Telehealth for Critical Illness Recovery

(WFIT Trial)

Overseen By Rita N Bakhru, MD, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Disqualifiers: Multiple hospitalizations, Hospice, 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 tests a new telehealth program called WFIT, designed to enhance recovery after ICU stays. It involves telehealth visits with a nurse practitioner and an activity tracker to monitor daily activity for six months post-hospitalization. The goal is to improve recovery, reduce hospital visits, and lower healthcare costs. Ideal participants are North Carolina residents who were in the ICU for sepsis or required breathing support and have been discharged home. As an unphased trial, this study provides a unique opportunity to contribute to innovative healthcare solutions and improve recovery experiences for future patients.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that the WFIT program is safe for post-critical illness care?

Research shows that telehealth programs, such as the Wake Forest Post-ICU Telehealth (WFIT) program, are generally safe for patients. Studies have found no major safety concerns when using telehealth to monitor health and activity levels. For example, one study found that telehealth for balance exercises was safe and improved walking and balance in participants.

Real-world data support telehealth's safety, demonstrating its ability to reach many people without introducing new safety risks. Although telehealth is not a traditional medical or surgical treatment, it has been well-received in healthcare settings. Significant reports of unexpected medical issues related to telehealth itself have not emerged.

Overall, telehealth programs like WFIT are considered safe and can provide important health insights and support after patients leave the hospital. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Wake Forest Post-ICU Telehealth (WFIT) Program because it introduces a novel approach to post-ICU care by utilizing telehealth. Unlike standard care, which typically involves in-person follow-ups with primary care providers and specialists, WFIT offers continuous remote monitoring through telehealth visits with a nurse practitioner. This method not only provides convenience for patients but also enhances care by using an activity tracker to deliver real-time data on the patient’s daily activity levels. This innovative approach has the potential to improve long-term recovery and outcomes for patients discharged from the ICU.

What evidence suggests that the WFIT program is effective for improving post-critical illness care?

Research has shown that telehealth programs like the Wake Forest Post-ICU Telehealth (WFIT), which participants in this trial may receive, can assist patients after hospital discharge. Studies have found that telemedicine for follow-up care can lead to fewer emergency room visits and lower healthcare costs. Patients using online health tools have reported better recovery from post-intensive care syndrome (PICS), which often occurs after an ICU stay. These digital tools also keep patients engaged in their recovery. Overall, this evidence suggests that WFIT could enhance quality of life and reduce the likelihood of hospital readmission for ICU survivors. ^{6 7 8 9 10}

Who Is on the Research Team?

Clark Files, MD

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

Inclusion Criteria

Admission to Wake Forest Baptist Health medical Intensive Care Unit (ICU)

ICU Diagnosis: Sepsis and/or acute respiratory failure defined by assisted ventilation (includes mechanical ventilation, Bilevel Positive Airway Pressure (BIPAP), Continuous Positive Airway Pressure (CPAP), or requiring > 15 Liter of supplemental oxygen

Consent to enrollment in the study

Exclusion Criteria

Admitted from hospice, a skilled nursing facility or Long-Term Acute Care Hospital (LTACH).

Discharge to a Skilled Nursing Facility or LTACH or Hospice. We will permit enrollment of patients who are discharged to acute rehabilitation.

>2 Hospitalizations in the past year.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive telehealth visits with a nurse practitioner and an activity tracker for 6 months post-hospital discharge

6 months

Monthly telehealth visits

Usual Care

Participants follow-up with primary care providers and specialists as recommended

6 months

Follow-up

Participants are monitored for safety and effectiveness after the intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• WFIT

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

Patients randomized to intervention will have 6 months of access after hospital discharge for telehealth visits with a nurse practitioner and an activity tracker providing data to the nurse practitioner about subject's daily level of activity.

Group II: Usual Care Active Control 1 Intervention

Patients randomized to usual care will follow-up with primary care providers and specialists as recommended by hospital providers, or seek medical care as needed after hospital discharge.

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

Published Research Related to This Trial

Adverse event reporting in randomized clinical trials (RCTs) is often inadequate, leading to potential safety concerns for new drugs once they are used in larger, more diverse patient populations.

