Vanderbilt ICU Recovery Program Pilot Trial

NCT03124342 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 232

Last updated 2019-10-08

Study results available
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Summary

Every year, millions of Americans are admitted to the intensive care unit. Due to advances in critical care, mortality rates are decreasing, increasing the number of ICU survivors. Survivors of critical illness, however, often face physical, functional, and cognitive deficits that place them at risk for a cycle of re-hospitalization that frequently culminates in premature death. Moreover, post-ICU interventions may be resource-intensive and may be most cost-effective only in a subgroup of patients at highest risk. Whether a multi-disciplinary program to facilitate recovery from critical illness can prevent hospital readmission and improve quality of life among high-risk ICU survivors remains unknown. The primary aim of this pilot is to examine the feasibility of implementing a multidisciplinary ICU Recovery Program and the influence of such a program on process measures including contact with the ICU recovery team and attendance of ICU recovery clinic. The secondary aims are to compare the effect of an ICU Recovery Program on 30-day same-hospital readmission and other clinical outcomes.

Conditions

  • Intensive Care Unit Syndrome
  • Intensive Care Neurological Disorder
  • Intensive Care (ICU) Myopathy
  • Intensive Care Psychiatric Disorder (Diagnosis)

Interventions

OTHER

VANDERBILT ICU RECOVERY PROGRAM

10-component ICU Recovery Program intervention, including: 1. Nurse Practitioner In-Person Visit at the time of transfer from the ICU 2. Provision of an ICU Recovery Program Pamphlet describing post-intensive care syndrome and providing online resources 3. Performance of formal medication reconciliation at the time of transfer from the ICU 4. Access to a dedicated 24-hour a day, 7-day a week contact line 5. ICU Recovery Clinic Visit Medical Examination. 6. ICU Recovery Clinic Medication Reconciliation and Counseling 7. ICU Recovery Clinic Cognitive/Mental Health Assessment and Psychoeducation. A brief session of psychotherapy conducted by a clinical psychologist 8. ICU Recovery Clinic Case Management. A brief case management consultation 9. ICU Recovery Clinic Patient Centered Consultation. A final consultation with patients and families by a PCCM physician 10. Directed Subspecialty Referrals

Sponsors & Collaborators

  • Vanderbilt University Medical Center

    lead OTHER

Principal Investigators

  • Joanna Stollings, PharmD · Vanderbilt University Medical Center

  • Carla Sevin, MD · Vanderbilt University Medical Center

  • Matthew W Semler, MD, MSc · Vanderbilt University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-01
Primary Completion
2017-10-31
Completion
2018-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03124342 on ClinicalTrials.gov