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OpenTrials
Completed

NCT Number: NCT02560129

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

About this study

Objectives:

  • To evaluate physical function, cognitive function, and overall functional status during recovery from critical illness.
  • To evaluate anxiety, depression, and PTSD during recovery from critical illness.
  • To evaluate resilience during recovery from critical illness.
  • To evaluate healthcare utilization rates, morbidity, and mortality following critical illness.
  • Added April 2016: To study the voice and swallowing function of patients following recovery from critical illness.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Wake Forest MICU Admission

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

Exclusion criteria

  • Active Malignancy

Treatment and study plan

Questionnaires, Physical and Cognitive Function

Other

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

Primary outcomes

  1. Physical Function

    Time frame: 6 months

    as measured by the Short Performance Physical Battery

Secondary outcomes

  1. Physical Function

    Time frame: 6 months

    Handgrip strength

  2. Cognitive Function

    Time frame: 6 months

    Montreal Cognitive Assessment

  3. Anxiety/ Depression Screening

    Time frame: 6 months

    Hospital Anxiety and Depression Scale

  4. Post Traumatic Stress Disorder Screening

    Time frame: 6 months

    Impact of Events Scale- Revised

  5. Functional Status

    Time frame: 6 months

    Activities of Daily Living and Instrumental Activities of Daily Living

  6. Resilience

    Time frame: 6 months

    Connor-Davidson Resilience Scale- 10

  7. Quality of Life

    Time frame: 6 months

    Short-Form 36

  8. Hospital Readmissions

    Time frame: 6 months

  9. Mortality

    Time frame: 6 months

Other outcomes

  1. Swallow Function

    Time frame: 6 months

    EAT 10 Questionnaire

  2. Speech

    Time frame: 6 months

    Voice Analysis

  3. Pain

    Time frame: 6 months

    Brief Pain Inventory, modified version of the modified musculoskeletal questionnaire

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Official study title

Evaluation of Outcomes Following Critical Illness Through a MICU Recovery Clinic

Important dates

Study start
2015
Primary completion
2023
Study completion
2023
First posted
Sep 25, 2015
Registry last updated
Jun 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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