Communicable DiseasesCOMPASSNCT03120975
Computerized Antibiotic Stewardship Study
A study testing Computerized decision support and audit & feedback, Audit & Feedback and Standard antibiotic stewardship in people with Communicable Diseases, run by Benedikt Huttner at 3 sites in Switzerland.
Trial summary
Prescribing antibiotics frequently poses problems in practice, since patients don't always receive the right dosage of the right antibiotic for the right period of time. This promotes the emergence and spread of antibiotic resistance. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Communicable Diseases
- What is being tested?
- Computerized decision support and audit & feedback, Audit & Feedback and Standard antibiotic stewardship
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16,176 participants
- Where
- 3 sitesSwitzerland
- Study dates
- 3 Sep 2018to 31 Mar 2020
- Phase
- Interventional
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- CLUSTER (WARD) LEVEL
- Acute-care wards with at least 150 admissions/year
- Use of a computerized physician order entry system (CPOE)
- PHYSICIAN LEVEL All physicians involved in antibiotic prescribing decisions in the participating wards
- PATIENT LEVEL
- All patients hospitalized in the participating wards
Who cannot join
- CLUSTER (WARD) LEVEL
- Emergency room
- Outpatient clinics
- Overflow wards
- Absence of a matchable wards with regard to specialty and baseline antibiotic use
- Hematopoietic stem cell
Show all 9Show fewer
- PHYSICIAN LEVEL None
- PATIENT LEVEL
- None
Trial locations and contacts
3 sites in 1 country.
Switzerland3 sites
Ente Ospedaliera Cantonale - Ospedale San Giovanni
Bellinzona, Canton Ticino, 6500
Geneva University Hospitals
Geneva, Canton of Geneva, 1211
Ente Ospedaliera Cantonale - Ospedale Civico
Lugano, Canton Ticino, 6903
About this study
Official title: Improvement of Antibiotic Use in Hospitals Through Pragmatic, Multifaceted, Computerized Interventions: a Multicentre, Cluster-randomized Trial - COMPASS Study (COMPuterized Antibiotic Stewardship Study)
Prescribing antibiotics frequently poses problems in practice, since patients don't always receive the right dosage of the right antibiotic for the right period of time. This promotes the emergence and spread of antibiotic resistance. The investigators of this trial aim to develop a system designed to help doctors to use antibiotics more appropriately. Under COMPASS (COMPuterized Antibiotic Stewardship Study), doctors in three Swiss hospitals will receive tips on the use of antibiotics that are integrated directly into electronic health record and will also be given regular feedback on their use of antibiotics. Parallel to this, data on the antimicrobial prescription practices of a control group which is not using the system will be collected.
Read the detailed description
Inappropriate use of antimicrobials favours the spread and emergence of antimicrobial resistance and other adverse patient outcomes. Antimicrobial stewardship (AMS) programs aim to promote the appropriate use of antimicrobials. Most AMS interventions are based on manual, personalized peer review of antibiotic prescriptions by specialists and are therefore time and resource intensive. Informatics based, computerized approaches to AMS are a promising way to "automatize" AMS, but there have been only few randomized controlled trials analysing their effectiveness in the hospital setting.
The primary research question of this study is whether a multi-modal, computerized antibiotic stewardship intervention (I) reduces overall antibiotic exposure (O) in adult patients hospitalized in acute-care wards of secondary and tertiary care centers (P) compared to no such intervention ("standard-of- care") (C) over a one year time period (T) (the letters refer to the corresponding constituents of the PICOT framework).
The primary objective of the study is to use the methodological rigor of a parallel group, cluster-randomized, controlled superiority trial in three Swiss hospitals to answer the primary research question. Secondary objectives are to assess the impact of the intervention on quality of antibiotic use, patient, microbiologic and economic outcomes.
