Vanderbilt ICU Recovery Program Pilot Trial

Study Overview
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Brief Summary
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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.

Official Title
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Vanderbilt ICU Recovery Program Pilot Trial

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

Intervention / Treatment
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* Other: VANDERBILT ICU RECOVERY PROGRAM


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years Admitted to the Medical Intensive Care Unit (MICU) at Vanderbilt University Medical Center for at least 48 hours Estimated risk of 30-day same-hospital readmission greater than 15% Not previously enrolled in the study. Exclusion Criteria: Long-term residence at a skilled nursing facility Long-term mechanical ventilation prior to admission Solid organ or stem cell transplantation Recorded primary residency > 200 miles from Vanderbilt Comfort care only

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VANDERBILT ICU RECOVERY PROGRAM (VIP)<br>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<br>* 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<br>* Other names: Intervention;|
| No Intervention: Usual care<br>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?
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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 |