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临床试验/NCT02259634
NCT02259634终止不适用

Impact of Patient Navigators on Health Education and Quality of Life in Formerly Incarcerated Patients

St. Luke's-Roosevelt Hospital Center2 个研究点 分布在 1 个国家目标入组 144 人开始时间: 2014年6月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
144
试验地点
2
主要终点
Health Education Impact

研究概览

简要总结

This is a 3-year prospective randomized comparative study of the efficacy of patient navigation on health education, health related quality of life, healthcare utilization, and medical outcomes in formerly incarcerated individuals. Individuals will be randomized to the patient-navigator intervention or to a care-as-usual control condition. A total of 300 recently incarcerated individuals will be enrolled with 150 subjects each in the intervention and usual care group.

The investigators hypothesize that the intervention will improve health education, health related quality of life, adherence to clinical appointments, glycemic/blood pressure control, and virologic suppression in HIV-infected. The results of this study will demonstrate interventions to eliminate health disparities in a highly marginalized group going through the transitional phase of re-entry into the community.

详细描述

This is a 3-year prospective randomized comparative trial that will examine the impact of an intervention that incorporates peer navigators to improve health education (heiQ), health related quality of life (HRQOL-14), healthcare utilization, and medical outcomes compared to usual care among formerly incarcerated individuals as they transition from the correctional system into the community over the course of 18 months. Multiple studies have shown the efficacy of patient navigators in improving healthcare utilization and outcomes in marginalized populations, but neither intervention has been studied with the formerly incarcerated population. A total of 300 formerly incarcerated individuals will be enrolled into the trial. This intervention is inherently patient-centered, as it facilitates a process by which patients continuously define and shape their engagement with the health care system. The potential impact of the study findings include: 1) evidence for or against the use of patient navigators to enhance linkage and engagement into care; 2) health outcomes that either support or discourage the use of patient navigators with formerly incarcerated people; 3) expansion of knowledge to inform the development of targeted interventions for this vulnerable population; and 4) dissemination of results that may contribute to larger scale studies that can be implemented widely with the aim at eliminating health disparities in a highly marginalized group of people. The investigators specific aim is to conduct a randomized comparative trial that will provide the evidence base to address two primary research questions:

  1. How does the use of patient navigators impact health education and health related quality of life of individuals as they transition from the correctional system into the community?
  2. How does a patient navigator for formerly incarcerated patients improve metrics of health care utilization (adherence to medical appointments, fewer visits to emergency rooms) and health outcomes (glycemic index, blood pressure control, and/or virological suppression in HIV-infected) compared to usual care of automated appointment reminder phone calls?

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
None

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

  • age 18 years or older
  • English or Spanish speaking
  • release from the correctional system within the previous 6 months

排除标准

  • unable to provide informed consent
  • report duration of incarceration of less than 5 days
  • report history of incarceration more than 6 months ago

结局指标

主要结局

Health Education Impact

时间窗: 18 months

Health education impact questionnaire (heiQ)

Quality of Life

时间窗: 18 months

Health related quality of life (HRQOL-14)

次要结局

  • Health Outcomes(18 months)
  • Healthcare Utilization(18 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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