StrokePRO

Project Title: Development and evaluation of a patient-centered electronic outcome assessment system for acute stroke trials – strokePRO

Patient-reported outcomes (PROs) are reports from patients about their own health, quality of life, or functional status associated with the healthcare or treatment they have received. Unfortunately, there is limited use of PROs in acute stroke trials with patients who have recently suffered a stroke. These types of stroke trials typically look at measures of functional disability, and exclude important aspects such as cognitive function, mood, mental health, anxiety, and fatigue, amongst others.

Electronic clinical outcome assessment (eCOA) systems offer a simpler and faster method of assessing patients and collecting PROs in stroke trials. There is an abundance of literature that suggests that use of eCOA systems in acute stroke trials can support increased diversity in patient recruitment and retention, better data quality, improved efficiency, and reduce missing data. Thus, this project addresses the gaps in this area by first understanding patient’s experiences in previous stroke trials, priorities about what matters to them, preferences about the method of electronic outcome assessment, and barriers to using these systems. This knowledge will inform the design and development of an electronic platform, called strokePRO, which aims to shift how clinical outcomes are collected and assessed in acute stroke trials.

The strokePRO tool will be a web-based app that will improve the quality of data in stroke research by being a more simple and reliable way of collecting and analyzing PROs. Furthermore, strokePRO will boost the recruitment and retention of patients in acute stroke trials by eliminating barriers that are faced by equity-deserving groups (e.g., transportation to visits and any other indirect costs) and by reducing trial costs and burden for stroke investigators and neurologists. The specific objectives of this study are to:

1. understand the priorities and experiences of stroke patients with respect to clinical and patient-reported outcomes assessment and elicit barriers to the update of electronic PROMs to inform the development of an evidence-based, patient-centered electronic platform for supporting the outcomes assessment in acute stroke trials .
2. co-design and develop, with patients and trial investigators, a patient-centered electronic clinical outcome assessment system (strokePRO) for the assessment of PROs and other clinical outcomes in acute stroke trials.
3. assess the agreement between clinician-reported stroke-related disability and QOL (as measured by the mRS and EQ-5D) and patients’ direct report of these outcomes.
4. assess the feasibility of implementing this electronic strokePRO platform in an acute stroke trial.

This project is financially supported by Alberta Innovates and the Canadian Institute for Health Research. 

The first step of our research involves meaningfully engaging with stroke patients and/or caregivers to understand patients' experiences and priorities regarding outcome assessment after a stroke. Thus, we are recruiting up to 60 ischemic stroke patients and/or stroke patient caregivers, to participate in this first phase of this research study. Participation in this study would involve two parts:

1) First, participants would be asked to attend an online, one-on-one meeting with a member of our research team, where they would be presented with findings of previous stroke research priorities and outcomes of an electronic clinical outcome assessment tool. We would ask if there were any additional priorities or outcomes they feel are missing, and then have them rank these priorities. This interview would be conducted through a digital format (i.e. Zoom video conferencing).

2) Second, participants would be asked to attend an online focus group with up to 5 stroke patients and caregivers. In these focus groups, we would ask our participants about their thoughts on how they are being assessed after their stroke, their experiences with participating in previous stroke trials, and their preferences for being assessed for stroke outcomes. These focus groups will be conducted using semi-structured interview guides through a digital format (i.e. Zoom video conferencing).
 

Eligibility:

The inclusion criteria are defined as:

1. Lived experience with ischemic stroke or transient ischemic attack OR previous or current caregiving experience for someone with a stroke
2. ability to provide informed consent
3. ability to read and communicate in English or French

Individuals will be considered ineligible for this study if they have significant impairment and are without a caregiver, or they are unable to read or communicate in English or French.