Clinical trial NCT02259634: Study on the Impact of Patient Navigators on the Health Education and Quality of Life in Formerly Incarcerated Patients
Official title: Impact of Patient Navigators on Health Education and Quality of Life in Formerly Incarcerated Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: HIV/AIDS
Diabetes Mellitus
Hypertension
Substance Use
Keywords: Patient Navigation
Motivational Interviewing
Formerly Incarcerated
Health Education
Quality of Life
Healthcare Utilization
Lead sponsor: St. Luke's-Roosevelt Hospital Center
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
name: Hunter College of The City University of New York
First posted: 2014-10-08
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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?

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

Primary outcomes:
measure: Health Education Impact
timeFrame: 18 months
measure: Quality of Life
timeFrame: 18 months
Secondary outcomes:
measure: Health Outcomes
timeFrame: 18 months
measure: Healthcare Utilization
timeFrame: 18 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai St. Luke's
state: New York
city: New York
country: United States
facility: Hunter College at The City University of New York
state: New York
Study officials:
affiliation: St. Luke's-Roosevelt Hospital Center
name: Georgina Osorio, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: