CSDS: Center for Stroke Disparities Solution - Community Transitions Intervention

Sponsor

Visiting Nurse Service of New York (Other)

Overall Status

Completed

CT.gov ID

NCT01918891

Collaborator

National Institute of Neurological Disorders and Stroke (NINDS) (NIH), NYU Langone Health (Other), Hebrew Home at Riverdale (Other), Columbia University (Other)

495

Enrollment

Location

Arms

Actual Duration (Months)

7.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypertension Stroke Transient Ischemic Attack	Behavioral: Nurse Practitioner Only Behavioral: Nurse Practitioner + Health Coach	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

495 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 1, 2012

Actual Primary Completion Date :

Jun 1, 2018

Actual Study Completion Date :

Jun 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Usual Home Care 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 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 Behavioral: Nurse Practitioner + Health Coach
Experimental: Nurse Practitioner Only 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

Arm

Intervention/Treatment

No Intervention: Usual Home Care

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

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

Behavioral: Nurse Practitioner + Health Coach

Experimental: Nurse Practitioner Only

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

Outcome Measures

Primary Outcome Measures

Reduction of systolic blood pressure [Baseline to 3 and 12 months.]
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.

Secondary Outcome Measures

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

Other Outcome Measures

Moderators and mediators that may affect treatment outcomes [Baseline to 3 and 12 months]
Exploratory aim to examine potential moderating/mediating variables which may include: moderators - race/ethnicity (i.e., Black/Hispanic differences), baseline HTN severity (Stage I vs. Stage II); mediators - 1) changes in health behaviors (i.e., diet, physical activity, weight loss, medication adherence); and 2) antihypertensive medication intensification (i.e., adding, changing dose, or changing class of medications).

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts 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