The primary outcome will be the difference in overall systemic antibiotic use measured in days of therapy (DOT) per admission based on administration data recorded in the electronic health record (EHR) over the whole intervention period. Secondary outcomes will include qualitative and quantitative antimicrobial use indicators (including non-HIV antivirals and antifungals), economic outcomes and key clinical and microbiologic indicators and patient safety indicators such as changes in readmission rates, need for intensive care and mortality.
The study hypothesis is that the multimodal intervention is superior to standard-of-care regarding the primary outcome, i.e. that the intervention leads to a statistically significant reduction in overall antibiotic use expressed as days of therapy per admission compared to no such intervention ("standard-of-care" antibiotic stewardship).
- Conditions
- Communicable Diseases
- Being tested
- Computerized decision support and audit & feedback, Audit & Feedback, Standard antibiotic stewardship
- Keywords
- Anti-Infective Agents, Decision Support Systems, Clinical, Quality Improvement
- Medical subject headings
- Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computerized decision support and audit & feedbackOther
- suggestion of guideline concordant antimicrobial treatment based on indication entry in the computerized physician order entry system
- mandatory reevaluation of antimicrobial therapy therapy on calendar day 4 of treatment
- suggestion of standard antimicrobial treatment duration according to indication
Audit & FeedbackOther
- regular (at least monthly) feedback of antibiotic use quality indicators (on the ward level)
Standard antibiotic stewardshipOther
- Infectious diseases consultation "on demand"
- Review of positive blood cultures
- Availability of a antibiotic use guidelines (on paper and as PDF)
| Study group | Role | What they receive |
|---|---|---|
| Computerized decision support | Experimental | Not described Receives: Other: Computerized decision support and audit & feedback; Other: Audit & Feedback; Other: Standard antibiotic stewardship |
| Standard antibiotic stewardship | Active comparator | Not described Receives: Other: Standard antibiotic stewardship |
What is being measured
The primary outcome is the main question the study is designed to answer.
Days of therapy (DOT)/admission
Overall days of therapy of antibiotics per admission on the ward level
Measured: 12 months
Secondary outcomes (21)
Days of therapy(DOT)/100 patient days
Overall days of therapy per 100 patient days (PD) on the ward level
Measured: 12 months
Defined daily doses (DDD)/100 patient days (PD) and per admission
Overall defined daily doses per 100 patient days and admission on the ward level
Measured: 12 months
Antimicrobial days (AD) per 100 PD and per admission
Length of therapy per 100 PD and per admission
Measured: 12 months
Days per treatment period overall
Overall days per treatment period. A treatment period is defined as antibiotic treatment not interrupted by more than one calendar day or discharge.
Measured: 12 months
30 day-mortality
All cause 30 day-mortality
Measured: 12 months
In-hospital mortality
All-cause in-hospital mortality
Measured: 12 months
Hospital readmission within 30 days of discharge
Unplanned hospital readmission within 30 days of discharge
Measured: 12 months
Hospital length of stay (LOS)
Hospital length of stay
Measured: 12 months
ICU transfer
% of admissions transferred to ICU after initial non-ICU admission
Measured: 12 months
Guideline compliance
Proportion of patients treated in compliance with facility-based guideline
Measured: 12 months
De-escalation
Proportion of patients with "de-escalation" and "escalation" of antibiotic therapy by calendar day 4 of treatment
Measured: 12 months
IV-oral switch
Proportion of patients converted from intravenous to oral therapy between days 4 and 7
Measured: 12 months
appropriate diagnostic exams
proportion of patients with appropriate diagnostic exams
Measured: 12 months
Incidence of Clostridium difficile infections (CDI)
Incidence of healthcare-facility onset Clostridium difficile infection denominated by 10 000 PD and admission
Measured: 12 months
Incidence of multidrug-resistant organisms (MDRO)
Incidence of clinical cultures with multidrug resistant organisms (methicillin-resistant Staphylococcus aureus (MRSA), Extended spectrum beta-lactamase producing Enterobacteriaceae (ESBL-E), carbapenemase-producing Enterobacteriaceae (CPE), vancomycin-resistant enterococci (VRE), multidrug resistant P. aeruginosa) denominated per 1000 PD and admissions
Measured: 12 months
User satisfaction
User satisfaction with the system
Measured: 12 months
Costs of administered antimicrobials
Costs of administered antimicrobials (overall and by class) per admission and per admission receiving antibiotics
Measured: 12 months
costs of the intervention
total costs of the intervention
Measured: 12 months
number of infectious diseases consultations
proportion of patients with infectious diseases consultation
Measured: 12 months
Days per treatment period for community acquired pneumonia
A treatment period is defined as antibiotic treatment not interrupted by more than one calendar day or discharge.
