HypertensionNCT01863290
Linking Former Inmates to Primary Care
An observational study of Hypertension and Substance Abuse, run by Yale University at 11 sites in 2 countries.
Trial summary
The Transitions Clinic Network (TCN)aims to connect former inmates to primary care using trained, culturally competent primary care providers and community health workers (CHWs). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension, Substance Abuse, Asthma
- What is being tested?
- Primary care redesign
- How many people
- 816 participants
- Where
- 11 sitesin 2 countries
- Study dates
- May 2013to May 2016
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Former inmates; released from state or federal prisons.
Who may be able to join
- Recently-released from prison (within one month)
- Has >=1 chronic disease condition , and/or age >=50 years
- Plans to live in the TCN area for the duration of the study
- Understands English or Spanish and able to provide consent
Who cannot join
- Does not plan to live in the TCN area for the duration of the study
- Does not understand English or Spanish, or unable to provide consent
- Does not plan to receive healthcare through a TCN clinic
Trial locations and contacts
11 sites in 2 countries.
11 sites in 2 countries
United States10 sites
East Baltimore Medical Center
Baltimore, Maryland, 21287
University of Alabama
Birmingham, Alabama, 25294-4410
Boston Healthcare for the Homeless Program
Boston, Massachusetts, 02118
Contra Costa Health Services (East and West Contra Costa)
Martinez, California, 94553
Yale Primary Care Center
New Haven, Connecticut, 06520
Morningside Clinic
New York, New York, 10025
Montefiore Transition Clinic
New York, New York, 10467
Medicine in Psychiatry Service clinic of the University of Rochester Medical Center
Rochester, New York, 14642
Southeast Health Center
San Francisco, California, 94103
Santa Clara Health Center
San Jose, California, 95128
About this study
Official title: Transitions Clinic Network: Linking High-Risk Medicaid Patients From Prison to Community Primary Care
The Transitions Clinic Network (TCN)aims to connect former inmates to primary care using trained, culturally competent primary care providers and community health workers (CHWs). The purpose of this project is to support ongoing quality improvement at the 13 participating sites by training culturally competent CHWs and measuring the health, health care utilization, and the costs of caring for former inmates.
Read the detailed description
The Transitions Clinic Network (TCN) is a network of 13 community-based transitional healthcare programs, which aim to improve health, improve health care, and lower costs for vulnerable, high-risk Medicaid patients returning from prison across the United States. The TCN aims to connect individuals released from prison to primary care using trained, culturally competent primary care providers and community health workers (CHWs). The providers and CHWs, help patients obtain timely healthcare; promote healthy reintegration into their communities; provide care coordination and chronic disease management; and prevent unnecessary emergency department utilization and hospitalizations.
The project supports ongoing quality improvement at each of the 13 clinical sites by measuring the health, health care utilization, and the costs of caring for recently released patients. We will prospectively examine the rates of primary care engagement, acute care utilization, substance abuse and reported health, and recidivism in a cohort of 2000 patients recently released from prison receiving primary care at the 13 TCN programs. We will compare these rates of utilization at 6, 12, 18, 24, 30, 36 months to patient self-reported utilization prior to incarceration and historical controls.
Additionally, we aim to describe the implementation of, fidelity to, and sustainability of the TCN model in each of these clinical programs. Specifically, we aim to capture assets and barriers to starting and sustaining primary care programs targeting returning prisoners.
- Conditions
- Hypertension, Substance Abuse, Asthma, Depression
- Being tested
- Primary care redesign
- Keywords
- prison, reentry, health care utilization
- Medical subject headings
- Hypertension, Substance-Related Disorders, Asthma, Depression, Patient Acceptance of Health Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primary care redesignOther
Connect individuals released from prison to primary care using trained, culturally competent primary care providers and community health workers (CHWs).
| Study group | Role | What they receive |
|---|---|---|
| Former inmates | Former inmates with a chronic disease condition or aged 50 years and above engaged into primary care through an innovative primary care redesign model of the Transitions Clinic Network. Receives: Other: Primary care redesign |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health outcomes
Patient health outcomes and quality of life, including self reported health, depression severity, hypertension, and relapse to alcohol and substance use.
