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(CONCERN) Clinical Decision Support (CDS) System

Primary Purpose

Hospital Acquired Condition

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CONCERN CDS system notification
Sponsored by
Columbia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Hospital Acquired Condition focused on measuring 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)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Brigham and Women's Hospital
  • Newton-Wellesley Hospital
  • New York Presbyterian Columbia University Medical Center
  • New York Presbyterian Allen Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control Group

Intervention Group

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

In-hospital mortality rate
Deaths occurring in the hospital
Average length of hospital stay
The number of days that a patient was in the hospital

Secondary Outcome Measures

Number of Cardiac Arrest
Cardiopulmonary events during hospitalization
Number of hospital acquired sepsis
Sepsis occurring during hospitalization
Number of unanticipated transfer to ICU
Transfer to ICU from acute care study units during hospitalization
Hospital readmission rates
Readmission to the hospital

Full Information

First Posted
February 28, 2019
Last Updated
September 22, 2023
Sponsor
Columbia University
Collaborators
National Institute of Nursing Research (NINR), Brigham and Women's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03911687
Brief Title
(CONCERN) Clinical Decision Support (CDS) System
Official Title
Communicating Narrative Concerns Entered by RNs (CONCERN) Clinical Decision Support (CDS) System
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
July 21, 2020 (Actual)
Primary Completion Date
October 31, 2022 (Actual)
Study Completion Date
October 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Columbia University
Collaborators
National Institute of Nursing Research (NINR), Brigham and Women's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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)

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
86508 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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).
Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
CONCERN CDS system notification
Other Intervention Name(s)
CONCERN SMARTapp notification, CONCERN Clinical Decision Support (CDS) system notification
Intervention Description
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
Primary Outcome Measure Information:
Title
In-hospital mortality rate
Description
Deaths occurring in the hospital
Time Frame
Up to 24 months
Title
Average length of hospital stay
Description
The number of days that a patient was in the hospital
Time Frame
Up to 24 months
Secondary Outcome Measure Information:
Title
Number of Cardiac Arrest
Description
Cardiopulmonary events during hospitalization
Time Frame
Up to 24 months
Title
Number of hospital acquired sepsis
Description
Sepsis occurring during hospitalization
Time Frame
Up to 24 months
Title
Number of unanticipated transfer to ICU
Description
Transfer to ICU from acute care study units during hospitalization
Time Frame
Up to 24 months
Title
Hospital readmission rates
Description
Readmission to the hospital
Time Frame
Up to 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patricia Dykes, PhD
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sarah Collins Rossetti, PhD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kenrick Cato, PhD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Newton-Wellesley Hospital
City
Newton
State/Province
Massachusetts
ZIP/Postal Code
02462
Country
United States
Facility Name
New York Presbyterian Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
New York Presbyterian Allen Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10034
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
This study will develop an open source SmartApp using interoperability standards. The investigators will make all source code available to any researchers upon request. This approach will ensure open access to all project aims, methods, resources, and deliverables by anyone via a study web-page. To aid in replication this web-page will include methods as well as other project processes such as stakeholder engagement, technical development, governance and lessons learned.
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