Antibiotic InitiationFIRST AID-LTCNCT04187742
Feedback to Improve Rational Strategies of Antibiotic Initiation and Duration in Long Term Care (FIRST AID -LTC) - Phase 2
A study testing Social Comparison Email vs. Standard Email, Maintenance Certification Email vs. Standard Email and Report Opening Status Email vs. Standard Email (among previous report openers and non-openers) in people with Antibiotic Initiation and Antibiotic Duration, run by Institute for Clinical Evaluative Sciences at 1 site in Canada.
Trial summary
There is a high rate of inappropriate antibiotic use in LTC facilities, with both unnecessary initiation and prolongation of treatments. Although there are challenges to rational antibiotic use in LTC, the variability in antibiotic initiation and use of prolonged treatment durations is driven by prescriber tendencies… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Antibiotic Initiation, Antibiotic Duration
- What is being tested?
- Social Comparison Email vs. Standard Email, Maintenance Certification Email vs. Standard Email and Report Opening Status Email vs. Standard Email (among previous report openers and non-openers)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 421 participants
- Where
- 1 siteCanada
- Study dates
- 15 May 2017to 31 Mar 2022
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- An individual having a minimum of 2 records on separate days within the quarter meeting any combination of the following criteria:
- a record for a non-emergency long-term care inpatient service OR
- an Ontario Drug Benefits record administered in long-term care
- Index date = The analysis will be anchored on the most recent of either of the records above with a given quarter or their date of death (whichever date is earliest)
Who cannot join
- Non-Ontario resident at index date
- Invalid age (age<19 or age>115) at index date
- Missing or invalid sex or date of birth at index date
- Death date is >7 days before index date
- If the individual does not live in a nursing home or home for the aged
- Cannot be linked to a Most Responsible Physician (MRP) (see methodology below)
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- To identify the Most Responsible Physician (MRP) Using Virtual Rostering
- For each patient in the above resident cohort, the study team will retrieve all records from health care providers in the 6 month period preceding the index date (180 days), keeping only records from physicians who have a specialty of 1) general practice, 2) community medicine or 3) geriatrics.
- Steps for MRP assignment:
- Step 1) The study team will first select physicians with highest count of OHIP records for the monthly management of a nursing home or home for the aged. This is completed for as many residents as possible.
- Step 2) If there were no monthly management fee records as described above then the physician with the highest count of non-emergency long-term care inpatient services records for each patient will be selected. This step is only applied to residents who could not be matched to a physician by Step 1. Physician must have seen the patient one or more times in 90 days prior to and including index date to be considered MRP. This criteria is applied to ensure the physician has seen the resident within the reporting quarter.
- Step 3) Some patients will virtually roster to physicians in Enrollment groups, some will virtually roster to physicians that are not in a group. For these, we will recode enrollment program type to 'NOR' (not otherwise rostered) - these are likely fee for service physicians.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feedback to Improve Rational Strategies of Antibiotic Initiation and Duration in Long Term Care (Phase 2)
There is a high rate of inappropriate antibiotic use in LTC facilities, with both unnecessary initiation and prolongation of treatments. Although there are challenges to rational antibiotic use in LTC, the variability in antibiotic initiation and use of prolonged treatment durations is driven by prescriber tendencies rather than resident characteristics. Audit-and-feedback is a well-established intervention to improve professional practices, and is ideally suited for use to improve antibiotic prescribing tendencies in LTC. The literature is saturated with trials indicating benefit of audit-and-feedback, but is in dire need of studies to identify methods to improve the impact of this technique. Health Quality Ontario (HQO), a key partner in the FIRST AID-LTC research program, is already providing audit-and-feedback for other inappropriate prescribing practices in LTC, and has identified antibiotic prescribing as a priority focus.
Read the detailed description
The overarching goals of FIRST AID - LTC are two-fold:
- Improve rational antibiotic prescribing by physicians to minimize harms among LTC residents.
- Advance the science of audit-and-feedback to improve physician prescribing practices.
Specific Aims
To advance audit-and-feedback implementation science:
- by determining whether social comparison incentives, personal maintenance of certification incentives, and informing physicians of their report opening status (i.e., never opened a report vs. opened at least one report), can lead to increased opening of the feedback report and greater reductions in antibiotic use than standard email messaging.
