Critical IllnessNCT02560129
MICU Recovery Clinic
An observational study of Critical Illness and Sepsis, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
Summary: Emerging data demonstrate long-term morbidity and mortality in those who survive critical illness. However, there is no data regarding long-term follow-up for ICU survivors. The investigators have begun the implementation of an ICU recovery clinic. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Critical Illness, Sepsis, Respiratory Failure
- What is being tested?
- Questionnaires, Physical and Cognitive Function
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to 30 Nov 2023
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Wake Forest MICU Survivors
Who may be able to join
- sepsis OR
- respiratory failure requiring >24 hrs of invasive mechanical ventilation
- previously functional
Who cannot join
- Active Malignancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157
About this study
Official title: Evaluation of Outcomes Following Critical Illness Through a MICU Recovery Clinic
Summary: Emerging data demonstrate long-term morbidity and mortality in those who survive critical illness. However, there is no data regarding long-term follow-up for ICU survivors. The investigators have begun the implementation of an ICU recovery clinic.
Rationale:
ICU survivors are at high risk for functional, cognitive and psychiatric impairments. However, methods to mitigate these impairments and improve recovery are lacking. Special follow-up clinics for survivors of critical illness have been proposed and implemented to some degree, but are uncommon.
Read the detailed description
Objectives:
- To evaluate physical function, cognitive function, and overall functional status during recovery from critical illness.
- To evaluate anxiety, depression, and PTSD during recovery from critical illness.
- To evaluate resilience during recovery from critical illness.
- To evaluate healthcare utilization rates, morbidity, and mortality following critical illness.
- Added April 2016: To study the voice and swallowing function of patients following recovery from critical illness.
- Added April 2016: To study the pain of patients following recovery from critical illness.
Intervention:
A prospective observational study of all patients who attend our ICU recovery clinic.
Methods:
Patients will be identified for participation in our ICU Recovery Clinic during their admission to the Wake Forest Baptist Medical Center Medical Intensive Care Unit (MICU). They will be asked to return to the ICU recovery clinic within 1 month of hospital discharge. Structured clinic visits as standard of care will include medication reconciliation and evaluation by a pharmacist, along with an evaluation by a clinic physician to address acute medical issues and provide counselling. They will also undergo standardized testing to evaluate physical function, cognitive function, and psychiatric function. Added April 2016: They will also undergo a standardized evaluation of speech, swallow, and pain.
- Conditions
- Critical Illness, Sepsis, Respiratory Failure, ARDS
- Being tested
- Questionnaires, Physical and Cognitive Function
- Keywords
- recovery, ICU, clinic, survivor, physical function
- Medical subject headings
- Critical Illness, Sepsis, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaires, Physical and Cognitive FunctionOther
ICU survivors will be administered a battery of questionnaires. Measurements of physical and cognitive function will also be performed.
| Study group | Role | What they receive |
|---|---|---|
| ICU Survivors | ICU survivors will be seen in a MICU Recovery Clinic where Questionnaires, Physical and Cognitive Function assessments will be measured Receives: Other: Questionnaires, Physical and Cognitive Function |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical Function
as measured by the Short Performance Physical Battery
Measured: 6 months
Secondary outcomes (9)
Physical Function
Handgrip strength
Measured: 6 months
Cognitive Function
Montreal Cognitive Assessment
Measured: 6 months
Anxiety/ Depression Screening
Hospital Anxiety and Depression Scale
Measured: 6 months
Post Traumatic Stress Disorder Screening
Impact of Events Scale- Revised
Measured: 6 months
Functional Status
Activities of Daily Living and Instrumental Activities of Daily Living
Measured: 6 months
Resilience
Connor-Davidson Resilience Scale- 10
Measured: 6 months
Quality of Life
Short-Form 36
Measured: 6 months
Hospital Readmissions
Measured: 6 months
Mortality
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2015 (estimated)
- Study startJul 2015
- Primary completion30 Nov 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- D. Clark Files, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02560129
- Sponsor's protocol ID
- IRB00031295
- Status last verified
- Jun 2024
- First submitted
- 24 Sep 2015
- Last updated
- 7 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Outcomes Following Critical Illness Through a MICU Recovery Clinic
- ClinicalTrials.gov ID
- NCT02560129
- Acronym / sponsor ID
- IRB00031295
- Conditions
- Critical Illness, Sepsis, Respiratory Failure, ARDS
- Keywords
- recovery, ICU, clinic, survivor, physical function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 25 Sep 2015 (estimated)
- 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.
Summary: Emerging data demonstrate long-term morbidity and mortality in those who survive critical illness. However, there is no data regarding long-term follow-up for ICU survivors. The investigators have begun the implementation of an ICU recovery clinic.
Rationale:
ICU survivors are at high risk for functional, cognitive and psychiatric impairments. However, methods to mitigate these impairments and improve recovery are lacking. Special follow-up clinics for survivors of critical illness have been proposed and implemented to some degree, but are uncommon.
Detailed description
Objectives:
- To evaluate physical function, cognitive function, and overall functional status during recovery from critical illness.
- To evaluate anxiety, depression, and PTSD during recovery from critical illness.
- To evaluate resilience during recovery from critical illness.
- To evaluate healthcare utilization rates, morbidity, and mortality following critical illness.
- Added April 2016: To study the voice and swallowing function of patients following recovery from critical illness.
- Added April 2016: To study the pain of patients following recovery from critical illness.
Intervention:
A prospective observational study of all patients who attend our ICU recovery clinic.
Methods:
Patients will be identified for participation in our ICU Recovery Clinic during their admission to the Wake Forest Baptist Medical Center Medical Intensive Care Unit (MICU). They will be asked to return to the ICU recovery clinic within 1 month of hospital discharge. Structured clinic visits as standard of care will include medication reconciliation and evaluation by a pharmacist, along with an evaluation by a clinic physician to address acute medical issues and provide counselling. They will also undergo standardized testing to evaluate physical function, cognitive function, and psychiatric function. Added April 2016: They will also undergo a standardized evaluation of speech, swallow, and pain.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICU Survivors | – | Other: Questionnaires, Physical and Cognitive FunctionICU survivors will be seen in a MICU Recovery Clinic where Questionnaires, Physical and Cognitive Function assessments will be measured |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Wake Forest MICU Survivors
Key inclusion criteria (3 listed)
- sepsis OR
- respiratory failure requiring >24 hrs of invasive mechanical ventilation
- previously functional
Key exclusion criteria (1 listed)
- Active Malignancy
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 |
|---|---|---|
| Questionnaires, Physical and Cognitive FunctionICU survivors will be administered a battery of questionnaires. Measurements of physical and cognitive function will also be performed. | Other | ICU Survivors |
Primary outcome
Physical Function
Time frame: 6 months
as measured by the Short Performance Physical Battery
9 secondary outcomes
Physical Function
Time frame: 6 months
Cognitive Function
Time frame: 6 months
Anxiety/ Depression Screening
Time frame: 6 months
Post Traumatic Stress Disorder Screening
Time frame: 6 months
Functional Status
Time frame: 6 months
Resilience
Time frame: 6 months
Quality of Life
Time frame: 6 months
Hospital Readmissions
Time frame: 6 months
Mortality
Time frame: 6 months
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 7 Jun 2024.
- Individual participant dataSharing planned: Undecided
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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.
D. 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?
An observational study of Critical Illness and Sepsis, 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 3 inclusion and 1 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 7 Jun 2024. 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?
Physical Function (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Jun 2024.