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

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

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.

Study Overview

• Status: Completed
• Conditions: Stroke; Hypertension; Transient Ischemic Attack
• Intervention / Treatment: Behavioral: Nurse Practitioner Only; Behavioral: Nurse Practitioner + Health Coach

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 Type: Interventional
• Enrollment (Actual): 495
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10001
      • Visiting Nurse Service of New York

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / 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

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Moderators and mediators that may affect treatment outcomes	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).	Baseline to 3 and 12 months

Collaborators and Investigators

• Sponsor: Visiting Nurse Service of New York
• Collaborators: Columbia University; National Institute of Neurological Disorders and Stroke (NINDS); NYU Langone Health; Hebrew Home at Riverdale
• Investigators: Principal Investigator: Penny H Feldman, PhD, Visiting Nurse Service of New York

Publications and helpful links

General Publications

• Osakwe ZT, Barron Y, McDonald MV, Feldman PH. Effect of Nurse Practitioner Interventions on Hospitalizations in the Community Transitions Intervention Trial. Nurs Res. 2021 Jul-Aug 01;70(4):266-272. doi: 10.1097/NNR.0000000000000508.
• Feldman PH, McDonald MV, Trachtenberg M, Trifilio M, Onorato N, Sridharan S, Silver S, Eimicke J, Teresi J. Reducing Hypertension in a Poststroke Black and Hispanic Home Care Population: Results of a Pragmatic Randomized Controlled Trial. Am J Hypertens. 2020 Apr 1;33(4):362-370. doi: 10.1093/ajh/hpz148.
• Feldman PH, McDonald MV, Trachtenberg MA, Schoenthaler A, Coyne N, Teresi J. Center for stroke disparities solutions community- based care transition interventions: study protocol of a randomized controlled trial. Trials. 2015 Jan 27;16:32. doi: 10.1186/s13063-015-0550-3.

Helpful Links

• NYU School of Medicine - Center for Stroke Disparities Solutions

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2012
• Primary Completion (Actual): June 1, 2018
• Study Completion (Actual): June 1, 2018

Study Registration Dates

• First Submitted: August 5, 2013
• First Submitted That Met QC Criteria: August 5, 2013
• First Posted (Estimate): August 8, 2013

Study Record Updates

• Last Update Posted (Actual): October 1, 2019
• Last Update Submitted That Met QC Criteria: September 30, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Hypertension; stroke; transient ischemic attack; High blood pressure
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia; Stroke; Hypertension; Ischemic Attack, Transient
• Other Study ID Numbers: I12-004; 1U54NS081765 (U.S. NIH Grant/Contract)