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Vanderbilt ICU Recovery Program Pilot Trial (VIP)

Primary Purpose

Intensive Care Unit Syndrome, Intensive Care Neurological Disorder, Intensive Care (ICU) Myopathy

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
VANDERBILT ICU RECOVERY PROGRAM
Sponsored by
Vanderbilt University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Intensive Care Unit Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Vanderbilt University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

VANDERBILT ICU RECOVERY PROGRAM (VIP)

Usual care

Arm Description

Patients assigned to the Vanderbilt ICU Recovery Program (VIP) group will receive the components of the ICU Recovery Program 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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
Number Participants With Same-hospital Emergency Department Visits in the 30 Days After Hospital Discharge
Number of Same-hospital Outpatient Clinic Visits in the 30 Days After Hospital Discharge

Full Information

First Posted
April 18, 2017
Last Updated
October 7, 2019
Sponsor
Vanderbilt University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03124342
Brief Title
Vanderbilt ICU Recovery Program Pilot Trial
Acronym
VIP
Official Title
Vanderbilt ICU Recovery Program Pilot Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
May 1, 2017 (Actual)
Primary Completion Date
October 31, 2017 (Actual)
Study Completion Date
April 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intensive Care Unit Syndrome, Intensive Care Neurological Disorder, Intensive Care (ICU) Myopathy, Intensive Care Psychiatric Disorder (Diagnosis)

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
232 (Actual)

8. Arms, Groups, and Interventions

Arm Title
VANDERBILT ICU RECOVERY PROGRAM (VIP)
Arm Type
Experimental
Arm Description
Patients assigned to the Vanderbilt ICU Recovery Program (VIP) group will receive the components of the ICU Recovery Program intervention.
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
VANDERBILT ICU RECOVERY PROGRAM
Other Intervention Name(s)
Intervention
Intervention Description
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
Primary Outcome Measure Information:
Title
Number of Components of the ICU Recovery Program Received
Description
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.
Time Frame
From the time of study enrollment to 30 days after hospital discharge
Secondary Outcome Measure Information:
Title
Number of Participants With Same-hospital Readmission in the 30 Days After Hospital Discharge
Description
Readmission to the study hospital in the 30 days after hospital discharge
Time Frame
Within 30 days of hospital discharge
Title
Number of Participants Death or Readmission in the 30 Days After Hospital Discharge
Description
Composite outcome of death or readmission in the 30 days after hospital discharge
Time Frame
Within 30 days of hospital discharge
Title
Number Participants With Same-hospital Emergency Department Visits in the 30 Days After Hospital Discharge
Time Frame
Within 30 days of hospital discharge
Title
Number of Same-hospital Outpatient Clinic Visits in the 30 Days After Hospital Discharge
Time Frame
Within 30 days of hospital discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joanna Stollings, PharmD
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Carla Sevin, MD
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Matthew W Semler, MD, MSc
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Vanderbilt ICU Recovery Program Pilot Trial

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