Measured: One year
Secondary outcomes (2)
Cost savings to the Centers for Medicare & Medicaid Services
Cost savings from prevented emergency department visits and hospitalizations, as well as improved health and decreased recidivism
Measured: 3 years
Health care utilization
Rates of engagement with primary care, all cause emergency department utilization and hospitalization rates, emergency department utilization and hospitalization rates for ambulatory care sensitive conditions.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2013 (estimated)
- Study startMay 2013
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 816 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emily A Wang, MD, MAS, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01863290
- Sponsor's protocol ID
- 1301011280
- Status last verified
- Oct 2017
- First submitted
- 22 May 2013
- Last updated
- 25 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Redmond N, Aminawung JA, Morse DS, Zaller N, Shavit S, Wang EA. Perceived Discrimination Based on Criminal Record in Healthcare Settings and Self-Reported Health Status among Formerly Incarcerated Individuals. J Urban Health. 2020 Feb;97(1):105-111. doi: 10.1007/s11524-019-00382-0.
PubMed 31628588
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transitions Clinic Network: Linking High-Risk Medicaid Patients From Prison to Community Primary Care
- ClinicalTrials.gov ID
- NCT01863290
- Acronym / sponsor ID
- 1301011280
- Conditions
- Hypertension, Substance Abuse, Asthma, Depression
- Keywords
- prison, reentry, health care utilization
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 816 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 27 May 2013 (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.
The Transitions Clinic Network (TCN)aims to connect former inmates to primary care using trained, culturally competent primary care providers and community health workers (CHWs). The purpose of this project is to support ongoing quality improvement at the 13 participating sites by training culturally competent CHWs and measuring the health, health care utilization, and the costs of caring for former inmates.
Detailed description
The Transitions Clinic Network (TCN) is a network of 13 community-based transitional healthcare programs, which aim to improve health, improve health care, and lower costs for vulnerable, high-risk Medicaid patients returning from prison across the United States. The TCN aims to connect individuals released from prison to primary care using trained, culturally competent primary care providers and community health workers (CHWs). The providers and CHWs, help patients obtain timely healthcare; promote healthy reintegration into their communities; provide care coordination and chronic disease management; and prevent unnecessary emergency department utilization and hospitalizations.
The project supports ongoing quality improvement at each of the 13 clinical sites by measuring the health, health care utilization, and the costs of caring for recently released patients. We will prospectively examine the rates of primary care engagement, acute care utilization, substance abuse and reported health, and recidivism in a cohort of 2000 patients recently released from prison receiving primary care at the 13 TCN programs. We will compare these rates of utilization at 6, 12, 18, 24, 30, 36 months to patient self-reported utilization prior to incarceration and historical controls.
Additionally, we aim to describe the implementation of, fidelity to, and sustainability of the TCN model in each of these clinical programs. Specifically, we aim to capture assets and barriers to starting and sustaining primary care programs targeting returning prisoners.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Former inmates | – | Other: Primary care redesignFormer inmates with a chronic disease condition or aged 50 years and above engaged into primary care through an innovative primary care redesign model of the Transitions Clinic Network. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Former inmates; released from state or federal prisons.
Key inclusion criteria (4 listed)
- Recently-released from prison (within one month)
- Has >=1 chronic disease condition , and/or age >=50 years
- Plans to live in the TCN area for the duration of the study
- Understands English or Spanish and able to provide consent
Key exclusion criteria (3 listed)
- Does not plan to live in the TCN area for the duration of the study
- Does not understand English or Spanish, or unable to provide consent
- Does not plan to receive healthcare through a TCN clinic
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 |
|---|---|---|
| Primary care redesignConnect individuals released from prison to primary care using trained, culturally competent primary care providers and community health workers (CHWs). | Other | Former inmates |
Primary outcome
Health outcomes
Time frame: One year
Patient health outcomes and quality of life, including self reported health, depression severity, hypertension, and relapse to alcohol and substance use.
2 secondary outcomes
Cost savings to the Centers for Medicare & Medicaid Services
Time frame: 3 years
Health care utilization
Time frame: One year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2017.
- Derived from this study: PubMed 31628588Redmond N, Aminawung JA, Morse DS, Zaller N, Shavit S, Wang EA. Perceived Discrimination Based on Criminal Record in Healthcare Settings and Self-Reported Health Status among Formerly Incarcerated Individuals. J Urban Health. 2020 Feb;97(1):105-111. doi: 10.1007/s11524-019-00382-0.
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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.
Emily A Wang, MD, MAS principal investigator
Yale University
11 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension and Substance Abuse, run by Yale University at 11 sites in 2 countries.
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 4 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: finished, as of the sponsor's last update on 25 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States, Puerto Rico. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 outcomes (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01863290, which also lists 1 linked publication.
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 25 Oct 2017.