Project Summary

*This project was terminated due to issues relating to its study enrollment.

Background: In January of 2008, nearly 2.3 million people were either currently or formerly incarcerated, representing an estimated 1 in every 100 adults in the United States. As of January 2011, an estimated 56,000 individuals in New York City were in custody: the majority were male (96%), on average 37 years old, black (51%), and first felony offenders (65%). Chronic medical conditions such as hypertension, cardiovascular disease, and diabetes have been reported in nearly a quarter of the prison population with high risk of mortality during the transition period of re-entry into the community. Recognizing the need for successful re-entry and linkage into care, St. Luke's-Roosevelt Hospital's Center for Comprehensive Care (SLRH CCC) established the Coming Home Program (CHP) in 2006. CHP has since served more than 1400 patients with many linked to care within 1 month of release.

Objectives: The primary specific aim of the study is to examine the effectiveness of using patient navigators to improve health education impact (heiQ) and quality of life (HRQOL-14) in formerly incarcerated individuals. Secondary aims are to examine the effectiveness of using patient navigators in improving health care utilization and medical outcomes.

Methods: This is a 3-year prospective randomized comparative study of the efficacy of patient navigation on health education, health-related quality of life, health care utilization, and medical outcomes in formerly incarcerated individuals. CHP patients at SLRH CCC will be recruited and screened for the study. Individuals will be randomized to the patient-navigator intervention or to a care-as-usual control condition (automated appointment reminder phone calls). Primary outcomes will be measures of heiQ and HRQOL-14. Secondary outcomes will be measures of health care utilization and chronic medical disease management (blood pressure control, trends in HgbA1c, and CD4 and HIV RNA in HIV-infected [patients] (sic)). A total of 300 recently incarcerated individuals will be enrolled, with 150 subjects each in the intervention and usual care group.

Patient Outcomes (Projected): This proposal responds to the PCORI call for “Addressing Disparities” as it will provide evidence for strategies to link and engage formerly incarcerated individuals into care, including:

  1. Do patient navigators improve the health education impact and quality of life of the individual? and
  2. Do patient navigators improve patient health care utilization and self-management of chronic diseases?

We 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 [patients] (sic). 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.

Project Information

Georgina Osorio, MD, MPH
St. Luke's-Roosevelt Hospital Center

Key Dates

September 2013
April 2015

Study Registration Information


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Last updated: June 23, 2023