MICU Recovery Clinic

Completed

• Conditions: Critical Illness; ARDS; Sepsis; Respiratory Failure
• Interventions: Other: Questionnaires, Physical and Cognitive Function

• Registration Number: NCT02560129
• Lead Sponsor: Wake Forest University Health Sciences

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2015-07
• Study First Submitted: 2015-09-24
• Study First Submitted QC: 2015-09-24
• Study First Posted: 2015-09-25
• Primary Completion: 2023-11-30
• Study Completion: 2023-11-30
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-06
• Last Update Posted: 2024-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

Wake Forest MICU Admission

• sepsis OR
• respiratory failure requiring >24 hrs of invasive mechanical ventilation
• previously functional

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Exclusion Criteria

• Active Malignancy

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ICU Survivors	Questionnaires, Physical and Cognitive Function	ICU survivors will be seen in a MICU Recovery Clinic where Questionnaires, Physical and Cognitive Function assessments will be measured

Primary Outcome Measures

Name	Time	Method
Physical Function	6 months	as measured by the Short Performance Physical Battery

Secondary Outcome Measures

Name	Time	Method
Hospital Readmissions	6 months
Mortality	6 months
Anxiety/ Depression Screening	6 months	Hospital Anxiety and Depression Scale
Quality of Life	6 months	Short-Form 36
Cognitive Function	6 months	Montreal Cognitive Assessment
Resilience	6 months	Connor-Davidson Resilience Scale- 10
Physical Function	6 months	Handgrip strength
Post Traumatic Stress Disorder Screening	6 months	Impact of Events Scale- Revised
Functional Status	6 months	Activities of Daily Living and Instrumental Activities of Daily Living

Trial Locations

Locations (1)

Wake Forest Baptist Medical Center; 🇺🇸 Winston-Salem, North Carolina, United States