Intensive Care Unit Syndrome Clinical Trial
— VIPOfficial title:
Vanderbilt ICU Recovery Program Pilot Trial
NCT number | NCT03124342 |
Other study ID # | 170126 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 1, 2017 |
Est. completion date | April 30, 2018 |
Verified date | October 2019 |
Source | Vanderbilt University Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 232 |
Est. completion date | April 30, 2018 |
Est. primary completion date | October 31, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Vanderbilt University Medical Center | Nashville | Tennessee |
Lead Sponsor | Collaborator |
---|---|
Vanderbilt University Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | Number Participants With Same-hospital Emergency Department Visits in the 30 Days After Hospital Discharge | Within 30 days of hospital discharge | ||
Secondary | Number of Same-hospital Outpatient Clinic Visits in the 30 Days After Hospital Discharge | Within 30 days of hospital discharge |
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