NCT04576065

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
413

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 29, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 5, 2020

Completed
6 months until next milestone

Study Start

First participant enrolled

March 19, 2021

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 14, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 14, 2023

Completed
Last Updated

December 13, 2023

Status Verified

May 1, 2023

Enrollment Period

2.5 years

First QC Date

September 29, 2020

Last Update Submit

December 6, 2023

Conditions

Critical Illness

Keywords

post-ICUpost-intensive careICU recoverycritical illness recovery

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Number of Emergency Room (ER) Visits

    6 months post hospital discharge

  • Number of hospital readmissions

    6 months post hospital discharge

  • Mortality Rate

    Through 6 months post hospital discharge

  • Patient Satisfaction Questionnaire 18 (PSQ-18)

    6 months post hospital discharge

  • Euro Quality of Life, 5 Dimension, 5 Level (EQ-5D-5L) Questionnaire

    6 months post hospital discharge

Study Arms (2)

Usual Care

NO 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.

Intervention

EXPERIMENTAL

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

Interventions

WFITOTHER

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

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • \>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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

Related Publications (1)

  • 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.

    PMID: 40532205DERIVED

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Clark Files, MD

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: usual care group compared to intervention group
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 29, 2020

First Posted

October 5, 2020

Study Start

March 19, 2021

Primary Completion

September 14, 2023

Study Completion

September 14, 2023

Last Updated

December 13, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)