Health Services Research, Prisons, Delivery of Health Care, Vulnerable Populations, Community Health AidesNCT01179035
Evaluation of Transitions Clinic: A Post-Release Clinic for Recently Released Parolees With Chronic Medical Conditions
A study testing Transitions Clinic - parolee-targeted care and Expedited Primary Care in people with Health Services Research, Prisons, Delivery of Health Care, Vulnerable Populations, Community Health Aides, run by Transitions Clinic at 1 site in United States.
Trial summary
The purpose of this study is to study the effectiveness of the Transitions Clinic, a post-release clinic for parolees with chronic medical conditions, in achieving increased primary care engagement, lower rates of inappropriate hospitalizations, psychiatric emergency service and emergency department use, and decreased… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Health Services Research, Prisons, Delivery of Health Care, Vulnerable Populations, Community Health Aides
- What is being tested?
- Transitions Clinic - parolee-targeted care and Expedited Primary Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- 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
- Adult, Older adult
Who may be able to join
- All adult parolees to San Francisco
- Must have one chronic condition or age >50 years old
Who cannot join
- Children
- Subjects who already have an established primary care provider in San Francisco
Trial locations and contacts
1 site in 1 country.
United States1 site
Southeast Health Center
San Francisco, California, 94124
About this study
Official title: The Impact of Parolee-Targeted Care Versus Expedited Usual Care on Health Care Utilization and Recidivism
The purpose of this study is to study the effectiveness of the Transitions Clinic, a post-release clinic for parolees with chronic medical conditions, in achieving increased primary care engagement, lower rates of inappropriate hospitalizations, psychiatric emergency service and emergency department use, and decreased recidivism.
We hypothesize that subjects receiving parolee-targeted care in the Transitions Clinic will have increased rates of non-emergency department ambulatory care and outpatient mental health care, lower rates of hospitalization, psychiatric emergency service (PES) utilization, emergency department (ED) utilization, decreased total hospital length of stay, and decreased recidivism compared to patients receiving primary care from other safety-net providers.
Read the detailed description
With ever increasing numbers of released inmates, policymakers are developing policy initiatives and directing funding towards community reentry programs for recent parolees to decrease recidivism and improve health outcomes. These reentry programs are comprehensive efforts that coordinate social and medical services for recently incarcerated people to achieve these aims. Due to documented poor health outcomes in this population and the resultant costs on the public health system, provision of medical care will be an integral part of these reentry initiatives. The manner in which medical care is incorporated into community reentry programs and directed to recently released prisoners needs to be studied to guide architects of reentry programs, policymakers and allocation of funding.
The Transitions Clinic (TC) was founded to address the medical needs of recently released prisoners. The TC is a pilot project designed to target primary care medical services to parolees in San Francisco and aid in coordination of medical and social services. It operates within the San Francisco Department of Public Health(SFDPH)-affiliated Community Health Network (CHN) and is part of the Safe Communities Reentry Council, a city-wide, collaborative effort of the Sheriff's office, Public Defenders' office and local community organizations to improve reentry services and outcomes for the 1500 annual parolees to San Francisco.
The proposed project will prospectively examine the effectiveness of the TC in achieving increased primary care engagement, decreased acute health care utilization and decreased recidivism. After intake in the TC, patients will be randomized to continued, parolee-targeted care in TC versus referral to safety net medical providers for non-targeted care. We believe that the results of the study will assist policymakers by improving our understanding of the:
- effect of targeted and non-targeted medical care provision to post-release prisoners on primary care engagement and utilization
- effect of targeted and non-targeted medical care provision to post-release prisoners on inpatient hospitalizations and emergency room and psychiatric emergency service utilization.
- effect of targeted and non-targeted care provision to post-release prisoners on recidivism
- costs for provision of targeted versus non-targeted medical care to post-release prisoners (Do we want to do a cost analysis?)
- Being tested
- Transitions Clinic - parolee-targeted care, Expedited Primary Care
- Keywords
- Post-release, community health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transitions Clinic - parolee-targeted careOther
Subjects receive ongoing primary care from the Transitions Clinic versus ongoing primary care in the San Francisco Department of Public Health affiliated primary care network.
Expedited Primary CareOther
Following randomization, subjects receive ongoing primary care in the San Francisco Department of Public Health affiliated primary care network. Appointments are expedited with safety-net primary care providers.
| Study group | Role | What they receive |
|---|---|---|
| Expedited Primary Care | Active comparator | Following randomization, subjects receive ongoing primary care in the San Francisco Department of Public Health affiliated primary care network. Appointments are expedited with safety-net primary care providers. Receives: Other: Expedited Primary Care |
| Transitions Clinic - Parolee Targeted Care | Experimental | Following randomization, subjects in this arm receive ongoing primary care in a parolee-targeted clinic. Parolee-targeted care includes care from clinicians with a knowledge of the impacts of incarceration on health and experience caring for formerly incarcerated patients, a community health worker that works in medical and social services coordination and chronic disease education, and linkages with community-based organizations serving formerly incarcerated individuals. Receives: Other: Transitions Clinic - parolee-targeted care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute Care Utilization
Hospitalization and hospital length of stay and psychiatric emergency and emergency department utilization
Measured: 6 months
Secondary outcomes (2)
Primary Care Engagement
Non-emergency department visits to ambulatory primary care and mental health providers
Measured: 6 months
Recidivism
Rate of re-incarceration during study period
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2010 (estimated)
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 Health Services Research, Prisons, Delivery of Health Care, Vulnerable Populations, Community Health AidesStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Transitions Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01179035
- Sponsor's protocol ID
- Transitions001
- Status last verified
- Aug 2010
- First submitted
- 8 Aug 2010
- Last updated
- 10 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Wang EA, Hong CS, Samuels L, Shavit S, Sanders R, Kushel M. Transitions clinic: creating a community-based model of health care for recently released California prisoners. Public Health Rep. 2010 Mar-Apr;125(2):171-7. doi: 10.1177/003335491012500205.
