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MICU Recovery Clinic

Evaluation of Outcomes Following Critical Illness Through a MICU Recovery Clinic

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02560129
Enrollment
14
Registered
2015-09-25
Start date
2015-07-31
Completion date
2023-11-30
Last updated
2024-06-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ARDS, Critical Illness, Respiratory Failure, Sepsis

Keywords

recovery, ICU, clinic, survivor, physical function

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.

Interventions

OTHERQuestionnaires, Physical and Cognitive Function

ICU survivors will be administered a battery of questionnaires. Measurements of physical and cognitive function will also be performed.

Sponsors

Wake Forest University Health Sciences
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

\- Active Malignancy

Design outcomes

Primary

MeasureTime frameDescription
Physical Function6 monthsas measured by the Short Performance Physical Battery

Secondary

MeasureTime frameDescription
Post Traumatic Stress Disorder Screening6 monthsImpact of Events Scale- Revised
Quality of Life6 monthsShort-Form 36
Hospital Readmissions6 months
Mortality6 months
Physical Function6 monthsHandgrip strength
Cognitive Function6 monthsMontreal Cognitive Assessment
Anxiety/ Depression Screening6 monthsHospital Anxiety and Depression Scale
Functional Status6 monthsActivities of Daily Living and Instrumental Activities of Daily Living
Resilience6 monthsConnor-Davidson Resilience Scale- 10

Other

MeasureTime frameDescription
Pain6 monthsBrief Pain Inventory, modified version of the modified musculoskeletal questionnaire
Speech6 monthsVoice Analysis
Swallow Function6 monthsEAT 10 Questionnaire

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026