Measured: 12 months
Days per treatment period for upper urinary tract infection
A treatment period is defined as antibiotic treatment not interrupted by more than one calendar day or discharge.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2017
- Study start3 Sep 2018
- Primary completion29 Feb 2020
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Communicable DiseasesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel group, cluster-randomized superiority trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 16,176 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benedikt Huttner
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss National Science Foundation, University of Geneva, Switzerland, Ente Ospedaliero Cantonale, Ticino, Switzerland
- Responsible party
- Sponsor-investigator, Benedikt Huttner, University Hospital, Geneva
- Investigators
- Benedikt D Huttner, MD, MS, Principal investigator, Geneva University Hospitals and University of Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03120975
- Sponsor's protocol ID
- 2017-00454
- Other IDs
- 407240_167079, 2017
- Acronym
- COMPASS
- Status last verified
- Nov 2020
- First submitted
- 14 Apr 2017
- Last updated
- 19 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Catho G, De Kraker M, Waldispuhl Suter B, Valotti R, Harbarth S, Kaiser L, Elzi L, Meyer R, Bernasconi E, Huttner BD. Study protocol for a multicentre, cluster randomised, superiority trial evaluating the impact of computerised decision support, audit and feedback on antibiotic use: the COMPuterized Antibiotic Stewardship Study (COMPASS). BMJ Open. 2018 Jun 27;8(6):e022666. doi: 10.1136/bmjopen-2018-022666.
PubMed 29950480Catho G, Centemero NS, Catho H, Ranzani A, Balmelli C, Landelle C, Zanichelli V, Huttner BD; on the behalf of the Q-COMPASS study group. Factors determining the adherence to antimicrobial guidelines and the adoption of computerised decision support systems by physicians: A qualitative study in three European hospitals. Int J Med Inform. 2020 Sep;141:104233. doi: 10.1016/j.ijmedinf.2020.104233. Epub 2020 Jul 13.
PubMed 32736330Catho G, Sauser J, Coray V, Da Silva S, Elzi L, Harbarth S, Kaiser L, Marti C, Meyer R, Pagnamenta F, Portela J, Prendki V, Ranzani A, Centemero NS, Stirnemann J, Valotti R, Vernaz N, Suter BW, Bernasconi E, Huttner BD; COMPASS study group. Impact of interactive computerised decision support for hospital antibiotic use (COMPASS): an open-label, cluster-randomised trial in three Swiss hospitals. Lancet Infect Dis. 2022 Oct;22(10):1493-1502. doi: 10.1016/S1473-3099(22)00308-5. Epub 2022 Jul 20.
PubMed 35870478
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improvement of Antibiotic Use in Hospitals Through Pragmatic, Multifaceted, Computerized Interventions: a Multicentre, Cluster-randomized Trial - COMPASS Study (COMPuterized Antibiotic Stewardship Study)
- ClinicalTrials.gov ID
- NCT03120975
- Acronym / sponsor ID
- COMPASS / 2017-00454
- Conditions
- Communicable Diseases
- Keywords
- Anti-Infective Agents, Decision Support Systems, Clinical, Quality Improvement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16,176 participants (actual)
- Lead sponsor
- Benedikt HuttnerUniversity, hospital or other
- Collaborators
- Swiss National Science Foundation, University of Geneva, Switzerland, Ente Ospedaliero Cantonale, Ticino, Switzerland
- Study start
- 3 Sep 2018 (actual)
- Primary completion
- 29 Feb 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 19 Apr 2017 (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.
