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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
Sponsor:
Collaborators:
University of Toronto
Ottawa Hospital Research Institute
QoC Health Inc.
Information provided by (Responsible Party):
Carolyn Steele Gray, Mount Sinai Hospital, Canada

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Other Names:
  • Electronic Patient Reported Outcome Mobile Application
  • ePRO




Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.


  5. 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


  6. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. a FHT patient at one of the FHT sites selected and is 60 years or older;
  2. physical capability to use a tablet and/or a caregiver who can use the tablet on their behalf;
  3. ability to read and write in English and/or the availability of a caregiver who can do so on their behalf;
  4. has complex care needs defined as two or more chronic conditions and 10 or more visits to their primary health care provider within the last 12 months; and
  5. be thinking about or ready to make changes to support their self-management.

In addition patients can self-identify and join the study, as well as providers can identify other patients they feel fit our eligibility criteria that may not have been pulled from the EMR system. This allows eligible patients to enroll into the study that may have been missed when identifying patients through the EMR system.

Exclusion Criteria:

1. Absence of Inclusion Criteria


Information from the National Library of Medicine

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


Locations
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Canada, Ontario
Dr. Carolyn Steele Gray
Toronto, Ontario, Canada, M4M 2B5
Sponsors and Collaborators
Mount Sinai Hospital, Canada
University of Toronto
Ottawa Hospital Research Institute
QoC Health Inc.
Investigators
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Principal Investigator: Carolyn Steele Gray, PhD MOUNT SINAI HOSPITAL
Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Carolyn Steele Gray, Post-doctoral Fellow, Scientific Lead, Mount Sinai Hospital, Canada
ClinicalTrials.gov Identifier: NCT02917954    
Other Study ID Numbers: ePRO2016
First Posted: September 28, 2016    Key Record Dates
Last Update Posted: March 22, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The reported data (which includes patient information at the aggregate level) will be disseminated widely via reports, conference presentations, peer reviewed journal articles and other standard modes of knowledge translation.
Supporting Materials: Clinical Study Report (CSR)
Time Frame: Data will be available through open access journal publications anticipated in the year 2020
Access Criteria: Open access peer reviewed journal publication
URL: http://eproapp.weebly.com/

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Carolyn Steele Gray, Mount Sinai Hospital, Canada:
eHealth/mHealth solutions
complex care needs
seniors
patient-centred care
goal-oriented care
primary health care
implementation
pragmatic trial
health outcomes
cost-effectiveness analysis
Additional relevant MeSH terms:
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Chronic Disease
Disease Attributes
Pathologic Processes