Addressing Social Vulnerabilities in Cardiovascular Disease

NCT03613064 | Withdrawn

• 2 other identifiers: STU 022016-0331K23HL133441
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (1)

• Readmission rate

  Up to 12 months

Study Arms (2)

Congestive Heart Failure (CHF)

EXPERIMENTAL

The CHF arm will include adults hospitalized with CHF who have been identified as being at high risk for readmission (in the top quintile of risk) by our readmission risk prediction algorithms, and who also have social vulnerabilities present. All subjects in the CHF arm will receive the Socially Enhanced Transitional Care Intervention.

Other: Socially Enhanced Transitional Care Intervention

Ischemic Heart Disease (IHD)

EXPERIMENTAL

The IHD arm will include adults hospitalized with IHD who have been identified as being at high risk for readmission (in the top quintile of risk) by our readmission risk prediction algorithms, and who also have social vulnerabilities present. All subjects in the IHD arm will receive the Socially Enhanced Transitional Care Intervention.

Other: Socially Enhanced Transitional Care Intervention

Interventions

Socially Enhanced Transitional Care Intervention OTHER

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.

Congestive Heart Failure (CHF); Ischemic Heart Disease (IHD)

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• none

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

MeSH Terms

Conditions

Heart Failure; Myocardial Ischemia; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases

Study Officials

• Oanh K Nguyen, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2018
• First Posted: August 2, 2018
• Study Start: June 1, 2023
• Primary Completion: June 1, 2024
• Study Completion: December 1, 2024
• Last Updated: September 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share