Hospital Acquired Condition
Conditions
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
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
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| In-hospital Mortalities | Up to 24 months | Number of patient deaths occurring in the hospital. |
| Average Length of Hospital Stay | Up to 24 months | The number of days that a patient was in the hospital |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Cardiac Arrests | Up to 24 months | Cardiopulmonary events during hospitalization |
| Number of Hospital Acquired Sepsis | Up to 24 months | Sepsis occurring during hospitalization |
| Number of Unanticipated Transfers to ICU | Up to 24 months | Transfer to ICU from acute care study units during hospitalization |
| Number of Hospital Readmissions | Up to 24 months | Readmission 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
| Arm | Count |
|---|---|
| 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 |
| Total | 60 |
Baseline characteristics
| Characteristic | Control Group | Intervention Group | Total |
|---|---|---|---|
| Age, Continuous | 63.67 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 Participants | 31,050 Participants | 56754 Participants |
| Clinical unit type ICU | 2,165 Participants | 1,974 Participants | 4139 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5,903 Participants | 7,442 Participants | 13345 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 20,304 Participants | 23,618 Participants | 43922 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1,662 Participants | 1,964 Participants | 3626 Participants |
| Primary language English | 22,584 Participants | 26,713 Participants | 49297 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 634 Participants | 703 Participants | 1337 Participants |
| Race (NIH/OMB) Black or African American | 4,224 Participants | 4,878 Participants | 9102 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 | 6,733 Participants | 8,520 Participants | 15253 Participants |
| Race (NIH/OMB) White | 16,278 Participants | 18,923 Participants | 35201 Participants |
| Region of Enrollment United States | 27,869 participants | 33,024 participants | 60893 participants |
| Sex: Female, Male Female | 13,903 Participants | 16,968 Participants | 30871 Participants |
| Sex: Female, Male Male | 13,966 Participants | 16,056 Participants | 30022 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 181 / 33,024 | 265 / 27,869 |
| other Total, other adverse events | 0 / 33,024 | 0 / 27,869 |
| serious Total, serious adverse events | 0 / 33,024 | 0 / 27,869 |
Outcome results
Average Length of Hospital Stay
The number of days that a patient was in the hospital
Time frame: Up to 24 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CONCERN Intervention Group | Average Length of Hospital Stay | 6.6 days | Standard Deviation 0.82 |
| Usual Care Group | Average Length of Hospital Stay | 7.2 days | Standard Deviation 0.9 |
In-hospital Mortalities
Number of patient deaths occurring in the hospital.
Time frame: Up to 24 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CONCERN Intervention Group | In-hospital Mortalities | 181 Participants |
| Usual Care Group | In-hospital Mortalities | 265 Participants |
Number of Cardiac Arrests
Cardiopulmonary events during hospitalization
Time frame: Up to 24 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CONCERN Intervention Group | Number of Cardiac Arrests | 123 Participants |
| Usual Care Group | Number of Cardiac Arrests | 128 Participants |
Number of Hospital Acquired Sepsis
Sepsis occurring during hospitalization
Time frame: Up to 24 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CONCERN Intervention Group | Number of Hospital Acquired Sepsis | 1,461 Participants |
| Usual Care Group | Number of Hospital Acquired Sepsis | 1,578 Participants |
Number of Hospital Readmissions
Readmission to the hospital within 30 days of being discharged alive.
Time frame: Up to 24 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CONCERN Intervention Group | Number of Hospital Readmissions | 2,544 Participants |
| Usual Care Group | Number of Hospital Readmissions | 2,234 Participants |
Number of Unanticipated Transfers to ICU
Transfer to ICU from acute care study units during hospitalization
Time frame: Up to 24 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CONCERN Intervention Group | Number of Unanticipated Transfers to ICU | 505 Participants |
| Usual Care Group | Number of Unanticipated Transfers to ICU | 377 Participants |