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(CONCERN) Clinical Decision Support (CDS) System

Communicating Narrative Concerns Entered by RNs (CONCERN) Clinical Decision Support (CDS) System

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03911687
Enrollment
60893
Registered
2019-04-11
Start date
2020-07-21
Completion date
2022-10-31
Last updated
2025-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hospital Acquired Condition

Keywords

Early warning system, Clinical decision support, Predictive analysis, Failure to rescue, Inter-professional situational awareness, Nursing surveillance, Healthcare process models of clinical concern (HPM-CC)

Brief summary

There are patients who die or have a bad outcome in the hospital and this could be prevented. Data in the nurses' notes could be used by computers to tell the rest of the care team that a patient is not doing well and that they should act more quickly. This project will build and evaluate a computer system that makes it easier for the care team to see and understand that data and act quickly to save patients. The aims of this study is to answer the questions, what is the level of provider use of the CONCERN CDS notification system (called CONCERN SMARTapp) and resulting impact on selected patient outcomes? Specifically, the study has 1) validated desired thresholds for the CONCERN CDS system and 2) integrated the CONCERN CDS system for early warning of risky patient states within CDS tools. In this portion of the study (aim 3), the investigator will implement and evaluate the CONCERN CDS system on primary outcomes of in-hospital mortality and length of stay and secondary outcomes of cardiac arrest, unanticipated transfers to the intensive care unit, and 30-day hospital readmission rates.

Detailed description

Annually, more than 200,000 patients die in U.S. hospitals from cardiac arrest and over 130,000 patients inpatients deaths are attributed to sepsis. These deaths are preventable if patients who are at risk are detected earlier. Prior work found that nursing documentation within electronic health records (EHRs) contains information that could contribute to early detection and treatment, but these data are not being analyzed and exposed by EHRs to clinicians to initiate interventions quickly enough to save patients. A new source of predictive data is defined by analyzing the frequency and types of nursing documentation that indicated nurses' increased surveillance and level of concern for a patient. These data documented in the 48 hours preceding a cardiac arrest and hospital mortality were predictive of the event. While clinicians strive to provide the best care, there is a systematic problem within hospital settings of non-optimal communication between nurses and doctors leading to delays in care for patient at risk. Well-designed and tested EHRs are able to trend data and support communication and decision making, but too often fall short of these goals and actually increase clinician cognitive load through fragmented information displays, note bloat, and information overload. Substitutable Medical Applications & Reusable Technologies (SMARTapps) using Fast Health Interoperability Resource (FHIR) standard allow for open sharing and use of innovations across EHR systems. The aim of this project is to design and evaluate a SMARTapp on FHIR used across two large academic medical centers that exposes to physicians and nurses our new predictive data source from nursing documentation to increase care team situational awareness of at risk patients to decrease preventable adverse outcomes. Communicating Narrative Concerns Entered by RNs (CONCERN) Clinical Decision Support (CDS) system is the application being designed and evaluated. CONCERN Intervention Trial Design will be a multiple time-series intervention. Baseline data will be collected at all study sites. Silent release mode (no SMARTapp notification) will be used in non-equivalent control units and as a post-intervention unit control to evaluate if notifying clinicians can decrease rates of length of stay on non-ICU units and rates of 30-day hospital readmissions. Different versions of the CDS system (SMARTapp) will be incorporated for dynamic, adaptive functionality and determine if the pattern of nursing documentation has changed. A burn-in phase is built in to evaluate adoption and adaptation to the algorithm and phases for deployment of the silent release mode within the multiple time-series intervention trial for a total of 18 months of data collection, including pre-intervention data collection and silent release modes.

Interventions

BEHAVIORALCONCERN CDS system notification

The CONCERN CDS will trigger based on analytics of nursing documentation that indicates recognition and concern of patient changes. The CONCERN CDS will alert the care team of the patients risky state to increase team-based situational awareness (i.e., shared understanding of the patient situation) of patients predicted to be at risk for patient decompensating in need of rapid intervention to prevent mortality and associated harm. Version 1: Burn in phase to evaluate adoption and adaptation to the algorithm being studied. Expected time frame - 3 months Version 2: Version 2 refined based on continuous monitoring of data. Expected time frame - 3 months Version 3: Version 3 refined based on continuous monitoring of data. Expected time frame - 3 months

Sponsors

National Institute of Nursing Research (NINR)
CollaboratorNIH
Brigham and Women's Hospital
CollaboratorOTHER
Columbia University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Study inclusion criteria for patients: * Inpatients with a stay of at least 24 hours on one of our study units Study

Exclusion criteria

for patients: * Inpatients with less than 24 hours on one of our study units * Patients less than 18 years of age * Hospice patients * Did not have a hospital encounter, patients not on one of our study units. Definition of Study Units: A clinical unit is considered a CONCERN Study unit if it meets the following criteria: * A general medical or surgical acute care or critical care unit The following clinical units are NOT considered CONCERN Study units: * Pediatric or Neonatal units * Hospice units * Emergency Department * Oncology units * Obstetrician (OB)/labor and delivery units * Behavioral/psych units * Observational units * Operating room * Pre-op * Post-op/Post Anesthesia Care Unit (PACU) * Same day surgical units * Plastics units * Virtual departments in EHR database.

