HIV/AIDSNCT02259634
Study on the Impact of Patient Navigators on the Health Education and Quality of Life in Formerly Incarcerated Patients
A study testing Patient Navigation in people with HIV/AIDS and Diabetes Mellitus, run by St. Luke's-Roosevelt Hospital Center at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV/AIDS, Diabetes Mellitus, Hypertension
- What is being tested?
- Patient Navigation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2014to Apr 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age 18 years or older
- English or Spanish speaking
- release from the correctional system within the previous 6 months
Who cannot join
- unable to provide informed consent
- report duration of incarceration of less than 5 days
- report history of incarceration more than 6 months ago
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Mount Sinai St. Luke's
New York, New York, 10025
Hunter College at The City University of New York
New York, New York, 10065
About this study
Official title: Impact of Patient Navigators on Health Education and Quality of Life in Formerly Incarcerated Patients
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.
Read the 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?
- Conditions
- HIV/AIDS, Diabetes Mellitus, Hypertension, Substance Use
- Being tested
- Patient Navigation
- Keywords
- Patient Navigation, Motivational Interviewing, Formerly Incarcerated, Health Education, Quality of Life, Healthcare Utilization
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Diabetes Mellitus, Hypertension, Substance-Related Disorders, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient NavigationBehavioural
Motivational Interviewing
| Study group | Role | What they receive |
|---|---|---|
| Patient Navigation | Experimental | Intensive Patient Navigation with Motivational Interviewing and Health Education for 8 months 18 month follow-up Receives: Behavioral: Patient Navigation |
| Treatment as Usual | No intervention | Case Management and Medical Care as provided by the Coming Home Program at Mount Sinai St. Luke's Institute of Advanced Medicine, Morningside Clinic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health Education Impact
Health education impact questionnaire (heiQ)
Measured: 18 months
Quality of Life
Health related quality of life (HRQOL-14)
Measured: 18 months
Secondary outcomes (2)
Health Outcomes
Glycemic index, blood pressure control, and/or virological suppression in HIV-infected
Measured: 18 months
Healthcare Utilization
Adherence to clinical appointments and contact with emergency services (emergency department)
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2014 (estimated)
- Study startJun 2014
- Primary completionApr 2015
- Study completionApr 2015
Why it stopped: Target sample size not reached for enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Luke's-Roosevelt Hospital Center
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, Hunter College of The City University of New York
- Responsible party
- Sponsor
- Investigators
- Georgina Osorio, MD, MPH, Principal investigator, St. Luke's-Roosevelt Hospital Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02259634
- Sponsor's protocol ID
- AD-1304-6854
- Status last verified
- Aug 2015
- First submitted
- 15 Sep 2014
- Last updated
- 20 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Patient Navigators on Health Education and Quality of Life in Formerly Incarcerated Patients
- ClinicalTrials.gov ID
- NCT02259634
- Acronym / sponsor ID
- AD-1304-6854
- Conditions
- HIV/AIDS, Diabetes Mellitus, Hypertension, Substance Use
- Keywords
- Patient Navigation, Motivational Interviewing, Formerly Incarcerated, Health Education, Quality of Life, Healthcare Utilization
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Target sample size not reached for enrollment.
- Enrolment
- 144 participants (actual)
- Lead sponsor
- St. Luke's-Roosevelt Hospital CenterUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, Hunter College of The City University of New York
- Study start
- Jun 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 8 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient Navigation | Experimental | Behavioral: Patient NavigationIntensive Patient Navigation with Motivational Interviewing and Health Education for 8 months 18 month follow-up |
| Treatment as Usual | No intervention | –Case Management and Medical Care as provided by the Coming Home Program at Mount Sinai St. Luke's Institute of Advanced Medicine, Morningside Clinic |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age 18 years or older
- English or Spanish speaking
- release from the correctional system within the previous 6 months
Key exclusion criteria (3 listed)
- unable to provide informed consent
- report duration of incarceration of less than 5 days
- report history of incarceration more than 6 months ago
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient NavigationMotivational Interviewing | Behavioural | Patient Navigation |
Primary outcome
Health Education Impact
Time frame: 18 months
Health education impact questionnaire (heiQ)
Quality of Life
Time frame: 18 months
Health related quality of life (HRQOL-14)
2 secondary outcomes
Health Outcomes
Time frame: 18 months
Healthcare Utilization
Time frame: 18 months
Results and safety
The study was stopped early (reason given: Target sample size not reached for enrollment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Georgina Osorio, MD, MPH principal investigator
St. Luke's-Roosevelt Hospital Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient Navigation in people with HIV/AIDS and Diabetes Mellitus, run by St. Luke's-Roosevelt Hospital Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Target sample size not reached for enrollment.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health Education Impact (time frame: 18 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2015.