Community Health Program for COVID-19

(WEAVE Trial)

Not currently recruiting at 3 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Diego

Disqualifiers: Under 18, Non-Spanish/Arabic/Vietnamese, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve a health program for COVID-19 by testing strategies such as mobile health messages and coordinated care (also known as Care Coordination). Participants will help shape the program to enhance its effectiveness and cultural relevance. The trial will compare these approaches to standard care to determine which works best. It seeks current patients at specific San Ysidro Health clinics who speak Spanish, Arabic, or Vietnamese. As an unphased trial, participants have a unique opportunity to directly influence and enhance healthcare strategies for their communities.

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

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators.

What prior data suggests that this multicomponent health program is safe?

Research has shown that using mobile health technology, such as text messages, is generally safe. One study found no major problems with mobile health clinics in communities, reporting only a few minor issues, which indicates it is well-tolerated.

Care coordination, which organizes a patient's healthcare services, plays a crucial role in managing COVID-19 care. While specific safety details are not provided, its common use in healthcare suggests it is safe and widely accepted.

Combining mobile health outreach with care coordination is expected to have minor side effects, according to research. This combination aims to improve health outcomes and access to care without major safety concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Community Health Program for COVID-19 because it explores innovative approaches like mHealth Outreach and Care Coordination. Unlike traditional treatments that primarily focus on medication and hospitalization, this program emphasizes using mobile health technology to reach patients, which can improve accessibility and engagement. Care Coordination adds another layer by ensuring seamless communication and management of healthcare services, potentially leading to better health outcomes. By integrating these elements, the program could offer a more holistic and proactive way to manage COVID-19, making healthcare more accessible and efficient for communities.

What evidence suggests that this trial's treatments could be effective for COVID-19?

Research has shown that mobile health (mHealth) tools, like apps and text messages, can improve COVID-19 health outcomes by increasing engagement and vaccination rates. For example, one study found that these tools helped collect more COVID-19 test samples from Latinx communities. Another study showed that mobile health methods, such as motivational interviewing, reduced vaccine hesitancy.

In this trial, participants may receive mHealth Outreach alone or with Care Coordination. Organizing patient care, known as care coordination, has shown promise. It helps identify patients at risk for COVID-19 complications and improves their care. Combining mHealth tools with care coordination may enhance these efforts. Studies suggest that this combination can lead to higher vaccine completion rates and better overall health outcomes in underserved communities. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults over 18 who are patients at specific San Ysidro Health clinics in Escondido, El Cajon, or Community Heights and speak Spanish, Arabic, or Vietnamese. It's not open to those who can't consent, aren't patients at these clinics, don't speak the required languages, or are under 18.

Inclusion Criteria

Current San Ysidro Health patient and receives care at select clinics in study locations (Escondido, El Cajon, Community Heights)

I speak Spanish, Arabic, or Vietnamese.

Exclusion Criteria

I do not speak Spanish, Arabic, or Vietnamese.

Is not a current San Ysidro Health patient or is a current San Ysidro Health patient but does not receive care at select clinics in study locations (Escondido, El Cajon, Community Heights)

I am unable to understand or sign the consent form.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implementation

Implementation of the multicomponent health program including mHealth outreach and care coordination

24 months

Monthly CAB meetings

Sustainment/Maintenance

Sustainment and maintenance of the health program to ensure long-term engagement and effectiveness

24 months

Follow-up

Participants are monitored for safety and effectiveness after the main intervention phases

36 months

What Are the Treatments Tested in This Trial?

Interventions

• Care Coordination
• mHealth Outreach

Trial Overview The study tests a health program aimed at increasing vaccination and preventive care through cultural engagement (Cultural Weavers), mobile health outreach with culturally relevant messages (mHealth), and improved care coordination. The effectiveness of these strategies will be evaluated using a participatory approach.

How Is the Trial Designed?

