Intensive Care Unit SyndromeVIPNCT03124342
Vanderbilt ICU Recovery Program Pilot Trial
A study testing VANDERBILT ICU RECOVERY PROGRAM in people with Intensive Care Unit Syndrome and Intensive Care Neurological Disorder, run by Vanderbilt University Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intensive Care Unit Syndrome, Intensive Care Neurological Disorder, Intensive Care (ICU) Myopathy
- What is being tested?
- VANDERBILT ICU RECOVERY PROGRAM
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 232 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2017to 30 Apr 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
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)
- Being tested
- VANDERBILT ICU RECOVERY PROGRAM
- Medical subject headings
- Muscular Diseases, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VANDERBILT ICU RECOVERY PROGRAMOther
Also called Intervention
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
| Study group | Role | What they receive |
|---|---|---|
| VANDERBILT ICU RECOVERY PROGRAM (VIP) | Experimental | Patients assigned to the Vanderbilt ICU Recovery Program (VIP) group will receive the components of the ICU Recovery Program intervention. Receives: Other: VANDERBILT ICU RECOVERY PROGRAM |
| Usual care | No 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From the time of study enrollment to 30 days after hospital discharge
Secondary outcomes (4)
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
Measured: Within 30 days of hospital discharge
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
Measured: Within 30 days of hospital discharge
Number Participants With Same-hospital Emergency Department Visits in the 30 Days After Hospital Discharge
Measured: Within 30 days of hospital discharge
Number of Same-hospital Outpatient Clinic Visits in the 30 Days After Hospital Discharge
Measured: Within 30 days of hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2017
- Study start1 May 2017
- Primary completion31 Oct 2017
- Study completion30 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Intensive Care Unit SyndromeStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 232 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthew Semler, Vanderbilt University Medical Center
- Investigators
- Joanna Stollings, PharmD, Study director, Vanderbilt University Medical CenterCarla Sevin, MD, Study chair, Vanderbilt University Medical CenterMatthew W Semler, MD, MSc, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03124342
- Sponsor's protocol ID
- 170126
- Acronym
- VIP
- Status last verified
- Oct 2019
- First submitted
- 18 Apr 2017
- Last updated
- 8 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vanderbilt ICU Recovery Program Pilot Trial
- ClinicalTrials.gov ID
- NCT03124342
- Acronym / sponsor ID
- VIP / 170126
- Conditions
- Intensive Care Unit Syndrome, Intensive Care Neurological Disorder, Intensive Care (ICU) Myopathy, Intensive Care Psychiatric Disorder (Diagnosis)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 232 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 31 Oct 2017 (actual)
- Study completion
- 30 Apr 2018 (actual)
- First posted
- 21 Apr 2017 (actual)
- Results
- Posted 8 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VANDERBILT ICU RECOVERY PROGRAM (VIP) | Experimental | Other: VANDERBILT ICU RECOVERY PROGRAMPatients assigned to the Vanderbilt ICU Recovery Program (VIP) group will receive the components of the ICU Recovery Program intervention. |
| Usual care | No 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VANDERBILT ICU RECOVERY PROGRAMAlso: Intervention10-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 | Other | VANDERBILT ICU RECOVERY PROGRAM (VIP) |
Primary outcome
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.
4 secondary outcomes
Number of Participants With Same-hospital Readmission in the 30 Days After Hospital Discharge
Time frame: Within 30 days of hospital discharge
Number of Participants Death or Readmission in the 30 Days After Hospital Discharge
Time frame: Within 30 days of hospital discharge
Number Participants With Same-hospital Emergency Department Visits in the 30 Days After Hospital Discharge
Time frame: Within 30 days of hospital discharge
Number of Same-hospital Outpatient Clinic Visits in the 30 Days After Hospital Discharge
Time frame: Within 30 days of hospital discharge
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VANDERBILT ICU RECOVERY PROGRAM in people with Intensive Care Unit Syndrome and Intensive Care Neurological Disorder, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Components of the ICU Recovery Program Received (time frame: From the time of study enrollment to 30 days after hospital discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2019.