- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05989282
Structural Conditions and Health After Release From Prison (SCHARP)
December 6, 2023 updated by: Kaiser Permanente
Healthcare Organizational Structural Conditions and the Health of People Recently Released From Prison
People released from prison experience two times higher cardiovascular (CV) mortality than the general population, have a high prevalence of poor CV health and increased risk of CV events within 2 years of release.
Access to high quality healthcare following release from prison is key to preventing poor health and CV outcomes.
Our study team will investigate facilitators and barriers to health care access experienced by people released from prison.
Study Overview
Status
Recruiting
Conditions
Detailed Description
Upon release from prison, people face numerous challenges including unstable housing, limited employment, stigma, and poor health.
Structural conditions in healthcare systems, including policies, practices and attitudes around healthcare access, transition programs, culture, support of social determinants of health, and specialized services for people released from prison, may influence access and health outcomes for people released from prison.
We will enroll people released from prison into a prospective cohort study to examine the association between exposure to structural conditions and 12-month primary outcomes of healthcare utilization (clinic visits, emergency visits, hospitalization) and secondary outcomes of CV hospitalization and all-cause mortality.
Moderation by participant characteristics such as self-reported race, ethnicity, gender, age and baseline CV health will be tested.
Study Type
Observational
Enrollment (Estimated)
400
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: SCHARP Study
- Phone Number: 1-833-660-5300
- Email: SCHARP@kp.org
Study Locations
-
-
Colorado
-
Aurora, Colorado, United States, 80011
- Recruiting
- Kaiser Permanente Institute for Health Research
-
Contact:
- SCHARP Study Team
- Email: SCHARP@kp.org
-
Principal Investigator:
- Ingrid Binswanger
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
We are enrolling people who were formerly in prison.
People on probation or on parole are responsible for meeting their own needs for health care, in contrast to people currently in prison, who receive these services from the prison system.
Thus, people recently released from prison are a high-risk group for a range of poor health outcomes and poor access to care.
For these reasons, the focus of this investigation is on people recently released from prison.
Description
Inclusion Criteria:
- Recenlty released from state prison into the Denver/Aurora Colorado metro area
- Age 18 and older
- Ability to understand study procedures in English or Spanish
- No plans to leave the area for six months
Exclusion Criteria:
- On "current inmate" status or still under correctional observation (i.e., under locked confinement part of the day or night)
- Plans to leave area within six months
- Unable to consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
Exposure to structural conditions
Using a survey, we will measure participant exposure to organizational: access policies, transition programs, culture, support for social determinants of health and specialized services.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Healthcare utilization
Time Frame: 12 months
|
Clinic visits, emergency visits, hospitalization
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cardiovascular hospitalization
Time Frame: 12 months
|
Hospitalization for a cardiovascular condition
|
12 months
|
Death
Time Frame: 12 months
|
All-cause death
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Stacie Daugherty, Kaiser Permanente Institute for Health Research
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 5, 2023
Primary Completion (Estimated)
June 30, 2027
Study Completion (Estimated)
June 30, 2028
Study Registration Dates
First Submitted
August 3, 2023
First Submitted That Met QC Criteria
August 3, 2023
First Posted (Actual)
August 14, 2023
Study Record Updates
Last Update Posted (Estimated)
December 7, 2023
Last Update Submitted That Met QC Criteria
December 6, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB# 00002931
- R01HL164106 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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