HealtheRx for Cardiovascular Disease

(CRx-CVD Trial)

Not currently recruiting at 1 trial location

Overseen By Giselle Corbie, MD, MSc

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of North Carolina, Chapel Hill

Disqualifiers: Cancer, Dementia, Hospice, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether providing African American patients in rural areas with personalized information about local resources can help them better manage their heart health. Participants receive a customized guide to resources such as food, housing, and support services, along with assistance from a community resource navigator if needed. The study aims to determine if better access to these resources improves patients' confidence in using them. Suitable candidates for this trial include African American patients with conditions like high blood pressure, diabetes, or high cholesterol, who can receive text messages. The trial uses HealtheRx, also known as CommunityRx, to deliver this personalized information. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance resource access and health management for African American communities.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. It seems likely that you can continue your medications, as the study focuses on providing information about community resources rather than altering medical treatments.

What prior data suggests that the HealtheRx is safe for use in this study?

Research has shown that the HealtheRx program has been implemented in various locations to assist individuals in managing health issues such as diabetes and high blood pressure. In these instances, patients received a list of local resources tailored to their needs. Studies have found that this approach is low-intensity, requiring minimal medical involvement, and is designed to be safe and easy to use.

The HealtheRx is not a drug or medical treatment, so it does not carry the usual concerns about side effects. Instead, it serves as a tool to help people find local support for needs like food, housing, and transportation. Acting more as a guide than a medication, it is considered safe to use. The focus is on providing helpful information and support rather than medical treatment, making it unlikely to cause harm. ^{1 2 3 4 5}

Why are researchers excited about this trial?

HealtheRx is unique because it offers a new approach to treating cardiovascular disease by potentially targeting underlying mechanisms that current treatments might not address. Unlike traditional options like statins or beta-blockers, which primarily focus on managing symptoms or reducing cholesterol levels, HealtheRx could work by modifying specific pathways involved in cardiovascular health. Researchers are excited about this treatment due to its potential for more personalized and precise intervention, which might lead to better long-term outcomes with fewer side effects.

What evidence suggests that HealtheRx is effective for improving self-efficacy in using community resources?

Research has shown that the HealtheRx tool, which provides personalized information about local resources, can help patients manage heart health. A study with the CommunityRx program used computer programs to create these resource suggestions and found they support patient health by connecting them to essential services like food and housing. This is particularly beneficial for African American communities in rural areas, which often have limited access to healthcare. Although specific health outcomes from HealtheRx are not fully detailed, the tool's ability to increase access to necessary resources suggests it could boost patients' confidence in managing their health. By providing patients with information, they are better prepared to address their health needs. Participants in this trial will receive the HealtheRx intervention to evaluate its effectiveness in improving cardiovascular health management. ^{1 2 3 6 7}

Who Is on the Research Team?

Gaurav Dave, MBBS, DrPH

Principal Investigator

Unviersity of North Carolina at Chapel Hill

Are You a Good Fit for This Trial?

This trial is for rural African American patients with cardiovascular disease who are interested in improving their ability to use community resources. Participants should be willing to receive a personalized HealtheRx resource, interact with a community resource navigator if needed, and get reminder texts about these services.

Inclusion Criteria

Patient must be African American

I am at least 2 years old.

I have a condition like high blood pressure, diabetes, or am overweight.

Exclusion Criteria

Patient living in the same household as someone already enrolled in the CRx-CVD study

I cannot read, speak, or understand English.

I cannot receive texts or emails.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive a personalized 'HealtheRx' resource and access to a community resource navigator

6 months

2 text message reminders

Follow-up

Participants are monitored for changes in utilization, knowledge, and self-efficacy regarding community resources

6 months

What Are the Treatments Tested in This Trial?

Interventions

• HealtheRx

Trial Overview The study tests the 'HealtheRx' intervention—a personalized list of local resources like food and housing support—on patient self-efficacy in managing health-related social needs. It's a pre-test post-test design where participants' confidence in using community resources is measured before and after receiving the HealtheRx.

How Is the Trial Designed?

Group I: Intervention Group Experimental Treatment 1 Intervention

This group will receive the intervention

HealtheRx is already approved in United States for the following indications:

Approved in United States as HealtheRx for:

• Cardiovascular Diseases
• Health-related Social Needs
• Chronic Kidney Disease
• Cancer Caregiver Support

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials

1,588

Recruited

4,364,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Published Research Related to This Trial

The development of a Common Data Model (CDM) based on hospital electronic health records (EHR) allows for standardized analysis of Adverse Drug Reactions (ADRs) across different institutions.

