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Center for stroke disparities solutions community- based care transition interventions: study protocol of a randomized controlled trial.

ABSTRACT: Racial and ethnic disparities persist in stroke occurrence, recurrence, morbidity and mortality. Uncontrolled hypertension (HTN) is the most important modifiable risk factor for stroke risk. Home health care organizations care for many patients with uncontrolled HTN and history of stroke; however, recurrent stroke prevention has not been a home care priority. We are conducting a randomized controlled trial (RCT) to compare the effectiveness, relative to usual home care (UHC), of two Community Transitions Interventions (CTIs). The CTIs aim to reduce recurrent stroke risk among post-stroke patients via home-based transitional care focused on better HTN management.This 3-arm trial will randomly assign 495 black and Hispanic post-stroke home care patients with uncontrolled systolic blood pressure (SBP) to one of three arms: UHC, UHC complemented by nurse practitioner-delivered transitional care (UHC?+?NP) or UHC complemented by an NP plus health coach (UHC?+?NP?+?HC). Both intervention arms emphasize: 1) linking patients to continuous, responsive preventive and primary care, 2) increasing patients'/caregivers' ability to manage a culturally and individually tailored BP reduction plan, and 3) facilitating the patient's reintegration into the community after home health care discharge. The primary hypothesis is that both NP-only and NP?+?HC transitional care will be more effective than UHC alone in achieving a SBP reduction. The primary outcome is change in SPB at 3 and 12 months. The study also will examine cost-effectiveness, quality of life and moderators (for example, race/ethnicity) and mediators (for example, changes in health behaviors) that may affect treatment outcomes. All outcome data are collected by staff blinded to group assignment.This study targets care gaps affecting a particularly vulnerable black/Hispanic population characterized by persistent stroke disparities. It focuses on care transitions, a juncture when patients are particularly susceptible to adverse events. The CTI is innovative in adapting for stroke patients an established transitional care model shown to be effective for HF patients, pairing the professional NP with a HC, implementing a culturally tailored intervention, and placing primary emphasis on longer-term risk factor reduction and community reintegration rather than shorter-term transitional care outcomes.ClinicalTrials.gov NCT01918891 ; Registered 5 August 2013.

SUBMITTER: Feldman PH

PROVIDER: S-EPMC4322449 | biostudies-literature | 2015 Jan

REPOSITORIES: biostudies-literature

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Center for stroke disparities solutions community- based care transition interventions: study protocol of a randomized controlled trial.

Feldman Penny H PH McDonald Margaret V MV Trachtenberg Melissa A MA Schoenthaler Antoinette A Coyne Noreen N Teresi Jeanne J

Trials 20150127

<h4>Background</h4>Racial and ethnic disparities persist in stroke occurrence, recurrence, morbidity and mortality. Uncontrolled hypertension (HTN) is the most important modifiable risk factor for stroke risk. Home health care organizations care for many patients with uncontrolled HTN and history of stroke; however, recurrent stroke prevention has not been a home care priority. We are conducting a randomized controlled trial (RCT) to compare the effectiveness, relative to usual home care (UHC), ...[more]

PMID: 25622823

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Project description:IntroductionThe objective of this parallel group, randomised controlled trial is to evaluate a community health navigator (CHN) intervention provided to patients aged over 40 years and living with chronic health conditions to transition from hospital inpatient care to their homes. Unplanned hospital readmissions are costly for the health system and negatively impact patients.Methods and analysisPatients are randomised post hospital discharge to the CHN intervention or usual care. A comparison of outcomes between intervention and control groups will use multivariate regression techniques that adjust for age, sex and any independent variables that are significantly different between the two groups, using multiple imputation for missing values. Time-to-event analysis will examine the relationship between seeing a CHN following discharge from the index hospitalisation and reduced rehospitalisations in the subsequent 60 days and 6 months. Secondary outcomes include medication adherence, health literacy, quality of life, experience of healthcare and health service use (including the cost of care). We will also conduct a qualitative assessment of the implementation of the navigator role from the viewpoint of stakeholders including patients, health professionals and the navigators themselves.Ethics approvalEthics approval was obtained from the Research Ethics and Governance Office, Sydney Local Health District, on 21 January 2022 (Protocol no. X21-0438 and 2021/ETH12171). The findings of the trial will be disseminated through peer-reviewed journals and national and international conference presentations. Data will be deposited in an institutional data repository at the end of the trial. This is subject to Ethics Committee approval, and the metadata will be made available on request.Trial registration numberAustralian New Zealand Clinical Trials Registry (ACTRN 12622000659707).Article summaryThe objective of this trial is to evaluate a CHN intervention provided to patients aged over 40 years and living with chronic health conditions to transition from hospital inpatient care to their homes.