Anticipated Contributions to Health-Related Knowledge
Although the literature is inundated with trials examining the impact of audit-and-feedback compared to usual care, there is a need for studies to improve audit-and-feedback delivery. FIRST AID-LTC will test optimal delivery and peer comparison techniques for audit-and-feedback. The knowledge learned can be extrapolated to antibiotic interventions in LTC in other provinces across Canada, as well more broadly to inappropriate medication prescribing practices in LTC.
Anticipated Contributions to Health Care, Health Systems and Health Outcomes
FIRST AID-LTC will lead to immediate reductions in excess antibiotic use in Ontario LTC facilities, which in turn should result in substantial reductions in direct drug costs, as well as downstream complications of allergy, organ toxicity, C. difficile infections and antimicrobial resistance. With easy transferability to other Canadian provinces, the improvements in cost-savings and patient outcomes could be massive in scope.
- Conditions
- Antibiotic Initiation, Antibiotic Duration
- Being tested
- Social Comparison Email vs. Standard Email, Maintenance Certification Email vs. Standard Email, Report Opening Status Email vs. Standard Email (among previous report openers and non-openers)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social Comparison Email vs. Standard EmailBehavioural
Evaluate whether emails with social comparison incentives will encourage greater report opening by physicians leading to greater reductions in antibiotic use, than a standard email without social comparison incentives
Maintenance Certification Email vs. Standard EmailBehavioural
Evaluate whether emails with maintenance certification incentives will encourage greater report opening by physicians leading to greater reductions in antibiotic use, than a standard email without social comparison incentives
Report Opening Status Email vs. Standard Email (among previous report openers and non-openers)Behavioural
Evaluate whether emails informing physicians of their report opening status (among those who have previously opened at least one report and those who have never opened a report) will encourage greater report opening by physicians leading to greater reductions in antibiotic use, than a standard email without report opening status information
| Study group | Role | What they receive |
|---|---|---|
| LTC Physicians Receive Social Comparison Email | Active comparator | All LTC physicians who receive a social comparison email Receives: Behavioral: Social Comparison Email vs. Standard Email |
| LTC Physicians Do Not Receive Social Comparison Email | No intervention | All LTC physicians who do not receive a social comparison email |
| LTC Physicians Receive Maintenance Certification Email | Active comparator | All LTC physicians who receive a maintenance certification email Receives: Behavioral: Maintenance Certification Email vs. Standard Email |
| LTC Physicians Do Not Receive Maintenance Certification Email | No intervention | All LTC physicians who do not receive a maintenance certification email |
| LTC Physician Has (or has not) Opened Prior Report | Active comparator | LTC physicians who opened (or has not opened) at least one report receive an email informing them of their report opening status Receives: Behavioral: Report Opening Status Email vs. Standard Email (among previous report openers and non-openers) |
| LTC Physician Has (or has not) Opened Prior Report (Control) | No intervention | LTC physicians who opened (or has not opened) at least one report receive a standard email without report opening status |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of report opening
Percentage of physicians opening/accessing the report at least once in the 3 month interval following email send out
Measured: 3 months
Secondary outcomes (7)
ER visit or hospitalization for infection
The percentage of a LTC physicians' patients that experienced an ER visit or hospitalization due to a potential antibiotic-related harm, including: allergy, general medicine adverse event, diarrhea, C. difficile infection, or infection with an antibiotic-resistant organism
Measured: 3 months
ER visit or hospitalization for antibiotic harms
To test for harms related to decreased antibiotic use by comparing the percentage of LTC physicians' patients that experience an infection-related ER visit or admission
Measured: 3 months
Net clinical impact
Measure the net clinical impact of the intervention, by comparing all-cause ER visits and hospitalizations and mortality
Measured: 3 months
Anti-psychotic use
The percent reduction in anti-psychotic use
Measured: 3 months
Benzodiazepine use
The percent reduction in benzodiazepines
Measured: 3 months
Antibiotic initiation
Percentage of patients initiated on an antibiotic
Measured: 3 months
Antibiotic duration
Percentage of antibiotic treatments prolonged > 7 days
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2019
- Study start15 May 2017
- Primary completion30 Sep 2021
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Antibiotic InitiationStudies 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
- Assess three interventional parallel study models consisting of two intervention arms each
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 421 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute for Clinical Evaluative Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Ontario Agency for Health Protection and Promotion, Health Quality Ontario
- Responsible party
- Principal investigator, Nick Daneman, Institute for Clinical Evaluative Sciences
- Investigators
- Nick Daneman, MD, Principal investigator, ICES
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04187742
- Sponsor's protocol ID
- 441-2017 (Phase 2)
- Acronym
- FIRST AID-LTC
- Status last verified
- Apr 2022
- First submitted
- 3 Dec 2019
- Last updated
- 7 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Daneman N, Lee S, Bai H, Bell CM, Bronskill SE, Campitelli MA, Dobell G, Fu L, Garber G, Ivers N, Kumar M, Lam JMC, Langford B, Laur C, Morris AM, Mulhall CL, Pinto R, Saxena FE, Schwartz KL, Brown KA. Behavioral Nudges to Improve Audit and Feedback Report Opening Among Antibiotic Prescribers: A Randomized Controlled Trial. Open Forum Infect Dis. 2022 Mar 2;9(5):ofac111. doi: 10.1093/ofid/ofac111. eCollection 2022 May.
