Vanderbilt ICU Recovery Program Pilot Trial

NCT03124342 | Completed Results

• 1 other identifier: 170126
• Study Type: interventional
• Target: 232
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Number of Participants With Same-hospital Readmission 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

  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

Study Arms (2)

VANDERBILT ICU RECOVERY PROGRAM (VIP)

EXPERIMENTAL

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

Usual care

NO INTERVENTION

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.

Interventions

VANDERBILT ICU RECOVERY PROGRAM OTHER

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

Also known as: Intervention

VANDERBILT ICU RECOVERY PROGRAM (VIP)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Muscular Diseases; Disease

Interventions

Methods

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques

Results Point of Contact

• Title: Matthew W. Semler, MD, MSc
• Organization: VANDERBILT UNIVERSITY MEDICAL CENTER

matthew.w.semler@vumc.org

(615) 322-3412

Study Officials

• Joanna Stollings, PharmD

  Vanderbilt University Medical Center

  STUDY DIRECTOR

• Carla Sevin, MD

  Vanderbilt University Medical Center

  STUDY CHAIR

• Matthew W Semler, MD, MSc

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: April 18, 2017
• First Posted: April 21, 2017
• Study Start: May 1, 2017
• Primary Completion: October 31, 2017
• Study Completion: April 30, 2018
• Last Updated: October 8, 2019
• Results First Posted: October 8, 2019

Record last verified: 2019-10

Locations

US (1)