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

Primary Purpose

Critical Illness

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
WFIT
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Critical Illness focused on measuring post-ICU, post-intensive care, ICU recovery, critical illness recovery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Wake Forest University Health Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Usual Care

Intervention

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Number of Emergency Room (ER) Visits
evaluated monthly through to 6 months.
Number of hospital readmissions
Readmissions to a hospital evaluated monthly through to 6 months.
Mortality Rate
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.
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.

Full Information

First Posted
September 29, 2020
Last Updated
June 2, 2023
Sponsor
Wake Forest University Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT04576065
Brief Title
Wake Forest Post-ICU Telehealth (WFIT) Program
Acronym
WFIT
Official Title
Randomized Controlled Trial of the Wake Forest Post-ICU Telehealth (WFIT) Program
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 19, 2021 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
October 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness
Keywords
post-ICU, post-intensive care, ICU recovery, critical illness recovery

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
usual care group compared to intervention group
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
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.
Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
WFIT
Intervention Description
access to nurse practitioner for telehealth visits and activity monitor for 6 months after hospital discharge
Primary Outcome Measure Information:
Title
Incremental Net Benefit (INB) Cost Effectiveness
Description
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.
Time Frame
6 months post hospital discharge
Secondary Outcome Measure Information:
Title
Number of Emergency Room (ER) Visits
Description
evaluated monthly through to 6 months.
Time Frame
6 months post hospital discharge
Title
Number of hospital readmissions
Description
Readmissions to a hospital evaluated monthly through to 6 months.
Time Frame
6 months post hospital discharge
Title
Mortality Rate
Time Frame
Through 6 months post hospital discharge
Title
Patient Satisfaction Questionnaire 18 (PSQ-18)
Description
Satisfaction with care evaluated monthly through to 6 months. Scores range from 18-90 with a higher score denoting more satisfaction.
Time Frame
6 months post hospital discharge
Title
Euro Quality of Life, 5 Dimension, 5 Level (EQ-5D-5L) Questionnaire
Description
Quality of life evaluated monthly through to 6 months. Scores range from 5-25 with higher scores indicating poorer health status.
Time Frame
6 months post hospital discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clark Files, MD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest University Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Wake Forest Post-ICU Telehealth (WFIT) Program

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