MICU Recovery Clinic

October 31, 2023 updated by: Wake Forest University Health Sciences

Evaluation of Outcomes Following Critical Illness Through a MICU Recovery Clinic

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.

Study Overview

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.

Study Type

Observational

Enrollment (Estimated)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Wake Forest MICU Survivors

Description

Inclusion Criteria: Wake Forest MICU Admission

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

Exclusion Criteria:

- Active Malignancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
ICU Survivors
ICU survivors will be seen in a MICU Recovery Clinic where Questionnaires, Physical and Cognitive Function assessments will be measured
ICU survivors will be administered a battery of questionnaires. Measurements of physical and cognitive function will also be performed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical Function
Time Frame: 6 months
as measured by the Short Performance Physical Battery
6 months

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Swallow Function
Time Frame: 6 months
EAT 10 Questionnaire
6 months
Speech
Time Frame: 6 months
Voice Analysis
6 months
Pain
Time Frame: 6 months
Brief Pain Inventory, modified version of the modified musculoskeletal questionnaire
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Rita Bakhru, MD, Wake Forest University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

June 1, 2024

Study Registration Dates

First Submitted

September 24, 2015

First Submitted That Met QC Criteria

September 24, 2015

First Posted (Estimated)

September 25, 2015

Study Record Updates

Last Update Posted (Actual)

November 2, 2023

Last Update Submitted That Met QC Criteria

October 31, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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