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Completed

NCT Number: NCT03124342

Vanderbilt ICU Recovery Program Pilot Trial

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.

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Key information

Conditions

Intensive Care Unit Syndrome Disease Intensive Care (ICU) Myopathy Intensive Care Neurological Disorder Intensive Care Psychiatric Disorder (Diagnosis) Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VANDERBILT ICU RECOVERY PROGRAM

Other

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

Other names: Intervention

Primary outcomes

  1. Number of Components of the ICU Recovery Program Received

    Time frame: From the time of study enrollment to 30 days after hospital discharge

    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 outcomes

  1. Number of Participants With Same-hospital Readmission in the 30 Days After Hospital Discharge

    Time frame: Within 30 days of hospital discharge

    Readmission to the study hospital in the 30 days after hospital discharge

  2. Number of Participants Death or Readmission in the 30 Days After Hospital Discharge

    Time frame: Within 30 days of hospital discharge

    Composite outcome of death or readmission in the 30 days after hospital discharge

  3. Number Participants With Same-hospital Emergency Department Visits in the 30 Days After Hospital Discharge

    Time frame: Within 30 days of hospital discharge

  4. Number of Same-hospital Outpatient Clinic Visits in the 30 Days After Hospital Discharge

    Time frame: Within 30 days of hospital discharge

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Registry information

Acronym: VIP

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Apr 21, 2017
Registry last updated
Oct 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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