Project description:Care transitions from the hospital to home are critical to the sustainability of our health care system. Ineffective care transitions can be caused by high incidences of post-discharge adverse events, by poor communication with patients, and/or by inadequate information transfer between providers from the hospital to home. Any one of these can lead to fragmented care, high readmission rates, increased visits to the emergency department, and ultimately poor patient outcomes. Despite the ongoing improvement efforts of health care organizations, the efficacy of person- and family-centered care transition interventions on the quality of care and on the patient experience are not known. The aim of this systematic review is to critically analyze the body of evidence regarding the effectiveness of person- and family-centered care transition interventions on the quality of care, and the experience of patients.We will conduct a systematic review using the Cochrane Handbook's guidelines and will adhere to a standardized reporting format: Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA). A comprehensive search strategy will be conducted in the following databases: MEDLINE, EMBASE, CINAHL, Cochrane Central Register of Controlled Trials, and the Cochrane Consumers and Communication Group. Following a two-step screening process, data including the full reference, objectives, target population, description of the intervention and control intervention, outcome measures, design, length of post-intervention follow-up period, and the study results will be extracted, synthesized, and reported. Risk of bias and quality of the studies will also be assessed.This systematic review will summarize and present the evidence base for person- and family-centered care transition interventions. This review will also inform further research and will lay the groundwork for more empirical studies on person- and family-centered care transitions. Specifically, the results of this systematic review may inform the development of measures to monitor safe and effective person- and family-centered transitions from the hospital to home. These results may also be important for policy makers, decision-makers, clinicians, and patients/families who are involved in navigating the health care system.PROSPERO CRD42017067990.

Project description:IntroductionThe virtual multidisciplinary stroke care clinic (VMSCC) is the first nurse-led clinic developed to offer support to community-dwelling stroke survivors and caregivers, and to promote poststroke recovery. This two-arm randomised controlled trial will evaluate its effectiveness on survivors' self-efficacy (SE), survivors' and caregivers' health-related quality of life (HRQoL) and cost-effectiveness on emergency admissions and length of readmission hospital stay.Methods and analysisA consecutive sample of 384 stroke survivor-caregiver dyads will be recruited from four hospitals. An online platform that embraces readily accessible and reliable information will be developed. Participants randomly assigned to the intervention group will receive usual care plus the VMSCC service. The service includes access to a tablet containing 30 videos demonstrating appropriate self-care strategies, communication with a registered nurse monthly through video and telephone calls and regular blood pressure monitoring. Primary outcomes include survivors' SE in self-management and survivors' and caregivers' HRQoL. Secondary outcomes include survivors' performance of self-management behaviours, depression and social participation; and caregivers' coping strategies, satisfaction with caring and depression. Data will be collected at baseline, and at 3 and 6 months after commencing the intervention. Survivors' and caregivers' satisfaction with the service will be assessed at 6-month follow-up. Multivariable regressions and generalised estimating equations model will be conducted. Survivors' emergency admissions and length of hospital stay will be evaluated during the 6-month follow-up period. Cost-effectiveness analysis will be performed on the average total cost incurred.DiscussionThe results will inform stakeholders about incorporating the VMSCC service into current stroke rehabilitation service.Ethics and disseminationThis protocol was approved by the Joint Chinese University of Hong Kong-New Territories East Cluster Clinical Research Ethics Committee (CREC Ref. No.: 2017.660). All participants will provide written informed consent. Results will be disseminated through scientific publications, and presentations at local and international conferences.Trial registration numberChiCTR1800016101; Pre-results.

