Congestive Heart FailureNCT03613064
Addressing Social Vulnerabilities in Cardiovascular Disease
A study testing Socially Enhanced Transitional Care Intervention in people with Congestive Heart Failure and Ischemic Heart Disease, run by University of California, San Francisco.
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… Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Congestive Heart Failure, Ischemic Heart Disease, Acute Myocardial Infarction
- What is being tested?
- Socially Enhanced Transitional Care Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2023to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients hospitalized with CHF and IHD at high-risk for readmission
Who cannot join
- none
About this study
Official title: Addressing Social Vulnerabilities to Prevent Hospital Readmissions in Adults With Cardiovascular Disease
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.
Read the 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.
- Conditions
- Congestive Heart Failure, Ischemic Heart Disease, Acute Myocardial Infarction, Coronary Artery Disease
- Being tested
- Socially Enhanced Transitional Care Intervention
- Medical subject headings
- Heart Failure, Myocardial Ischemia, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Socially Enhanced Transitional Care InterventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Socially Enhanced Transitional Care Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reach of the intervention ('R' of the RE-AIM Implementation Science Framework)
Proportion of individuals enrolled, of those who are eligible for the intervention
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Up to 12 months
Secondary outcomes (1)
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
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2018
- Study startJun 2023 (estimated)
- Primary completionJun 2024 (estimated)
- Study completionDec 2024 (estimated)
Why it stopped: Not feasible due to local restrictions relating to COVID-19 public health emergency
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congestive Heart FailureStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Oanh K Nguyen, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03613064
- Sponsor's protocol ID
- STU 022016-033
- Other IDs
- 1K23HL133441
- Status last verified
- Aug 2025
- First submitted
- 31 May 2018
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addressing Social Vulnerabilities to Prevent Hospital Readmissions in Adults With Cardiovascular Disease
- ClinicalTrials.gov ID
- NCT03613064
- Acronym / sponsor ID
- STU 022016-033
- Conditions
- Congestive Heart Failure, Ischemic Heart Disease, Acute Myocardial Infarction, Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Not feasible due to local restrictions relating to COVID-19 public health emergency
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jun 2023 (estimated)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 2 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Congestive Heart Failure (CHF) | Experimental | Other: Socially Enhanced Transitional Care InterventionThe 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. |
| Ischemic Heart Disease (IHD) | Experimental | Other: Socially Enhanced Transitional Care InterventionThe 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. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients hospitalized with CHF and IHD at high-risk for readmission
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Socially Enhanced Transitional Care InterventionComponents: 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. | Other | Congestive Heart Failure (CHF), Ischemic Heart Disease (IHD) |
Primary outcome
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
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.
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
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
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
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
1 secondary outcome
Readmission rate
Time frame: Up to 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oanh K Nguyen, MD principal investigator
University of California, San Francisco
Questions about this trial
What is this clinical trial studying?
A study testing Socially Enhanced Transitional Care Intervention in people with Congestive Heart Failure and Ischemic Heart Disease, run by University of California, San Francisco.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 5 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reach of the intervention ('R' of the RE-AIM Implementation Science Framework) (time frame: Up to 12 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2025; AzTrials last refreshed its copy on 1 Nov 2026.