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Antibiotic Side EffectSCORE_UCNCT03932708

Improving Antibiotic Use in Urgent Care Facilities

A study testing CDC Core Elements of Outpatient Stewardship in people with Antibiotic Side Effect and Behavioral Changes, run by Intermountain Health Care, Inc. at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study will implement a comprehensive outpatient stewardship program targeting a large network of Urgent Care (UC) clinics within Intermountain Helathcare. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Antibiotic Side Effect, Behavioral Changes
What is being tested?
CDC Core Elements of Outpatient Stewardship
Could I receive a placebo?
No, everyone receives an active treatment
How many people
700,000 participants
Where
1 siteUnited States
Study dates
1 Jul 2019to 23 Apr 2023
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
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • Intermountain Healthcare "InstaCare" Clinics
  • Intermountain Healthcare "KidsCare" Clinics
  • Intermountain Healthcare "ConnectCare"

Who cannot join

  • Intermountain Healthcare Hospitals and Medical Centers
  • All non-Intermountain Healthcare urgent care clinics

Trial locations and contacts

1 site in 1 country.

Eddie Stenehjem, MD contact

801-507-7781

eddie.stenehjem@imail.org

Carlos Barbagelata, MS contact

801-507-4607

carlos.barbagelata@imail.org

United States1 site, 1 recruiting
  • Intermountain Medical Center

    Murray, Utah, 84017

    Valerie Aston, 801-507-4606, valerie.aston@imail.org

    Carlos Barbagelata, MS, 801-507-4607, carlos.barbagelata@imail.org

    Recruiting

Other trials in United States

About this study

Official title: Improving Antibiotic Use in Urgent Care Facilities Through Implementation and Evaluation of Core Elements of Outpatient Antibiotic Stewardship

This study will implement a comprehensive outpatient stewardship program targeting a large network of Urgent Care (UC) clinics within Intermountain Helathcare.

Read the detailed description

This study will characterize baseline antibiotic prescribing practices throughout the Intermountain Healthcare Urgent Care (IH UC) system and implement a bundle of stewardship interventions throughout the IH UC system with the intention of both scalability across a large number of sites and sustainability. The urgent care (UC) antibiotic stewardship intervention was designed to meet the unique challenges of UC providers and patients and will directly incorporate all Core Elements of Outpatient Antibiotic Stewardship.

Leadership Commitment. Improving the use of antibiotics is a priority for IH leaders. IH leaders created two new system-wide leadership roles to direct antibiotic stewardship efforts across IH's continuum of care: Dr. Eddie Stenehjem is the system's Antimicrobial Stewardship Medical Director and Dr. Whitney Buckel is IH's Antimicrobial Stewardship Pharmacy Manager. Drs. Stenehjem and Buckel direct and lead all inpatient and outpatient stewardship efforts across the system. The creation of a system-wide antimicrobial stewardship leadership structure demonstrates the IH commitment to deploy best practices in antibiotic stewardship across the healthcare system. IH has designated a new system-wide outpatient stewardship leadership position that serves as a direct liaison between UC leadership (Medical Directors and Associate Medical Directors), participating UC facilities, and antibiotic stewardship leadership. The outpatient stewardship leader will participate in education efforts around appropriate antibiotic use and will work closely with prescribers that have been identified to have high rates of inappropriate antibiotic prescribing and/or high rates of sinusitis/AOM diagnoses. Additionally, the Medical Director for UC has designated antibiotic prescribing as one of only two quality metrics that will be assessed longitudinally for UC clinicians across the system.

