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

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02259634
Enrollment
144
Registered
2014-10-08
Start date
2014-06-30
Completion date
2015-04-30
Last updated
2015-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, HIV/AIDS, Hypertension, Substance Use

Keywords

Patient Navigation, Motivational Interviewing, Formerly Incarcerated, Health Education, Quality of Life, Healthcare Utilization

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?

Interventions

BEHAVIORALPatient Navigation

Motivational Interviewing

Sponsors

Patient-Centered Outcomes Research Institute
CollaboratorOTHER
Hunter College of The City University of New York
CollaboratorOTHER
St. Luke's-Roosevelt Hospital Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Health Education Impact18 monthsHealth education impact questionnaire (heiQ)
Quality of Life18 monthsHealth related quality of life (HRQOL-14)

Secondary

MeasureTime frameDescription
Health Outcomes18 monthsGlycemic index, blood pressure control, and/or virological suppression in HIV-infected
Healthcare Utilization18 monthsAdherence to clinical appointments and contact with emergency services (emergency department)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026