Clinical trial NCT02560129: MICU Recovery Clinic
Official title: Evaluation of Outcomes Following Critical Illness Through a MICU Recovery Clinic
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Critical Illness
Sepsis
Respiratory Failure
ARDS
Keywords: recovery
ICU
clinic
survivor
physical function
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2015-09-25
Enrollment: 14
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Wake Forest MICU Survivors

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.

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

Primary outcomes:
measure: Physical Function
timeFrame: 6 months
Secondary outcomes:
measure: Physical Function
timeFrame: 6 months
measure: Cognitive Function
timeFrame: 6 months
measure: Anxiety/ Depression Screening
timeFrame: 6 months
measure: Post Traumatic Stress Disorder Screening
timeFrame: 6 months
measure: Functional Status
timeFrame: 6 months
measure: Resilience
timeFrame: 6 months
measure: Quality of Life
timeFrame: 6 months
measure: Hospital Readmissions
timeFrame: 6 months
measure: Mortality
timeFrame: 6 months
Other outcomes:
measure: Swallow Function
timeFrame: 6 months
measure: Speech
timeFrame: 6 months
measure: Pain
timeFrame: 6 months
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Medical Center
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: D. Clark Files, MD
role: PRINCIPAL_INVESTIGATOR
References: