Critical IllnessWFITNCT04576065
Wake Forest Post-ICU Telehealth (WFIT) Program
A study testing WFIT in people with Critical Illness, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness
- What is being tested?
- WFIT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 413 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Mar 2021to 14 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- >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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: 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.
Read the 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.
- Conditions
- Critical Illness
- Being tested
- WFIT
- Keywords
- post-ICU, post-intensive care, ICU recovery, critical illness recovery
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WFITOther
access to nurse practitioner for telehealth visits and activity monitor for 6 months after hospital discharge
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: WFIT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months post hospital discharge
Secondary outcomes (5)
Number of Emergency Room (ER) Visits
evaluated monthly through to 6 months.
Measured: 6 months post hospital discharge
Number of hospital readmissions
Readmissions to a hospital evaluated monthly through to 6 months.
Measured: 6 months post hospital discharge
Mortality Rate
Measured: 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.
Measured: 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.
Measured: 6 months post hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2020
- Study start19 Mar 2021
- Primary completion14 Sep 2023
- Study completion14 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- usual care group compared to intervention group
- Masking
- None (open label)
- Enrolment
- 413 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Clark Files, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04576065
- Sponsor's protocol ID
- IRB00068761
- Acronym
- WFIT
- Status last verified
- May 2023
- First submitted
- 29 Sep 2020
- Last updated
- 13 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40532205
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of the Wake Forest Post-ICU Telehealth (WFIT) Program
- ClinicalTrials.gov ID
- NCT04576065
- Acronym / sponsor ID
- WFIT / IRB00068761
- Conditions
- Critical Illness
- Keywords
- post-ICU, post-intensive care, ICU recovery, critical illness recovery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 413 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 19 Mar 2021 (actual)
- Primary completion
- 14 Sep 2023 (actual)
- Study completion
- 14 Sep 2023 (actual)
- First posted
- 5 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- usual care group compared to intervention group
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: WFITPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- >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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WFITaccess to nurse practitioner for telehealth visits and activity monitor for 6 months after hospital discharge | Other | Intervention |
Primary outcome
Incremental Net Benefit (INB) Cost Effectiveness
Time frame: 6 months post hospital discharge
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.
5 secondary outcomes
Number of Emergency Room (ER) Visits
Time frame: 6 months post hospital discharge
Number of hospital readmissions
Time frame: 6 months post hospital discharge
Mortality Rate
Time frame: Through 6 months post hospital discharge
Patient Satisfaction Questionnaire 18 (PSQ-18)
Time frame: 6 months post hospital discharge
Euro Quality of Life, 5 Dimension, 5 Level (EQ-5D-5L) Questionnaire
Time frame: 6 months post hospital discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2023.
- Derived from this study: PubMed 40532205Bakhru 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clark Files, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WFIT in people with Critical Illness, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incremental Net Benefit (INB) Cost Effectiveness (time frame: 6 months post hospital discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04576065, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2023.