Prescribing antibiotics frequently poses problems in practice, since patients don't always receive the right dosage of the right antibiotic for the right period of time. This promotes the emergence and spread of antibiotic resistance. The investigators of this trial aim to develop a system designed to help doctors to use antibiotics more appropriately. Under COMPASS (COMPuterized Antibiotic Stewardship Study), doctors in three Swiss hospitals will receive tips on the use of antibiotics that are integrated directly into electronic health record and will also be given regular feedback on their use of antibiotics. Parallel to this, data on the antimicrobial prescription practices of a control group which is not using the system will be collected.
Detailed description
Inappropriate use of antimicrobials favours the spread and emergence of antimicrobial resistance and other adverse patient outcomes. Antimicrobial stewardship (AMS) programs aim to promote the appropriate use of antimicrobials. Most AMS interventions are based on manual, personalized peer review of antibiotic prescriptions by specialists and are therefore time and resource intensive. Informatics based, computerized approaches to AMS are a promising way to "automatize" AMS, but there have been only few randomized controlled trials analysing their effectiveness in the hospital setting.
The primary research question of this study is whether a multi-modal, computerized antibiotic stewardship intervention (I) reduces overall antibiotic exposure (O) in adult patients hospitalized in acute-care wards of secondary and tertiary care centers (P) compared to no such intervention ("standard-of- care") (C) over a one year time period (T) (the letters refer to the corresponding constituents of the PICOT framework).
The primary objective of the study is to use the methodological rigor of a parallel group, cluster-randomized, controlled superiority trial in three Swiss hospitals to answer the primary research question. Secondary objectives are to assess the impact of the intervention on quality of antibiotic use, patient, microbiologic and economic outcomes.
The primary outcome will be the difference in overall systemic antibiotic use measured in days of therapy (DOT) per admission based on administration data recorded in the electronic health record (EHR) over the whole intervention period. Secondary outcomes will include qualitative and quantitative antimicrobial use indicators (including non-HIV antivirals and antifungals), economic outcomes and key clinical and microbiologic indicators and patient safety indicators such as changes in readmission rates, need for intensive care and mortality.
The study hypothesis is that the multimodal intervention is superior to standard-of-care regarding the primary outcome, i.e. that the intervention leads to a statistically significant reduction in overall antibiotic use expressed as days of therapy per admission compared to no such intervention ("standard-of-care" antibiotic stewardship).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel group, cluster-randomized superiority trial
| Arm | Type | Receives |
|---|---|---|
| Computerized decision support | Experimental | Other: Computerized decision support and audit & feedback, Other: Audit & Feedback, Other: Standard antibiotic stewardship |
| Standard antibiotic stewardship | Active comparator | Other: Standard antibiotic stewardship |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- CLUSTER (WARD) LEVEL
- Acute-care wards with at least 150 admissions/year
- Use of a computerized physician order entry system (CPOE)
- PHYSICIAN LEVEL All physicians involved in antibiotic prescribing decisions in the participating wards
- PATIENT LEVEL
Key exclusion criteria (9 listed)
- CLUSTER (WARD) LEVEL
- Emergency room
- Outpatient clinics
- Overflow wards
- Absence of a matchable wards with regard to specialty and baseline antibiotic use
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 |
|---|---|---|
| Computerized decision support and audit & feedback* suggestion of guideline concordant antimicrobial treatment based on indication entry in the computerized physician order entry system * mandatory reevaluation of antimicrobial therapy therapy on calendar day 4 of treatment * suggestion of standard antimicrobial treatment duration according to indication | Other | Computerized decision support |