Action for Policy and Practice. Our bundle of stewardship interventions is based on prior evidence of effectiveness and the unique features of UC sites. Additionally, our bundle allows for adaptability based on knowledge gained from the qualitative components of the proposal described previously and the experiences gained throughout implementation. An essential component to our bundle will be the implementation of tools that are designed to improve the quality and efficiency of care provided in UC settings. The action elements of our intervention will include the following components:

  1. Commitment Posters: All UC clinics will display commitment posters demonstrating support from corporate, infectious diseases, and urgent care leaders and signed by providers. These posters will be in the clinic waiting room attesting to the providers' commitment to judicious antibiotic prescribing.
  2. EHR Tools: With the input of our frontline clinicians and assistance of our internal EHR developers, the study team has created electronic clinical decision support tools within our EHR to improve antibiotic prescribing for acute bacterial sinusitis and acute otitis media (AOM). This tool will improve efficiency of clinical documentation, improve diagnostic accuracy by embedding the required diagnostic elements of upper respiratory infections, provide quick access to patient education material, and facilitate the ordering of a guideline concordant antibiotic prescription. This tool also incorporates delayed antibiotic prescriptions, which is our new default prescribing method for AOM and sinusitis. The delayed antibiotic prescription order was specifically developed for this intervention to assist in tracking delayed prescribing. These tools will be tailored with help from our frontline caregivers and piloted at a small sampling of UC clinics prior to widespread implementation. The tools are expected to be of special interest for UC clinicians because they target the most common diagnoses associated with antibiotic prescribing, have the potential to enhance efficiency with documentation, and facilitate appropriate antibiotic selection.
  3. Prescription Justification: Azithromycin is 2nd most common antibiotic prescribed in the IH outpatient network. However, azithromycin prescriptions are rarely appropriate in UC. Besides a few relatively uncommon ID conditions (e.g., mycobacterial infections), azithromycin is only recommended for community acquired pneumonia, gonorrhea and chlamydia, and Streptococcal pharyngitis with a penicillin allergy. However, in the IH outpatient population, it is the most common antibiotic used for acute bronchitis and cough, 5th most common for sinusitis, and 2nd most common antibiotic given for unspecified acute pharyngitis. Given the very high rates of azithromycin misuse, providers will now be required to justify their ordering of azithromycin with documentation. When azithromycin is ordered, the provider will be required to fill out an "azithromycin justification form" prior to having the order signed. The justification form will populate the medical record and display the indication for the antibiotic that was selected by the provider. This method of "accountable justification" is an effective method to reduce antibiotic overuse.

Tracking and Reporting. Using IH data analysts to access the Enterprise Data Warehouse, system level, facility level, and provider level reports have been developed to detail antibiotic prescribing practices. During the first 4 months of the baseline period, feedback from urgent care clinicians and leaders was generated on the design of the reports.

The individual provider reports will focus on the following elements:

  • Rate of antibiotics prescribed for respiratory encounter visits
  • Percent of sinusitis, pharyngitis, and AOM (respiratory, tier 2) encounters that received an order for appropriate first-line antibiotics
  • Percent of sinusitis and AOM visits receiving a delayed antibiotic prescription
  • Percent of Tier 3 respiratory encounters in which an antibiotic was prescribed
  • Diagnosis rate of sinusitis (adults) and AOM (children)

Each of the above reported elements will include the providers' data along with comparison data for the individual facility and the UC type (i.e., InstaCare or KidsCare). These data will be available via an antibiotic stewardship dashboard that individual clinicians may access anytime. The dashboard will be fully transparent (all providers data will be displayed without blinding of names/locations) and include other antibiotic prescribing data (e.g. most common antibiotics used, duration of therapy, etc.) The study team and the outpatient stewardship lead will be available to review data with individual providers as needed. Throughout the study period the study team will receive feedback about the design and usability of the monthly reports and dashboard and modifications can occur accordingly.