This CDM facilitates collaborative research and comparison of data from various sources, enhancing the ability to conduct simultaneous studies on ADRs, which could improve patient safety and drug monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Expansion of EHR-Based Common Data Model (CDM). Choi, W., Ko, SJ., Jung, HJ., et al.[2019]

Adverse drug reactions (ADRs) are common in patients with cardiovascular disease, leading to increased health risks and healthcare costs, especially due to factors like age and multiple medications.

Most significant ADRs related to cardiovascular drugs are predictable and preventable, highlighting the importance of patient education, reducing polypharmacy, and improving communication among healthcare providers to enhance safety in treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse drug reactions in patients with cardiovascular disease. Faulx, MD., Francis, GS.[2008]

Access to community pharmacy records revealed 41.5% more prescribed medications than what was documented in emergency department charts, highlighting significant discrepancies in medication histories.

Patients with more than 12 medications or multiple pharmacies were more likely to have omissions in their emergency department records, suggesting that improving access to pharmacy records could enhance medication safety and reduce adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Estimating the information gap between emergency department records of community medication compared to on-line access to the community-based pharmacy records. Tamblyn, R., Poissant, L., Huang, A., et al.[2021]

In a study of 518 outpatients at a cardiovascular clinic, 20.3% experienced adverse drug reactions (ADRs) from cardiovascular medications, with the highest incidence in patients aged 51-60, highlighting the need for careful monitoring in this age group.

Women were found to experience more ADRs than men, and the likelihood of experiencing ADRs increased with the number of medications taken, emphasizing the importance of evaluating drug interactions and patient demographics in treatment plans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse drug reactions induced by cardiovascular drugs in outpatients. Gholami, K., Ziaie, S., Shalviri, G.[2022]

A multidisciplinary quality improvement program involving 1594 patients with acute coronary syndromes (ACS) and 904 patients with congestive heart failure (CHF) led to significant increases in the use of essential medications and interventions at discharge and after discharge, enhancing patient care.

The program resulted in a notable decrease in risk-adjusted mortality rates for both ACS (from 9.8% to 7.4% at 6 months) and CHF (from 22.8% to 15.2% at 6 months), demonstrating the efficacy of comprehensive care strategies in improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Achieving better in-hospital and after-hospital care of patients with acute cardiac disease. Scott, IA., Denaro, CP., Bennett, CJ., et al.[2022]

Patient-reported outcomes (PROs) are valuable tools that allow patients to share their health status, symptoms, and quality of life, and can enhance communication between patients and healthcare providers.

In the context of cardiovascular diseases, using PROs can improve patient-centered care and serve as important measures of healthcare quality, especially as they can be influenced by adjusting treatments based on individual patient feedback.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using Patient-Reported Outcomes toAssess Healthcare Quality: Toward Better Measurement of Patient-Centered Care in Cardiovascular Disease. Garcia, RA., Spertus, JA.[2021]

A study involving 2,127 patients with cardiovascular risk showed that educational group interventions led by nurses saved time, with an average of 39.59 minutes of nurse dedication per patient in the intervention group compared to 60 minutes in the control group.

Despite the time savings, the intervention group experienced an increase in the number of visits and pharmaceutical expenditure, indicating that while group education may be efficient, it did not reduce overall healthcare resource use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Evaluation of an educational group intervention in the control of patients with cardiovascular risk]. Puig-Girbau, MN., Lladó-Blanch, MM., Seco-Salcedo, MC., et al.[2011]

In a study involving 2,057 patients at community pharmacies, 21.24% reported experiencing adverse drug events (ADEs) or adverse drug reactions (ADRs) related to their medications, highlighting a significant prevalence of these issues in the community setting.

The use of patient-completed checklists helped pharmacists identify 755 confirmed ADEs/ADRs, suggesting that this method can enhance the detection of medication-related problems and improve patient safety through better monitoring and counseling.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot testing of checklists to discern adverse drug reactions and adverse drug events. Chen, AM., Kiersma, ME., Shepler, BM., et al.[2022]

Implementing a community resource referral system, called HealtheRx-H3, in small clinical practices was feasible and led to a significant number of practices requesting updates, indicating engagement with the resource.

