Video-based Intervention to Address Disparities in Blood Pressure Control After Stroke

Study Overview
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Brief Summary
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The purpose of this study is to examine the impact of a multidisciplinary telehealth-based model of outpatient stroke care on blood pressure control following stroke, and further, to evaluate its impact on racial disparities in post-stroke blood pressure control.

Detailed Description
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Blood pressure is poorly controlled for many stroke survivors and racial disparities in blood pressure control and stroke recurrence exist. The purpose of this study is to examine the impact of a multidisciplinary, telehealth based, outpatient model of care on outcomes after stroke with a focus on blood pressure control. The Video-based Intervention to Reduce Treatment and Outcome Disparities in Adults Livings with Stroke and Transient Ischemic Attack (VIRTUAL) has several components including early follow-up via telehealth with a multidisciplinary team, remote blood pressure monitoring, and medication adjustment by a pharmacist.

Official Title
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Video-based Intervention to Reduce Treatment and OUtcome Disparities in Adults Living With Stroke or Transient Ischemic Attack (VIRTUAL)

Conditions
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Stroke

Intervention / Treatment
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* Other: VIRTUAL
* Other: Standard care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ischemic stroke, hemorrhagic stroke (intracerebral hemorrhage),or transient ischemic attack (TIA Presence of hypertension (by clinical history or hospital BP ≥140/90 mmHg on two occasions) Plan to discharge home after stroke Ability to provide consent (patient or caregiver) in English or Spanish. Patients with cognitive impairment or aphasia limiting participation will be included if they have a caregiver to assist with monitoring and telehealth visits. Two neurologists must agree on TIA diagnosis Exclusion Criteria: Modified Rankin scale (mRs) > 4 (severe disability) at time of discharge Life expectancy < 1 year or terminal illness Stroke unrelated to vascular risk factors (RFs) (drug use, trauma, vasculitis) Pregnancy Symptomatic flow limiting carotid stenosis without plan for intervention Long-term BP goal ≥ 130/80 mmHg according to clinical team

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VIRTUAL Intervention (Treatment)<br>Participants assigned to intervention arm will have scheduled video telehealth appointments with a multidisciplinary team (Stroke provider, social worker, pharmacist) and remote telemonitoring of blood pressure with blood pressure medication adjustments biweekly as needed by pharmacists. | Other: VIRTUAL<br>* At the time of discharge, stroke survivors in the VIRTUAL arm will receive a package containing an iPad and a remote BP monitoring device that allows transmission of BP to the study team.The first telehealth visit will occur 7-14 days after discharge. Patient will be counseled on the importance of BP monitoring, salt reduction, and the importance of diet and exercise for stroke prevention. Medications, side effects and interactions will be reviewed. The social worker will refer the patient to specific resources according to social needs abd patient will be referred to a primary care provider if they do not have one. Subsequent video visits will be 1-month (30 days +/- 7) , 3 months (90 days +/- 14), and 5 months (150 days +/- 14) days after enrollment.<br>|
| Active Comparator: Standard Care<br>Participants assigned to standard care will follow-up with a stroke provider within 2 weeks of discharge and primary care as per usual recommendations. Participants will monitor their blood pressure on their own and pharmacists will contact participants monthly to review blood pressure. Pharmacists will make recommendations for blood pressure medication adjustment to participant primary care provider. | Other: Standard care<br>* Participants randomized to standard care will receive an educational packet and a blood pressure monitor prior to hospital discharge. They will be contacted by a social worker to determine if they received their medications and appointments. The stroke practitioner will evaluate the patients at 7-14 days and then follow up according to current standard of care. They will be seen over video or in-person, according to their preference and capabilities. The pharmacist will contact patients at 1-month (30 +/- 7 days) days over the telephone to review BP logs and will make recommendations to their primary care provider to adjust BP medications. Subsequent pharmacist calls will occur monthly until 6 months and recommendations for medication adjustments will be communicated to their primary care provider.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6 month blood pressure control (24-hour ambulatory) | Proportion of participants with controlled BP according to 24- hour ambulatory BP (<125/75 mmHg) | 6 months after discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 12 month blood pressure control (24-hour ambulatory) | Proportion of participants with controlled BP according to 24- hour ambulatory BP (<125/75 mmHg) | 12 months after discharge | 
| Composite Recurrent Vascular Events | Number of patients with myocardial infarction, ischemic or hemorrhagic stroke, coronary revascularization, acute cardiac death, and heart failure hospitalization) | 12 months after discharge | 
| Proportion of uninsured who obtain insurance | Proportion of uninsured patients who obtain insurance | 3 months after hospital discharge | 
| Proportion of uninsured who obtain insurance | Proportion of uninsured patients who obtain insurance | 6 months after hospital discharge | 
| Acute healthcare utilization | Number of hospital readmissions, emergency department (ED) visits, and urgent care visits | 3 months after hospital discharge | 
| Acute healthcare utilization | Number of hospital readmissions, ED visits, and urgent care visits | 6 months after hospital discharge | 
| Acute healthcare utilization | Number of hospital readmissions, ED visits, and urgent care visits | 12 months after hospital discharge |