Group I: Stage 2 mHealth Outreach + Care Coordination Experimental Treatment 2 Interventions

Group II: Stage 2 mHealth Outreach Experimental Treatment 1 Intervention

Group III: Stage 1 mHealth Outreach Experimental Treatment 1 Intervention

Group IV: Stage 1 Standard of Care Active Control 1 Intervention

Group V: Stage 2 Standard of Care Active Control 1 Intervention

Care Coordination is already approved in United States, Canada, European Union for the following indications:

Approved in United States as Care Coordination for:

• Early psychosis intervention
• Chronic disease management
• Complex condition management

Approved in Canada as Care Coordination for:

• Early psychosis intervention
• Mental health care coordination
• Chronic disease management

Approved in European Union as Care Coordination for:

• Early psychosis intervention
• Integrated care pathways
• Chronic condition management

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+

San Ysidro Health Center

Collaborator

Trials

7

Recruited

9,600+

Published Research Related to This Trial

A symposium with 31 healthcare professionals highlighted that preventing adverse events in community care requires a multi-faceted approach involving policy changes at various levels, including system integration and improved communication among providers.

Key recommendations from the symposium include prioritizing education for clinicians and caregivers, enhancing organizational culture, and leveraging technology to improve patient safety and reduce adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events in community care: implications for practice, policy and research. Masotti, P., Green, M., McColl, MA.[2019]

Memorial Hospital implemented a program combining clinical pathways and disease management to reduce readmission rates and length of stay for chronic conditions, enhancing patient care continuity.

The program involves a coordinated effort between hospital care managers and outpatient case managers, ensuring smooth transitions from hospital to home care, which is expected to improve efficiency and offset revenue losses from reduced admissions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hospital program weds case, disease management. [2007]

The Johns Hopkins Community Health Partnership (J-CHiP) effectively improved care coordination for high-risk patients by implementing redesigned acute care delivery and seamless transitions of care, targeting adults discharged from hospitals and those receiving primary care in the community.

Key interventions included risk screening, multidisciplinary care planning, and collaboration with skilled nursing facilities, which collectively enhanced patient engagement and strengthened partnerships with community organizations, ultimately aiming to improve health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of a comprehensive program to improve coordination of care in an urban academic health care system. Hsiao, YL., Bass, EB., Wu, AW., et al.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8803391/

Patients, Families, and Communities COVID-19 Impact ... The result has been a persistent inability to focus on coordinated and effective preventive services addressing the health and well-being of communities and has ...

2. aihcp.net aihcp.net/2024/05/01/case-management-and-its-role-in-covid-care/

Case Management and its Role in Covid Care This article explores the significant shifts and ongoing developments in case management as a response to the challenges posed by the pandemic.

3. cdc.gov cdc.gov/covid/hcp/clinical-care/management-and-treatment.html

Clinical Course: Progression, Management, and Treatment Most patients with COVID-19 experience asymptomatic, mild, or moderate illness that can be managed in an outpatient setting.

4. healthcatalyst.com healthcatalyst.com/learn/success-stories/covid-19-risk-prediction-christianacare

Predictive Analytics and Care Management Reduces ... Predictive analytics can help healthcare organizations identify patients at risk for COVID-19 hospitalization, potentially preventing complications, and ...

5. nature.com nature.com/articles/s41746-024-01152-2

Effectiveness of telehealth versus in-person care during the ... In this review, we assess the effectiveness of telehealth compared with in-person care among patients who received care during the COVID-19 ...

6. cdc.gov cdc.gov/covid/hcp/clinical-care/underlying-conditions.html

Underlying Conditions and the Higher Risk for Severe ... Risk of severe outcomes is increased in people of all ages with certain underlying medical conditions and in people who are 50 years and older.

7. who.int who.int/emergencies/diseases/novel-coronavirus-2019/technical-guidance/patient-management

Case management This guidance document is intended for clinicians caring for COVID-19 patients during all phases of their disease (ie screening to discharge).

8. sciencedirect.com sciencedirect.com/science/article/pii/S193665742400116X

Experiences with care coordination and backup plans in ... The purpose of this study was to explore whether backup plans and care coordination met the needs of HCBS consumers during the COVID-19 pandemic in Kansas.