The article highlights specific shortcomings in AE reporting for tumor necrosis factor (TNF) inhibitors, including issues with time-to-event reporting, standardized incidence ratios, and insufficient sample sizes, which can obscure the true safety profile of these medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Some concerns about adverse event reporting in randomized clinical trials. Yazici, Y.[2008]

The safety profile of newly approved drugs is often less established than their efficacy before they are marketed, relying heavily on voluntary reporting of adverse events by healthcare providers and patients.

The FDA has been using various epidemiological studies and has implemented initiatives for active surveillance to better identify and investigate safety signals associated with marketed drugs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Informatic tools and approaches in postmarketing pharmacovigilance used by FDA. Weaver, J., Willy, M., Avigan, M.[2021]

Randomized clinical trials (RCTs) provide valuable initial safety data for drugs, but they often involve a small number of subjects and short follow-up periods, which can leave some safety signals undiscovered until after approval.

The integration of post-marketing real-world data (RWD) with RCT data can enhance safety evaluations, particularly for cardiovascular risks associated with antidiabetic therapies, by identifying new safety signals and validating findings in broader patient populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrative Analysis of Randomized Clinical Trial and Observational Study Data to Inform Post-marketing Safety Decision-Making. Lin, LA., Zhang, Y., Straus, W., et al.[2022]

The definition of an adverse drug event (ADE) should be tailored to the specific purpose of the evaluation, with stricter definitions needed for scientific studies and more flexible ones for clinical use.

Postmarketing safety data for drugs is limited at launch, but can be supplemented through systems like the FDA's Spontaneous Reporting System and targeted research projects, emphasizing the importance of robust epidemiological evidence for regulatory actions like drug recalls.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse drug events: identification and attribution. Rogers, AS.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40532205/

A Randomized Controlled Trial of a Post-ICU Telehealth ... The primary outcome is the cost-effectiveness of the intervention. Measurements and Main Results: Overall healthcare spending on emergency room (ER) visits ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11594565/

Telemedicine and Lab Follow-up after Hospital Discharge Using a seamlessly shared inpatient-outpatient EHR was associated with greater rates of post-discharge follow-up delivered through telemedicine ...

3. ccforum.biomedcentral.com ccforum.biomedcentral.com/articles/10.1186/s13054-024-05089-6

Exploring the effectiveness of eHealth interventions in treating ... The use of eHealth interventions to rehabilitate patients in the early post-discharge phase could promote better PICS recovery. Evidence from ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1036731424002856

Digital health interventions to improve recovery for ... Digital health interventions can be successfully implemented for critical care survivors and have varying intervention adherence and retention rate success.

5. formative.jmir.org formative.jmir.org/2024/1/e53455

Efficacy of Remote Health Monitoring in Reducing Hospital ... This study aimed to determine the efficacy of home telemonitoring follow-up in reducing hospital readmissions, emergency department (ED) visits, and total ...

6. withpower.com withpower.com/trial/phase-critical-illness-2-2021-babbf

Wake Forest Post-ICU Telehealth (WFIT) Program ... Real-world data and studies help identify and understand safety concerns that might not appear in initial trials. Show more ...

7. sciencedirect.com sciencedirect.com/org/science/article/pii/S192907481400078X

A Telehealth Intervention Using Nintendo Wii Fit Balance ... Preliminary evidence suggests Wii Fit training is a feasible and safe method leading to improvements in balance [25,26], walking [25-27], and ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8293040/

The Impact of a Telehealth Intervention on Activity Profiles ... Telehealth presents a safe platform for conducting health-related interventions that may have additional benefits such as widespread reach. Our pilot study ...

9. clinicaltrials.gov clinicaltrials.gov/study/NCT04714840

NCT04714840 | Telehealth Based Intervention to Improve ... Telehealth Based Intervention to Improve Functional Capacity in Survivors of Childhood Cancer With Significantly Limited Exercise Tolerance · Study Overview.

10. clinicaltrials.gov clinicaltrials.gov/study/NCT05746741

NCT05746741 | Telehealth Intervention Strategies for WIC ... Data will be collected, and this outcome measure will be assessed via survey completion by study participants. During the study period, approximately 18 months.