Stroke
Conditions
Brief summary
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
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.
Interventions
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.
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.
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 6 month blood pressure control (24-hour ambulatory) | 6 months after discharge | Proportion of participants with controlled BP according to 24- hour ambulatory BP (\<125/75 mmHg) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 12 month blood pressure control (24-hour ambulatory) | 12 months after discharge | Proportion of participants with controlled BP according to 24- hour ambulatory BP (\<125/75 mmHg) |
| Composite Recurrent Vascular Events | 12 months after discharge | Number of patients with myocardial infarction, ischemic or hemorrhagic stroke, coronary revascularization, acute cardiac death, and heart failure hospitalization) |
| Proportion of uninsured who obtain insurance | 3 months after hospital discharge | Proportion of uninsured patients who obtain insurance |
| Acute healthcare utilization | 3 months after hospital discharge | Number of hospital readmissions, emergency department (ED) visits, and urgent care visits |
Other
| Measure | Time frame | Description |
|---|---|---|
| Night time ambulatory diastolic blood pressure | 6 month | Night time diastolic blood pressure as assessed by an ambulatory blood pressure monitor |
| Proportion of participants who quit smoking or attempt to quit smoking | 6 months | Among participants who are tobacco users at time of enrollment |
| 24 hour ambulatory systolic blood pressure | 6 month | 24 hour systolic blood pressure as assessed by an ambulatory blood pressure monitor |
| Depressive symptoms as assessed by score on the Patient Health Questionnaire 9 | 6 months | Patient Health Questionnaire 9 total score ranges from 0 to 27 |
| Proportion of participants who quit smoking | 6 months | Among participants who are tobacco users at time of enrollment |
| 24 hour ambulatory diastolic blood pressure | 6 month | 24 hour diastolic blood pressure as assessed by an ambulatory blood pressure monitor |
| Daytime ambulatory systolic blood pressure | 6 month | Daytime systolic blood pressure as assessed by an ambulatory blood pressure monitor |
| Daytime ambulatory diastolic blood pressure | 6 month | Daytime diastolic blood pressure as assessed by an ambulatory blood pressure monitor |
| Night time ambulatory systolic blood pressure | 6 month | Night time systolic blood pressure as assessed by an ambulatory blood pressure monitor |
Countries
United States