Wake Forest Post-ICU Telehealth (WFIT) Program (WFIT)

Randomized Controlled Trial of the Wake Forest Post-ICU Telehealth (WFIT) Program

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.

Study Overview

• Status: Completed
• Conditions: Critical Illness
• Intervention / Treatment: Other: WFIT

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.

• Study Type: Interventional
• Enrollment (Actual): 413
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 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.
Experimental: 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.	Other: WFIT; access to nurse practitioner for telehealth visits and activity monitor for 6 months after hospital discharge

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incremental Net Benefit (INB) Cost Effectiveness	Determine if the WFIT Program is cost-effective by measuring INB in the intervention arm (WFIT program) compared to an attention control arm. Incremental net benefit ($) = [Change in Quality of Adjusted Life Year (QALY) *100,000] - [Change in health care spending] INB is defined as the difference between change in quality of life evaluated at monetary valuation of 1 QALY (currently $100,000) and change in health care spending. Using this measure, even if WFIT does not affect patient quality of life, then INB will equal the reduction in health care spending.	6 months post hospital discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Emergency Room (ER) Visits	evaluated monthly through to 6 months.	6 months post hospital discharge
Number of hospital readmissions	Readmissions to a hospital evaluated monthly through to 6 months.	6 months post hospital discharge
Mortality Rate		Through 6 months post hospital discharge
Patient Satisfaction Questionnaire 18 (PSQ-18)	Satisfaction with care evaluated monthly through to 6 months. Scores range from 18-90 with a higher score denoting more satisfaction.	6 months post hospital discharge
Euro Quality of Life, 5 Dimension, 5 Level (EQ-5D-5L) Questionnaire	Quality of life evaluated monthly through to 6 months. Scores range from 5-25 with higher scores indicating poorer health status.	6 months post hospital discharge

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Clark Files, MD, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): March 19, 2021
• Primary Completion (Actual): September 14, 2023
• Study Completion (Actual): September 14, 2023

Study Registration Dates

• First Submitted: September 29, 2020
• First Submitted That Met QC Criteria: September 29, 2020
• First Posted (Actual): October 5, 2020

Study Record Updates

• Last Update Posted (Estimated): December 13, 2023
• Last Update Submitted That Met QC Criteria: December 6, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: post-ICU; post-intensive care; ICU recovery; critical illness recovery
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: IRB00068761

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No