Intensive Care (ICU) Myopathy, Intensive Care Neurological Disorder, Intensive Care Psychiatric Disorder (Diagnosis), Intensive Care Unit Syndrome
Conditions
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.
Interventions
OTHERVANDERBILT 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
Sponsors
Vanderbilt University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Components of the ICU Recovery Program Received | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Same-hospital Readmission in the 30 Days After Hospital Discharge | Within 30 days of hospital discharge | Readmission to the study hospital in the 30 days after hospital discharge |
| Number of Participants Death or Readmission in the 30 Days After Hospital Discharge | Within 30 days of hospital discharge | Composite outcome of death or readmission in the 30 days after 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 | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| VANDERBILT ICU RECOVERY PROGRAM (VIP) 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 | 111 |
| 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. | 121 |
| Total | 232 |
Baseline characteristics
| Characteristic | VANDERBILT ICU RECOVERY PROGRAM (VIP) | Usual Care | Total |
|---|---|---|---|
| Age, Continuous | 56 years | 56 years | 56 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 21 Participants | 20 Participants | 41 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 7 Participants | 12 Participants | 19 Participants |
| Race (NIH/OMB) White | 83 Participants | 89 Participants | 172 Participants |
| Sex: Female, Male Female | 60 Participants | 54 Participants | 114 Participants |
| Sex: Female, Male Male | 51 Participants | 67 Participants | 118 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 7 / 111 | 10 / 121 |
| other Total, other adverse events | 0 / 111 | 0 / 121 |
| serious Total, serious adverse events | 0 / 111 | 0 / 121 |
Outcome results
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.
Time frame: From the time of study enrollment to 30 days after hospital discharge
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| VANDERBILT ICU RECOVERY PROGRAM (VIP) | Number of Components of the ICU Recovery Program Received | 2 interventions |
| Usual Care | Number of Components of the ICU Recovery Program Received | 1 interventions |
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
Time frame: Within 30 days of hospital discharge
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| VANDERBILT ICU RECOVERY PROGRAM (VIP) | Number of Participants Death or Readmission in the 30 Days After Hospital Discharge | 20 Participants |
| Usual Care | Number of Participants Death or Readmission in the 30 Days After Hospital Discharge | 36 Participants |
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
Time frame: Within 30 days of hospital discharge
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| VANDERBILT ICU RECOVERY PROGRAM (VIP) | Number of Participants With Same-hospital Readmission in the 30 Days After Hospital Discharge | 16 Participants |
| Usual Care | Number of Participants With Same-hospital Readmission in the 30 Days After Hospital Discharge | 26 Participants |
Secondary
Number of Same-hospital Outpatient Clinic Visits in the 30 Days After Hospital Discharge
Time frame: Within 30 days of hospital discharge
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| VANDERBILT ICU RECOVERY PROGRAM (VIP) | Number of Same-hospital Outpatient Clinic Visits in the 30 Days After Hospital Discharge | 14 visits |
| Usual Care | Number of Same-hospital Outpatient Clinic Visits in the 30 Days After Hospital Discharge | 0 visits |
Secondary
Number Participants With Same-hospital Emergency Department Visits in the 30 Days After Hospital Discharge
Time frame: Within 30 days of hospital discharge
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| VANDERBILT ICU RECOVERY PROGRAM (VIP) | Number Participants With Same-hospital Emergency Department Visits in the 30 Days After Hospital Discharge | 1 Participants |
| Usual Care | Number Participants With Same-hospital Emergency Department Visits in the 30 Days After Hospital Discharge | 1 Participants |