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Clinical Trials/NCT02259634
NCT02259634
Terminated
N/A

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

St. Luke's-Roosevelt Hospital Center2 sites in 1 country144 target enrollmentJune 2014

Overview

Phase
N/A
Intervention
Not specified
Conditions
HIV/AIDS
Sponsor
St. Luke's-Roosevelt Hospital Center
Enrollment
144
Locations
2
Primary Endpoint
Health Education Impact
Status
Terminated
Last Updated
10 years ago

Overview

Brief Summary

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.

Detailed Description

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?

Registry
clinicaltrials.gov
Start Date
June 2014
End Date
April 2015
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Health Education Impact

Time Frame: 18 months

Health education impact questionnaire (heiQ)

Quality of Life

Time Frame: 18 months

Health related quality of life (HRQOL-14)

Secondary Outcomes

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

Study Sites (2)

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