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

Sponsor
St. Luke's-Roosevelt Hospital Center (Other)
Overall Status
Terminated
CT.gov ID
NCT02259634
Collaborator
Patient-Centered Outcomes Research Institute (Other), Hunter College of The City University of New York (Other)
144
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2
10
72
7.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Patient Navigation
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
144 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Impact of Patient Navigators on Health Education and Quality of Life in Formerly Incarcerated Patients
Study Start Date :
Jun 1, 2014
Actual Primary Completion Date :
Apr 1, 2015
Actual Study Completion Date :
Apr 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: Patient Navigation

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

Behavioral: Patient Navigation
Motivational Interviewing

No Intervention: Treatment as Usual

Case Management and Medical Care as provided by the Coming Home Program at Mount Sinai St. Luke's Institute of Advanced Medicine, Morningside Clinic

Outcome Measures

Primary Outcome Measures

  1. Health Education Impact [18 months]

    Health education impact questionnaire (heiQ)

  2. Quality of Life [18 months]

    Health related quality of life (HRQOL-14)

Secondary Outcome Measures

  1. Health Outcomes [18 months]

    Glycemic index, blood pressure control, and/or virological suppression in HIV-infected

  2. Healthcare Utilization [18 months]

    Adherence to clinical appointments and contact with emergency services (emergency department)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mount Sinai St. Luke's New York New York United States 10025
2 Hunter College at The City University of New York New York New York United States 10065

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Georgina Osorio, MD, MPH, St. Luke's-Roosevelt Hospital Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
St. Luke's-Roosevelt Hospital Center
ClinicalTrials.gov Identifier:
NCT02259634
Other Study ID Numbers:
  • AD-1304-6854
First Posted:
Oct 8, 2014
Last Update Posted:
Aug 20, 2015
Last Verified:
Aug 1, 2015
Keywords provided by St. Luke's-Roosevelt Hospital Center
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 20, 2015