(CONCERN) Clinical Decision Support (CDS) System

September 22, 2023 updated by: Sarah Collins Rossetti, Columbia University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

86508

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital
      • Newton, Massachusetts, United States, 02462
        • Newton-Wellesley Hospital
    • New York
      • New York, New York, United States, 10032
        • New York Presbyterian Columbia University Medical Center
      • New York, New York, United States, 10034
        • New York Presbyterian Allen Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 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).
Experimental: 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).
Behavioral: CONCERN 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

Other Names:
  • CONCERN SMARTapp notification
  • CONCERN Clinical Decision Support (CDS) system notification

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
In-hospital mortality rate
Time Frame: Up to 24 months
Deaths occurring in the hospital
Up to 24 months
Average length of hospital stay
Time Frame: Up to 24 months
The number of days that a patient was in the hospital
Up to 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Cardiac Arrest
Time Frame: Up to 24 months
Cardiopulmonary events during hospitalization
Up to 24 months
Number of hospital acquired sepsis
Time Frame: Up to 24 months
Sepsis occurring during hospitalization
Up to 24 months
Number of unanticipated transfer to ICU
Time Frame: Up to 24 months
Transfer to ICU from acute care study units during hospitalization
Up to 24 months
Hospital readmission rates
Time Frame: Up to 24 months
Readmission to the hospital
Up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Columbia University

Collaborators

National Institute of Nursing Research (NINR)
Brigham and Women's Hospital

Investigators

  • Principal Investigator: Patricia Dykes, PhD, Brigham and Women's Hospital
  • Principal Investigator: Sarah Collins Rossetti, PhD, Columbia University
  • Principal Investigator: Kenrick Cato, PhD, Columbia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 21, 2020

Primary Completion (Actual)

October 31, 2022

Study Completion (Actual)

October 31, 2022

Study Registration Dates

First Submitted

February 28, 2019

First Submitted That Met QC Criteria

April 9, 2019

First Posted (Actual)

April 11, 2019

Study Record Updates

Last Update Posted (Actual)

September 25, 2023

Last Update Submitted That Met QC Criteria

September 22, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAAR1389
  • R01NR016941 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD 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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hospital Acquired Condition

Clinical Trials on CONCERN CDS system notification

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kyrgyzstan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe