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Evaluation of GeoHAI Implementation

Primary Purpose

Clostridioides Difficile Infection, Healthcare Associated Infection

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
GeoHAI
Sponsored by
Ohio State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Clostridioides Difficile Infection focused on measuring Geographic information system

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Infection preventionist or physician involved in infection prevention at participating health system Exclusion Criteria: Not an infection preventionist nor a physician involved in infection prevention Does not work at the participating health system

Sites / Locations

  • The Ohio State UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

GeoHAI Use

Arm Description

Participants will use the GeoHAI tool

Outcomes

Primary Outcome Measures

Change from Baseline Healthcare-Associated Infection (HAI) Rate
HAI rate at healthcare system level before intervention and after

Secondary Outcome Measures

Knowledge of tool
Knowledge questions to assess understanding of how to use the GeoHAI tool, assessed after participants are trained on how to use the tool
Change from baseline skill confidence at one year
Self-reported level of confidence on investigating HAI clusters
Usability score
System Usability Scale score, and impacts of the tool on work and workflow (interruptions, workarounds, issues/challenges)
GeoHAI Use
Self-reported frequency of use of the GeoHAI tool
Change in Healthcare-Associated Infection (HAI) Investigation Process
Change in how infection preventionists investigate Healthcare-Associated Infections (HAIs)
Number of months healthcare system is below goal HAI rate
Monthly HAI rate at healthcare system level before intervention and after
Feasibility score
Score on feasibility, acceptability, and appropriateness domains of validated Implementation Outcome scale (minimum score = 1, maximum score = 5, where higher scores indicate better feasibility)
Time to HAI cluster identification
Time from when an HAI test was ordered for the first positive patient ultimately contained in an identified HAI cluster, to when that HAI cluster is identified.

Full Information

First Posted
April 18, 2022
Last Updated
March 15, 2023
Sponsor
Ohio State University
Collaborators
Agency for Healthcare Research and Quality (AHRQ)
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1. Study Identification

Unique Protocol Identification Number
NCT05612672
Brief Title
Evaluation of GeoHAI Implementation
Official Title
GeoHAI Implementation in IP Workflow
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 13, 2023 (Actual)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
September 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University
Collaborators
Agency for Healthcare Research and Quality (AHRQ)

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
Geographic Information Systems (GIS) and spatial analysis have become important tools in public health informatics but have rarely been applied to the hospital setting. In this study we apply these tools to address the challenge of Hospital Acquired Infections (HAIs) by building, implementing, and evaluating a new computer application which incorporates mapping and geographic data to assist hospital epidemiologists in identifying HAI clusters and assessing transmission risk. We expect that incorporation of geographic information into the workflow of hospital epidemiologists will have a profound effect on our understanding of disease transmission and HAI risk factors in the hospital setting, radically altering the workflow and speed of response of infection preventionists and improving their ability to prevent HAIs.
Detailed Description
Hospital Acquired Infections are common, affecting 3.2% of acute care hospital admissions. Recent reports have shown an improvement in overall HAI rates, primarily driven by improvements in surgical site (SSI) and catheter associated urinary tract infections (CAUTI). Transmissible infections, such as Clostridium difficile (CDI), have not shown the same decrease over time. This may be because prevention of CDI requires a comprehensive hospital-wide approach addressing environmental and patient-level risk factors. Geographic Information Systems (GIS) and spatial analysis techniques have become an important tool in public health informatics because they can integrate a vast number of data sources and explore associations and patterns in the data not visible using traditional biostatistical methods. Applications of GIS and spatial analysis are wide ranging but have largely been ignored in the hospital setting. The objective of this research is to develop a HAI assessment tool, which incorporates geographic data on the hospital and patient-level data from the electronic health record system, that is useful for hospital infection preventionists in better identifying clusters of HAI and assessing potential risk. We bring together a multidisciplinary team of clinical, operational, and academic investigators with expertise in GIS and spatial analysis, patient safety, public health informatics, usability assessment, and mixed- methods evaluation. As part of a larger study, this aim will seek to implement a GeoHAI tool that uses spatio-temporal Bayesian models to identify clusters of NHSN-defined hospital onset CDI and multidrug resistant organisms (MDRO) and predict potential high risk areas given hospital and patient risk factors. Unique to our approach is an evaluation strategy that focuses on the reduction of hospital acquired infection, but also seeks to understand how the tool and the information derived from the tool impacts patient safety practices in the hospital. We expect the implementation of this tool to radically change the workflow and speed of response of infection preventionists, greatly improving their ability to prevent HAI instead of reacting after they have occurred.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Clostridioides Difficile Infection, Healthcare Associated Infection
Keywords
Geographic information system

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Participants will get the intervention and outcomes will be measured pre- and post-implementation
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
GeoHAI Use
Arm Type
Experimental
Arm Description
Participants will use the GeoHAI tool
Intervention Type
Other
Intervention Name(s)
GeoHAI
Intervention Description
A Geographic healthcare-associated infection (HAI) visualization and assessment tool (GeoHAI) which uses spatio-temporal Bayesian models to identify clusters of National Healthcare Safety Network (NHSN)-defined hospital onset Clostridium difficile (CDI) and multidrug resistant organisms (MDRO), and predict potential high risk areas given hospital and patient risk factors.
Primary Outcome Measure Information:
Title
Change from Baseline Healthcare-Associated Infection (HAI) Rate
Description
HAI rate at healthcare system level before intervention and after
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Knowledge of tool
Description
Knowledge questions to assess understanding of how to use the GeoHAI tool, assessed after participants are trained on how to use the tool
Time Frame
Immediately post-training
Title
Change from baseline skill confidence at one year
Description
Self-reported level of confidence on investigating HAI clusters
Time Frame
1 year
Title
Usability score
Description
System Usability Scale score, and impacts of the tool on work and workflow (interruptions, workarounds, issues/challenges)
Time Frame
1 year
Title
GeoHAI Use
Description
Self-reported frequency of use of the GeoHAI tool
Time Frame
1 year
Title
Change in Healthcare-Associated Infection (HAI) Investigation Process
Description
Change in how infection preventionists investigate Healthcare-Associated Infections (HAIs)
Time Frame
1 year
Title
Number of months healthcare system is below goal HAI rate
Description
Monthly HAI rate at healthcare system level before intervention and after
Time Frame
1 year
Title
Feasibility score
Description
Score on feasibility, acceptability, and appropriateness domains of validated Implementation Outcome scale (minimum score = 1, maximum score = 5, where higher scores indicate better feasibility)
Time Frame
1 year
Title
Time to HAI cluster identification
Description
Time from when an HAI test was ordered for the first positive patient ultimately contained in an identified HAI cluster, to when that HAI cluster is identified.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Infection preventionist or physician involved in infection prevention at participating health system Exclusion Criteria: Not an infection preventionist nor a physician involved in infection prevention Does not work at the participating health system
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ohio State University Office of Responsible Research Practices
Phone
1-800-678-6251
Email
biomedicalirbinfo@osu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Courtney Hebert, MD
Organizational Affiliation
Ohio State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Courtney Hebert, MS, MD
Phone
614-688-6549
Email
courtney.hebert@osumc.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Evaluation of GeoHAI Implementation

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