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Addressing Social Vulnerabilities in Cardiovascular Disease

Primary Purpose

Congestive Heart Failure, Ischemic Heart Disease, Acute Myocardial Infarction

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Socially Enhanced Transitional Care Intervention
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Congestive Heart Failure

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patients hospitalized with CHF and IHD at high-risk for readmission

Exclusion Criteria:

  • none

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Congestive Heart Failure (CHF)

    Ischemic Heart Disease (IHD)

    Arm Description

    The CHF arm will include adults hospitalized with CHF who have been identified as being at high risk for readmission (in the top quintile of risk) by our readmission risk prediction algorithms, and who also have social vulnerabilities present. All subjects in the CHF arm will receive the Socially Enhanced Transitional Care Intervention.

    The IHD arm will include adults hospitalized with IHD who have been identified as being at high risk for readmission (in the top quintile of risk) by our readmission risk prediction algorithms, and who also have social vulnerabilities present. All subjects in the IHD arm will receive the Socially Enhanced Transitional Care Intervention.

    Outcomes

    Primary Outcome Measures

    Reach of the intervention ('R' of the RE-AIM Implementation Science Framework)
    Proportion of individuals enrolled, of those who are eligible for the intervention
    Effectiveness of the intervention ('E' of the RE-AIM Implementation Science Framework) - Referrals
    Proportion of referrals to community-based service programs that are completed, of referrals that are sent. 'Completed' will be defined as individuals arriving in-person at a community-based service program after a referral is placed.
    Effectiveness of the intervention ('E' of the RE-AIM Implementation Science Framework) - Health Services Utilization
    Changes in acute health services use (composite of emergency department visits, hospitalizations) before and after the intervention using interrupted time series
    Effectiveness of the intervention ('E' of the RE-AIM Implementation Science Framework) - Satisfaction
    Patient satisfaction with the intervention program using brief verbal questionnaires
    Adoption of the intervention ('A' of the RE-AIM Implementation Science Framework)
    Number of community organizations active in referral and information exchange intervention
    Implementation of the intervention ('I' of the RE-AIM Implementation Science Framework)
    Acceptability, feasibility, and fidelity to intervention, ascertained through semi-structured interviews of research subjects, discharge planners, case managers, community program directors with thematic analysis of interview findings. We will ascertain perspectives on all three constructs during interviews and identify common themes across constructs to understand barriers and facilitators to implementation in aggregate

    Secondary Outcome Measures

    Readmission rate
    Rate of 30-day readmissions among research subjects. We anticipate that we will be underpowered to detect a difference with our limited planned enrollment during this pilot feasibility study

    Full Information

    First Posted
    May 31, 2018
    Last Updated
    June 4, 2021
    Sponsor
    University of California, San Francisco
    Collaborators
    National Heart, Lung, and Blood Institute (NHLBI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03613064
    Brief Title
    Addressing Social Vulnerabilities in Cardiovascular Disease
    Official Title
    Addressing Social Vulnerabilities to Prevent Hospital Readmissions in Adults With Cardiovascular Disease
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2022 (Anticipated)
    Primary Completion Date
    December 2022 (Anticipated)
    Study Completion Date
    December 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of California, San Francisco
    Collaborators
    National Heart, Lung, and Blood Institute (NHLBI)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The investigators will conduct a feasibility study of an enhanced transitional care intervention, that will: 1) automate identification and risk-stratification of patients with CHF and IHD with social vulnerabilities; 2) incorporate a new standardized social vulnerabilities screening tool into clinical care; 3) enable electronic referrals to community resources; and 4) add novel community-based interventions to the existing medically-oriented transitional care intervention that is the standard of care at the study hospital (Parkland Hospital in Dallas, Texas) and other hospitals nationwide.
    Detailed Description
    The investigators plan to develop, pilot and evaluate the feasibility of an existing medically oriented transitional care intervention enhanced to also address social vulnerabilities, to prevent readmissions in congestive heart failure (CHF) & ischemic heart disease (IHD). The intervention design will be based on the Andersen Behavior Model of Health Services Use, highlighting pathways for clinical linkages to community resources to facilitate individual behavior change. To summarize, although existing interventions have largely focused on individual- and health system-level factors such as optimizing medication regimens, discharge education, and post-discharge follow-up, much of the risk for readmission in patients with CHF and IHD is also driven by social vulnerabilities that are currently not addressed in medical settings. Community-based organizations are a valuable but untapped resource to ameliorate key social vulnerabilities (i.e., food/housing insecurity, behavioral health needs) that are major barriers to effective medication and visit adherence, self-management and lifestyle modification in patients with heart disease. Thus, the investigators propose an enhanced transitional care intervention that uses the Dallas Information Exchange Portal, a health information technology platform, to link patients to local community organizations at discharge. Addressing social vulnerabilities to enable better adherence, self-management, and lifestyle behaviors can in turn prevent readmissions and improve downstream health outcomes. The investigators will conduct a feasibility study of an enhanced transitional care intervention, that will: 1) automate identification and risk-stratification of patients with CHF and IHD with social vulnerabilities; 2) incorporate a new standardized social vulnerabilities screening tool into clinical care; 3) enable electronic referrals to community resources; and 4) add novel community-based interventions to the existing medically-oriented transitional care intervention that is the standard of care at Parkland and other hospitals nationwide. The investigators will assess feasibility and acceptability of our intervention using measures derived from the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) implementation science framework.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Congestive Heart Failure, Ischemic Heart Disease, Acute Myocardial Infarction, Coronary Artery Disease

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Congestive Heart Failure (CHF)
    Arm Type
    Experimental
    Arm Description
    The CHF arm will include adults hospitalized with CHF who have been identified as being at high risk for readmission (in the top quintile of risk) by our readmission risk prediction algorithms, and who also have social vulnerabilities present. All subjects in the CHF arm will receive the Socially Enhanced Transitional Care Intervention.
    Arm Title
    Ischemic Heart Disease (IHD)
    Arm Type
    Experimental
    Arm Description
    The IHD arm will include adults hospitalized with IHD who have been identified as being at high risk for readmission (in the top quintile of risk) by our readmission risk prediction algorithms, and who also have social vulnerabilities present. All subjects in the IHD arm will receive the Socially Enhanced Transitional Care Intervention.
    Intervention Type
    Other
    Intervention Name(s)
    Socially Enhanced Transitional Care Intervention
    Intervention Description
    Components: 1) Standardized social vulnerabilities assessment tool, to be developed and incorporated into admission workflows. 2) Electronic community service referrals to existing community resources (i.e. food banks, shelters, community rehab), via the Dallas IEP or other information technology platform, for material (food, housing) and psychosocial needs (mental health/drug treatment). 3) Community-based cardiovascular self-management interventions, to be developed and piloted in conjunction with #3 - e.g., customized 'heart healthy' food baskets for CHF/IHD; risk factor monitoring (i.e., weight and blood pressure measurement at food banks, shelters, churches, modeled on the barber shop hypertension intervention); and 'heart buddy' support groups for CHF and IHD at community sites.
    Primary Outcome Measure Information:
    Title
    Reach of the intervention ('R' of the RE-AIM Implementation Science Framework)
    Description
    Proportion of individuals enrolled, of those who are eligible for the intervention
    Time Frame
    Up to 12 months
    Title
    Effectiveness of the intervention ('E' of the RE-AIM Implementation Science Framework) - Referrals
    Description
    Proportion of referrals to community-based service programs that are completed, of referrals that are sent. 'Completed' will be defined as individuals arriving in-person at a community-based service program after a referral is placed.
    Time Frame
    Up to 12 months
    Title
    Effectiveness of the intervention ('E' of the RE-AIM Implementation Science Framework) - Health Services Utilization
    Description
    Changes in acute health services use (composite of emergency department visits, hospitalizations) before and after the intervention using interrupted time series
    Time Frame
    Up to 12 months
    Title
    Effectiveness of the intervention ('E' of the RE-AIM Implementation Science Framework) - Satisfaction
    Description
    Patient satisfaction with the intervention program using brief verbal questionnaires
    Time Frame
    Up to 12 months
    Title
    Adoption of the intervention ('A' of the RE-AIM Implementation Science Framework)
    Description
    Number of community organizations active in referral and information exchange intervention
    Time Frame
    Up to 12 months
    Title
    Implementation of the intervention ('I' of the RE-AIM Implementation Science Framework)
    Description
    Acceptability, feasibility, and fidelity to intervention, ascertained through semi-structured interviews of research subjects, discharge planners, case managers, community program directors with thematic analysis of interview findings. We will ascertain perspectives on all three constructs during interviews and identify common themes across constructs to understand barriers and facilitators to implementation in aggregate
    Time Frame
    Up to 12 months
    Secondary Outcome Measure Information:
    Title
    Readmission rate
    Description
    Rate of 30-day readmissions among research subjects. We anticipate that we will be underpowered to detect a difference with our limited planned enrollment during this pilot feasibility study
    Time Frame
    Up to 12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    120 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: patients hospitalized with CHF and IHD at high-risk for readmission Exclusion Criteria: none
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Oanh K Nguyen, MD
    Phone
    415-206-3755
    Email
    Oanh.Nguyen@ucsf.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Oanh K Nguyen, MD
    Organizational Affiliation
    University of California, San Francisco
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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