MICU Recovery Clinic

Sepsis Clinical Trial

Official title:

Evaluation of Outcomes Following Critical Illness Through a MICU Recovery Clinic

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02560129
• Other study ID #: IRB00031295
• Status: Completed
• Start date: July 2015
• Est. completion date: November 30, 2023

Study information

• Verified date: June 2024
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: November 30, 2023
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria: Wake Forest MICU Admission

• sepsis OR

• respiratory failure requiring >24 hrs of invasive mechanical ventilation

• previously functional

Exclusion Criteria:

• Active Malignancy

Related Conditions & MeSH terms

• ARDS
• Critical Illness
• Respiratory Failure
• Respiratory Insufficiency
• Sepsis

Intervention

Other:
• Questionnaires, Physical and Cognitive Function
ICU survivors will be administered a battery of questionnaires. Measurements of physical and cognitive function will also be performed.

Locations

Country	Name	City	State
United States	Wake Forest Baptist Medical Center	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Swallow Function	EAT 10 Questionnaire	6 months
Other	Speech	Voice Analysis	6 months
Other	Pain	Brief Pain Inventory, modified version of the modified musculoskeletal questionnaire	6 months
Primary	Physical Function	as measured by the Short Performance Physical Battery	6 months
Secondary	Physical Function	Handgrip strength	6 months
Secondary	Cognitive Function	Montreal Cognitive Assessment	6 months
Secondary	Anxiety/ Depression Screening	Hospital Anxiety and Depression Scale	6 months
Secondary	Post Traumatic Stress Disorder Screening	Impact of Events Scale- Revised	6 months
Secondary	Functional Status	Activities of Daily Living and Instrumental Activities of Daily Living	6 months
Secondary	Resilience	Connor-Davidson Resilience Scale- 10	6 months
Secondary	Quality of Life	Short-Form 36	6 months
Secondary	Hospital Readmissions		6 months
Secondary	Mortality		6 months