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Wake Forest Post-ICU Telehealth (WFIT) Program

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04576065
Acronym
WFIT
Enrollment
413
Registered
2020-10-05
Start date
2021-03-19
Completion date
2023-09-14
Last updated
2023-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Illness

Keywords

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

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.

Interventions

OTHERWFIT

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

Sponsors

Wake Forest University Health Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

usual care group compared to intervention group

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Incremental Net Benefit (INB) Cost Effectiveness6 months post hospital dischargeDetermine 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.

Secondary

MeasureTime frameDescription
Number of Emergency Room (ER) Visits6 months post hospital dischargeevaluated monthly through to 6 months.
Number of hospital readmissions6 months post hospital dischargeReadmissions to a hospital evaluated monthly through to 6 months.
Mortality RateThrough 6 months post hospital discharge
Patient Satisfaction Questionnaire 18 (PSQ-18)6 months post hospital dischargeSatisfaction with care evaluated monthly through to 6 months. Scores range from 18-90 with a higher score denoting more satisfaction.
Euro Quality of Life, 5 Dimension, 5 Level (EQ-5D-5L) Questionnaire6 months post hospital dischargeQuality of life evaluated monthly through to 6 months. Scores range from 5-25 with higher scores indicating poorer health status.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026