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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to assist children with complex chronic illnesses after hospital discharge. The main focus is whether a special telehealth program, the GET2HOME Intervention, which includes family meetings and a task tracker, can improve care compared to standard hospital care. Children with long-term health issues who are about to be discharged from a pediatric hospital are ideal candidates for this study. The goal is to determine if this approach can make at-home care more organized and effective. As an unphased trial, this study offers families the chance to contribute to innovative care solutions that could enhance the quality of life for children with chronic illnesses.

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 prior data suggests that the GET2HOME Intervention is safe?

Research has shown that telehealth programs, such as the GET2HOME bundle, effectively help manage COVID-19 patients. These programs offer supportive care that patients find easy to handle. Previous studies found that patients using telehealth did not experience more serious side effects than those receiving in-person care. Telehealth involves remote communication and monitoring, which is generally considered safe. This suggests that the GET2HOME program is likely safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the GET2HOME intervention because it offers a personalized approach to managing COVID-19 patient care post-hospitalization. Unlike standard hospital-based care, which typically involves routine follow-up, GET2HOME incorporates telehealth huddles that connect the family, inpatient team, primary care, and home care nursing in a coordinated effort. This ensures a seamless transition from hospital to home and supports the family in real-time through a visual discharge task tracker. These features aim to improve patient outcomes by making the post-discharge process more collaborative and transparent.

What evidence suggests that the GET2HOME Intervention is effective for COVID-19?

Research has shown that telehealth and remote patient monitoring help care for COVID-19 patients by providing support. In this trial, the GET2HOME Intervention uses telehealth to connect families with healthcare teams, improving communication and care coordination. This method ensures patients receive necessary follow-up care after leaving the hospital, potentially leading to better health outcomes. Early studies suggest these telehealth programs can increase patient involvement and reduce the risk of COVID-19 complications. Although specific data on GET2HOME is limited, the overall success of telehealth in similar situations appears promising. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

Citations

1. withpower.com withpower.com/trial/phase-children-with-complex-chronic-conditions-10-2022-3938f

Telehealth Intervention for COVID-19 (GET2HOME Trial) The research shows that telehealth and remote patient monitoring programs have been effective in managing COVID-19 patients by providing supportive care, ...

2. shmpublications.onlinelibrary.wiley.com shmpublications.onlinelibrary.wiley.com/doi/abs/10.1002/jhm.13192

Garnering effective telehealth to help optimize ... We will conduct a pragmatic 2-arm randomized controlled trial (RCT) comparing the GET2HOME bundle intervention to the standard hospital-based ...

3. researchgate.net researchgate.net/publication/373264918_Garnering_effective_telehealth_to_help_optimize_multidisciplinary_team_engagement_GET2HOME_for_children_with_medical_complexity_Protocol_for_a_pragmatic_randomized_control_trial

Protocol for a pragmatic randomized control trial Objective: We will compare the effectiveness of the garnering effective telehealth 2 help optimize multidisciplinary team engagement (GET2HOME) ...

4. pcori.org pcori.org/explore-our-portfolio?hgcrm_trackingsetid=a0h8W00000FlDFsQAN&f%5B0%5D=populations%3A3037&page=1

Explore Our Portfolio Search a repository of PCORI-funded comparative clinical effectiveness research (CER) studies, as well as projects that seek to ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9308645/

Evaluating effectiveness of public health intervention ... We show that lockdown has the largest effect on reducing transmission and reopening bars significantly increase transmission.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11180098/

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 ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37602537/

Protocol for a pragmatic randomized control trial - PubMed - NIH GET2HOME is a telehealth intervention for children with medical complexity, including pre/post-discharge huddles and a care tracker, compared to standard care.