Stroke Telemedicine Outpatient Prevention Program for Blood Pressure Reduction

Not Applicable

Completed

Conditions: Telemedicine
Stroke Prevention
Blood Pressure
Psychosocial Impairment

Interventions: Behavioral: Educational Packet
Behavioral: Phone call at 72 hours by discharge nurse navigator
Behavioral: Telehealth visit at 7 days, 1 month, 3 months, and 5 months after discharge
Behavioral: Educational messages every other week
Diagnostic Test: BP monitoring by QardioARM with periodic transmission of BP data

Registration Number: NCT03923790

Lead Sponsor: The University of Texas Health Science Center, Houston

Brief Summary: The purpose of this pilot trial is to compare post-stroke care blood pressure (BP) treatment using an interdisciplinary telehealth model \[called the Stroke Telemedicine Outpatient Program (STOP) for Blood Pressure Reduction\] to usual care in stroke patients at risk for uncontrolled BP. The intervention will address general and stroke-related factors associated with racial disparities in BP control. We will assess feasibility of implementation of the trial and will use the measures and outcomes assessed in the pilot to examine knowledge gaps.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 83

Inclusion Criteria

Ischemic and hemorrhagic stroke patients
Presence of at least one of the following high risk criteria: uninsured, Medicaid payer status, small vessel ischemic stroke, hypertensive ICH)
Age ≥ 18; presence of hypertension (by clinical history or hospital BP ≥140/90 on two occasions)
Plan to discharge home after stroke
Ability to provide consent (patient or caregiver)
Ability to communicate in English

Exclusion Criteria

modified Rankin scale > 4 at the time of enrollment (severe disability)
life expectancy < 1 year or terminal illness,
eGFR < 30 at time of discharge
pregnancy
symptomatic flow limiting carotid stenosis without plan for intervention
urine toxicology positive for cocaine or methamphetamine or recent use
long-term BP goal ≥ 130/80 mmHg according to clinical team

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
STOP model	BP monitoring by QardioARM with periodic transmission of BP data	Pharmacist evaluates patient prior to discharge and a nurse navigator contacts patient 72 hours after discharge. Patient receives educational packet and a blue tooth enabled BP monitor with an iPad. A video telehealth visit occurs 7 days after discharge attended by a nurse practitioner (NP) or MD , social worker (SW), and pharmacist. The NP and pharmacist review the BP data to determine the need for medication adjustment. The SW assesses the need for resources. BP is reviewed via an online portal every 2 weeks until average BP is \< 130/80mmHg, then monthly. Uncontrolled BP prompts a call from the pharmacist to discuss medication adherence and titration. Subsequent video telehealth visits occur 1 month, 3 months, and 5 months after enrollment.
STOP model	Educational Packet	Pharmacist evaluates patient prior to discharge and a nurse navigator contacts patient 72 hours after discharge. Patient receives educational packet and a blue tooth enabled BP monitor with an iPad. A video telehealth visit occurs 7 days after discharge attended by a nurse practitioner (NP) or MD , social worker (SW), and pharmacist. The NP and pharmacist review the BP data to determine the need for medication adjustment. The SW assesses the need for resources. BP is reviewed via an online portal every 2 weeks until average BP is \< 130/80mmHg, then monthly. Uncontrolled BP prompts a call from the pharmacist to discuss medication adherence and titration. Subsequent video telehealth visits occur 1 month, 3 months, and 5 months after enrollment.
STOP model	Educational messages every other week	Pharmacist evaluates patient prior to discharge and a nurse navigator contacts patient 72 hours after discharge. Patient receives educational packet and a blue tooth enabled BP monitor with an iPad. A video telehealth visit occurs 7 days after discharge attended by a nurse practitioner (NP) or MD , social worker (SW), and pharmacist. The NP and pharmacist review the BP data to determine the need for medication adjustment. The SW assesses the need for resources. BP is reviewed via an online portal every 2 weeks until average BP is \< 130/80mmHg, then monthly. Uncontrolled BP prompts a call from the pharmacist to discuss medication adherence and titration. Subsequent video telehealth visits occur 1 month, 3 months, and 5 months after enrollment.
Usual Care	Educational Packet	Pharmacist evaluates patient prior to discharge and a nurse navigator contacts patient 72 hours after discharge. Patient receives educational packet.
STOP model	Telehealth visit at 7 days, 1 month, 3 months, and 5 months after discharge	Pharmacist evaluates patient prior to discharge and a nurse navigator contacts patient 72 hours after discharge. Patient receives educational packet and a blue tooth enabled BP monitor with an iPad. A video telehealth visit occurs 7 days after discharge attended by a nurse practitioner (NP) or MD , social worker (SW), and pharmacist. The NP and pharmacist review the BP data to determine the need for medication adjustment. The SW assesses the need for resources. BP is reviewed via an online portal every 2 weeks until average BP is \< 130/80mmHg, then monthly. Uncontrolled BP prompts a call from the pharmacist to discuss medication adherence and titration. Subsequent video telehealth visits occur 1 month, 3 months, and 5 months after enrollment.
STOP model	Phone call at 72 hours by discharge nurse navigator	Pharmacist evaluates patient prior to discharge and a nurse navigator contacts patient 72 hours after discharge. Patient receives educational packet and a blue tooth enabled BP monitor with an iPad. A video telehealth visit occurs 7 days after discharge attended by a nurse practitioner (NP) or MD , social worker (SW), and pharmacist. The NP and pharmacist review the BP data to determine the need for medication adjustment. The SW assesses the need for resources. BP is reviewed via an online portal every 2 weeks until average BP is \< 130/80mmHg, then monthly. Uncontrolled BP prompts a call from the pharmacist to discuss medication adherence and titration. Subsequent video telehealth visits occur 1 month, 3 months, and 5 months after enrollment.
Usual Care	Phone call at 72 hours by discharge nurse navigator	Pharmacist evaluates patient prior to discharge and a nurse navigator contacts patient 72 hours after discharge. Patient receives educational packet.

Primary Outcome Measures

Name	Time	Method
Daytime Ambulatory Systolic Blood Pressure	6 months after enrollment	Blood pressure will be assessed with an ambulatory blood pressure monitor (ABPM).

Secondary Outcome Measures

Name	Time	Method
Nighttime Diastolic Blood Pressure	6 months	Blood pressure will be assessed with an ambulatory blood pressure monitor (ABPM).
Body Mass Index(BMI)	6 months	BMI will be calculated from height and weight.
Night Time Ambulatory Systolic Blood Pressure	6 months	Blood pressure will be assessed with an ambulatory blood pressure monitor (ABPM).
Daytime Ambulatory Diastolic Blood Pressure	6 months	Blood pressure will be assessed with an ambulatory blood pressure monitor (ABPM).
Number of Participants With Recurrent Vascular Events (Stroke, Myocardial Infarction, Acute Cardiac Death)	6 months	Recurrent vascular events include stroke, myocardial infarction, or acute cardiac death.
Number of Participants With Acute Healthcare Utilization	6 months	Acute healthcare utilization includes hospital readmission and acute care visits to emergency room and/or urgent care.