Electronic Patient Reported Outcome (ePRO) Mobile Application Pragmatic Trial
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02917954|
Recruitment Status : Completed
First Posted : September 28, 2016
Last Update Posted : March 22, 2021
Canadian and international health care systems require solutions on how to address the needs of a relatively small population that take up a large portion of health care resources. In Ontario, 10% of the population accounts for 79% of total system costs, with similar trends found in other parts of Canada and internationally. Most high-cost users are seniors, older adults, with multiple chronic conditions and complex care needs who are living in the community. Beyond the cost issues, older adults experiencing multi-morbidity are at higher-risk of poor health outcomes and experience lower quality of life as compared to individuals experiencing single illness only.
Since April 2013 the electronic Patient Reported Outcomes (ePRO) mobile application and portal, has undergone a multi-phased, user-centred design evaluation approach to develop a tool designed to meet the needs of older adults with complex care needs and their primary care providers. The ePRO tool is designed to collect person-centred, person-reported indicators to improve care by supporting primary care delivery and enhancing patient self-management.
The ePRO tool includes two features: 1) My Goal Tracker and 2) Health Journal. My Goal Tracker allows patients and providers to collaboratively create goal-oriented patient care-plans, and helps patients to track outcomes related to their goals using a mobile device. The Health Journal allows patients, their caregivers and primary care providers to monitor patients' symptoms and outcomes. The ePRO tool was re-evaluated and modified following each previous study phase (I-IV). This project marks the final phase of the study in which the investigators will conduct a pragmatic trial of the ePRO tool in 8-16 Family Health Teams in Ontario through a stepped-wedge randomized trial with an embedded case study. In this evaluation of the tool the investigators will assess outcome, process and context measures to identify how the tool affects patients, providers and the system at point-of-care.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Disease Quality of Life||Device: ePRO Tool Intervention||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||45 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Stepped-wedge randomized trial. Group 1: 3 month control period followed by a 12 month intervention period. Group 2: 6 month control period followed by a 9 month intervention period.|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Full Evaluation, Scale and Spread: Pragmatic Trial of the HSPRN-Bridgepoint Electronic Patient Reported Outcome (ePRO) Mobile Application to Support the Needs of Persons With Complex Chronic Disease and Disability|
|Actual Study Start Date :||May 4, 2017|
|Actual Primary Completion Date :||August 19, 2019|
|Actual Study Completion Date :||August 19, 2019|
No Intervention: ePRO Control (3 or 6 months)
Control participants will complete surveys at baseline, 3 months, and/or 6 months. Surveys will capture patient demographics, their assessment of quality-of-life, chronic disease management, and primary care experience. A part from completing these surveys, no change to routine care will be seen.
Experimental: ePRO intervention (12 or 9 months)
During the ePRO Tool intervention participants will complete surveys at every 3 months intervals starting month at 4 or month 7, for study duration. Surveys capture patient demographics, assessment of quality-of-life, chronic disease management, primary care experience, and Electronic Patient Reported Outcome (ePRO) Mobile Application tool usability.
Participants will also meet with their provider to setup and monitor a health goal to track during the study via the ePRO application. During the study, participants will meet with their primary care providers 4-5 times to discuss their health goal monitoring. Post-study participants will discuss their experience using the ePRO app in an interview or focus group setting.
Device: ePRO Tool Intervention
The ePRO tool includes two features: 1) My Goal Tracker and 2) Health Journal. My Goal Tracker allows patients and providers to collaboratively create goal-oriented patient care-plans, and helps patients to track outcomes related to their goals using a mobile device. The Health Journal allows patients, their caregivers and primary care providers to monitor patients' symptoms and outcomes.
- Change from baseline Assessment of Quality-of-Life at 3 month intervals for 15 months [ Time Frame: Baseline, 3 months, 6 months, 9 months, 12 months, and study end (15-months) ]
Our primary measure of patient oriented outcome is quality of life measured by the Assessment for Quality of Life Scale.
12 Item survey, with each item having 4 response levels.
- ePRO cost-effectiveness - health system perspective [ Time Frame: 15-months ]Only costs that are borne to the government, such as costs of intervention and costs of health services incurred during the 1-year follow-up period will be considered. Costs of the intervention will be estimated based on anticipated real-world licensing and ongoing costs for: software access, hosting and data management, program support and device management, application support, training, incremental data plan(s) (depending on volume of use in the intervention group), and for the Cloud Connect platform.
- Patient Demographic and Characteristic information [ Time Frame: Baseline ]We will capture patient demographic and characteristic information such as age, gender, ethnicity, chronic illness profile, socio-economic status, and IT skills using the Patient Demographic forms.
- Provider Demographic and Characteristic Information [ Time Frame: Baseline ]We will capture provider demographic and characteristic information such as age, gender, ethnicity, chronic illness profile, socio-economic status, and IT skills using the Provider Demographic forms.
- Change from baseline Patient/Caregiver Self-Reported Costs at 3 month intervals for study duration (15 months) [ Time Frame: Baseline, 3 months, 6 months, 9 months, 12 months, and study-end (15-months) ]
Patient/Caregiver Self-Reported Costs form will provide contextual information about our users to support data analysis.
Responses will be captured using a 6-point Likert scale.
- Change from baseline Patient Experience at 3 month intervals for study duration (15 months) [ Time Frame: Baseline, 3 months, 6 months, 9 months,12 months, and study-end (15-months) ]
Patient Experience will be captured from the patient-experience survey distributed by the Family Health Teams of Ontario Association (AFHTO) to all Family Health Teams.
3 Item survey, with responses captured on a 5-point Likert scale
- Change from baseline Patient Activation Measure at 3 month intervals for study duration (15 months) [ Time Frame: Baseline, 3 months, 6 months, 9 months, 12 months, and study-end (15-months) ]Patient Self-Management will be captured by the 13-Item Patient Activation Measure. Each item will have a 5-point Likert scale response level.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02917954
|Dr. Carolyn Steele Gray|
|Toronto, Ontario, Canada, M4M 2B5|
|Principal Investigator:||Carolyn Steele Gray, PhD||MOUNT SINAI HOSPITAL|