Clinical trial NCT04576065: Wake Forest Post-ICU Telehealth (WFIT) Program
Official title: Randomized Controlled Trial of the Wake Forest Post-ICU Telehealth (WFIT) Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Critical Illness
Keywords: post-ICU
post-intensive care
ICU recovery
critical illness recovery
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2020-10-05
Enrollment: 413
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: usual care group compared to intervention group
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Primary outcomes:
measure: Incremental Net Benefit (INB) Cost Effectiveness
timeFrame: 6 months post hospital discharge
Secondary outcomes:
measure: Number of Emergency Room (ER) Visits
timeFrame: 6 months post hospital discharge
measure: Number of hospital readmissions
timeFrame: 6 months post hospital discharge
measure: Mortality Rate
timeFrame: Through 6 months post hospital discharge
measure: Patient Satisfaction Questionnaire 18 (PSQ-18)
timeFrame: 6 months post hospital discharge
measure: Euro Quality of Life, 5 Dimension, 5 Level (EQ-5D-5L) Questionnaire
timeFrame: 6 months post hospital discharge
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Clark Files, MD
role: PRINCIPAL_INVESTIGATOR
References: