Trial Outcomes & Findings for Vanderbilt ICU Recovery Program Pilot Trial (NCT NCT03124342)
NCT ID: NCT03124342
Last Updated: 2019-10-08
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
232 participants
Primary outcome timeframe
From the time of study enrollment to 30 days after hospital discharge
Results posted on
2019-10-08
Participant Flow
Participant milestones
| Measure |
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
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
111
|
121
|
|
Overall Study
COMPLETED
|
111
|
121
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Vanderbilt ICU Recovery Program Pilot Trial
Baseline characteristics by cohort
| Measure |
VANDERBILT ICU RECOVERY PROGRAM (VIP)
n=111 Participants
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
|
Usual Care
n=121 Participants
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.
|
Total
n=232 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56 years
n=99 Participants
|
56 years
n=107 Participants
|
56 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
60 Participants
n=99 Participants
|
54 Participants
n=107 Participants
|
114 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
51 Participants
n=99 Participants
|
67 Participants
n=107 Participants
|
118 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
21 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
41 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
83 Participants
n=99 Participants
|
89 Participants
n=107 Participants
|
172 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: From the time of study enrollment to 30 days after hospital dischargeNumber 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.
Outcome measures
| Measure |
VANDERBILT ICU RECOVERY PROGRAM (VIP)
n=111 Participants
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
|
Usual Care
n=121 Participants
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.
|
|---|---|---|
|
Number of Components of the ICU Recovery Program Received
|
2 interventions
Interval 1.0 to 3.0
|
1 interventions
Interval 0.0 to 1.0
|
SECONDARY outcome
Timeframe: Within 30 days of hospital dischargeReadmission to the study hospital in the 30 days after hospital discharge
Outcome measures
| Measure |
VANDERBILT ICU RECOVERY PROGRAM (VIP)
n=111 Participants
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
|
Usual Care
n=121 Participants
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.
|
|---|---|---|
|
Number of Participants With Same-hospital Readmission in the 30 Days After Hospital Discharge
|
16 Participants
|
26 Participants
|
SECONDARY outcome
Timeframe: Within 30 days of hospital dischargeComposite outcome of death or readmission in the 30 days after hospital discharge
Outcome measures
| Measure |
VANDERBILT ICU RECOVERY PROGRAM (VIP)
n=111 Participants
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
|
Usual Care
n=121 Participants
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.
|
|---|---|---|
|
Number of Participants Death or Readmission in the 30 Days After Hospital Discharge
|
20 Participants
|
36 Participants
|
SECONDARY outcome
Timeframe: Within 30 days of hospital dischargeOutcome measures
| Measure |
VANDERBILT ICU RECOVERY PROGRAM (VIP)
n=111 Participants
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
|
Usual Care
n=121 Participants
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.
|
|---|---|---|
|
Number Participants With Same-hospital Emergency Department Visits in the 30 Days After Hospital Discharge
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Within 30 days of hospital dischargeOutcome measures
| Measure |
VANDERBILT ICU RECOVERY PROGRAM (VIP)
n=111 Participants
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
|
Usual Care
n=121 Participants
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.
|
|---|---|---|
|
Number of Same-hospital Outpatient Clinic Visits in the 30 Days After Hospital Discharge
|
14 visits
|
0 visits
|
Adverse Events
VANDERBILT ICU RECOVERY PROGRAM (VIP)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 7 deaths
Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 10 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Matthew W. Semler, MD, MSc
VANDERBILT UNIVERSITY MEDICAL CENTER
Phone: (615) 322-3412
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place