Electronic Patient Reported Outcome (ePRO) Mobile Application Pragmatic Trial

NCT02917954 | Completed

• 1 other identifier: ePRO2016
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Disease; Quality of Life

Keywords

eHealth/mHealth solutions; complex care needs; seniors; patient-centred care; goal-oriented care; primary health care; implementation; pragmatic trial; health outcomes; cost-effectiveness analysis

Outcome Measures

Primary Outcomes (1)

• Change from baseline Assessment of Quality-of-Life at 3 month intervals for 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.

  Baseline, 3 months, 6 months, 9 months, 12 months, and study end (15-months)

Secondary Outcomes (6)

• ePRO cost-effectiveness - health system perspective

  15-months

• Patient Demographic and Characteristic information

  Baseline

• Provider Demographic and Characteristic Information

  Baseline

• Change from baseline Patient/Caregiver Self-Reported Costs at 3 month intervals for study duration (15 months)

  Baseline, 3 months, 6 months, 9 months, 12 months, and study-end (15-months)

• Change from baseline Patient Experience at 3 month intervals for study duration (15 months)

  Baseline, 3 months, 6 months, 9 months,12 months, and study-end (15-months)

Study Arms (2)

ePRO Control (3 or 6 months)

NO INTERVENTION

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.

ePRO intervention (12 or 9 months)

EXPERIMENTAL

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

Interventions

ePRO Tool Intervention DEVICE

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.

Also known as: Electronic Patient Reported Outcome Mobile Application, ePRO

ePRO intervention (12 or 9 months)

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• a FHT patient at one of the FHT sites selected and is 60 years or older;
• physical capability to use a tablet and/or a caregiver who can use the tablet on their behalf;
• ability to read and write in English and/or the availability of a caregiver who can do so on their behalf;
• 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
• 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.

Sponsors & Collaborators

• Mount Sinai Hospital, Canada: lead
• University of Toronto: collaborator
• Ottawa Hospital Research Institute: collaborator
• QoC Health Inc.: collaborator

Study Sites (1)

Dr. Carolyn Steele Gray

Toronto, Ontario, M4M 2B5, Canada

Location

Related Publications (13)

• Commission on the Reform of Ontario's Public Services, Public Services for Ontarians: A Path to Sustainability and Excellence. 2012.

  BACKGROUND

• Reid R, Evans R, Barer M, Sheps S, Kerluke K, McGrail K, Hertzman C, Pagliccia N. Conspicuous consumption: characterizing high users of physician services in one Canadian province. J Health Serv Res Policy. 2003 Oct;8(4):215-24. doi: 10.1258/135581903322403281.

  PMID: 14596756 BACKGROUND

• Heslop L, Athan D, Gardner B, Diers D, Poh BC. An analysis of high-cost users at an Australian public health service organization. Health Serv Manage Res. 2005 Nov;18(4):232-43. doi: 10.1258/095148405774518633.

  PMID: 16259671 BACKGROUND

• Department of Health, Long Term Conditions Compedium of Information, Third Edition, D.o. Health, Editor. 2012: United Kingdom.

  BACKGROUND

• Emanuel EJ. Where are the health care cost savings? JAMA. 2012 Jan 4;307(1):39-40. doi: 10.1001/jama.2011.1927. No abstract available.

  PMID: 22215161 BACKGROUND

• Rosella LC, Fitzpatrick T, Wodchis WP, Calzavara A, Manson H, Goel V. High-cost health care users in Ontario, Canada: demographic, socio-economic, and health status characteristics. BMC Health Serv Res. 2014 Oct 31;14:532. doi: 10.1186/s12913-014-0532-2.

  PMID: 25359294 BACKGROUND

• Marengoni A, Angleman S, Melis R, Mangialasche F, Karp A, Garmen A, Meinow B, Fratiglioni L. Aging with multimorbidity: a systematic review of the literature. Ageing Res Rev. 2011 Sep;10(4):430-9. doi: 10.1016/j.arr.2011.03.003. Epub 2011 Mar 23.

  PMID: 21402176 BACKGROUND

• Bayliss EA, Bosworth HB, Noel PH, Wolff JL, Damush TM, Mciver L. Supporting self-management for patients with complex medical needs: recommendations of a working group. Chronic Illn. 2007 Jun;3(2):167-75. doi: 10.1177/1742395307081501.

  PMID: 18083671 BACKGROUND

• Tahsin F, Austin T, McKinstry B, Mercer SW, Loganathan M, Thavorn K, Upshur R, Steele Gray C. Examining Use Behavior of a Goal-Supporting mHealth App in Primary Care Among Patients With Multiple Chronic Conditions: Qualitative Descriptive Study. JMIR Hum Factors. 2022 Nov 30;9(4):e37684. doi: 10.2196/37684.

  PMID: 36449335 DERIVED

• Miranda RN, Bhuiya AR, Thraya Z, Hancock-Howard R, Chan BC, Steele Gray C, Wodchis WP, Thavorn K. An Electronic Patient-Reported Outcomes Tool for Older Adults With Complex Chronic Conditions: Cost-Utility Analysis. JMIR Aging. 2022 Apr 20;5(2):e35075. doi: 10.2196/35075.

  PMID: 35442194 DERIVED

• Singh H, Tahsin F, Nie JX, McKinstry B, Thavorn K, Upshur R, Harvey S, Wodchis WP, Gray CS. Exploring the perspectives of primary care providers on use of the electronic Patient Reported Outcomes tool to support goal-oriented care: a qualitative study. BMC Med Inform Decis Mak. 2021 Dec 29;21(1):366. doi: 10.1186/s12911-021-01734-0.

  PMID: 34965860 DERIVED

• Tahsin F, Tracy S, Chau E, Harvey S, Loganathan M, McKinstry B, Mercer SW, Nie J, Ramsay T, Thavorn K, Palen T, Sritharan J, Steele Gray C. Exploring the relationship between the usability of a goal-oriented mobile health application and non-usage attrition in patients with multimorbidity: A blended data analysis approach. Digit Health. 2021 Oct 5;7:20552076211045579. doi: 10.1177/20552076211045579. eCollection 2021 Jan-Dec.

  PMID: 34868614 DERIVED

• Steele Gray C, Chau E, Tahsin F, Harvey S, Loganathan M, McKinstry B, Mercer SW, Nie JX, Palen TE, Ramsay T, Thavorn K, Upshur R, Wodchis WP. Assessing the Implementation and Effectiveness of the Electronic Patient-Reported Outcome Tool for Older Adults With Complex Care Needs: Mixed Methods Study. J Med Internet Res. 2021 Dec 2;23(12):e29071. doi: 10.2196/29071.

  PMID: 34860675 DERIVED

Related Links

• ePRO Published Protocol DOI: 10.2196/resprot.5756 (PMID: 27341765)

MeSH Terms

Conditions

Chronic Disease

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Carolyn Steele Gray, PhD

  MOUNT SINAI HOSPITAL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Post-doctoral Fellow, Scientific Lead

Model Details: 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.

Study Record Dates

• First Submitted: September 13, 2016
• First Posted: September 28, 2016
• Study Start: May 4, 2017
• Primary Completion: August 19, 2019
• Study Completion: August 19, 2019
• Last Updated: March 22, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: 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

Locations

CA (1)