Clinical trial NCT03613064: Addressing Social Vulnerabilities in Cardiovascular Disease
Official title: Addressing Social Vulnerabilities to Prevent Hospital Readmissions in Adults With Cardiovascular Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Congestive Heart Failure
Ischemic Heart Disease
Acute Myocardial Infarction
Coronary Artery Disease
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2018-08-02
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* none

Primary outcomes:
measure: Reach of the intervention ('R' of the RE-AIM Implementation Science Framework)
timeFrame: Up to 12 months
measure: Effectiveness of the intervention ('E' of the RE-AIM Implementation Science Framework) - Referrals
timeFrame: Up to 12 months
measure: Effectiveness of the intervention ('E' of the RE-AIM Implementation Science Framework) - Health Services Utilization
timeFrame: Up to 12 months
measure: Effectiveness of the intervention ('E' of the RE-AIM Implementation Science Framework) - Satisfaction
timeFrame: Up to 12 months
measure: Adoption of the intervention ('A' of the RE-AIM Implementation Science Framework)
timeFrame: Up to 12 months
measure: Implementation of the intervention ('I' of the RE-AIM Implementation Science Framework)
timeFrame: Up to 12 months
Secondary outcomes:
measure: Readmission rate
timeFrame: Up to 12 months
Other outcomes:
Locations:
Study officials:
affiliation: University of California, San Francisco
name: Oanh K Nguyen, MD
role: PRINCIPAL_INVESTIGATOR
References: