Cardiovascular DiseasesSCHARPNCT05989282
Structural Conditions and Health After Release From Prison
An observational study of Cardiovascular Diseases and Health Care Utilization, run by Kaiser Permanente at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases, Health Care Utilization
- How many people
- 508 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Aug 2023to 30 Jun 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Kaiser Permanente Institute for Health Research
Aurora, Colorado, 80011
About this study
Official title: 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.
Read the 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.
- Conditions
- Cardiovascular Diseases, Health Care Utilization
- Medical subject headings
- Cardiovascular Diseases, Patient Acceptance of Health Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Healthcare utilization
Clinic visits, emergency visits, hospitalization
Measured: 12 months
Secondary outcomes (2)
Cardiovascular hospitalization
Hospitalization for a cardiovascular condition
Measured: 12 months
Death
All-cause death
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start5 Aug 2023
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe 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
- 508 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Collaborators
- University of Colorado, Denver, Denver Health and Hospital Authority, National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Stacie Daugherty, Principal investigator, Kaiser Permanente Institute for Health Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05989282
- Sponsor's protocol ID
- IRB# 00002931
- Other IDs
- R01HL164106
- Acronym
- SCHARP
- Status last verified
- Aug 2026
- First submitted
- 3 Aug 2023
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthcare Organizational Structural Conditions and the Health of People Recently Released From Prison
- ClinicalTrials.gov ID
- NCT05989282
- Acronym / sponsor ID
- SCHARP / IRB# 00002931
- Conditions
- Cardiovascular Diseases, Health Care Utilization
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 508 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Collaborators
- University of Colorado, Denver, Denver Health and Hospital Authority, National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 5 Aug 2023 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 14 Aug 2023 (actual)
- 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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Healthcare utilization
Time frame: 12 months
Clinic visits, emergency visits, hospitalization
2 secondary outcomes
Cardiovascular hospitalization
Time frame: 12 months
Death
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Individual participant dataSharing planned: No
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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.
Stacie Daugherty principal investigator
Kaiser Permanente Institute for Health Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Health Care Utilization, run by Kaiser Permanente 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 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: under way, not looking for participants, as of the sponsor's last update on 14 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Healthcare utilization (time frame: 12 months). 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 14 Aug 2026.