Post-Endoscopic Infection Rate Notifications to Improve the Delivery of Care

NCT03922971 | Completed

• 1 other identifier: IRB00203304
• Study Type: interventional
• Target: 303
• Locations: 1 country
• Sites: 1

Brief Summary

This project will notify centers of center's post-endoscopic infection rates and evaluate the effectiveness of this notification system to decrease infection rates. The investigators aim to notify centers of the number of patients and center's risk-adjusted rates of hospitalizations for infections after colonoscopy and esophagogastroduodenoscopy (EGD) procedures performed between January 2015 and September 2018. The investigators will randomize centers to two notification groups: (1) Ability to view center's rate compared with all other centers (ASCs and outpatient centers notified and compared separately) or (2) Ability to view center's rate compared with the other centers with a similar patient comorbidity profile and in addition to viewing option 1. Facilities will answer questions about center's infection control practices. The investigators hypothesize that centers with high rates of post-procedural infections will (1) be more likely to report that the center took action to investigate the center's infection control practices after the first notification and (2) observe a decrease in infections after the notification. The investigators anticipate that centers with high rates of post-procedural infections that are randomized to group 2 will have greater change. The investigators anticipate no change in rates of infection in the facilities that had zero or very low (n=1) event rates.

Conditions

Infection

Keywords

colonoscopy; EGD; endoscopy; ASC; outpatient; infection; Endoscopic procedures

Outcome Measures

Primary Outcomes (1)

• Change in the infection rate among centers with elevated infection rates

  Baseline, 12 months

Study Arms (2)

National comparison

OTHER

Ability to view center's rate compared with all others

Other: Option 1: National comparison

National comparison with benchmarking

OTHER

Ability to view center's rate compared with the others with a similar patient comorbidity profile and in addition to viewing option 1

Other: Option 2: National comparison with benchmarking

Interventions

Option 1: National comparison OTHER

Ability to view center's rate compared with all others.

National comparison

Option 2: National comparison with benchmarking OTHER

Ability to view center's rate compared with the others with a similar patient comorbidity profile and in addition to viewing option 1.

National comparison with benchmarking

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Facilities that bill to fee for service Medicare for gastrointestinal endoscopy

Sponsors & Collaborators

• Johns Hopkins University: lead
• Medivators Cantel: collaborator

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 212187, United States

Location

MeSH Terms

Conditions

Infections

Interventions

Benchmarking

Intervention Hierarchy (Ancestors)

Management Audit; Organization and Administration; Health Services Administration; Program Evaluation; Quality of Health Care; Quality Assurance, Health Care; Health Care Quality, Access, and Evaluation; Health Care Evaluation Mechanisms

Study Officials

• Susan Hutfless

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2019
• First Posted: April 22, 2019
• Study Start: August 7, 2019
• Primary Completion: December 31, 2019
• Study Completion: June 15, 2023
• Last Updated: June 23, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)