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| Name | Class |
|---|---|
| Takeda | INDUSTRY |
| Lundbeck LLC | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pathway Platform application use | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pathway Platform mobile app | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to 6 months post-implementation of the Pathway app |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to 6 months post-implementation of the Pathway app |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Kemp, MD | Advocate Medical Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Advocate Christ Medical Center | Oak Lawn | Illinois | 60453 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11556941 | Background | 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. | |
| 30464471 | Background | 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. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Pre-Implementation Cohort | Retrospective control group identified from study sites. |
| FG001 | Pathway Participants | Consented and activated Pathway app. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Screening |
| |||||||||||||
| Enrollment |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pre-Implementation Cohort (N=90) | Retrospective control group identified from study sites. |
| BG001 | Pathway Participants (N=89) | Consented and activated Pathway app. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Number | participants | Baseline to 6 months post-implementation of the Pathway app |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pathway Platform Application Use | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Attempted Overdose hospitalization | Psychiatric disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Carpel tunnel surgery | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
Small sample size and high attrition rates in both cohorts.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ramona Donovan, Research Project Manager | Advocate Health Care | 847-723-5792 | ramona.donovan@aah.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 21, 2022 | Apr 30, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 9, 2022 | Apr 30, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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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.
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|
| 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 |
| Process Outcome: Referrals to Behavioral Health | The proportion of patients with at least one referral will be compared. | 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. | 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. | 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. | Baseline to 6 months post-implementation of the Pathway app |
| 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 | The number of emergency room admissions among patients receiving care at a clinic participating in this study. | 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. | 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. | 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. | 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. | Baseline to 6 months post-implementation of the Pathway app |
| 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. | 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. | 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. | 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. | 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. | 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. | throughout 6-month of Pathway app use |
| 24412323 | Background | 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. |
| 32250858 | Background | Chen X, Hu N, Wang Y, Gao X. Validation of a brain-computer interface version of the digit symbol substitution test in healthy subjects. Comput Biol Med. 2020 May;120:103729. doi: 10.1016/j.compbiomed.2020.103729. Epub 2020 Mar 25. |
| 20550019 | Background | Buysse DJ, Yu L, Moul DE, Germain A, Stover A, Dodds NE, Johnston KL, Shablesky-Cade MA, Pilkonis PA. Development and validation of patient-reported outcome measures for sleep disturbance and sleep-related impairments. Sleep. 2010 Jun;33(6):781-92. doi: 10.1093/sleep/33.6.781. |
| 10693114 | Background | McGahuey CA, Gelenberg AJ, Laukes CA, Moreno FA, Delgado PL, McKnight KM, Manber R. The Arizona Sexual Experience Scale (ASEX): reliability and validity. J Sex Marital Ther. 2000 Jan-Mar;26(1):25-40. doi: 10.1080/009262300278623. |
| 27085518 | Background | 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. |
| 16336556 | Background | 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. |
| 28678426 | Background | 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. |
| 11983645 | Background | 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. |
| 37351941 | Derived | Khatib R, McCue M, Blair C, Roy A, Franco J, Fehnert B, King J, Sarkey S, Chrones L, Martin M, Kabir C, Kemp DE. Design and Implementation of a Digitally Enabled Care Pathway to Improve Management of Depression in a Large Health Care System: Protocol for the Implementation of a Patient Care Platform. JMIR Res Protoc. 2023 Jun 23;12:e43788. doi: 10.2196/43788. |
| NOT COMPLETED |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Type of Insurance | Count of Participants | Participants |
|
