Trial Outcomes & Findings for (CONCERN) Clinical Decision Support (CDS) System (NCT NCT03911687)
NCT ID: NCT03911687
Last Updated: 2025-05-09
Results Overview
Number of patient deaths occurring in the hospital.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
60893 participants
Primary outcome timeframe
Up to 24 months
Results posted on
2025-05-09
Participant Flow
Clusters were the individual clinical units across the four hospitals that included all non-specialty acute care units (ACUs) and intensive care units (ICUs).
Unit of analysis: clinical unit
Participant milestones
| Measure |
Control Group
Control data will be collected in the CONCERN CDS system that will be "live" in the EHR, but in silent release mode (e.g., not providing notification to clinicians).
|
Intervention Group
Experimental data will be collected in the CONCERN CDS system that will be "live" in the EHR in "active" release mode (e.g., providing CONCERN CDS system notification to clinicians).
|
|---|---|---|
|
Overall Study
STARTED
|
27869 37
|
33024 37
|
|
Overall Study
COMPLETED
|
27869 37
|
33024 37
|
|
Overall Study
NOT COMPLETED
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
(CONCERN) Clinical Decision Support (CDS) System
Baseline characteristics by cohort
| Measure |
Control Group
n=27 Participants
Control data will be collected in the CONCERN CDS system that will be "live" in the EHR, but in silent release mode (e.g., not providing notification to clinicians).
|
Intervention Group
n=33 Participants
Experimental data will be collected in the CONCERN CDS system that will be "live" in the EHR in "active" release mode (e.g., providing CONCERN CDS system notification to clinicians).
|
Total
n=60893 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.67 years
STANDARD_DEVIATION 17.10 • n=5 Participants
|
62.62 years
STANDARD_DEVIATION 17.56 • n=7 Participants
|
63.1 years
STANDARD_DEVIATION 17.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13,903 Participants
n=5 Participants
|
16,968 Participants
n=7 Participants
|
30871 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13,966 Participants
n=5 Participants
|
16,056 Participants
n=7 Participants
|
30022 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5,903 Participants
n=5 Participants
|
7,442 Participants
n=7 Participants
|
13345 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20,304 Participants
n=5 Participants
|
23,618 Participants
n=7 Participants
|
43922 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1,662 Participants
n=5 Participants
|
1,964 Participants
n=7 Participants
|
3626 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
634 Participants
n=5 Participants
|
703 Participants
n=7 Participants
|
1337 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4,224 Participants
n=5 Participants
|
4,878 Participants
n=7 Participants
|
9102 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
16,278 Participants
n=5 Participants
|
18,923 Participants
n=7 Participants
|
35201 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6,733 Participants
n=5 Participants
|
8,520 Participants
n=7 Participants
|
15253 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
27,869 participants
n=5 Participants
|
33,024 participants
n=7 Participants
|
60893 participants
n=5 Participants
|
|
Primary language English
|
22,584 Participants
n=5 Participants
|
26,713 Participants
n=7 Participants
|
49297 Participants
n=5 Participants
|
|
Clinical unit type
ACU
|
25,704 Participants
n=5 Participants
|
31,050 Participants
n=7 Participants
|
56754 Participants
n=5 Participants
|
|
Clinical unit type
ICU
|
2,165 Participants
n=5 Participants
|
1,974 Participants
n=7 Participants
|
4139 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 24 monthsNumber of patient deaths occurring in the hospital.
Outcome measures
| Measure |
CONCERN Intervention Group
n=33 Participants
Experimental data will be collected in the CONCERN CDS system that will be "live" in the EHR in "active" release mode (e.g., providing CONCERN CDS system notification to clinicians).
|
Usual Care Group
n=27 Participants
Control data will be collected in the CONCERN CDS system that will be "live" in the EHR, but in silent release mode (e.g., not providing notification to clinicians).
|
|---|---|---|
|
In-hospital Mortalities
|
181 Participants
|
265 Participants
|
PRIMARY outcome
Timeframe: Up to 24 monthsThe number of days that a patient was in the hospital
Outcome measures
| Measure |
CONCERN Intervention Group
n=33 Participants
Experimental data will be collected in the CONCERN CDS system that will be "live" in the EHR in "active" release mode (e.g., providing CONCERN CDS system notification to clinicians).
|
Usual Care Group
n=27 Participants
Control data will be collected in the CONCERN CDS system that will be "live" in the EHR, but in silent release mode (e.g., not providing notification to clinicians).
|
|---|---|---|
|
Average Length of Hospital Stay
|
6.6 days
Standard Deviation 0.82
|
7.2 days
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: Up to 24 monthsCardiopulmonary events during hospitalization
Outcome measures
| Measure |
CONCERN Intervention Group
n=33 Participants
Experimental data will be collected in the CONCERN CDS system that will be "live" in the EHR in "active" release mode (e.g., providing CONCERN CDS system notification to clinicians).
|
Usual Care Group
n=27 Participants
Control data will be collected in the CONCERN CDS system that will be "live" in the EHR, but in silent release mode (e.g., not providing notification to clinicians).
|
|---|---|---|
|
Number of Cardiac Arrests
|
123 Participants
|
128 Participants
|
SECONDARY outcome
Timeframe: Up to 24 monthsSepsis occurring during hospitalization
Outcome measures
| Measure |
CONCERN Intervention Group
n=33 Participants
Experimental data will be collected in the CONCERN CDS system that will be "live" in the EHR in "active" release mode (e.g., providing CONCERN CDS system notification to clinicians).
|
Usual Care Group
n=27 Participants
Control data will be collected in the CONCERN CDS system that will be "live" in the EHR, but in silent release mode (e.g., not providing notification to clinicians).
|
|---|---|---|
|
Number of Hospital Acquired Sepsis
|
1,461 Participants
|
1,578 Participants
|
SECONDARY outcome
Timeframe: Up to 24 monthsTransfer to ICU from acute care study units during hospitalization
Outcome measures
| Measure |
CONCERN Intervention Group
n=33 Participants
Experimental data will be collected in the CONCERN CDS system that will be "live" in the EHR in "active" release mode (e.g., providing CONCERN CDS system notification to clinicians).
|
Usual Care Group
n=27 Participants
Control data will be collected in the CONCERN CDS system that will be "live" in the EHR, but in silent release mode (e.g., not providing notification to clinicians).
|
|---|---|---|
|
Number of Unanticipated Transfers to ICU
|
505 Participants
|
377 Participants
|
SECONDARY outcome
Timeframe: Up to 24 monthsReadmission to the hospital within 30 days of being discharged alive.
Outcome measures
| Measure |
CONCERN Intervention Group
n=33 Participants
Experimental data will be collected in the CONCERN CDS system that will be "live" in the EHR in "active" release mode (e.g., providing CONCERN CDS system notification to clinicians).
|
Usual Care Group
n=27 Participants
Control data will be collected in the CONCERN CDS system that will be "live" in the EHR, but in silent release mode (e.g., not providing notification to clinicians).
|
|---|---|---|
|
Number of Hospital Readmissions
|
2,544 Participants
|
2,234 Participants
|
Adverse Events
CONCERN Intervention Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 181 deaths
Usual Care Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 265 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place