PubMed 35392461
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feedback to Improve Rational Strategies of Antibiotic Initiation and Duration in Long Term Care (Phase 2)
- ClinicalTrials.gov ID
- NCT04187742
- Acronym / sponsor ID
- FIRST AID-LTC / 441-2017 (Phase 2)
- Conditions
- Antibiotic Initiation, Antibiotic Duration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 421 participants (actual)
- Lead sponsor
- Institute for Clinical Evaluative SciencesUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Ontario Agency for Health Protection and Promotion, Health Quality Ontario
- Study start
- 15 May 2017 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 5 Dec 2019 (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.
There is a high rate of inappropriate antibiotic use in LTC facilities, with both unnecessary initiation and prolongation of treatments. Although there are challenges to rational antibiotic use in LTC, the variability in antibiotic initiation and use of prolonged treatment durations is driven by prescriber tendencies rather than resident characteristics. Audit-and-feedback is a well-established intervention to improve professional practices, and is ideally suited for use to improve antibiotic prescribing tendencies in LTC. The literature is saturated with trials indicating benefit of audit-and-feedback, but is in dire need of studies to identify methods to improve the impact of this technique. Health Quality Ontario (HQO), a key partner in the FIRST AID-LTC research program, is already providing audit-and-feedback for other inappropriate prescribing practices in LTC, and has identified antibiotic prescribing as a priority focus.
Detailed description
The overarching goals of FIRST AID - LTC are two-fold:
- Improve rational antibiotic prescribing by physicians to minimize harms among LTC residents.
- Advance the science of audit-and-feedback to improve physician prescribing practices.
Specific Aims
To advance audit-and-feedback implementation science:
- by determining whether social comparison incentives, personal maintenance of certification incentives, and informing physicians of their report opening status (i.e., never opened a report vs. opened at least one report), can lead to increased opening of the feedback report and greater reductions in antibiotic use than standard email messaging.
Anticipated Contributions to Health-Related Knowledge
Although the literature is inundated with trials examining the impact of audit-and-feedback compared to usual care, there is a need for studies to improve audit-and-feedback delivery. FIRST AID-LTC will test optimal delivery and peer comparison techniques for audit-and-feedback. The knowledge learned can be extrapolated to antibiotic interventions in LTC in other provinces across Canada, as well more broadly to inappropriate medication prescribing practices in LTC.
