to study procedures for all SAEs = related/not related to the intervention. AE/SAE/mortality data not collected for retrospective Pre-Implementation Cohort, so it cannot be reported.
|
—
0/0 • Baseline through week 75
Only data collected prospectively on Pathway cohort is reported here. All spontaneously reported SAEs collected. Causality to study procedures for all SAEs = related/not related to the intervention. AE/SAE/mortality data not collected for retrospective Pre-Implementation Cohort, so it cannot be reported.
|
|
Surgical and medical procedures
Scar Repair
|
1.1%
1/89 • Baseline through week 75
Only data collected prospectively on Pathway cohort is reported here. All spontaneously reported SAEs collected. Causality to study procedures for all SAEs = related/not related to the intervention. AE/SAE/mortality data not collected for retrospective Pre-Implementation Cohort, so it cannot be reported.
|
—
0/0 • Baseline through week 75
Only data collected prospectively on Pathway cohort is reported here. All spontaneously reported SAEs collected. Causality to study procedures for all SAEs = related/not related to the intervention. AE/SAE/mortality data not collected for retrospective Pre-Implementation Cohort, so it cannot be reported.
|
|
Investigations
L sided chest pain, ED visit
|
1.1%
1/89 • Baseline through week 75
Only data collected prospectively on Pathway cohort is reported here. All spontaneously reported SAEs collected. Causality to study procedures for all SAEs = related/not related to the intervention. AE/SAE/mortality data not collected for retrospective Pre-Implementation Cohort, so it cannot be reported.
|
—
0/0 • Baseline through week 75
Only data collected prospectively on Pathway cohort is reported here. All spontaneously reported SAEs collected. Causality to study procedures for all SAEs = related/not related to the intervention. AE/SAE/mortality data not collected for retrospective Pre-Implementation Cohort, so it cannot be reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Abdominal pain/Ovarian cyst rupture
|
1.1%
1/89 • Baseline through week 75
Only data collected prospectively on Pathway cohort is reported here. All spontaneously reported SAEs collected. Causality to study procedures for all SAEs = related/not related to the intervention. AE/SAE/mortality data not collected for retrospective Pre-Implementation Cohort, so it cannot be reported.
|
—
0/0 • Baseline through week 75
Only data collected prospectively on Pathway cohort is reported here. All spontaneously reported SAEs collected. Causality to study procedures for all SAEs = related/not related to the intervention. AE/SAE/mortality data not collected for retrospective Pre-Implementation Cohort, so it cannot be reported.
|
|
Reproductive system and breast disorders
Observational hospitalization for abnormal vaginal bleeding
|
1.1%
1/89 • Baseline through week 75
Only data collected prospectively on Pathway cohort is reported here. All spontaneously reported SAEs collected. Causality to study procedures for all SAEs = related/not related to the intervention. AE/SAE/mortality data not collected for retrospective Pre-Implementation Cohort, so it cannot be reported.
|
—
0/0 • Baseline through week 75
Only data collected prospectively on Pathway cohort is reported here. All spontaneously reported SAEs collected. Causality to study procedures for all SAEs = related/not related to the intervention. AE/SAE/mortality data not collected for retrospective Pre-Implementation Cohort, so it cannot be reported.
|
|
Reproductive system and breast disorders
L Breast Mass Excision
|
1.1%
1/89 • Baseline through week 75
Only data collected prospectively on Pathway cohort is reported here. All spontaneously reported SAEs collected. Causality to study procedures for all SAEs = related/not related to the intervention. AE/SAE/mortality data not collected for retrospective Pre-Implementation Cohort, so it cannot be reported.
|
—
0/0 • Baseline through week 75
Only data collected prospectively on Pathway cohort is reported here. All spontaneously reported SAEs collected. Causality to study procedures for all SAEs = related/not related to the intervention. AE/SAE/mortality data not collected for retrospective Pre-Implementation Cohort, so it cannot be reported.
|
|
Surgical and medical procedures
Laparoscopic Lysis of Adhesions (renal)
|
1.1%
1/89 • Baseline through week 75
Only data collected prospectively on Pathway cohort is reported here. All spontaneously reported SAEs collected. Causality to study procedures for all SAEs = related/not related to the intervention. AE/SAE/mortality data not collected for retrospective Pre-Implementation Cohort, so it cannot be reported.
|
—
0/0 • Baseline through week 75
Only data collected prospectively on Pathway cohort is reported here. All spontaneously reported SAEs collected. Causality to study procedures for all SAEs = related/not related to the intervention. AE/SAE/mortality data not collected for retrospective Pre-Implementation Cohort, so it cannot be reported.
|
|
General disorders
ED visit Anxiety
|
1.1%
1/89 • Baseline through week 75
Only data collected prospectively on Pathway cohort is reported here. All spontaneously reported SAEs collected. Causality to study procedures for all SAEs = related/not related to the intervention. AE/SAE/mortality data not collected for retrospective Pre-Implementation Cohort, so it cannot be reported.
|
—
0/0 • Baseline through week 75
Only data collected prospectively on Pathway cohort is reported here. All spontaneously reported SAEs collected. Causality to study procedures for all SAEs = related/not related to the intervention. AE/SAE/mortality data not collected for retrospective Pre-Implementation Cohort, so it cannot be reported.
|
|
Skin and subcutaneous tissue disorders
ED Visit Cellulitis R hand
|
1.1%
1/89 • Baseline through week 75
Only data collected prospectively on Pathway cohort is reported here. All spontaneously reported SAEs collected. Causality to study procedures for all SAEs = related/not related to the intervention. AE/SAE/mortality data not collected for retrospective Pre-Implementation Cohort, so it cannot be reported.
|
—
0/0 • Baseline through week 75
Only data collected prospectively on Pathway cohort is reported here. All spontaneously reported SAEs collected. Causality to study procedures for all SAEs = related/not related to the intervention. AE/SAE/mortality data not collected for retrospective Pre-Implementation Cohort, so it cannot be reported.
|
Additional Information
Ramona Donovan, Research Project Manager
Advocate Health Care
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place