Skip to content

Addressing Social Vulnerabilities in Cardiovascular Disease

Addressing Social Vulnerabilities to Prevent Hospital Readmissions in Adults With Cardiovascular Disease

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03613064
Enrollment
0
Registered
2018-08-02
Start date
2023-06-30
Completion date
2024-12-31
Last updated
2025-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myocardial Infarction, Congestive Heart Failure, Coronary Artery Disease, Ischemic Heart Disease

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.

Interventions

OTHERSocially Enhanced Transitional Care Intervention

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.

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH
University of California, San Francisco
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* none

Design outcomes

Primary

MeasureTime frameDescription
Effectiveness of the intervention ('E' of the RE-AIM Implementation Science Framework) - Health Services UtilizationUp to 12 monthsChanges in acute health services use (composite of emergency department visits, hospitalizations) before and after the intervention using interrupted time series
Reach of the intervention ('R' of the RE-AIM Implementation Science Framework)Up to 12 monthsProportion of individuals enrolled, of those who are eligible for the intervention
Effectiveness of the intervention ('E' of the RE-AIM Implementation Science Framework) - ReferralsUp to 12 monthsProportion 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.
Implementation of the intervention ('I' of the RE-AIM Implementation Science Framework)Up to 12 monthsAcceptability, 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
Effectiveness of the intervention ('E' of the RE-AIM Implementation Science Framework) - SatisfactionUp to 12 monthsPatient satisfaction with the intervention program using brief verbal questionnaires
Adoption of the intervention ('A' of the RE-AIM Implementation Science Framework)Up to 12 monthsNumber of community organizations active in referral and information exchange intervention

Secondary

MeasureTime frameDescription
Readmission rateUp to 12 monthsRate 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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026