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A remote monitoring and telephone nurse coaching intervention to reduce readmissions among patients with heart failure: study protocol for the Better Effectiveness After Transition - Heart Failure (BEAT-HF) randomized controlled trial.

ABSTRACT: Heart failure is a prevalent health problem associated with costly hospital readmissions. Transitional care programs have been shown to reduce readmissions but are costly to implement. Evidence regarding the effectiveness of telemonitoring in managing the care of this chronic condition is mixed. The objective of this randomized controlled comparative effectiveness study is to evaluate the effectiveness of a care transition intervention that includes pre-discharge education about heart failure and post-discharge telephone nurse coaching combined with home telemonitoring of weight, blood pressure, heart rate, and symptoms in reducing all-cause 180-day hospital readmissions for older adults hospitalized with heart failure.A multi-center, randomized controlled trial is being conducted at six academic health systems in California. A total of 1,500 patients aged 50 years and older will be enrolled during a hospitalization for treatment of heart failure. Patients in the intervention group will receive intensive patient education using the 'teach-back' method and receive instruction in using the telemonitoring equipment. Following hospital discharge, they will receive a series of nine scheduled health coaching telephone calls over 6 months from nurses located in a centralized call center. The nurses also will call patients and patients' physicians in response to alerts generated by the telemonitoring system, based on predetermined parameters. The primary outcome is readmission for any cause within 180 days. Secondary outcomes include 30-day readmission, mortality, hospital days, emergency department (ED) visits, hospital cost, and health-related quality of life.BEAT-HF is one of the largest randomized controlled trials of telemonitoring in patients with heart failure, and the first explicitly to adapt the care transition approach and combine it with remote telemonitoring. The study population also includes patients with a wide range of demographic and socioeconomic characteristics. Once completed, the study will be a rich resource of information on how best to use remote technology in the care management of patients with chronic heart failure.ClinicalTrials.gov # NCT01360203.

SUBMITTER: Black JT

PROVIDER: S-EPMC3990010 | biostudies-literature | 2014 Apr

REPOSITORIES: biostudies-literature

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A remote monitoring and telephone nurse coaching intervention to reduce readmissions among patients with heart failure: study protocol for the Better Effectiveness After Transition - Heart Failure (BEAT-HF) randomized controlled trial.

Black Jeanne T JT Romano Patrick S PS Sadeghi Banafsheh B Auerbach Andrew D AD Ganiats Theodore G TG Greenfield Sheldon S Kaplan Sherrie H SH Ong Michael K MK

Trials 20140413

<h4>Background</h4>Heart failure is a prevalent health problem associated with costly hospital readmissions. Transitional care programs have been shown to reduce readmissions but are costly to implement. Evidence regarding the effectiveness of telemonitoring in managing the care of this chronic condition is mixed. The objective of this randomized controlled comparative effectiveness study is to evaluate the effectiveness of a care transition intervention that includes pre-discharge education abo ...[more]

PMID: 24725308

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Project description:IMPORTANCE:It remains unclear whether telemonitoring approaches provide benefits for patients with heart failure (HF) after hospitalization. OBJECTIVE:To evaluate the effectiveness of a care transition intervention using remote patient monitoring in reducing 180-day all-cause readmissions among a broad population of older adults hospitalized with HF. DESIGN, SETTING, AND PARTICIPANTS:We randomized 1437 patients hospitalized for HF between October 12, 2011, and September 30, 2013, to the intervention arm (715 patients) or to the usual care arm (722 patients) of the Better Effectiveness After Transition-Heart Failure (BEAT-HF) study and observed them for 180 days. The dates of our study analysis were March 30, 2014, to October 1, 2015. The setting was 6 academic medical centers in California. Participants were hospitalized individuals 50 years or older who received active treatment for decompensated HF. INTERVENTIONS:The intervention combined health coaching telephone calls and telemonitoring. Telemonitoring used electronic equipment that collected daily information about blood pressure, heart rate, symptoms, and weight. Centralized registered nurses conducted telemonitoring reviews, protocolized actions, and telephone calls. MAIN OUTCOMES AND MEASURES:The primary outcome was readmission for any cause within 180 days after discharge. Secondary outcomes were all-cause readmission within 30 days, all-cause mortality at 30 and 180 days, and quality of life at 30 and 180 days. RESULTS:Among 1437 participants, the median age was 73 years. Overall, 46.2% (664 of 1437) were female, and 22.0% (316 of 1437) were African American. The intervention and usual care groups did not differ significantly in readmissions for any cause 180 days after discharge, which occurred in 50.8% (363 of 715) and 49.2% (355 of 722) of patients, respectively (adjusted hazard ratio, 1.03; 95% CI, 0.88-1.20; P = .74). In secondary analyses, there were no significant differences in 30-day readmission or 180-day mortality, but there was a significant difference in 180-day quality of life between the intervention and usual care groups. No adverse events were reported. CONCLUSIONS AND RELEVANCE:Among patients hospitalized for HF, combined health coaching telephone calls and telemonitoring did not reduce 180-day readmissions. TRIAL REGISTRATION:clinicaltrials.gov Identifier: NCT01360203.

