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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02259634
• Other study ID #: AD-1304-6854
• Status: Terminated
• Phase: N/A
• First received: September 15, 2014
• Last updated: August 18, 2015
• Start date: June 2014
• Est. completion date: April 2015

Study information

• Verified date: August 2015
• Source: St. Luke's-Roosevelt Hospital Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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?

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 144
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Diabetes Mellitus
• HIV/AIDS
• Hypertension
• Substance Use

Intervention

Behavioral:
• Patient Navigation
Motivational Interviewing

Locations

Country	Name	City	State
United States	Hunter College at The City University of New York	New York	New York
United States	Mount Sinai St. Luke's	New York	New York

Sponsors (3)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Health Education Impact	Health education impact questionnaire (heiQ)	18 months	No
Primary	Quality of Life	Health related quality of life (HRQOL-14)	18 months	No
Secondary	Health Outcomes	Glycemic index, blood pressure control, and/or virological suppression in HIV-infected	18 months	No
Secondary	Healthcare Utilization	Adherence to clinical appointments and contact with emergency services (emergency department)	18 months	No