Addressing Social Vulnerabilities in Cardiovascular Disease

• ClinicalTrials.gov Identifier: NCT03613064
• Recruitment Status: Not yet recruiting
• First Posted: August 2, 2018
• Last Update Posted: December 17, 2019
• Sponsor: University of California, San Francisco
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI)
• Information provided by (Responsible Party): University of California, San Francisco

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Congestive Heart Failure; Ischemic Heart Disease; Acute Myocardial Infarction; Coronary Artery Disease	Other: Socially Enhanced Transitional Care Intervention	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 50 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Addressing Social Vulnerabilities to Prevent Hospital Readmissions in Adults With Cardiovascular Disease
• Estimated Study Start Date: June 2020
• Estimated Primary Completion Date: May 2022
• Estimated Study Completion Date: May 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: Congestive Heart Failure (CHF); 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; 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.
Experimental: Ischemic Heart Disease (IHD); 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; 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.

Outcome Measures

Primary Outcome Measures :

1. Reach of the intervention ('R' of the RE-AIM Implementation Science Framework) [ Time Frame: Up to 12 months ]
   Proportion of individuals enrolled, of those who are eligible for the intervention
2. Effectiveness of the intervention ('E' of the RE-AIM Implementation Science Framework) - Referrals [ Time Frame: 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.
3. Effectiveness of the intervention ('E' of the RE-AIM Implementation Science Framework) - Health Services Utilization [ Time Frame: 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
4. Effectiveness of the intervention ('E' of the RE-AIM Implementation Science Framework) - Satisfaction [ Time Frame: Up to 12 months ]
   Patient satisfaction with the intervention program using brief verbal questionnaires
5. Adoption of the intervention ('A' of the RE-AIM Implementation Science Framework) [ Time Frame: Up to 12 months ]
   Number of community organizations active in referral and information exchange intervention
6. Implementation of the intervention ('I' of the RE-AIM Implementation Science Framework) [ Time Frame: 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

Secondary Outcome Measures :

1. Readmission rate [ Time Frame: 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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 120 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• none

Contacts and Locations

Contacts

Contact: Oanh K Nguyen, MD; 415-206-3755; Oanh.Nguyen@ucsf.edu

Sponsors and Collaborators

University of California, San Francisco

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

• Principal Investigator: Oanh K Nguyen, MD; University of California, San Francisco

More Information

• Responsible Party: University of California, San Francisco
• ClinicalTrials.gov Identifier: NCT03613064
• Other Study ID Numbers: STU 022016-033; 1K23HL133441 ( U.S. NIH Grant/Contract )
• First Posted: August 2, 2018
• Last Update Posted: December 17, 2019
• Last Verified: December 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Heart Failure; Cardiovascular Diseases; Coronary Artery Disease; Myocardial Ischemia; Myocardial Infarction; Heart Diseases; Infarction; Ischemia; Pathologic Processes; Necrosis; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases