MICU Recovery Clinic

• Sponsor: Wake Forest University Health Sciences (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT02560129
• Collaborator: (none)
• Enrollment: 250
• Location: 1
• Duration (Months): 107
• Patients Per Site Per Month: 2.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Critical Illness; Sepsis; Respiratory Failure; ARDS	Other: Questionnaires, Physical and Cognitive Function

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 Design

• Study Type: Observational
• Anticipated Enrollment: 250 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Evaluation of Outcomes Following Critical Illness Through a MICU Recovery Clinic
• Study Start Date: Jul 1, 2015
• Anticipated Primary Completion Date: Jun 1, 2024
• Anticipated Study Completion Date: Jun 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
ICU Survivors ICU survivors will be seen in a MICU Recovery Clinic where Questionnaires, Physical and Cognitive Function assessments will be measured	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.

Outcome Measures

Primary Outcome Measures

1. Physical Function [6 months]

   as measured by the Short Performance Physical Battery

Secondary Outcome Measures

1. Physical Function [6 months]

   Handgrip strength

2. Cognitive Function [6 months]

   Montreal Cognitive Assessment

3. Anxiety/ Depression Screening [6 months]

   Hospital Anxiety and Depression Scale

4. Post Traumatic Stress Disorder Screening [6 months]

   Impact of Events Scale- Revised

5. Functional Status [6 months]

   Activities of Daily Living and Instrumental Activities of Daily Living

6. Resilience [6 months]

   Connor-Davidson Resilience Scale- 10

7. Quality of Life [6 months]

   Short-Form 36

8. Hospital Readmissions [6 months]

9. Mortality [6 months]

Other Outcome Measures

1. Swallow Function [6 months]

   EAT 10 Questionnaire

2. Speech [6 months]

   Voice Analysis

3. Pain [6 months]

   Brief Pain Inventory, modified version of the modified musculoskeletal questionnaire

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Wake Forest Baptist Medical Center	Winston-Salem	North Carolina	United States	27157

Sponsors and Collaborators

• Wake Forest University Health Sciences

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Wake Forest University Health Sciences
• ClinicalTrials.gov Identifier: NCT02560129
• Other Study ID Numbers: IRB00031295
• First Posted: Sep 25, 2015
• Last Update Posted: Jun 30, 2022
• Last Verified: Nov 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Wake Forest University Health Sciences: recovery; ICU; clinic; survivor; physical function
• Additional relevant MeSH terms: Respiratory Insufficiency; Critical Illness

Study Results

No Results Posted as of Jun 30, 2022