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

Primary Purpose

Hypertension, Stroke, Transient Ischemic Attack

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nurse Practitioner Only
Nurse Practitioner + Health Coach
Sponsored by
Visiting Nurse Service of New York
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring stroke, transient ischemic attack, High blood pressure, Hypertension

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Visiting Nurse Service of New York

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Usual Home Care

Nurse Practitioner + Health Coach

Nurse Practitioner Only

Arm 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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
August 5, 2013
Last Updated
September 30, 2019
Sponsor
Visiting Nurse Service of New York
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS), NYU Langone Health, Hebrew Home at Riverdale, Columbia University
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1. Study Identification

Unique Protocol Identification Number
NCT01918891
Brief Title
Center for Stroke Disparities Solution - Community Transitions Intervention
Acronym
CSDS
Official Title
Center for Stroke Disparities Solution (CSDS) Project II: Community Transitions Intervention (CTI)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
September 2012 (Actual)
Primary Completion Date
June 2018 (Actual)
Study Completion Date
June 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Visiting Nurse Service of New York
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS), NYU Langone Health, Hebrew Home at Riverdale, Columbia University

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Stroke, Transient Ischemic Attack
Keywords
stroke, transient ischemic attack, High blood pressure, Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
495 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual Home Care
Arm Type
No Intervention
Arm 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.
Arm Title
Nurse Practitioner + Health Coach
Arm Type
Experimental
Arm 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.
Arm Title
Nurse Practitioner Only
Arm Type
Experimental
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Nurse Practitioner Only
Intervention Type
Behavioral
Intervention Name(s)
Nurse Practitioner + Health Coach
Primary Outcome Measure Information:
Title
Reduction of systolic blood pressure
Description
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.
Time Frame
Baseline to 3 and 12 months.
Secondary Outcome Measure Information:
Title
Cost-effectiveness of NP-only and NP+HC relative to UHC
Description
Both interventions will be more costly but more cost-effective than usual home care.
Time Frame
VNSNY home care admission to 3 and 12 months post admission
Title
Influence on post-stroke patients' function and health-related quality of life (QoL)
Description
Both interventions will yield significant comparative improvements in function and health-related QoL; NP+HC will be more effective than NP-only.
Time Frame
Baseline to 3 and 12 months
Other Pre-specified Outcome Measures:
Title
Moderators and mediators that may affect treatment outcomes
Description
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).
Time Frame
Baseline to 3 and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Penny H Feldman, PhD
Organizational Affiliation
Visiting Nurse Service of New York
Official's Role
Principal Investigator
Facility Information:
Facility Name
Visiting Nurse Service of New York
City
New York
State/Province
New York
ZIP/Postal Code
10001
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
34160182
Citation
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.
Results Reference
derived
PubMed Identifier
31541606
Citation
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.
Results Reference
derived
PubMed Identifier
25622823
Citation
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.
Results Reference
derived
Links:
URL
http://pophealth.med.nyu.edu/divisions/chbc/research/csds
Description
NYU School of Medicine - Center for Stroke Disparities Solutions

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Center for Stroke Disparities Solution - Community Transitions Intervention

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