Vanderbilt ICU Recovery Program Pilot Trial

NCT ID: NCT03124342

Last Updated: 2019-10-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 232 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-01
• Study Completion Date: 2018-04-30

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)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

VANDERBILT ICU RECOVERY PROGRAM (VIP)

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

Group Type: EXPERIMENTAL

VANDERBILT ICU RECOVERY PROGRAM

Intervention Type: 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

Usual care

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

VANDERBILT ICU RECOVERY PROGRAM

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

Intervention Type: OTHER

Other Intervention Names

Intervention

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vanderbilt University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Matthew Semler

Assistant Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joanna Stollings, PharmD

Role: STUDY_DIRECTOR

Vanderbilt University Medical Center

Carla Sevin, MD

Role: STUDY_CHAIR

Vanderbilt University Medical Center

Matthew W Semler, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Locations

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

170126

Identifier Type: -

Identifier Source: org_study_id