| Qualifying PHQ Score | Scores from this nine item questionnaire can range from 0 - 27. Higher scores indicate greater severity of depression. | Median | Inter-Quartile Range | units on a scale |
|
| Medications at the qualifying visit | Count of Participants | Participants |
|
|
|
| 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. | Posted | Number | participants | Baseline to 6 months post-implementation of the Pathway app |
|
|
|
| Secondary | Process Outcome: Shared-decision Making | The proportion of patients reflecting shared-decision making using the OPTION12 Tool framework. | 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. | Posted | 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. | Posted | Number | participants | Baseline to 6 months post-implementation of the Pathway app |
|
|
|
| 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. | Posted | Count of Participants | Participants | 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. | Data for emergency department visits (ED) and ED visits related to behavioral health were analyzed for Pre-implementation cohort and Pathway participants. | Posted | Count of Participants | Participants | Baseline to 6 months post-implementation of the Pathway 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. | Data were analyzed for hospitalization and behavioral health related hospitalizations for both cohorts. | Posted | Number | participants | Baseline to 6 months post-implementation of the Pathway app |
|
|
|
| Secondary | Process Outcome: Number of Behavioral Related Hospitalizations | 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. | Posted | Count of Participants | Participants | 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. | Posted | Count of Participants | Participants | Baseline to 6 months post-implementation of the Pathway 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. | It was not feasible to accurately gather this information on patients in both cohorts because patients can seek care outside of our healthcare system. | Posted | Number | number of units | 6 months prior to and 6 months post-implementation of the Pathway Platform app. |
|
|
|
| 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. | 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. | Posted | 6 months prior to and 6 months post-implementation of the Pathway Platform app. |
|
|
| 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. | Posted | Median | Inter-Quartile Range | median PHQ-9 total score | Baseline to 6 months post-implementation of the Pathway app |
|
|
|
| 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. | Posted | Number | participants | Baseline to 6 months post-implementation of the Pathway app |
|
|
|
| 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. | Only 54 patients out of the 89 Pathway participants completed a baseline and 6-month Patient Activation Measure-13. | Posted | Median | Inter-Quartile Range | score on a scale | Baseline and 6-month post-Pathway app use |
|
|
|
| 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. | 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. | Posted | Baseline, 3 months and 6 months post-Pathway app use. |
|
|
| 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. | Posted | Mean | Inter-Quartile Range | score on a scale | Baseline and 6-month post-Pathway app use |
|
|
|
| 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. | Posted | Median | Inter-Quartile Range | score on a scale | 6 months prior to and 6 months post-implementation of the Pathway app |
|
|
|
| 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. | Pre-implementation cohort did not complete these assessments. | Posted | Median | Inter-Quartile Range | score on a scale | Baseline to 6-month post-Pathway app use |
|
|
|
| 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. | Pre-implementation cohort did not complete these assessments. | Posted | Median | Inter-Quartile Range | score on a scale | Baseline to 6-month post-Pathway app use |
|
|
|
| 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. | Pre-implementation cohort did not complete these assessments. | Posted | Number | participants | throughout 6-month of Pathway app use |
|
|
|
| 0 |
| 89 |
| 5 |
| 89 |
| 10 |
| 89 |
| EG001 | Pre-Implementation Cohort Retrospective Control Group Identified From Study Sites. | Retrospective control group identified from study sites. | 0 | 0 | 0 | 0 | 0 | 0 |
| Hospitalization for Cholecystectomy | Gastrointestinal disorders | Non-systematic Assessment |
|
| D & C procedure | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
|
| Mitral Valve repair | Cardiac disorders | Non-systematic Assessment |
|
| Dizziness | Ear and labyrinth disorders | Non-systematic Assessment |
|
| Scar Repair | Surgical and medical procedures | Non-systematic Assessment |
|
| L sided chest pain, ED visit | Investigations | Non-systematic Assessment |
|
| Abdominal pain/Ovarian cyst rupture | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Observational hospitalization for abnormal vaginal bleeding | Reproductive system and breast disorders | Non-systematic Assessment |
|
| L Breast Mass Excision | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Laparoscopic Lysis of Adhesions (renal) | Surgical and medical procedures | Non-systematic Assessment |
|
| ED visit Anxiety | General disorders | Non-systematic Assessment |
|
| ED Visit Cellulitis R hand | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
Not provided
Not provided
| Number of Outpatient Visits |
|
| 6-months |
|