Project description:AimsHeart failure (HF) readmission commonly arises owing to insufficient patient knowledge and failure of recognition of the early stages of recurrent fluid congestion. In previous work, we developed a score to predict short-term hospital readmission and showed that higher-risk patients benefit most from a disease management programme (DMP) that included enhancing knowledge and education by a nurse. We aim to evaluate the effectiveness of a novel, nurse-led HF DMP in selected patients at high risk of short-term hospital readmission, using ultrasound-guided diuretic management and artificial intelligence to enhance HF knowledge in an outpatient setting.Methods and resultsRisk-HF is a prospective multisite randomized controlled trial that will allocate 404 patients hospitalized with acute decompensated HF, and ≥33% risk of readmission and/or death at 30 days, into risk-guided nurse intervention (DMP-Plus group) compared with usual care. Intervention elements include (i) fluid management with a handheld ultrasound (HHU) device at point of care; (ii) post-discharge follow-up; (iii) optimal programmed drug titration; (iv) better transition of care; (v) intensive self-care education via an avatar-based 'digital health coach'; and (vi) exercise guidance through the digital coach. Usual care involves standard post-discharge hospital care. The primary outcome is reduced death and/or hospital readmissions at 30 days post-discharge, and secondary outcomes include quality of life, fluid management efficacy, and feasibility and patient engagement. Assuming that our intervention will reduce readmissions and/or deaths by 50%, with a 1:1 ratio of intervention vs. usual care, we plan to randomize 404 patients to show a difference at a statistical power of 80%, using a two-sided alpha of 0.05. We anticipate this recruitment will be achieved by screening 2020 hospitalized HF patients for eligibility. An 8 week pilot programme of our digital health coach in 21 HF patients, age > 75 years, showed overall improvements in quality of life (13 of 21), self-care (12 of 21), and HF knowledge (13 of 21). A pilot of the use of HHU by nurses showed that it was feasible and accurate.ConclusionsThe Risk-HF trial will evaluate the effectiveness of a risk-guided intervention to improve HF outcomes and will evaluate the efficacy of trained HF nurses delivering a fluid management protocol that is guided by lung ultrasound with an HHU at point of care.

