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| ID | Type | Description | Link |
|---|---|---|---|
| 1U54NS081765 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Neurological Disorders and Stroke (NINDS) | NIH |
| NYU Langone Health | OTHER |
| Hebrew Home at Riverdale | OTHER |
| Columbia University |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Home Care | No Intervention | 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. | |
| Nurse Practitioner + Health Coach | Experimental | 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. |
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| Nurse Practitioner Only | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nurse Practitioner Only | Behavioral |
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| Nurse Practitioner + Health Coach |
| 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. |
| 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) |
| 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). |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Penny H Feldman, PhD | Visiting Nurse Service of New York | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Visiting Nurse Service of New York | New York | New York | 10001 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34160182 | Derived | 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. | |
| 31541606 | Derived | 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. |
| Label | URL |
|---|---|
| NYU School of Medicine - Center for Stroke Disparities Solutions | View source |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D020521 | Stroke |
| D002546 | Ischemic Attack, Transient |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
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| ID | Term |
|---|---|
| D009722 | Nurse Practitioners |
| ID | Term |
|---|---|
| D009726 | Nurses |
| D006282 | Health Personnel |
| D005159 | Health Care Facilities Workforce and Services |
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| OTHER |
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| Behavioral |
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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 |
| Baseline to 3 and 12 months |
| 25622823 | Derived | 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. |
| D002493 |
| Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D002545 | Brain Ischemia |