Addressing Social Vulnerabilities in Cardiovascular Disease

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03613064
• Other study ID #: STU 022016-033
• Secondary ID: 1K23HL133441
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2022
• Est. completion date: December 2022

Study information

• Verified date: June 2021
• Source: University of California, San Francisco
• Contact: Oanh K Nguyen, MD
• Phone: 415-206-3755
• Email: Oanh.Nguyen[@]ucsf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• none

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Cardiovascular Diseases
• Congestive Heart Failure
• Coronary Artery Disease
• Heart Diseases
• Heart Failure
• Infarction
• Ischemic Heart Disease
• Myocardial Infarction
• Myocardial Ischemia

Intervention

Other:
• Socially 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reach of the intervention ('R' of the RE-AIM Implementation Science Framework)	Proportion of individuals enrolled, of those who are eligible for the intervention	Up to 12 months
Primary	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.	Up to 12 months
Primary	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	Up to 12 months
Primary	Effectiveness of the intervention ('E' of the RE-AIM Implementation Science Framework) - Satisfaction	Patient satisfaction with the intervention program using brief verbal questionnaires	Up to 12 months
Primary	Adoption of the intervention ('A' of the RE-AIM Implementation Science Framework)	Number of community organizations active in referral and information exchange intervention	Up to 12 months
Primary	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	Up to 12 months
Secondary	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	Up to 12 months