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Clinical Trials/NCT02560129
NCT02560129
Completed
N/A

Evaluation of Outcomes Following Critical Illness Through a MICU Recovery Clinic

Wake Forest University Health Sciences1 site in 1 country14 target enrollmentJuly 2015

Overview

Phase
N/A
Intervention
Not specified
Conditions
Critical Illness
Sponsor
Wake Forest University Health Sciences
Enrollment
14
Locations
1
Primary Endpoint
Physical Function
Status
Completed
Last Updated
last year

Overview

Brief 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.

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: 1. To evaluate physical function, cognitive function, and overall functional status during recovery from critical illness. 2. To evaluate anxiety, depression, and PTSD during recovery from critical illness. 3. To evaluate resilience during recovery from critical illness. 4. To evaluate healthcare utilization rates, morbidity, and mortality following critical illness. 5. Added April 2016: To study the voice and swallowing function of patients following recovery from critical illness. 6. 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.

Registry
clinicaltrials.gov
Start Date
July 2015
End Date
November 30, 2023
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Wake Forest MICU Admission
  • sepsis OR
  • respiratory failure requiring \>24 hrs of invasive mechanical ventilation
  • previously functional

Exclusion Criteria

  • Active Malignancy

Outcomes

Primary Outcomes

Physical Function

Time Frame: 6 months

as measured by the Short Performance Physical Battery

Secondary Outcomes

  • Cognitive Function(6 months)
  • Resilience(6 months)
  • Hospital Readmissions(6 months)
  • Anxiety/ Depression Screening(6 months)
  • Quality of Life(6 months)
  • Physical Function(6 months)
  • Post Traumatic Stress Disorder Screening(6 months)
  • Functional Status(6 months)
  • Mortality(6 months)

Study Sites (1)

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