Center for Stroke Disparities Solution - Community Transitions Intervention (CSDS)

Visiting Nurse Service of New York

Status: Completed

Conditions: Hypertension; Stroke; Transient Ischemic Attack

Treatments: Behavioral: Nurse Practitioner + Health Coach; Behavioral: Nurse Practitioner Only

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01918891

1U54NS081765 (U.S. NIH Grant/Contract)

I12-004

Details and patient eligibility

About

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.

Full 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.

Enrollment: 495 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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495 participants in 3 patient groups

Usual Home Care

No Intervention group

Description:

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.

Nurse Practitioner + Health Coach

Experimental group

Description:

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.

Treatment:

Behavioral: Nurse Practitioner + Health Coach

Behavioral: Nurse Practitioner Only

Nurse Practitioner Only

Experimental group

Description:

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.

Treatment:

Behavioral: Nurse Practitioner Only