Clinical trial NCT02917954: Electronic Patient Reported Outcome (ePRO) Mobile Application Pragmatic Trial
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Mount Sinai Hospital, Canada
Sponsor class: OTHER
Collaborators: name: University of Toronto
name: Ottawa Hospital Research Institute
name: QoC Health Inc.
First posted: 2016-09-28
Enrollment: 45
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: The pragmatic trial will take place at 6 Family Health Teams (FHTs) to a maximum of 16 FHTs in Ontario utilizing a stepped-wedge randomized method with an embedded case study of implementation at four sites. The research team will observe provider-patient goal-setting visits at the time of onboarding onto the intervention. Additional consent will be obtained from the patient and provider prior to initiating the observational visit. In addition, the research team will attend FHT rounds at the identified case study sites (when appropriate) to observe and document how providers discuss and set goals in an interdisciplinary team environment. Using a stepped-wedge design, each FHT will receive the ePRO tool (intervention) but will be randomized on when in the stepped-wedge design they will receive the intervention. The stepped-wedge randomization will assign (through number generator or coin flip) each of the FHTs to either a: 1) 3 month control period and a 12 month intervention period, or 2) 6 month control period and a 9 month intervention period; and their respective participants will be assigned accordingly.

Providers and patients recruited at all sites will receive training on how to use the ePRO tool prior to the start of the trial. During the intervention period, patients will receive one-on-one training with a research assistant; and provider training will occur in a group setting. Training will be led by a member of the research team and will take between 30-60 minutes. Patients and providers will also be provided with a manual and training video on how to use the tool and portal, and the patients will be offered refresher sessions (individual or group) every 3 months over the duration of the study.

Following consent, all patients will complete pre and post surveys every 3 months (through control and intervention periods). Patients will also complete an additional survey at study closeout to capture tool usability feedback. We anticipate survey completion to take 20-35 minutes.

Additionally, patients are requested to attend a minimum of two schedule appointments with their provider during the study. The first (on-boarding) visit will have the patient and provider collaboratively discuss and set monitoring protocols for tracking. The second (off-boarding) visit, following the monitoring period, will allow patients and providers to privately discuss their experience with the ePRO tool, before participating in their respective focus group or interview. As was the case in our usability pilot and exploratory trial, we anticipate that patients will have additional appointments with their providers during the study at which point they can use the tool to discuss patient progress towards goals. All patients are requested to attend 4-5 scheduled appointments with their provider during the study. In accordance to earlier study phases on-boarding and off-boarding visits typically take 30 minutes. Other scheduled visits take between 10-30 minutes depending on the type of visit and provider they are seeing.

Embedded within the pragmatic trial will be case studies of 4 intervention sites. Provider and patient participants at case sites will participate in mid and post-intervention period semi-structured interviews to capture implementation enables and barriers. To adequately capture organizational level barriers and enablers we will additionally conduct semi-structured interviews with organizational leaders (executive directors and/or clinical leads). We will also collect relevant documents from all sites (i.e. organizational policies regarding the use of mobile applications or provider trainings and manuals in using technology as part of usual care).

This described stepped-wedge design is an update from the initially conceived pragmatic cluster trial of 22 sites. This shift was necessary due to site recruitment challenges experienced, in particular that sites did not want to be recruited to the study unless they could use the technology. As such a stepped-wedge trial was deemed more appropriate. With this new design the updated power calculation for the study indicated a new target of 176 patients across sites whereas the initial calculation was for 660.

Stepped-wedge sample size calculation:

Minimum sample size required for the recruitment of sites and patients was determined using closed-form analytical formulae with a power of 80% based on: a minimal clinically important difference of our core measure of quality of life (the AQoL-4D) of 0.06, an expected standard deviation in AQoL of 0.22, an expected ICC of 0.01 (calculated based on total primary care utilization over a one year period among a 10% sample of the Ontario population, which served here as a proxy measure for patient outcomes), and an expected attrition rate of 10% (rated based on previous studies in similar population groups using similar technology). A minimum sample size of 176 patients was calculated.

Eligibility 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

Primary outcomes:
measure: Change from baseline Assessment of Quality-of-Life at 3 month intervals for 15 months
timeFrame: Baseline, 3 months, 6 months, 9 months, 12 months, and study end (15-months)
Secondary outcomes:
measure: ePRO cost-effectiveness - health system perspective
timeFrame: 15-months
measure: Patient Demographic and Characteristic information
timeFrame: Baseline
measure: Provider Demographic and Characteristic Information
timeFrame: Baseline
measure: Change from baseline Patient/Caregiver Self-Reported Costs at 3 month intervals for study duration (15 months)
timeFrame: Baseline, 3 months, 6 months, 9 months, 12 months, and study-end (15-months)
measure: Change from baseline Patient Experience at 3 month intervals for study duration (15 months)
timeFrame: Baseline, 3 months, 6 months, 9 months,12 months, and study-end (15-months)
measure: Change from baseline Patient Activation Measure at 3 month intervals for study duration (15 months)
timeFrame: Baseline, 3 months, 6 months, 9 months, 12 months, and study-end (15-months)
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Dr. Carolyn Steele Gray
state: Ontario
Study officials:
affiliation: MOUNT SINAI HOSPITAL
name: Carolyn Steele Gray, PhD
role: PRINCIPAL_INVESTIGATOR
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citation: 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.
citation: 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.
citation: 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.
citation: 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.