- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02560129
MICU Recovery Clinic
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Lori Flores
- Phone Number: 336-713-0008
- Email: lflores@wakehealth.edu
Study Contact Backup
- Name: Rita Bakhru, MD
- Phone Number: 336-716-1210
- Email: rbakhru@wakehealth.edu
Study Locations
-
-
North Carolina
-
Winston-Salem, North Carolina, United States, 27157
- Recruiting
- Wake Forest Baptist Medical Center
-
Contact:
- Rita Bakhru, MD
- Phone Number: 336-716-1210
- Email: rbakhru@wakehealth.edu
-
Contact:
- D Clark Files, MD
- Phone Number: 336-716-8898
- Email: dfiles@wakehealth.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria: Wake Forest MICU Admission
- sepsis OR
- respiratory failure requiring >24 hrs of invasive mechanical ventilation
- previously functional
Exclusion Criteria:
- Active Malignancy
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
ICU Survivors
ICU survivors will be seen in a MICU Recovery Clinic where Questionnaires, Physical and Cognitive Function assessments will be measured
|
ICU survivors will be administered a battery of questionnaires.
Measurements of physical and cognitive function will also be performed.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Physical Function
Time Frame: 6 months
|
as measured by the Short Performance Physical Battery
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mortality
Time Frame: 6 months
|
6 months
|
|
Physical Function
Time Frame: 6 months
|
Handgrip strength
|
6 months
|
Cognitive Function
Time Frame: 6 months
|
Montreal Cognitive Assessment
|
6 months
|
Anxiety/ Depression Screening
Time Frame: 6 months
|
Hospital Anxiety and Depression Scale
|
6 months
|
Post Traumatic Stress Disorder Screening
Time Frame: 6 months
|
Impact of Events Scale- Revised
|
6 months
|
Functional Status
Time Frame: 6 months
|
Activities of Daily Living and Instrumental Activities of Daily Living
|
6 months
|
Resilience
Time Frame: 6 months
|
Connor-Davidson Resilience Scale- 10
|
6 months
|
Quality of Life
Time Frame: 6 months
|
Short-Form 36
|
6 months
|
Hospital Readmissions
Time Frame: 6 months
|
6 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Swallow Function
Time Frame: 6 months
|
EAT 10 Questionnaire
|
6 months
|
Speech
Time Frame: 6 months
|
Voice Analysis
|
6 months
|
Pain
Time Frame: 6 months
|
Brief Pain Inventory, modified version of the modified musculoskeletal questionnaire
|
6 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Rita Bakhru, MD, Wake Forest University
Study record dates
Study Major Dates
Study Start
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00031295
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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