Wake Forest Post-ICU Telehealth (WFIT) Program

NCT ID: NCT04576065

Last Updated: 2023-12-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 413 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-19
• Study Completion Date: 2023-09-14

Brief Summary

Wake Forest Post-Intensive Care Unit Telehealth (WFIT) program consists of a nurse practitioner who has access to daily activity data as well as telehealth capabilities for 6 months post-hospital discharge in order to improve the post-critical illness care of patients. The study team expects that this program will reduce costs to patients. Through this intervention the study team hopes to improve quality of life, patient satisfaction, reduce readmissions and ER visits, and reduce mortality. The study team will perform a formal randomized controlled trial with a cost-effectiveness analysis to demonstrate its value.

Detailed Description

Wake Forest Baptist Health (WFBH) discharges over 1,000 patients annually after a critical illness such as septic shock and/or acute respiratory failure. This number is expected to be even higher due to the ongoing coronavirus pandemic. To try to bridge this gap, the Wake Forest Intensive Care Unit (ICU) Recovery Clinic was created in 2014. WFBH ICU Recovery Clinic (1 of ~15 nationwide) uses a multidisciplinary approach to transition care for ICU survivors back to Primary Care Physicians (PCPs). However, currently only about 5% of patients leaving the ICU who had respiratory failure and/or septic shock and may benefit from follow-up. In addition, patients seen in WFBH Recovery Clinic typically are only seen one time and then return to the care of their PCPs.

Poor physical function following critical illness is associated with hospital readmissions and mortality. However, barriers to post-ICU follow-up are common and include financial concerns as well as transportation barriers. Additionally, the Wake Forest ICU Recovery Clinic only sees patients once in the post-critical illness period, despite the fact that post-ICU morbidity remains high for at least six months following discharge. Finally, data demonstrates availability of internet services on a daily basis to the vast majority of the population (79% total of NC Congressional Districts 5, 6, and 13 in 2013; 68% in a random sample of 28 medical ICU patients). Taken together, this prompts the study team to propose this Wake Forest Post-ICU Telehealth (WFIT) program of a nurse practitioner who has access to daily activity data as well as telehealth capabilities in order to improve the post-critical illness care of these patients. The study team expects that this program will reduce costs to patients. Through this intervention the study team hopes to improve quality of life, patient satisfaction, reduce readmissions and ER visits, and reduce mortality. The study team will perform a formal randomized controlled trial with a cost-effectiveness analysis to demonstrate its value.

Conditions

Critical Illness

Keywords

post-ICU; post-intensive care; ICU recovery; critical illness recovery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Usual Care

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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 Type: EXPERIMENTAL

WFIT

Intervention Type: OTHER

access to nurse practitioner for telehealth visits and activity monitor for 6 months after hospital discharge

Interventions

WFIT

access to nurse practitioner for telehealth visits and activity monitor for 6 months after hospital discharge

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Admission to Wake Forest Baptist Health medical Intensive Care Unit (ICU)
• North Carolina Residents
• 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
• Survive to hospital discharge

Exclusion Criteria

• >2 Hospitalizations in the past year.
• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clark Files, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Countries

United States

References

Bakhru RN, Flores L, Cain JM, Province V, Fanning J, Rawal H, Bundy R, Obermiller CS, Moses A, Dharod A, Abdelfattah L, Hanchate A, Files DC. A Randomized Controlled Trial of a Post-ICU Telehealth Care Model (WFIT). Am J Respir Crit Care Med. 2025 Sep;211(9):1662-1670. doi: 10.1164/rccm.202411-2167OC.

Reference Type: DERIVED

PMID: 40532205 (View on PubMed)

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

IRB00068761

Identifier Type: -

Identifier Source: org_study_id