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

Primary Purpose

HIV/AIDS, Diabetes Mellitus, Hypertension

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Patient Navigation
Sponsored by
St. Luke's-Roosevelt Hospital Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for HIV/AIDS focused on measuring Patient Navigation, Motivational Interviewing, Formerly Incarcerated, Health Education, Quality of Life, Healthcare Utilization

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Mount Sinai St. Luke's
  • Hunter College at The City University of New York

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Patient Navigation

Treatment as Usual

Arm Description

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

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

Outcomes

Primary Outcome Measures

Health Education Impact
Health education impact questionnaire (heiQ)
Quality of Life
Health related quality of life (HRQOL-14)

Secondary Outcome Measures

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

Full Information

First Posted
September 15, 2014
Last Updated
August 18, 2015
Sponsor
St. Luke's-Roosevelt Hospital Center
Collaborators
Patient-Centered Outcomes Research Institute, Hunter College of The City University of New York
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1. Study Identification

Unique Protocol Identification Number
NCT02259634
Brief Title
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

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Terminated
Why Stopped
Target sample size not reached for enrollment.
Study Start Date
June 2014 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Luke's-Roosevelt Hospital Center
Collaborators
Patient-Centered Outcomes Research Institute, Hunter College of The City University of New York

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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: 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? 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?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV/AIDS, Diabetes Mellitus, Hypertension, Substance Use
Keywords
Patient Navigation, Motivational Interviewing, Formerly Incarcerated, Health Education, Quality of Life, Healthcare Utilization

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
144 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patient Navigation
Arm Type
Experimental
Arm Description
Intensive Patient Navigation with Motivational Interviewing and Health Education for 8 months 18 month follow-up
Arm Title
Treatment as Usual
Arm Type
No Intervention
Arm Description
Case Management and Medical Care as provided by the Coming Home Program at Mount Sinai St. Luke's Institute of Advanced Medicine, Morningside Clinic
Intervention Type
Behavioral
Intervention Name(s)
Patient Navigation
Intervention Description
Motivational Interviewing
Primary Outcome Measure Information:
Title
Health Education Impact
Description
Health education impact questionnaire (heiQ)
Time Frame
18 months
Title
Quality of Life
Description
Health related quality of life (HRQOL-14)
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Health Outcomes
Description
Glycemic index, blood pressure control, and/or virological suppression in HIV-infected
Time Frame
18 months
Title
Healthcare Utilization
Description
Adherence to clinical appointments and contact with emergency services (emergency department)
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Georgina Osorio, MD, MPH
Organizational Affiliation
St. Luke's-Roosevelt Hospital Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mount Sinai St. Luke's
City
New York
State/Province
New York
ZIP/Postal Code
10025
Country
United States
Facility Name
Hunter College at The City University of New York
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States

12. IPD Sharing Statement

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

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