Structural Conditions and Health After Release From Prison

Cardiovascular Diseases Clinical Trial

— SCHARP  

Official title:

Healthcare Organizational Structural Conditions and the Health of People Recently Released From Prison

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05989282
• Other study ID #: IRB# 00002931
• Secondary ID: R01HL164106
• Status: Recruiting
• Start date: August 5, 2023
• Est. completion date: June 30, 2028

Study information

• Verified date: December 2023
• Source: Kaiser Permanente
• Contact: SCHARP Study
• Phone: 1-833-660-5300
• Email: SCHARP[@]kp.org
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: June 30, 2028
• Est. primary completion date: June 30, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Health Care Utilization

Locations

Country	Name	City	State
United States	Kaiser Permanente Institute for Health Research	Aurora	Colorado

Sponsors (4)

Lead Sponsor	Collaborator
Kaiser Permanente	Denver Health and Hospital Authority, National Heart, Lung, and Blood Institute (NHLBI), University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Healthcare utilization	Clinic visits, emergency visits, hospitalization	12 months
Secondary	Cardiovascular hospitalization	Hospitalization for a cardiovascular condition	12 months
Secondary	Death	All-cause death	12 months