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临床试验/NCT02723019
NCT02723019已完成不适用

Mi Puente: My Bridge to Better Cardiometabolic Health and Well-Being

Scripps Whittier Diabetes Institute2 个研究点 分布在 1 个国家目标入组 536 人开始时间: 2016年7月14日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
536
试验地点
2
主要终点
Number of Patients With at Least 1 Hospital Readmission Within 180 Days After Enrollment

研究概览

简要总结

Mi Puente (or "My Bridge") is a culturally-tailored, interdisciplinary approach designed to support at-risk Hispanic patients and their caregivers pre- and post-hospital discharge as they navigate the multi-level barriers that contribute to inequities in health care access and use, and in turn, perpetuate disparities in cardiometabolic and behavioral health. Mi Puente utilizes a sustainable nurse + volunteer peer team-based model, bridging partnership between inpatient and outpatient care settings to meet the integrated (i.e., physical and behavioral) health needs of Hispanics who are hospitalized with multiple chronic cardiometabolic conditions and one or more behavioral health concern(s). Participants will be tested at Scripps Mercy Hospital - a large, non-profit, safety net hospital located in the US/Mexico border region of South San Diego County, California. The proposed randomized controlled trial will test Mi Puente versus Usual Care (evidence-based, best practice discharge procedures) in improving hospital utilization, patient-reported, and cost effectiveness outcomes. Electronic medical records (EMR) will be used to identify eligible patients and examine primary outcomes.

详细描述

This study targets disparities in cardiometabolic disease prevalence and outcomes, and the unmet behavioral health needs in the US Hispanic population. Differences in the quantity and quality of health care targeted to and received by members of the Hispanic population contribute to these disparities. Inequities in health care access and use are likely the result of an interaction of several multi-level factors, such as those related to low Socio-Economic Status (e.g., lack of transportation or health coverage, time constraints, unsafe environments, knowledge barriers), cultural factors, language or communication-style differences, and others. Mi Puente (or "My Bridge") is a culturally-tailored, interdisciplinary approach designed to support at-risk Hispanic patients and their caregivers pre- and post-hospital discharge as they navigate the multi-level barriers that contribute to inequities in health care access and use, and in turn, perpetuate disparities in cardiometabolic and behavioral health. Mi Puente builds upon a sustainable nurse + volunteer peer team-based model and a strong collaborative, bridging partnership between inpatient and outpatient care settings to meet the integrated (i.e., physical and behavioral) health needs of Hispanics who are hospitalized with multiple chronic cardiometabolic conditions and one or more behavioral health concern(s). The program is guided by the Social Ecological Model,34 Resources and Support for Self-Management Model,35,36 and Transtheoretical Model of behavior change,37,38 and will be tested at Scripps Mercy Hospital - a large, non-profit, safety net hospital located in the US/Mexico border region of South San Diego County, California. The proposed randomized controlled trial will test Mi Puente versus Usual Care (evidence-based, best practice discharge procedures) in improving hospital utilization, patient-reported, and cost effectiveness outcomes. Electronic medical records (EMR) will be used to identify eligible patients and examine primary outcomes. Ultimately the investigators seek to evaluate an effective, culturally appropriate, sustainable, and scalable program that addresses integrated health needs and reduces health disparities in Hispanics and other at-risk populations.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Must be Hispanic
  • Must be ≥18 years
  • Must have ≥2 cardiometabolic conditions (e.g., obesity, diabetes, hypertension, dyslipidemia ischemic heart diseases, congestive heart failure, other chronic coronary conditions)
  • Must have ≥1 behavioral health concern(s) (i.e., related to mental health, life stressors, medication adherence, healthcare use)
  • Must have telephone access

排除标准

  • Serious life-threatening condition with life expectancy < 6 months
  • Psychiatric morbidity or neurological/cognitive impairment of sufficient severity to preclude participation in the intervention
  • Discharging to location other than home (e.g., nursing care)
  • Does not speak Spanish or English

结局指标

主要结局

Number of Patients With at Least 1 Hospital Readmission Within 180 Days After Enrollment

时间窗: 180 days from baseline

Number of patients with at least one hospital readmission within 180 days after enrollment

Number of Patients With at Least 1 Hospital Readmission Within 30 Days After Enrollment

时间窗: 30 days from baseline

Number of patients with at least one hospital readmission within 30 days after enrollment

次要结局

  • Patient Activation Measure (PAM) 13-Item - Patient-reported Outcome(6 months from baseline)
  • Patient-Reported Outcomes Measurement Information System (PROMIS) Global-10 Health Scale - Patient-reported Outcome(6 months from baseline)
  • Self-Management Resources for Chronic Disease, Chronic Illness Resources Survey (CIRS) - Short Version - Patient-reported Outcome(6 months from baseline)
  • Number of Outpatient Visits Over the Past 6 Months - Patient-reported(6 months from baseline)

研究者

发起方
Scripps Whittier Diabetes Institute
申办方类型
Other
责任方
Principal Investigator
主要研究者

Athena Philis-Tsimikas

Principal Investigator

Scripps Whittier Diabetes Institute

研究点 (2)

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