| Audit & Feedback* regular (at least monthly) feedback of antibiotic use quality indicators (on the ward level) | Other | Computerized decision support |
| Standard antibiotic stewardship* Infectious diseases consultation "on demand" * Review of positive blood cultures * Availability of a antibiotic use guidelines (on paper and as PDF) | Other | Computerized decision support, Standard antibiotic stewardship |
Primary outcome
Days of therapy (DOT)/admission
Time frame: 12 months
Overall days of therapy of antibiotics per admission on the ward level
21 secondary outcomes
Days of therapy(DOT)/100 patient days
Time frame: 12 months
Defined daily doses (DDD)/100 patient days (PD) and per admission
Time frame: 12 months
Antimicrobial days (AD) per 100 PD and per admission
Time frame: 12 months
Days per treatment period overall
Time frame: 12 months
30 day-mortality
Time frame: 12 months
In-hospital mortality
Time frame: 12 months
Hospital readmission within 30 days of discharge
Time frame: 12 months
Hospital length of stay (LOS)
Time frame: 12 months
ICU transfer
Time frame: 12 months
Guideline compliance
Time frame: 12 months
De-escalation
Time frame: 12 months
IV-oral switch
Time frame: 12 months
appropriate diagnostic exams
Time frame: 12 months
Incidence of Clostridium difficile infections (CDI)
Time frame: 12 months
Incidence of multidrug-resistant organisms (MDRO)
Time frame: 12 months
User satisfaction
Time frame: 12 months
Costs of administered antimicrobials
Time frame: 12 months
costs of the intervention
Time frame: 12 months
number of infectious diseases consultations
Time frame: 12 months
Days per treatment period for community acquired pneumonia
Time frame: 12 months
Days per treatment period for upper urinary tract infection
Time frame: 12 months
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 Nov 2020.
- Background: PubMed 29950480Catho G, De Kraker M, Waldispuhl Suter B, Valotti R, Harbarth S, Kaiser L, Elzi L, Meyer R, Bernasconi E, Huttner BD. Study protocol for a multicentre, cluster randomised, superiority trial evaluating the impact of computerised decision support, audit and feedback on antibiotic use: the COMPuterized Antibiotic Stewardship Study (COMPASS). BMJ Open. 2018 Jun 27;8(6):e022666. doi: 10.1136/bmjopen-2018-022666.
- Results publication: PubMed 32736330Catho G, Centemero NS, Catho H, Ranzani A, Balmelli C, Landelle C, Zanichelli V, Huttner BD; on the behalf of the Q-COMPASS study group. Factors determining the adherence to antimicrobial guidelines and the adoption of computerised decision support systems by physicians: A qualitative study in three European hospitals. Int J Med Inform. 2020 Sep;141:104233. doi: 10.1016/j.ijmedinf.2020.104233. Epub 2020 Jul 13.
- Derived from this study: PubMed 35870478Catho G, Sauser J, Coray V, Da Silva S, Elzi L, Harbarth S, Kaiser L, Marti C, Meyer R, Pagnamenta F, Portela J, Prendki V, Ranzani A, Centemero NS, Stirnemann J, Valotti R, Vernaz N, Suter BW, Bernasconi E, Huttner BD; COMPASS study group. Impact of interactive computerised decision support for hospital antibiotic use (COMPASS): an open-label, cluster-randomised trial in three Swiss hospitals. Lancet Infect Dis. 2022 Oct;22(10):1493-1502. doi: 10.1016/S1473-3099(22)00308-5. Epub 2022 Jul 20.
- Lay summary of the projectLink provided by the sponsor.
- 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.
Benedikt D Huttner, MD, MS principal investigator
Geneva University Hospitals and University of Geneva
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computerized decision support and audit & feedback, Audit & Feedback and Standard antibiotic stewardship in people with Communicable Diseases, run by Benedikt Huttner at 3 sites in Switzerland.
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 6 inclusion and 9 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 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Switzerland. 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?
Days of therapy (DOT)/admission (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03120975, which also lists 3 linked publications.
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 Nov 2020.