Project description:BACKGROUND:Heart failure (HF) is a chronic condition affecting nearly 5.7 million Americans and is a leading cause of morbidity and mortality. With an aging population, the cost associated with managing HF is expected to more than double from US $31 billion in 2012 to US $70 billion by 2030. Readmission rates for HF patients are high-25% are readmitted at 30 days and nearly 50% at 6 months. Low medication adherence contributes to poor HF management and higher readmission rates. Remote telehealth monitoring programs aimed at improved medication management and adherence may improve HF management and reduce readmissions. OBJECTIVE:The primary goal of this randomized controlled pilot study is to compare the MedSentry remote medication monitoring system versus usual care in older HF adult patients who recently completed a HF telemonitoring program. We hypothesized that remote medication monitoring would be associated with fewer unplanned hospitalizations and emergency department (ED) visits, increased medication adherence, and improved health-related quality of life (HRQoL) compared to usual care. METHODS:Participants were randomized to usual care or use of the remote medication monitoring system for 90 days. Twenty-nine participants were enrolled and the final analytic sample consisted of 25 participants. Participants completed questionnaires at enrollment and closeout to gather data on medication adherence, health status, and HRQoL. Electronic medical records were reviewed for data on baseline classification of heart function and the number of unplanned hospitalizations and ED visits during the study period. RESULTS:Use of the medication monitoring system was associated with an 80% reduction in the risk of all-cause hospitalization and a significant decrease in the number of all-cause hospitalization length of stay in the intervention arm compared to usual care. Objective device data indicated high adherence rates (95%-99%) among intervention group participants despite finding no significant difference in self-reported adherence between study arms. The intervention group had poorer heart function and HRQoL at baseline, and HRQoL declined significantly in the intervention group compared to controls. CONCLUSIONS:The MedSentry medication monitoring system is a promising technology that merits continued development and evaluation. The MedSentry medication monitoring system may be useful both as a standalone system for patients with complex medication regimens or used to complement existing HF telemonitoring interventions. We found significant reductions in risk of all-cause hospitalization and the number of all-cause length of stay in the intervention group compared to controls. Although HRQoL deteriorated significantly in the intervention group, this may have been due to the poorer HF-functioning at baseline in the intervention group compared to controls. Telehealth medication adherence technologies, such as the MedSentry medication monitoring system, are a promising method to improve patient self-management,the quality of patient care, and reduce health care utilization and expenditure for patients with HF and other chronic diseases that require complex medication regimens. TRIAL REGISTRATION:ClinicalTrials.gov NCT01814696; https://clinicaltrials.gov/ct2/show/study/NCT01814696 (Archived by WebCite® at http://www.webcitation.org/6giqAVhno).

Project description:BACKGROUND:Presently, 6.5 million Americans are living with heart failure (HF). These patients are expected to follow a complex self-management regimen at home. Several demographic and psychosocial factors limit patients with HF in following the prescribed self-management recommendations at home. Poor self-care is associated with increased hospital re-admissions. Under the Affordable Care Act, there are financial implications related to hospital re-admissions for hospitals and programs such as the Program of All-Inclusive Care for the Elderly (PACE) in Pinellas County, Florida. Previous studies and systematic reviews demonstrated improvement in self-management and quality of life (QoL) in patients with HF with structured telephone support (STS) and short message service text messaging (SMS). OBJECTIVE:This study aimed to evaluate the effects of STS and SMS on self-care, knowledge, medication adherence, and QoL of patients with HF. METHODS:A prospective quality improvement project using a pre-post design was implemented. Data were collected at baseline, 30 days, and 3 months from 51 patients with HF who were enrolled in PACE in Pinellas County, Florida. All participants received STS and SMS for 30 days. The feasibility and sustained benefit of using STS and SMS was assessed at a 3-month follow-up. RESULTS:A paired t test was used to compare the mean difference in HF outcomes at the baseline and 30-day follow-up, which demonstrated improved HF self-care maintenance (t49=0.66; P=.01), HF knowledge (t49=0.71; P=.01), medication adherence (t49=0.92; P=.01), and physical and mental health measured using Short-Form-12 (SF-12; t49=0.81; P=.01). The results also demonstrated the sustained benefit with improved HF self-care maintenance, self-care management, self-care confidence, knowledge, medication adherence, and physical and mental health (SF-12) at 3 months with P<.05 for all outcomes. Living status and social support had a strong correlation with HF outcomes. Younger participants (aged less than 65 years) performed extremely well compared with older adults. CONCLUSIONS:STS and SMS were feasible to use among PACE participants with sustained benefits at 3 months. Implementing STS and SMS may serve as viable options to improve HF outcomes. Improving outcomes with HF affects hospital systems and the agencies that monitor and provide care for outpatients and those in independent or assisted-living facilities. Investigating viable options and support for implementation will improve outcomes.

Dataset Information

A remote monitoring and telephone nurse coaching intervention to reduce readmissions among patients with heart failure: study protocol for the Better Effectiveness After Transition - Heart Failure (BEAT-HF) randomized controlled trial.

Publications

A remote monitoring and telephone nurse coaching intervention to reduce readmissions among patients with heart failure: study protocol for the Better Effectiveness After Transition - Heart Failure (BEAT-HF) randomized controlled trial.

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