Telehealth Intervention for COVID-19

(GET2HOME Trial)

Overseen By Hadley Sauers-Ford, MPH

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Children's Hospital Medical Center, Cincinnati

Disqualifiers: Independent living, End of life, Suicidal, Homicidal, County custody, Others

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

Compensation: Varies

Number of Visits: Unknown

650 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to determine the effectiveness of the GET2HOME Intervention bundle.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the GET2HOME Intervention treatment for COVID-19?

The research shows that telehealth and remote patient monitoring programs have been effective in managing COVID-19 patients by providing supportive care, facilitating direct hospital admissions, and reducing hospital stays. These programs have been safe, efficient, and patient-centered, suggesting that similar telehealth interventions like GET2HOME could be beneficial. ^{1 2 3 4 5}

Is the Telehealth Intervention for COVID-19 safe for humans?

The safety of telehealth interventions, like the GET2HOME Intervention, has been explored in various studies. For example, the VA CONNECT telehealth program showed that participants experienced reduced stress and improved coping skills without significant safety concerns. This suggests that telehealth interventions are generally safe for humans. ^{6 7 8 9 10}

How does the telehealth treatment for COVID-19 differ from other treatments?

The telehealth treatment for COVID-19 is unique because it allows healthcare to be delivered remotely, reducing the risk of virus exposure for both patients and providers. It also provides a way to continue care when in-person visits are not possible, offering support and skills training to help manage pandemic-related stress and improve coping strategies. ^{8 11 12 13 14}

Eligibility Criteria

This trial is for children with complex chronic diseases, as determined by a specific score (PMCA score of 3), and their families. They must have been discharged from the pediatric hospital medicine service at the study's hospital. It excludes those living independently without a guardian, in skilled nursing facilities, admitted for end-of-life care or severe mental health crises, previously enrolled in the study, or under county custody.

Inclusion Criteria

Patients discharged from pediatric hospital medicine service at our hospital

Patients with complex chronic disease based on a Pediatric Medical Complexity Algorithm (PMCA) score of 3 and their families and their primary care providers

Exclusion Criteria

Patients who previously enrolled in the study

Patients who live independently without a parent or guardian in the home, including those that live at skilled nursing facilities

Patients admitted for end of life care

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

The GET2HOME intervention includes a pre-discharge telehealth huddle, a visual discharge task tracker, and an optional post-discharge telehealth huddle

2-7 days post-discharge

Telehealth huddles pre- and post-discharge

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of return to baseline, transition process failures, and quality of life

90 days

Treatment Details

Interventions

• GET2HOME Intervention

Trial Overview The GET2HOME Intervention bundle is being tested to see if it can improve care for children with chronic conditions through telehealth. The effectiveness of this intervention will be evaluated after discharge from pediatric services.

Participant Groups

Group I: GET2HOME Intervention Experimental Treatment 1 Intervention

The GET2HOME intervention includes: 1) a pre-discharge telehealth huddle with the family, inpatient team, primary care team, and home care nursing; 2) a visual discharge task tracker (DTT) to monitor progress across care management tasks; and if desired by family and primary care 3) a post-discharge telehealth huddle 2-7 days after discharge with the family, inpatient team, primary care team, and home care nursing

Group II: Standard Hospital-Based Care Coordination Active Control 1 Intervention

Patients and families randomized to this arm will receive best practice standard of care hospital-based transition planning in the hospital with routine outpatient care team follow-up post-discharge.

Who Is Running the Clinical Trial?

Children's Hospital Medical Center, Cincinnati

Lead Sponsor

Trials

844

Recruited

6,566,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

Findings from Research

A multimodal treatment program combining interdisciplinary care and physical rehabilitation is safe and feasible for patients recovering from acute respiratory failure due to COVID-19, with no significant differences in safety events between in-person and telehealth groups.

Patients showed significant improvement in physical function, as evidenced by a 101-meter increase in the six-minute walk distance after the program, indicating effective rehabilitation regardless of the delivery method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Feasibility of an Interdisciplinary Treatment Approach to Optimize Recovery From Critical Coronavirus Disease 2019. Mayer, KP., Parry, SM., Kalema, AG., et al.[2021]

In a survey of 2,849 individuals aged 18-49 who completed mRNA COVID-19 vaccinations, about 90% reported adverse events (AEs), with 3.3% after the first dose and 4.3% after the second dose experiencing severe AEs.

Factors associated with a higher incidence of AEs included receiving the mRNA-1273 vaccine, being female, having dermatologic diseases, and a history of serious allergic reactions or anticoagulant medication use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Nationwide Survey of mRNA COVID-19 Vaccinee's Experiences on Adverse Events and Its Associated Factors. Yoon, D., Jeon, HL., Noh, Y., et al.[2023]

References

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

Safety and Feasibility of an Interdisciplinary Treatment Approach to Optimize Recovery From Critical Coronavirus Disease 2019. [2021]

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

Using Virtual Care to Facilitate Direct Hospital Admissions in Outpatients with Worsening COVID-19 Infection. [2022]

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

Remote Patient Monitoring Identifies the Need for Triage in Patients with Acute COVID-19 Infection. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

[Home telemonitoring and oxygen therapy in COVID-19 patients: safety, patient satisfaction, and cost-effectiveness]. [2021]

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

Post-COVID-19 Syndrome Clinical Pathway for the US Veterans Health Administration. [2023]

6. Korea (South) pubmed.ncbi.nlm.nih.gov

A Nationwide Survey of mRNA COVID-19 Vaccinee's Experiences on Adverse Events and Its Associated Factors. [2023]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Changes in incidence rates of outcomes of interest in vaccine safety studies during the COVID-19 pandemic. [2023]

8. Netherlands pubmed.ncbi.nlm.nih.gov

An open trial of VA CONNECT: Caring for Our Nation's Needs Electronically during the COVID-19 Transition. [2023]

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

Clinical Trial Drug Safety Assessment for Studies and Submissions Impacted by COVID-19. [2021]

10. Switzerland pubmed.ncbi.nlm.nih.gov

How Has COVID-19 Changed the Way We Do Virtual Care? A Scoping Review Protocol. [2022]

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

Nurse-Led Telehealth Interventions During COVID-19: A Scoping Review. [2023]

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

Responding to an Emerging Need: Implementing Telehealth in Acute Hospital Rehabilitation. [2021]

13. England pubmed.ncbi.nlm.nih.gov

Implementations and strategies of telehealth during COVID-19 outbreak: a systematic review. [2022]

14. Ireland pubmed.ncbi.nlm.nih.gov

Physiotherapists' perspective of telehealth during the Covid-19 pandemic. [2022]