CDIPASTCDINCT05508607
Precision Antimicrobial STewardship for Clostridioides DIfficile Prevention
An observational study of CDI, run by Intermountain Health Care, Inc. at 1 site in United States.
Trial summary
To decrease CDI incidence by implementing an electronic health record-integrated CDI-risk classification tool for Clostridioides difficile infection (CDI) to focus a bundle of antimicrobial stewardship (AMS) CDI prevention recommendations on high-risk patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CDI
- What is being tested?
- CDI-risk Classification Tool
- How many people
- 13,319 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2021to 30 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Our goal is to study the all adults admitted to any of the 22 Intermountain Healthcare network acute care hospitals who are classified as high risk for CDI by the risk classification tool. In this pre-post design study, we will identify two cohorts, the first representing a two-year cohort prior to implementation of the risk classification-enhanced AMS process and the second a post-implementation cohort representing one-year after implementation. These cohorts will be identified retrospectively.
Who may be able to join
- adult acute care patients identified as high-CDI risk by the CDI risk classification tool. This sub-group represents approximately 6% of all acute care admissions
Who cannot join
- Behavioral health units
- Inpatient rehabilitation units
- Labor and Delivery units
- Same day surgery and observation units
Trial locations and contacts
1 site in 1 country.
United States1 site
Intermountain Medical Center
Salt Lake City, Utah, 84107
About this study
To decrease CDI incidence by implementing an electronic health record-integrated CDI-risk classification tool for Clostridioides difficile infection (CDI) to focus a bundle of antimicrobial stewardship (AMS) CDI prevention recommendations on high-risk patients.
Read the detailed description
This study aims to use a pre/post implementation design to evaluate the use of a novel risk classification tool to improve existing methods of identifying patients eligible for routine antimicrobial stewardship (AMS) care processes targeting reduction of Clostridioides difficile infection (CDI). Antimicrobial stewardship is an established, evidence-based quality improvement program that is required by The Joint Commission and a condition of participation by the Centers for Medicare and Medicaid. AMS processes of care are evidence based, supported by published research demonstrating outcomes benefits, are recommended by national guidelines and are not investigational. Treatment decisions remain at the discretion of clinicians and patients
- Conditions
- CDI
- Being tested
- CDI-risk Classification Tool
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CDI-risk Classification ToolOther
This tool will focus a bundle of antimicrobial stewardship (AMS) CDI prevention recommendations on high-risk patients.
| Study group | Role | What they receive |
|---|---|---|
| Pre-Implementation | Not described | |
| Post-Implementation | Not described Receives: Other: CDI-risk Classification Tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
Per-Admission Rate
per-admission rate of hospital-associated CDI, defined as: positive toxin B by enzyme-linked immunoassay or polymerase chain reaction test at least 72 hours after admission
Measured: 30 days after discharge
Secondary outcomes (5)
Total Antibiotic Usage
Measured: through study completion, an average of 1 year
High-Risk Antibiotic Usage
Measured: through study completion, an average of 1 year
Proton Pump Inhibitor Therapy Administered
Measured: through study completion, an average of 1 year
Total Variable Cost per Admission
Measured: through study completion, an average of 1 year
Hospital Length of Stay
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2022
- Study start1 May 2021
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CDIStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 13,319 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intermountain Health Care, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05508607
- Sponsor's protocol ID
- 1051390
- Acronym
- PASTCDI
- Status last verified
- Aug 2022
- First submitted
- 27 May 2020
- Last updated
- 19 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Precision Antimicrobial STewardship for Clostridioides DIfficile Prevention
- ClinicalTrials.gov ID
- NCT05508607
- Acronym / sponsor ID
- PASTCDI / 1051390
- Conditions
- CDI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13,319 participants (actual)
- Lead sponsor
- Intermountain Health Care, Inc.University, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 19 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To decrease CDI incidence by implementing an electronic health record-integrated CDI-risk classification tool for Clostridioides difficile infection (CDI) to focus a bundle of antimicrobial stewardship (AMS) CDI prevention recommendations on high-risk patients.
Detailed description
This study aims to use a pre/post implementation design to evaluate the use of a novel risk classification tool to improve existing methods of identifying patients eligible for routine antimicrobial stewardship (AMS) care processes targeting reduction of Clostridioides difficile infection (CDI). Antimicrobial stewardship is an established, evidence-based quality improvement program that is required by The Joint Commission and a condition of participation by the Centers for Medicare and Medicaid. AMS processes of care are evidence based, supported by published research demonstrating outcomes benefits, are recommended by national guidelines and are not investigational. Treatment decisions remain at the discretion of clinicians and patients
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-Implementation | – | – |
| Post-Implementation | – | Other: CDI-risk Classification Tool |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Our goal is to study the all adults admitted to any of the 22 Intermountain Healthcare network acute care hospitals who are classified as high risk for CDI by the risk classification tool. In this pre-post design study, we will identify two cohorts, the first representing a two-year cohort prior to implementation of the risk classification-enhanced AMS process and the second a post-implementation cohort representing one-year after implementation. These cohorts will be identified retrospectively.
Key inclusion criteria (1 listed)
- adult acute care patients identified as high-CDI risk by the CDI risk classification tool. This sub-group represents approximately 6% of all acute care admissions
Key exclusion criteria (4 listed)
- Behavioral health units
- Inpatient rehabilitation units
- Labor and Delivery units
- Same day surgery and observation units
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CDI-risk Classification ToolThis tool will focus a bundle of antimicrobial stewardship (AMS) CDI prevention recommendations on high-risk patients. | Other | Post-Implementation |
Primary outcome
Per-Admission Rate
Time frame: 30 days after discharge
per-admission rate of hospital-associated CDI, defined as: positive toxin B by enzyme-linked immunoassay or polymerase chain reaction test at least 72 hours after admission
5 secondary outcomes
Total Antibiotic Usage
Time frame: through study completion, an average of 1 year
High-Risk Antibiotic Usage
Time frame: through study completion, an average of 1 year
Proton Pump Inhibitor Therapy Administered
Time frame: through study completion, an average of 1 year
Total Variable Cost per Admission
Time frame: through study completion, an average of 1 year
Hospital Length of Stay
Time frame: through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of CDI, run by Intermountain Health Care, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Per-Admission Rate (time frame: 30 days after discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2022.