Clinical trial NCT03124342: Vanderbilt ICU Recovery Program Pilot Trial
Official title: Vanderbilt ICU Recovery Program Pilot Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intensive Care Unit Syndrome
Intensive Care Neurological Disorder
Intensive Care (ICU) Myopathy
Intensive Care Psychiatric Disorder (Diagnosis)
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2017-04-21
Enrollment: 232
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years
2. Admitted to the Medical Intensive Care Unit (MICU) at Vanderbilt University Medical Center for at least 48 hours
3. Estimated risk of 30-day same-hospital readmission greater than 15%
4. Not previously enrolled in the study.

Exclusion Criteria:

1. Long-term residence at a skilled nursing facility
2. Long-term mechanical ventilation prior to admission
3. Solid organ or stem cell transplantation
4. Recorded primary residency \> 200 miles from Vanderbilt
5. Comfort care only

Primary outcomes:
measure: Number of Components of the ICU Recovery Program Received
timeFrame: From the time of study enrollment to 30 days after hospital discharge
Secondary outcomes:
measure: Number of Participants With Same-hospital Readmission in the 30 Days After Hospital Discharge
timeFrame: Within 30 days of hospital discharge
measure: Number of Participants Death or Readmission in the 30 Days After Hospital Discharge
timeFrame: Within 30 days of hospital discharge
measure: Number Participants With Same-hospital Emergency Department Visits in the 30 Days After Hospital Discharge
timeFrame: Within 30 days of hospital discharge
measure: Number of Same-hospital Outpatient Clinic Visits in the 30 Days After Hospital Discharge
timeFrame: Within 30 days of hospital discharge
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Joanna Stollings, PharmD
role: STUDY_DIRECTOR
affiliation: Vanderbilt University Medical Center
name: Carla Sevin, MD
role: STUDY_CHAIR
affiliation: Vanderbilt University Medical Center
name: Matthew W Semler, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: