NCT03124342|CompletedResults
Vanderbilt ICU Recovery Program Pilot Trial
VIP
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VIP
Sponsor study identifier
interventional
232
1 country
1
Study Start
May 1, 2017
Actual (reported)Primary Completion
October 31, 2017
Actual (reported)Study Completion
April 30, 2018
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 30, 2018
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 18, 2017
Actual (reported)April 21, 2017
Actual (reported)May 1, 2017
Actual (reported)October 31, 2017
Actual (reported)April 30, 2018
Actual (reported)October 8, 2019
Actual (reported)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
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
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.
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
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Joanna Stollings, PharmD
Vanderbilt University Medical Center
Carla Sevin, MD
Vanderbilt University Medical Center
Matthew W Semler, MD, MSc
Vanderbilt University Medical Center
232 participants (actual enrollment reported by the registry).
First Submitted
April 18, 2017
First Posted
April 21, 2017
Study Start
May 1, 2017
Actual (reported)Move to Music Video Intervention for ICU Survivors
Contact the study team to confirm eligibility.
Primary Completion
October 31, 2017
Actual (reported)Study Completion
April 30, 2018
Actual (reported)Last Updated
October 8, 2019
Results First Posted
October 8, 2019
Record last verified: 2019-10
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