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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VANDERBILT ICU RECOVERY PROGRAM | Other | 10-component ICU Recovery Program intervention, including:
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Number of Participants Death or Readmission in the 30 Days After Hospital Discharge |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joanna Stollings, PharmD | Vanderbilt University Medical Center | Study Director |
| Carla Sevin, MD | Vanderbilt University Medical Center | Study Chair |
| Matthew W Semler, MD, MSc | Vanderbilt University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | VANDERBILT ICU RECOVERY PROGRAM (VIP) | VANDERBILT ICU RECOVERY PROGRAM -- 10-component ICU Recovery Program intervention, including:
|
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | VANDERBILT ICU RECOVERY PROGRAM (VIP) | VANDERBILT ICU RECOVERY PROGRAM -- 10-component ICU Recovery Program intervention, including:
|
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Median | Inter-Quartile Range | interventions | From the time of study enrollment to 30 days after hospital discharge |
|
30 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | VANDERBILT ICU RECOVERY PROGRAM (VIP) | VANDERBILT ICU RECOVERY PROGRAM -- 10-component ICU Recovery Program intervention, including:
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Matthew W. Semler, MD, MSc | VANDERBILT UNIVERSITY MEDICAL CENTER | (615) 322-3412 | matthew.w.semler@vumc.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 12, 2017 | Aug 19, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D004194 | Disease |
| ID | Term |
|---|---|
| D009140 | Musculoskeletal Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D008722 | Methods |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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|
|
Composite outcome of death or readmission in the 30 days after hospital discharge |
| Within 30 days of hospital discharge |
| Number Participants With 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 |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| VANDERBILT ICU RECOVERY PROGRAM (VIP) |
VANDERBILT ICU RECOVERY PROGRAM -- 10-component ICU Recovery Program intervention, including:
|
| OG001 | 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. |
|
|
| 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 | Posted | Count of Participants | Participants | 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 | Posted | Count of Participants | Participants | Within 30 days of hospital discharge |
|
|
|
| Secondary | Number Participants With Same-hospital Emergency Department Visits in the 30 Days After Hospital Discharge | Posted | Count of Participants | Participants | Within 30 days of hospital discharge |
|
|
|
| Secondary | Number of Same-hospital Outpatient Clinic Visits in the 30 Days After Hospital Discharge | Posted | Number | visits | Within 30 days of hospital discharge |
|
|
|
| 7 |
| 111 |
| 0 |
| 111 |
| 0 |
| 111 |
| EG001 | 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. | 10 | 121 | 0 | 121 | 0 | 121 |
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| D013568 | Pathological Conditions, Signs and Symptoms |