Center for Stroke Disparities Solution - Community Transitions Intervention
CSDS
2 other identifiers
interventional
495
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable hypertension
Started Sep 2012
Longer than P75 for not_applicable hypertension
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2012
CompletedFirst Submitted
Initial submission to the registry
August 5, 2013
CompletedFirst Posted
Study publicly available on registry
August 8, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2018
CompletedOctober 1, 2019
September 1, 2019
5.8 years
August 5, 2013
September 30, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Cost-effectiveness of NP-only and NP+HC relative to UHC
VNSNY home care admission to 3 and 12 months post admission
Influence on post-stroke patients' function and health-related quality of life (QoL)
Baseline to 3 and 12 months
Other Outcomes (1)
Moderators and mediators that may affect treatment outcomes
Baseline to 3 and 12 months
Study Arms (3)
Usual Home Care
NO INTERVENTIONRegardless 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
EXPERIMENTALThe 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.
Nurse Practitioner Only
EXPERIMENTALThe 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.
Interventions
Eligibility Criteria
You may qualify if:
- Newly admitted to the VNSNY post acute care program
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Visiting Nurse Service of New Yorklead
- National Institute of Neurological Disorders and Stroke (NINDS)collaborator
- NYU Langone Healthcollaborator
- Hebrew Home at Riverdalecollaborator
- Columbia Universitycollaborator
Study Sites (1)
Visiting Nurse Service of New York
New York, New York, 10001, United States
Related Publications (3)
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.
PMID: 34160182DERIVEDFeldman 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.
PMID: 31541606DERIVEDFeldman 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.
PMID: 25622823DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Penny H Feldman, PhD
Visiting Nurse Service of New York
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 5, 2013
First Posted
August 8, 2013
Study Start
September 1, 2012
Primary Completion
June 1, 2018
Study Completion
June 1, 2018
Last Updated
October 1, 2019
Record last verified: 2019-09