Anticipated Contributions to Health Care, Health Systems and Health Outcomes
FIRST AID-LTC will lead to immediate reductions in excess antibiotic use in Ontario LTC facilities, which in turn should result in substantial reductions in direct drug costs, as well as downstream complications of allergy, organ toxicity, C. difficile infections and antimicrobial resistance. With easy transferability to other Canadian provinces, the improvements in cost-savings and patient outcomes could be massive in scope.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 6
- Model description
- Assess three interventional parallel study models consisting of two intervention arms each
| Arm | Type | Receives |
|---|---|---|
| LTC Physicians Receive Social Comparison Email | Active comparator | Behavioral: Social Comparison Email vs. Standard EmailAll LTC physicians who receive a social comparison email |
| LTC Physicians Do Not Receive Social Comparison Email | No intervention | –All LTC physicians who do not receive a social comparison email |
| LTC Physicians Receive Maintenance Certification Email | Active comparator | Behavioral: Maintenance Certification Email vs. Standard EmailAll LTC physicians who receive a maintenance certification email |
| LTC Physicians Do Not Receive Maintenance Certification Email | No intervention | –All LTC physicians who do not receive a maintenance certification email |
| LTC Physician Has (or has not) Opened Prior Report | Active comparator | Behavioral: Report Opening Status Email vs. Standard Email (among previous report openers and non-openers)LTC physicians who opened (or has not opened) at least one report receive an email informing them of their report opening status |
| LTC Physician Has (or has not) Opened Prior Report (Control) | No intervention | –LTC physicians who opened (or has not opened) at least one report receive a standard email without report opening status |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- An individual having a minimum of 2 records on separate days within the quarter meeting any combination of the following criteria:
- a record for a non-emergency long-term care inpatient service OR
- an Ontario Drug Benefits record administered in long-term care
- Index date = The analysis will be anchored on the most recent of either of the records above with a given quarter or their date of death (whichever date is earliest)
Key exclusion criteria (12 listed)
- Non-Ontario resident at index date
- Invalid age (age<19 or age>115) at index date
- Missing or invalid sex or date of birth at index date
- Death date is >7 days before index date
- If the individual does not live in a nursing home or home for the aged
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 |
|---|---|---|
| Social Comparison Email vs. Standard EmailEvaluate whether emails with social comparison incentives will encourage greater report opening by physicians leading to greater reductions in antibiotic use, than a standard email without social comparison incentives | Behavioural | LTC Physicians Receive Social Comparison Email |
| Maintenance Certification Email vs. Standard EmailEvaluate whether emails with maintenance certification incentives will encourage greater report opening by physicians leading to greater reductions in antibiotic use, than a standard email without social comparison incentives | Behavioural | LTC Physicians Receive Maintenance Certification Email |
| Report Opening Status Email vs. Standard Email (among previous report openers and non-openers)Evaluate whether emails informing physicians of their report opening status (among those who have previously opened at least one report and those who have never opened a report) will encourage greater report opening by physicians leading to greater reductions in antibiotic use, than a standard email without report opening status information | Behavioural | LTC Physician Has (or has not) Opened Prior Report |
Primary outcome
Rate of report opening
Time frame: 3 months
Percentage of physicians opening/accessing the report at least once in the 3 month interval following email send out
7 secondary outcomes
ER visit or hospitalization for infection
Time frame: 3 months
ER visit or hospitalization for antibiotic harms
Time frame: 3 months
Net clinical impact
Time frame: 3 months
Anti-psychotic use
Time frame: 3 months
Benzodiazepine use
Time frame: 3 months
Antibiotic initiation
Time frame: 3 months
Antibiotic duration
Time frame: 3 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 7 Apr 2022.
- Derived from this study: PubMed 35392461Daneman N, Lee S, Bai H, Bell CM, Bronskill SE, Campitelli MA, Dobell G, Fu L, Garber G, Ivers N, Kumar M, Lam JMC, Langford B, Laur C, Morris AM, Mulhall CL, Pinto R, Saxena FE, Schwartz KL, Brown KA. Behavioral Nudges to Improve Audit and Feedback Report Opening Among Antibiotic Prescribers: A Randomized Controlled Trial. Open Forum Infect Dis. 2022 Mar 2;9(5):ofac111. doi: 10.1093/ofid/ofac111. eCollection 2022 May.
- Individual participant dataSharing planned: No
Related trials for Antibiotic Initiation
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.
Nick Daneman, MD principal investigator
ICES
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Social Comparison Email vs. Standard Email, Maintenance Certification Email vs. Standard Email and Report Opening Status Email vs. Standard Email (among previous report openers and non-openers) in people with Antibiotic Initiation and Antibiotic Duration, run by Institute for Clinical Evaluative Sciences at 1 site in Canada.
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 4 inclusion and 12 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 7 Apr 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 Canada. 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?
Rate of report opening (time frame: 3 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 NCT04187742, which also lists 1 linked publication.
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 7 Apr 2022.