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

Not Applicable

Terminated

• Conditions: Hypertension; Substance Use; HIV/AIDS; Diabetes Mellitus
• Interventions: Behavioral: Patient Navigation

• Registration Number: NCT02259634
• Lead Sponsor: St. Luke's-Roosevelt Hospital Center

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?

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-09-15
• Study First Submitted QC: 2014-10-07
• Study First Posted: 2014-10-08
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-18
• Last Update Posted: 2015-08-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 144

Inclusion Criteria

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patient Navigation	Patient Navigation	Intensive Patient Navigation with Motivational Interviewing and Health Education for 8 months 18 month follow-up

Primary Outcome Measures

Name	Time	Method
Health Education Impact	18 months	Health education impact questionnaire (heiQ)
Quality of Life	18 months	Health related quality of life (HRQOL-14)

Secondary Outcome Measures

Name	Time	Method
Health Outcomes	18 months	Glycemic index, blood pressure control, and/or virological suppression in HIV-infected
Healthcare Utilization	18 months	Adherence to clinical appointments and contact with emergency services (emergency department)

Trial Locations

Locations (2)

Mount Sinai St. Luke's; 🇺🇸 New York, New York, United States

Hunter College at The City University of New York; 🇺🇸 New York, New York, United States