Project description:INTRODUCTION:Survival after stroke is improving, leading to increased demand on primary care and community services to meet the long-term care needs of people living with stroke. No formal primary care-based holistic model of care with clinical trial evidence exists to support stroke survivors living in the community, and stroke survivors report that many of their needs are not being met. We have developed a multifactorial primary care model to address these longer term needs. We aim to evaluate the clinical and cost-effectiveness of this new model of primary care for stroke survivors compared with standard care. METHODS AND ANALYSIS:Improving Primary Care After Stroke (IPCAS) is a two-arm cluster-randomised controlled trial with general practice as the unit of randomisation. People on the stroke registers of general practices will be invited to participate. One arm will receive the IPCAS model of care including a structured review using a checklist; a self-management programme; enhanced communication pathways between primary care and specialist services; and direct point of contact for patients. The other arm will receive usual care. We aim to recruit 920 people with stroke registered with 46 general practices. The primary endpoint is two subscales (emotion and handicap) of the Stroke Impact Scale (SIS) as coprimary outcomes at 12 months (adjusted for baseline). Secondary outcomes include: SIS Short Form, EuroQol EQ-5D-5L, ICEpop CAPability measure for Adults, Southampton Stroke Self-management Questionnaire, Health Literacy Questionnaire and medication use. Cost-effectiveness of the new model will be determined in a within-trial economic evaluation. ETHICS AND DISSEMINATION:Favourable ethical opinion was gained from Yorkshire and the Humber-Bradford Leeds NHS Research Ethics Committee. Approval to start was given by the Health Research Authority prior to recruitment of participants at any NHS site. Data will be presented at national and international conferences and published in peer-reviewed journals. Patient and public involvement helped develop the dissemination plan. TRIAL REGISTRATION NUMBER:NCT03353519.

Project description:BackgroundStroke survivors constantly feel helpless and unprepared after discharge from hospitals. More flexible and pragmatic support are needed for their optimized recovery. We examined the effects of a virtual multidisciplinary stroke care clinic on survivors' health and self-management outcomes.MethodsA randomized controlled trial was conducted. Survivors were recruited from 10 hospitals and randomized at 1:1 ratio into the intervention or the control groups. Intervention group participants received the Virtual Multidisciplinary Stroke Care Clinic service (monthly online consultations with a nurse, follow-up phone calls, and access to an online platform). Control group participants received the usual care. Outcomes of self-efficacy (stroke self-efficacy questionnaire; primary), self-management behaviors (Stroke Self-Management Behaviors Performance Scale), social participation (reintegration to normal living index), and depression (Geriatric Depression Scale; secondary) were measured at baseline, and 3 and 6 months after commencing the intervention (post-randomization). A generalized estimating equations model was used to compare the differential changes in outcomes at 3 and 6 months with respect to baseline between 2 groups.ResultsBetween July 2019 and June 2022, 335 eligible participants were enrolled in the study. Participants (intervention group; n=166) showed significantly greater improvements in outcomes of self-efficacy (group-by-time interaction regression coefficient, B=4.60 [95% CI, 0.16 to 9.05]), social participation (B=5.07 [95% CI, 0.61 to 9.53]), and depression (B=-2.33 [95% CI, -4.06 to -0.61]), and no significant improvement in performance of self-management behaviors (B=3.45, [95% CI, -0.87 to 7.77]), compared with the control group (n=169) right after the intervention (6 months after its commencement). Hedges' g effect sizes of the intervention on outcomes: 0.19 to 0.36.ConclusionsThe results provide some positive evidence on the usefulness of the Virtual Multidisciplinary Stroke Care Clinic service. The effect sizes are regarded as small to medium, which may not be of clinical relevance. The baseline levels in outcomes were in favor of the control group, the intervention effects might be overestimated. The service must be tested further to determine its effectiveness.RegistrationURL: https://www.chictr.org.cn; Unique identifier: ChiCTR1800016101.

