Vanderbilt ICU Recovery Program Pilot Trial (VIP)

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.

Study Overview

• Status: Completed
• Conditions: Intensive Care Unit Syndrome; Intensive Care Neurological Disorder; Intensive Care (ICU) Myopathy; Intensive Care Psychiatric Disorder (Diagnosis)
• Intervention / Treatment: Other: VANDERBILT ICU RECOVERY PROGRAM

• Study Type: Interventional
• Enrollment (Actual): 232
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VANDERBILT ICU RECOVERY PROGRAM (VIP); Patients assigned to the Vanderbilt ICU Recovery Program (VIP) group will receive the components of the ICU Recovery Program intervention.	Other: VANDERBILT ICU RECOVERY PROGRAM; 10-component ICU Recovery Program intervention, including: Nurse Practitioner In-Person Visit at the time of transfer from the ICU; Provision of an ICU Recovery Program Pamphlet describing post-intensive care syndrome and providing online resources; Performance of formal medication reconciliation at the time of transfer from the ICU; Access to a dedicated 24-hour a day, 7-day a week contact line; ICU Recovery Clinic Visit Medical Examination.; ICU Recovery Clinic Medication Reconciliation and Counseling; ICU Recovery Clinic Cognitive/Mental Health Assessment and Psychoeducation. A brief session of psychotherapy conducted by a clinical psychologist; ICU Recovery Clinic Case Management. A brief case management consultation; ICU Recovery Clinic Patient Centered Consultation. A final consultation with patients and families by a PCCM physician; Directed Subspecialty Referrals; Other Names: Intervention
No Intervention: Usual care; Patients in the usual care group will receive care as dictated by their clinical team. In usual care in the study institution, patients frequently receive medication reconciliation by and ICU pharmacist at the time of transfer out of the ICU to the hospital ward, medication reconciliation by a physician at the time of hospital discharge, and follow up with their primary care physician within two weeks of hospital discharge. Usual care does not currently include an in-person assessment of the patient's cognitive and functional status or anticipated post-ICU needs by a nurse practitioner between ICU transfer and hospital discharge, access to a 24/7 contact line after hospital discharge, or assessment in a multi-disciplinary ICU Recovery Clinic.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Components of the ICU Recovery Program Received	Number of components of the ICU Recovery Program intervention received by patients between ICU transfer and 30 days after hospital discharge. The 10-components considered part of the ICU Recovery Program include: (1) nurse practitioner in-person visit between ICU transfer and hospital discharge, (2) ICU Recovery Program pamphlet, (3) pharmacist medication reconciliation at the time of ICU transfer, (4) ICU Recovery Program contact line, (5) nurse practitioner history and physical in ICU Recovery Clinic, (6) pharmacist medication reconciliation in ICU Recovery Clinic, (7) cognitive/mental health assessment and psychoeducation in ICU Recovery Clinic, (8) case management consultation in ICU Recovery Clinic, (9) patient centered consultation with pulmonary and critical care medicine physician in ICU Recovery clinic, (10), directed subspecialty referrals.	From the time of study enrollment to 30 days after hospital discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Same-hospital Readmission in the 30 Days After Hospital Discharge	Readmission to the study hospital in the 30 days after hospital discharge	Within 30 days of hospital discharge
Number of Participants Death or Readmission in the 30 Days After Hospital Discharge	Composite outcome of death or readmission in the 30 days after hospital discharge	Within 30 days of hospital discharge
Number Participants With Same-hospital Emergency Department Visits in the 30 Days After Hospital Discharge		Within 30 days of hospital discharge
Number of Same-hospital Outpatient Clinic Visits in the 30 Days After Hospital Discharge		Within 30 days of hospital discharge

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center
• Investigators: Study Director: Joanna Stollings, PharmD, Vanderbilt University Medical Center; Study Chair: Carla Sevin, MD, Vanderbilt University Medical Center; Principal Investigator: Matthew W Semler, MD, MSc, Vanderbilt University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2017
• Primary Completion (Actual): October 31, 2017
• Study Completion (Actual): April 30, 2018

Study Registration Dates

• First Submitted: April 18, 2017
• First Submitted That Met QC Criteria: April 18, 2017
• First Posted (Actual): April 21, 2017

Study Record Updates

• Last Update Posted (Actual): October 8, 2019
• Last Update Submitted That Met QC Criteria: October 7, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Pathologic Processes; Disease; Problem Behavior; Mental Disorders; Nervous System Diseases
• Other Study ID Numbers: 170126

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