MedPath

Addressing Social Vulnerabilities in Cardiovascular Disease

Not Applicable
Conditions
Acute Myocardial Infarction
Ischemic Heart Disease
Coronary Artery Disease
Congestive Heart Failure
Registration Number
NCT03613064
Lead Sponsor
University of California, San Francisco
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.

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
50
Inclusion Criteria
  • patients hospitalized with CHF and IHD at high-risk for readmission
Exclusion Criteria
  • none

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Effectiveness of the intervention ('E' of the RE-AIM Implementation Science Framework) - SatisfactionUp to 12 months

Patient satisfaction with the intervention program using brief verbal questionnaires

Implementation of the intervention ('I' of the RE-AIM Implementation Science Framework)Up to 12 months

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

Reach of the intervention ('R' of the RE-AIM Implementation Science Framework)Up to 12 months

Proportion of individuals enrolled, of those who are eligible for the intervention

Effectiveness of the intervention ('E' of the RE-AIM Implementation Science Framework) - Health Services UtilizationUp to 12 months

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) - ReferralsUp to 12 months

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.

Adoption of the intervention ('A' of the RE-AIM Implementation Science Framework)Up to 12 months

Number of community organizations active in referral and information exchange intervention

Secondary Outcome Measures
NameTimeMethod
Readmission rateUp to 12 months

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

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.