PubMed 20297743
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Parolee-Targeted Care Versus Expedited Usual Care on Health Care Utilization and Recidivism
- ClinicalTrials.gov ID
- NCT01179035
- Acronym / sponsor ID
- Transitions001
- Keywords
- Post-release, community health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Transitions ClinicUniversity, hospital or other
- Collaborators
- University of California, Davis
- First posted
- 10 Aug 2010 (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 purpose of this study is to study the effectiveness of the Transitions Clinic, a post-release clinic for parolees with chronic medical conditions, in achieving increased primary care engagement, lower rates of inappropriate hospitalizations, psychiatric emergency service and emergency department use, and decreased recidivism.
We hypothesize that subjects receiving parolee-targeted care in the Transitions Clinic will have increased rates of non-emergency department ambulatory care and outpatient mental health care, lower rates of hospitalization, psychiatric emergency service (PES) utilization, emergency department (ED) utilization, decreased total hospital length of stay, and decreased recidivism compared to patients receiving primary care from other safety-net providers.
Detailed description
With ever increasing numbers of released inmates, policymakers are developing policy initiatives and directing funding towards community reentry programs for recent parolees to decrease recidivism and improve health outcomes. These reentry programs are comprehensive efforts that coordinate social and medical services for recently incarcerated people to achieve these aims. Due to documented poor health outcomes in this population and the resultant costs on the public health system, provision of medical care will be an integral part of these reentry initiatives. The manner in which medical care is incorporated into community reentry programs and directed to recently released prisoners needs to be studied to guide architects of reentry programs, policymakers and allocation of funding.
The Transitions Clinic (TC) was founded to address the medical needs of recently released prisoners. The TC is a pilot project designed to target primary care medical services to parolees in San Francisco and aid in coordination of medical and social services. It operates within the San Francisco Department of Public Health(SFDPH)-affiliated Community Health Network (CHN) and is part of the Safe Communities Reentry Council, a city-wide, collaborative effort of the Sheriff's office, Public Defenders' office and local community organizations to improve reentry services and outcomes for the 1500 annual parolees to San Francisco.
The proposed project will prospectively examine the effectiveness of the TC in achieving increased primary care engagement, decreased acute health care utilization and decreased recidivism. After intake in the TC, patients will be randomized to continued, parolee-targeted care in TC versus referral to safety net medical providers for non-targeted care. We believe that the results of the study will assist policymakers by improving our understanding of the:
- effect of targeted and non-targeted medical care provision to post-release prisoners on primary care engagement and utilization
- effect of targeted and non-targeted medical care provision to post-release prisoners on inpatient hospitalizations and emergency room and psychiatric emergency service utilization.
- effect of targeted and non-targeted care provision to post-release prisoners on recidivism
- costs for provision of targeted versus non-targeted medical care to post-release prisoners (Do we want to do a cost analysis?)
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Expedited Primary Care | Active comparator | Other: Expedited Primary CareFollowing randomization, subjects receive ongoing primary care in the San Francisco Department of Public Health affiliated primary care network. Appointments are expedited with safety-net primary care providers. |
| Transitions Clinic - Parolee Targeted Care | Experimental | Other: Transitions Clinic - parolee-targeted careFollowing randomization, subjects in this arm receive ongoing primary care in a parolee-targeted clinic. Parolee-targeted care includes care from clinicians with a knowledge of the impacts of incarceration on health and experience caring for formerly incarcerated patients, a community health worker that works in medical and social services coordination and chronic disease education, and linkages with community-based organizations serving formerly incarcerated individuals. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All adult parolees to San Francisco
- Must have one chronic condition or age >50 years old
Key exclusion criteria (2 listed)
- Children
- Subjects who already have an established primary care provider in San Francisco
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 |
|---|---|---|
| Transitions Clinic - parolee-targeted careSubjects receive ongoing primary care from the Transitions Clinic versus ongoing primary care in the San Francisco Department of Public Health affiliated primary care network. | Other | Transitions Clinic - Parolee Targeted Care |
| Expedited Primary CareFollowing randomization, subjects receive ongoing primary care in the San Francisco Department of Public Health affiliated primary care network. Appointments are expedited with safety-net primary care providers. | Other | Expedited Primary Care |
Primary outcome
Acute Care Utilization
Time frame: 6 months
Hospitalization and hospital length of stay and psychiatric emergency and emergency department utilization
2 secondary outcomes
Primary Care Engagement
Time frame: 6 months
Recidivism
Time frame: 6 months
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 10 Aug 2010.
- Background: PubMed 20297743Wang EA, Hong CS, Samuels L, Shavit S, Sanders R, Kushel M. Transitions clinic: creating a community-based model of health care for recently released California prisoners. Public Health Rep. 2010 Mar-Apr;125(2):171-7. doi: 10.1177/003335491012500205.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transitions Clinic - parolee-targeted care and Expedited Primary Care in people with Health Services Research, Prisons, Delivery of Health Care, Vulnerable Populations, Community Health Aides, run by Transitions Clinic at 1 site 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 2 inclusion and 2 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 10 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 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?
Acute Care Utilization (time frame: 6 months). 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 NCT01179035, 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 10 Aug 2010.