Design outcomes

Primary

MeasureTime frameDescription
In-hospital MortalitiesUp to 24 monthsNumber of patient deaths occurring in the hospital.
Average Length of Hospital StayUp to 24 monthsThe number of days that a patient was in the hospital

Secondary

MeasureTime frameDescription
Number of Cardiac ArrestsUp to 24 monthsCardiopulmonary events during hospitalization
Number of Hospital Acquired SepsisUp to 24 monthsSepsis occurring during hospitalization
Number of Unanticipated Transfers to ICUUp to 24 monthsTransfer to ICU from acute care study units during hospitalization
Number of Hospital ReadmissionsUp to 24 monthsReadmission to the hospital within 30 days of being discharged alive.

Countries

United States

Participant flow

Pre-assignment details

Clusters were the individual clinical units across the four hospitals that included all non-specialty acute care units (ACUs) and intensive care units (ICUs).

Participants by arm

ArmCount
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).
27
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).
33
Total60

Baseline characteristics

CharacteristicControl GroupIntervention GroupTotal
Age, Continuous63.67 years
STANDARD_DEVIATION 17.1
62.62 years
STANDARD_DEVIATION 17.56
63.1 years
STANDARD_DEVIATION 17.4
Clinical unit type
ACU
25,704 Participants31,050 Participants56754 Participants
Clinical unit type
ICU
2,165 Participants1,974 Participants4139 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
5,903 Participants7,442 Participants13345 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
20,304 Participants23,618 Participants43922 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
1,662 Participants1,964 Participants3626 Participants
Primary language English22,584 Participants26,713 Participants49297 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
634 Participants703 Participants1337 Participants
Race (NIH/OMB)
Black or African American
4,224 Participants4,878 Participants9102 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
6,733 Participants8,520 Participants15253 Participants
Race (NIH/OMB)
White
16,278 Participants18,923 Participants35201 Participants
Region of Enrollment
United States
27,869 participants33,024 participants60893 participants
Sex: Female, Male
Female
13,903 Participants16,968 Participants30871 Participants
Sex: Female, Male
Male
13,966 Participants16,056 Participants30022 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
181 / 33,024265 / 27,869
other
Total, other adverse events
0 / 33,0240 / 27,869
serious
Total, serious adverse events
0 / 33,0240 / 27,869

Outcome results

Primary

Average Length of Hospital Stay

The number of days that a patient was in the hospital

Time frame: Up to 24 months

ArmMeasureValue (MEAN)Dispersion
CONCERN Intervention GroupAverage Length of Hospital Stay6.6 daysStandard Deviation 0.82
Usual Care GroupAverage Length of Hospital Stay7.2 daysStandard Deviation 0.9
Primary

In-hospital Mortalities

Number of patient deaths occurring in the hospital.

Time frame: Up to 24 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
CONCERN Intervention GroupIn-hospital Mortalities181 Participants
Usual Care GroupIn-hospital Mortalities265 Participants
Secondary

Number of Cardiac Arrests

Cardiopulmonary events during hospitalization

Time frame: Up to 24 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
CONCERN Intervention GroupNumber of Cardiac Arrests123 Participants
Usual Care GroupNumber of Cardiac Arrests128 Participants
Secondary

Number of Hospital Acquired Sepsis

Sepsis occurring during hospitalization

Time frame: Up to 24 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
CONCERN Intervention GroupNumber of Hospital Acquired Sepsis1,461 Participants
Usual Care GroupNumber of Hospital Acquired Sepsis1,578 Participants
Secondary

Number of Hospital Readmissions

Readmission to the hospital within 30 days of being discharged alive.

Time frame: Up to 24 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
CONCERN Intervention GroupNumber of Hospital Readmissions2,544 Participants
Usual Care GroupNumber of Hospital Readmissions2,234 Participants
Secondary

Number of Unanticipated Transfers to ICU

Transfer to ICU from acute care study units during hospitalization

Time frame: Up to 24 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
CONCERN Intervention GroupNumber of Unanticipated Transfers to ICU505 Participants
Usual Care GroupNumber of Unanticipated Transfers to ICU377 Participants

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026