Wake Forest Post-ICU Telehealth (WFIT) Program

(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

413 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a program where a nurse practitioner uses telehealth to help patients after they leave the ICU. It aims to improve their recovery, reduce hospital visits, and lower costs. The program targets patients with serious illnesses who have trouble accessing follow-up care.

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 safety data exists for the treatment known as null or WFIT?

The safety of new treatments is often not fully known until after they are used by many people over time. The FDA collects reports of side effects from doctors and patients to help understand safety better. Real-world data and studies help identify and understand safety concerns that might not appear in initial trials. ^{1 2 3 4 5}

Research Team

Clark Files, MD

Principal Investigator

Wake Forest University Health Sciences

Eligibility Criteria

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

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

Treatment Details

Interventions

• WFIT

Participant Groups

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+

Findings from Research

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]

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 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]

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]

References

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

Informatic tools and approaches in postmarketing pharmacovigilance used by FDA. [2021]

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

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

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

Adverse drug events: identification and attribution. [2022]

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

Estimation of causal effect in integrating randomized clinical trial and observational data - An example application to cardiovascular outcome trial. [2021]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Integrative Analysis of Randomized Clinical Trial and Observational Study Data to Inform Post-marketing Safety Decision-Making. [2022]