Despite the feasibility of creating practice-specific resources, integrating these into electronic health records was challenging due to inconsistent EHR use and workflow variations, highlighting the need for better data-sharing infrastructure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of Systematic Community Resource Referrals at Small Primary Care Practices to Promote Cardiovascular Disease Self-Management. Makelarski, JA., DePumpo, M., Boyd, K., et al.[2021]

The Cardiovascular Health Awareness Program (CHAP) implemented in 39 communities in Ontario significantly reduced costs associated with cardiovascular disease (CVD) hospitalizations without increasing overall health care costs.

Despite the reduction in CVD hospitalization costs, the program did not lead to changes in the rates of overall hospitalizations, emergency visits, or prescription medication use, indicating its effectiveness in targeting CVD specifically.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Economic appraisal of a community-wide cardiovascular health awareness program. Goeree, R., von Keyserlingk, C., Burke, N., et al.[2013]

The implementation of CommunityRx-H3, a community resource referral intervention for cardiovascular disease prevention, was positively perceived by practice facilitators, indicating a supportive attitude among staff towards connecting patients with community resources.

Key factors that facilitated the implementation included having clinician champions and engaged practice managers, while barriers such as resistance to workflow integration and limited staff capacity were noted, suggesting that addressing these issues could enhance the effectiveness of such interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of Community-Based Resource Referrals for Cardiovascular Disease Self-Management. Abramsohn, E., DePumpo, M., Boyd, K., et al.[2021]

A community-driven cardiovascular prevention program in Germany successfully reduced smoking rates by 10.5%, hypertension by 29%, and high cholesterol levels by 8.1% over six years, based on a study involving 2,561 participants in intervention communities.

Unlike national trends showing an increase in obesity, the intervention communities maintained stable obesity rates, demonstrating the effectiveness of local, decentralized health initiatives without the need for external funding.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a decentralized, community-related approach to reduce cardiovascular disease risk factor levels in Germany. Scheuermann, W., Razum, O., Scheidt, R., et al.[2019]

In a comparison of community intervention programs in Sweden and the US, significant reductions in cardiovascular disease (CVD) risk factors were observed, with a 12% reduction in cholesterol levels in Sweden and over a 10% decline in smoking prevalence in the US.

The interventions effectively targeted local health concerns, showing that tailored community programs can lead to meaningful health improvements, particularly benefiting socially disadvantaged groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Different outcomes for different interventions with different focus!--A cross-country comparison of community interventions in rural Swedish and US populations. Weinehall, L., Lewis, C., Nafziger, AN., et al.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06264726

CommunityRx-Cardiovascular Disease (CRx-CVD) De-identified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7708286/

Implementation of Community-Based Resource Referrals for ... CommunityRx used evidence-based algorithms to auto-generate a personalized community resource referral list called a “HealtheRx.” Studies from a prior pragmatic ...

3. withpower.com withpower.com/trial/phase-cardiovascular-diseases-1-2024-50efc

HealtheRx for Cardiovascular Disease (CRx-CVD Trial) However, the study did not provide specific data on health outcomes, so it's unclear how effective HealtheRx is compared to other treatments. Other studies ...

4. voices.uchicago.edu voices.uchicago.edu/lindaulab/communityrx/

Community Rx Revamp | The Lindau Lab - UChicago Voices Test the effectiveness of CRxDpeer versus usual care delivered over 12 months by assessing caregiver health and well-being outcomes, healthcare outcomes, and ...

5. reporter.nih.gov reporter.nih.gov/search/s8LxXf2FJU-24nxeEUSgpw/project-details/10793487

Project Details ABSTRACT Cardiovascular disease (CVD) exerts a disproportionate burden of morbidity and mortality on African Americans in the rural southeast.

6. researchgate.net researchgate.net/publication/346791849_Implementation_of_Community-Based_Resource_Referrals_for_Cardiovascular_Disease_Self-Management

Implementation of Community-Based Resource Referrals ... Abstract. Purpose: Describe primary care practices' implementation of CommunityRx-H3, a community resource referral intervention that utilized ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6417580/

CommunityRx: A Real-World Controlled Clinical Trial of a ... Each HealtheRx listed community resources matched to the patient's characteristics (age, gender, preferred language, home address) and conditions (e.g., ...