Project description:Racial-ethnic disparities in acute stroke care can contribute to inequality in stroke outcomes. We examined race-ethnic disparities in acute stroke performance metrics in a voluntary stroke registry among Florida and Puerto Rico Get With the Guidelines-Stroke hospitals.Seventy-five sites in the Florida Puerto Rico Stroke Registry (66 Florida and 9 Puerto Rico) recorded 58 864 ischemic stroke cases (2010-2014). Logistic regression models examined racial-ethnic differences in acute stroke performance measures and defect-free care (intravenous tissue plasminogen activator treatment, in-hospital antithrombotic therapy, deep vein thrombosis prophylaxis, discharge antithrombotic therapy, appropriate anticoagulation therapy, statin use, smoking cessation counseling) and temporal trends. Among ischemic stroke cases, 63% were non-Hispanic white (NHW), 18% were non-Hispanic black (NHB), 14% were Hispanic living in Florida, and 6% were Hispanic living in Puerto Rico. NHW patients were the oldest, followed by Hispanics, and NHBs. Defect-free care was greatest among NHBs (81%), followed by NHWs (79%) and Florida Hispanics (79%), then Puerto Rico Hispanics (57%) (P<0.0001). Puerto Rico Hispanics were less likely than Florida whites to meet any stroke care performance metric other than anticoagulation. Defect-free care improved for all groups during 2010-2014, but the disparity in Puerto Rico persisted (2010: NHWs=63%, NHBs=65%, Florida Hispanics=59%, Puerto Rico Hispanics=31%; 2014: NHWs=93%, NHBs=94%, Florida Hispanics=94%, Puerto Rico Hispanics=63%).Racial-ethnic/geographic disparities were observed for acute stroke care performance metrics. Adoption of a quality improvement program improved stroke care from 2010 to 2014 in Puerto Rico and all Florida racial-ethnic groups. However, stroke care quality delivered in Puerto Rico is lower than in Florida. Sustained support of evidence-based acute stroke quality improvement programs is required to improve stroke care and minimize racial-ethnic disparities, particularly in resource-strained Puerto Rico.

Project description:While prehospital triage to the closest comprehensive stroke center (CSC) may improve the delivery of care for patients with suspected emergent large-vessel occlusion (ELVO), efficient systems of care must also exist for patients with ELVO who first present to a primary stroke center (PSC).To describe the association of a PSC protocol focused on 3 key steps (early CSC notification based on clinical severity, vessel imaging at the PSC, and cloud-based image sharing) with the efficiency of care and the outcomes of patients with suspected ELVO who first present to a PSC.In this retrospective cohort study, 14 regional PSCs unfamiliar with the management of patients with ELVO were instructed on the use of the following protocol for patients presenting with a Los Angeles Motor Scale score 4 or higher: (1) notify the CSC on arrival, (2) perform computed tomographic angiography concurrently with noncontract computed tomography of the brain and within 30 minutes of arrival, and (3) share imaging data with the CSC using a cloud-based platform. A total of 101 patients were transferred from regional PSCs to the CSC between July 1, 2015, and May 31, 2016, and received mechanical thrombectomy for acute ischemic stroke. The CSC serves approximately 1.7 million people and partners with 14 PSCs located between 6.4 and 73.6 km away. All consecutive patients with internal carotid artery or middle cerebral artery occlusions transferred over an 11-month period were reviewed, and they were divided into 2 groups based on whether the PSC protocol was partially or fully executed.The primary outcomes were efficiency measures including time from PSC door in to PSC door out, time from PSC door to CSC groin puncture, and 90-day modified Rankin Scale score (range, 0-6; scores of 0-2 indicate a good outcome).Although 101 patients were transferred, only 70 patients met the inclusion criteria during the study period. The protocol was partially executed for 48 patients (68.6%) (mean age, 77 years [interquartile range, 65-84 years]; 22 of the 48 patients [45.0%] were women) and fully executed for 22 patients (31.4%) (mean age, 76 years [interquartile range, 59-86 years]; 13 of the 22 patients [59.1%] were women). When fully executed, the protocol was associated with a reduction in the median time for PSC arrival to CSC groin puncture (from 151 minutes [95% CI, 141-166 minutes] to 111 minutes [95% CI, 88-130 minutes]; P?<?.001). This was primarily related to an improvement in the time from PSC door in to door out that reduced from a median time of 104 minutes (95% CI, 82-112 minutes) to a median time of 64 minutes (95% CI, 51-71.0 minutes) (P?<?.001). When the protocol was fully executed, patients were twice as likely to have a favorable outcome (50% vs 25%, P?<?.04).When fully implemented, a standardized protocol at PSCs for patients with suspected ELVO consisting of early CSC notification, computed tomographic angiography on arrival to the PSC, and cloud-based image sharing is associated with a reduction in time to groin puncture and improved outcomes.

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Center for stroke disparities solutions community- based care transition interventions: study protocol of a randomized controlled trial.

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Center for stroke disparities solutions community- based care transition interventions: study protocol of a randomized controlled trial.

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