Community Health Program for COVID-19

(WEAVE Trial)

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

300 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will optimize, implement, and test the impact of our multicomponent health program that includes three primary implementation strategies (Cultural Weavers and co-creation, mHealth strategies using culturally meaningful text and voice messages, and care coordination). The investigators will use a participatory approach to engage community members in co-creating and optimizing our mHealth outreach and enhanced care coordination program components. The investigators will use a hybrid type 3 effectiveness-implementation sequential multiple assignment randomized trial (SMART) design to assess the impact of our multicomponent health program on implementation and outcome measures.

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 data supports the effectiveness of the treatment in the Community Health Program for COVID-19?

Research shows that coordinated care programs, like the Community Care Coordination Service, can significantly reduce hospital admissions and emergency room visits, while improving patients' quality of life. This suggests that similar approaches in the COVID-19 program could help manage patient care effectively. ^{1 2 3 4 5}

Is the Community Health Program for COVID-19 safe for humans?

The research on care coordination and management programs, like the Johns Hopkins Community Health Partnership and the Kaiser Permanente Outpatient Safety Net Program, suggests that these programs are generally safe. They focus on improving care coordination, patient safety, and reducing care gaps, which are important for overall health care quality. ^{6 7 8 9 10}

How is the Community Health Program for COVID-19 treatment different from other treatments?

The Community Health Program for COVID-19 is unique because it combines care coordination and mHealth outreach to manage patient care, focusing on connecting patients with community services and providing personalized support. This approach is different from traditional treatments as it emphasizes proactive community engagement and personalized care management rather than just medical interventions. ^{5 11 12 13 14}

Eligibility Criteria

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 am 18 years old or older.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Hospital-based case management: results from a demonstration. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Hospital program weds case, disease management. [2007]

3. United States pubmed.ncbi.nlm.nih.gov

Opening a window of opportunity through technology and coordination: a multisite case study. [2018]

4. Australia pubmed.ncbi.nlm.nih.gov

Beyond community-based diabetes management and the COAG coordinated care trial. [2004]

5. United States pubmed.ncbi.nlm.nih.gov

Association of care management intensity with healthcare utilization in an all-condition care management program. [2020]

6. England pubmed.ncbi.nlm.nih.gov

Implementation of a comprehensive program to improve coordination of care in an urban academic health care system. [2018]

7. England pubmed.ncbi.nlm.nih.gov

Electronic Clinical Surveillance to Improve Outpatient Care: Diverse Applications within an Integrated Delivery System. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Designing a care pathway for a maternity support service program in a rural health department. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Case management for patients with poorly controlled diabetes: a randomized trial. [2022]

10. Canada pubmed.ncbi.nlm.nih.gov

Adverse events in community care: implications for practice, policy and research. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

Implementation of Drive-Through Testing for COVID-19 With Community Paramedics. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Developing a community care team: lessons learned from the community connections program, a health care home-community care team partnership. [2019]

13. United States pubmed.ncbi.nlm.nih.gov

Greater Covid-19 vaccine uptake among enrollees offered health and social needs case management: Results from a randomized trial. [2023]

14. Netherlands pubmed.ncbi.nlm.nih.gov

An equity-focused approach to improving access to COVID-19 vaccination using mobile health clinics. [2023]