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SCHARP: Structural Conditions and Health After Release From Prison

Sponsor
Kaiser Permanente (Other)
Overall Status
Recruiting
CT.gov ID
NCT05989282
Collaborator
University of Colorado, Denver (Other), Denver Health and Hospital Authority (Other), National Heart, Lung, and Blood Institute (NHLBI) (NIH)
400
Enrollment
1
Location
58.8
Anticipated Duration (Months)
6.8
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    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

    Study Type:
    Observational
    Anticipated Enrollment :
    400 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Healthcare Organizational Structural Conditions and the Health of People Recently Released From Prison
    Anticipated Study Start Date :
    Aug 5, 2023
    Anticipated Primary Completion Date :
    Jun 30, 2027
    Anticipated Study Completion Date :
    Jun 30, 2028

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. Healthcare utilization [12 months]

      Clinic visits, emergency visits, hospitalization

    Secondary Outcome Measures

    1. Cardiovascular hospitalization [12 months]

      Hospitalization for a cardiovascular condition

    2. Death [12 months]

      All-cause death

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Kaiser Permanente Institute for Health Research Aurora Colorado United States 80014

    Sponsors and Collaborators

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

    Investigators

    • Principal Investigator: Stacie Daugherty, Kaiser Permanente Institute for Health Research

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Kaiser Permanente
    ClinicalTrials.gov Identifier:
    NCT05989282
    Other Study ID Numbers:
    • IRB# 00002931
    • R01HL164106
    First Posted:
    Aug 14, 2023
    Last Update Posted:
    Aug 14, 2023
    Last Verified:
    Aug 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Cardiovascular Diseases

    Study Results

    No Results Posted as of Aug 14, 2023