Center for Stroke Disparities Solution - Community Transitions Intervention

Study Overview
=================
Brief Summary
-----------------
The Stroke CTI study is a 3 arm randomized, controlled trial designed to assess the effectiveness of a nurse practitioner (NP) only and a NP and health coach (HC) community transitions intervention (CTI) in reducing secondary stroke risk by helping patients lower their systolic blood pressure.

Detailed Description
-----------------
Targeted study participants are Black and Hispanic patients with a history of stroke and a current systolic blood pressure (BP) above JNC7 recommended range (>=140 mmHg) who recently entered home care service. The NP only program will provide a 30 day intervention while the NP/HC team will provide 3 months of support via in-home and telephone encounters for patients randomized to one of these groups. In the first 30 days post-enrollment the NP will focus on medical case management and coordination with primary care providers and specialists, provide self-management coaching, and intervene if gaps in care are identified - all with a focus on BP reduction and preparing the patient for ongoing BP maintenance. As applicable, the HC will pick up the case after 30 days and follow up with the plan of care jointly established by the patient, NP and HC. The focus will be on ongoing self-management coaching, providing preparation support for physician visits, and linking patient to additional community resources, as needed.

Official Title
-----------------
Center for Stroke Disparities Solution (CSDS) Project II: Community Transitions Intervention (CTI)

Conditions
-----------------
Hypertension, Stroke, Transient Ischemic Attack

Intervention / Treatment
-----------------
* Behavioral: Nurse Practitioner Only
* Behavioral: Nurse Practitioner + Health Coach


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Newly admitted to the VNSNY post acute care program 21 years of age or older Black and/or Hispanic Speaks English or Spanish History of stroke or transient ischemic attack (TIA) Hypertension diagnosis Average screening systolic BP >= 140 mmHg Is available to participate in intervention activities during the study timeframe if randomized to treatment group Exclusion Criteria: Dialysis End stage renal disease Kidney transplant Severe heart failure Significant cognitive impairment. Unable to provide informed consent, accurate self-report, and/or unable to participate effectively in intervention Significant verbal speech impairment. Unable to participate in intervention telephone sessions Patients with upper arm circumference outside of valid use parameters for the automated device used for eligibility screening

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual Home Care<br>Regardless of study arm, all patients will receive usual home health services: a physician-ordered plan of care; skilled nursing and/or therapy services as prescribed by the MD; patient education, monitoring and hands-on care; and home health aide services depending on functional deficits and availability of unpaid caregivers. | |
| Experimental: Nurse Practitioner + Health Coach<br>The NP + HC arm will include the same protocol as the NP only arm plus 30 additional days of support. The HC will pick up the case after the initial 30 days and follow up with the plan of care jointly established by the patient, NP and HC. The focus will be on ongoing self-management coaching, providing preparation support for physician visits, and linking patient to additional community resources, as needed. | Behavioral: Nurse Practitioner Only<br> <br> Behavioral: Nurse Practitioner + Health Coach<br> <br> |
| Experimental: Nurse Practitioner Only<br>The NP only program will provide a 30 day intervention via in-home and telephone encounters for patients randomized to this group. In the first 30 days post-enrollment the NP will focus on medical case management and coordination with primary care providers and specialists, provide self-management coaching, and intervene if gaps in care are identified - all with a focus on BP reduction and preparing the patient for ongoing BP maintenance. | Behavioral: Nurse Practitioner Only<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of systolic blood pressure | Patients randomized to the NP only and the NP+HC transitional care interventions will have greater 3 and 12 month reduction in SBP than patients in Usual Home Care. | Baseline to 3 and 12 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost-effectiveness of NP-only and NP+HC relative to UHC | Both interventions will be more costly but more cost-effective than usual home care. | VNSNY home care admission to 3 and 12 months post admission | 
| Influence on post-stroke patients' function and health-related quality of life (QoL) | Both interventions will yield significant comparative improvements in function and health-related QoL; NP+HC will be more effective than NP-only. | Baseline to 3 and 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stroke, transient ischemic attack, High blood pressure, Hypertension