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.

Study Timeline

• Study First Submitted: 2018-05-31
• Study First Submitted QC: 2018-07-27
• Study First Posted: 2018-08-02
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-04
• Last Update Posted: 2021-06-08
• Study Start: 2022-01
• Primary Completion: 2022-12
• Study Completion: 2022-12

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

Name	Time	Method
Effectiveness of the intervention ('E' of the RE-AIM Implementation Science Framework) - Satisfaction	Up 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 Utilization	Up 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) - Referrals	Up 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

Name	Time	Method
Readmission rate	Up 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