Clinical trial NCT06442631: MyStroke for Stroke Survivors and Caregivers
Official title: An Individualized Video-based Stroke Education Platform for Stroke Survivors and Caregivers
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Stroke, Acute
Ischemic Stroke, Acute
Keywords: stroke education
ischemic stroke
stroke knowledge
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2024-06-04
Enrollment: 690
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this multicenter randomized trial is to evaluate the impact of a personalized video-based stroke education platform on patient-centered and health system-centered outcomes. The main questions this study aims to address are:

1. Does a personalized, video-based educational platform improve stroke knowledge?
2. Does a personalized, video-based educational platform reduce post-discharge health system utilization?
3. Do different strategies of nudging improve engagement with educational material after hospital discharge?

In order to determine the effect of this personalized stroke education strategy, researchers will compare subjects who receive standard stroke education with those who receive the personalized stroke education platform in addition to standard standard education. Patient knowledge will be assessed 90-days after discharge. Study participants will include both stroke patients and caregivers, who will:

1. Receive standard education during the stroke hospitalization
2. Complete a survey on the day of hospital discharge to assess their baseline knowledge.
3. Half of the subjects will be randomly assigned to also receive access to the personalized stroke education platform on the day of discharge.
4. All subjects will complete two follow-up study visits (7 and 90 days after discharge) in order to complete surveys.

Detailed description: Stroke education represents a unique opportunity to empower stroke survivors (and caregivers) to promote self-management, augment adherence, and reduce post-stroke healthcare utilization. Despite being a key quality metric for stroke centers, most patient and caregiver education is poorly retained and a common source of dissatisfaction. In fact, most survivors are unaware of the cause of their stroke, their modifiable risk factors, and how to properly respond to future stroke symptoms. Although there is no gold standard, most centers rely on a combination of bedside verbal communication and standardized printed materials. Prior work has clarified that effective and durable educational interventions benefit from engaging content, personalization, accessibility, and low cost/burden. Retention is very poor during the stroke hospitalization, but this can be overcome by promoting ongoing engagement after discharge.

To that end, our group developed a web-based educational platform (MyStroke) that leverages the electronic health record to personalize video-based educational content for each stroke survivor. Simple but engaging videos are curated to address each patient's stroke etiology, individualized risk factors, prescribed stroke prevention medications, and post-stroke lifestyle issues. This approach transforms point-of-care stroke education, and integrated nudges reveal opportunities for re-education and re-engagement after hospital discharge to achieve a durable impact. In a recent single-center pilot trial, MyStroke improved patient and caregiver satisfaction and improved key elements of stroke knowledge. The objective of this proposal is to build upon our encouraging preliminary experience and conduct a multicenter randomized trial to evaluate the impact of MyStroke on both patient-centered (stroke knowledge, self-efficacy, satisfaction, quality of life) and health system-centered outcomes (medication adherence and health system utilization).

Electronic nudges will leverage principles of behavioral economics (i.e. enhanced nudges) to promote ongoing engagement. Our preliminary data indicate that even bland nudges promote engagement, but here we propose to use both bland nudges and enhanced nudges, such that platform analytics will compare the influence of different nudge types. Use of technology in this context stands to bridge geographic distances, connect stakeholders, and increase access to information, but it important to recognize the potential to exacerbate inequities for elderly patients and those with limited access to technology. Issues of digital inclusivity will be evaluated to reveal opportunities for platform improvement. The MyStroke platform offers a scalable solution stroke education which imposes no burden on the clinical team due to its reliance on a limited number of input fields which can be harvested from the electronic health record to individualized content for each patient.

Eligibility criteria: Inclusion Criteria:

* At least 18 years old
* Admitted to hospital with clinical diagnosis of acute ischemic stroke (imaging confirmation not required)
* Stroke symptom onset within 30 days of enrollment
* Being discharged to either home or an acute rehabilitation facility
* Access to internet enabled device (smartphone, tablet, computer)
* Fluent in either English or Spanish (does not need to be native or primary language)
* Willingness and ability to sign informed consent

Exclusion Criteria:

* Severe aphasia (score of ≥2 on NIHSS item 9)
* Ischemic stroke that is attributed to a surgical procedure
* Resides in a skilled nursing facility prior to admission
* Being discharged to skilled nursing facility or long-term acute care facility
* Unwillingness or inability to participate in remote/virtual study visits
* A terminal or advanced condition that raises the possibility the subject may not survive 90 days
* Any other illness or condition that the investigator feels would pose a hazard to the subject from participation in the study

Primary outcomes:
measure: The Stroke Patient Education Retention (SPER) survey
timeFrame: 90 days
Secondary outcomes:
measure: Patient satisfaction with stroke education
timeFrame: 90 days
measure: Stroke etiology awareness
timeFrame: 90 days
measure: Stroke risk factor awareness
timeFrame: 90 days
measure: Antithrombotic medication awareness
timeFrame: 90 days
measure: Stroke Self-Efficacy Questionnaire (SSEQ)
timeFrame: 90 days
measure: EuroQoL EQ-5D-5L
timeFrame: 90 days
measure: Medication adherence
timeFrame: 90 days
measure: Emergency Department utilization
timeFrame: 90 days
measure: Urgent outpatient visits
timeFrame: 90 days
measure: Outpatient provider communication
timeFrame: 90 days
Other outcomes:
measure: The Stroke Patient Education Retention (SPER) survey (7 days)
timeFrame: 7 days
measure: Patient satisfaction with stroke education (7 days)
timeFrame: 7 days
measure: Stroke etiology awareness (7 days)
timeFrame: 7 days
measure: Stroke risk factor awareness (7 days)
timeFrame: 7 days
measure: Antithrombotic medication awareness (7 days)
timeFrame: 7 days
measure: Stroke Self-Efficacy Questionnaire (SSEQ) (7 days)
timeFrame: 7 days
measure: EuroQoL EQ-5D-5L (7 days)
timeFrame: 7 days
Locations:
city: Lancaster
country: United States
facility: Lancaster General Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Penn Presbyterian Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: The Hospital of the University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Pennsylvania Hospital
state: Pennsylvania
city: West Chester
country: United States
facility: Chester County Hospital
state: Pennsylvania
Study officials:
affiliation: Assistant Professor of Neurology at the University of Pennsylvania
name: Christopher G Favilla, MD
role: PRINCIPAL_INVESTIGATOR
References: