Vanderbilt ICU Recovery Program Pilot Trial

Vanderbilt ICU Recovery Program Pilot Trial



Sponsors


Source

Vanderbilt University Medical Center

Oversight Info

Has Dmc

No

Is Fda Regulated Drug

No

Is Fda Regulated Device

No


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.

Overall Status

Recruiting

Start Date

2017-05-01

Completion Date

2018-10-31

Primary Completion Date

2017-10-31

Phase

N/A

Study Type

Interventional

Primary Outcome

Measure

Time Frame

Number of components of the ICU Recovery Program received
From the time of study enrollment to 30 days after hospital discharge

Secondary Outcome

Measure

Time Frame

Same-hospital readmission in the 30 days after hospital discharge
Within 30 days of hospital discharge
Readmission-free days
Within 30 days of hospital discharge
Death or readmission in the 30 days after hospital discharge
Within 30 days of hospital discharge
Number of 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
Number of referrals to specialty providers
Within 30 days of hospital discharge

Enrollment

550

Conditions


Intervention

Intervention Type

Other

Intervention Name


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

Arm Group Label

VANDERBILT ICU RECOVERY PROGRAM (VIP)

Other Name

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 25%

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

Gender

All

Minimum Age

18 Years

Maximum Age

N/A

Healthy Volunteers

No


Overall Official

Last Name

Role

Affiliation

Joanna Stollings, PharmD
Study Director
Vanderbilt University Medical Center
Carla Sevin, MD
Study Chair
Vanderbilt University Medical Center
Matthew W Semler, MD, MSc
Principal Investigator
Vanderbilt University Medical Center

Overall Contact

Last Name

Matthew W Semler, MD, MSc

Phone

615 322-3412

Email

[email protected]


Location

Facility

Status

Contact

Vanderbilt University Medical Center
Nashville Tennessee 37232 United States
Recruiting
Last Name: Matthew W Semler, MD, MSc
Phone: 615-322-3412
Email: [email protected]

Location Countries

Country

United States


Verification Date

2017-04-01

Lastchanged Date

2017-04-18

Firstreceived Date

2017-04-18

Responsible Party

Responsible Party Type

Principal Investigator

Investigator Affiliation

Vanderbilt University Medical Center

Investigator Full Name

Matthew Semler

Investigator Title

Assistant Professor of Medicine


Has Expanded Access

No

Condition Browse


Number Of Arms

2

Arm Group

Arm Group Label

VANDERBILT ICU RECOVERY PROGRAM (VIP)

Arm Group Type

Experimental

Description

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


Arm Group Label

Usual care

Arm Group Type

No Intervention

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.



Firstreceived Results Date

N/A

Overall Contact Backup

Last Name

Sarah Bloom, MSN

Phone

615 322-3412

Email

[email protected]


Acronym

VIP

Patient Data

Sharing Ipd

Undecided


Firstreceived Results Disposition Date

N/A

Study Design Info

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary Purpose

Prevention

Masking

Outcomes Assessor



ClinicalTrials.gov processed this data on April 21, 2017

Conditions

Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov, conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.



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