Clinical trial NCT01918891: Center for Stroke Disparities Solution - Community Transitions Intervention
Official title: Center for Stroke Disparities Solution (CSDS) Project II: Community Transitions Intervention (CTI)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Stroke
Transient Ischemic Attack
Keywords: stroke
transient ischemic attack
High blood pressure
Hypertension
Lead sponsor: Visiting Nurse Service of New York
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
name: NYU Langone Health
name: Hebrew Home at Riverdale
name: Columbia University
First posted: 2013-08-08
Enrollment: 495
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Reduction of systolic blood pressure
timeFrame: Baseline to 3 and 12 months.
Secondary outcomes:
measure: Cost-effectiveness of NP-only and NP+HC relative to UHC
timeFrame: VNSNY home care admission to 3 and 12 months post admission
measure: Influence on post-stroke patients' function and health-related quality of life (QoL)
timeFrame: Baseline to 3 and 12 months
Other outcomes:
measure: Moderators and mediators that may affect treatment outcomes
timeFrame: Baseline to 3 and 12 months
Locations:
city: New York
country: United States
facility: Visiting Nurse Service of New York
state: New York
Study officials:
affiliation: Visiting Nurse Service of New York
name: Penny H Feldman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.