Daily huddles are a method to help teams focus on quality and safety. Huddle boards are standardized visual tool a tool to help teams collaborate on and visualize the tasks and operations of a group or clinic. All IH UC facilities now have dynamic huddle boards. IH huddle boards highlight data and metrics surrounding our 5 Intermountain fundamentals of care - stewardship, safety, quality, patient experience, and access. Prior to the start of each clinic day, each clinic team reviews their huddle board and discusses any potential foreseeable challenges. With our antibiotic stewardship intervention, weekly antibiotic prescribing metrics will be posted to the quality section of each clinic's huddle board. Antibiotic prescribing metrics may be presented monthly if insufficient volume is identified. The clinical manager will be responsible for posting facility and provider metrics (obtained from the online dashboard). An antibiotic stewardship leader (study leader, UC leader, or the outpatient stewardship leader) will be present for the huddle board review intermittently to review antibiotic prescribing metrics, answer questions from providers, discuss improvement strategies, and promote judicious prescribing. The study team will develop a cadence in which a stewardship leader will be present for each clinic's huddle board review with more contact early in the intervention. Lastly, senior IH leaders will maintain oversight of this initiative and receive quarterly executive-level formative reporting on program results using the same structured data reports. Dr. Stenehjem and the UC leadership will be responsible for the quarterly updates.

Education and Expertise. Our UC focused stewardship intervention will incorporate several key educational components for both providers and patients. For our UC providers, the study team will conduct a presentation at each of the monthly regional meetings that outlines appropriate antibiotic use and provides an overview of the UC stewardship initiative, expectations, and interventions. Second, all UC providers will have their antibiotic stewardship metrics reviewed with them during their annual review by either the UC Medical Director or Associate Medical Director. This will allow for focused education by UC leaders directly to individual clinicians. Third, a quarterly newsletter and/or blog post will be written and disseminated to all UC clinicians on topics relevant to appropriate antibiotic prescribing. Fourth, clinic computer screen savers will be developed and implemented in all UC sites highlighting key stewardship interventions. Lastly, clinical managers will be provided with education to disseminate to their nursing staff and medical assistants to ensure antibiotic stewardship messages are consistent throughout the clinic visit. UC clinicians will continue to have the ongoing clinical support from the existing ID telehealth program. The ID telehealth program operates an ID hotline that is available 24 hours a day, 7 day a week, allowing outpatient clinicians the ability to discuss complex cases with physicians that have ID expertise.

Our patients will also be a target for an educational initiative. Currently, IH is involved in a large opioid reduction campaign that has already reduced over 1 million tablets for acute pain. This campaign consists of publicly facing messages raising awareness of opioid use and instructing patients to talk with their provider about alternative pain control options. The study team will initiate a similar antibiotic stewardship campaign running in parallel with, and at times, in conjunction with the opioid messaging. Antibiotic stewardship messaging will be posted at the entrance of and within Urgent Care sites. Similar messaging will be run in parallel on IH social media sites and patient facing webpages. The study team has also developed educational materials that can be given to patients during a provider visit explaining in clear language why an antibiotic was not given and how a delayed antibiotic prescription should be managed. The study team has also developed a checklist of common over-the-counter symptomatic therapies for congestion, fever, and pain that will assist the provider in instructing the patient on symptomatic therapies and assist the patient on finding the appropriate medications at retail stores.

Being tested
CDC Core Elements of Outpatient Stewardship
Keywords
Antibiotic Stewardship, Outpatient Antibiotic Stewardship, Urgent Care

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CDC Core Elements of Outpatient StewardshipBehavioural

    The intervention is described above and includes components of leadership, action of policy and practice, tracking and reporting, and education and expertise.

Study groups in NCT03932708
Study groupRoleWhat they receive
Urgent Care Antibiotic Stewardship InterventionExperimentalAll 38 urgent care clinics will implement CDC Core Elements of outpatient antibiotic stewardship as described above.
Receives: Behavioral: CDC Core Elements of Outpatient Stewardship

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Antibiotic prescribing for respiratory encounters measured at the encounter level

    Respiratory encounters are defined as an urgent care encounter for any ICD10 defined respiratory condition, excluding encounters with concomitant other infectious diseases codes.

    Measured: Intervention period is one year

Secondary outcomes (3)
  1. Antibiotic prescribing appropriateness in respiratory encounters

    The secondary outcome of antibiotic appropriateness will also be measured at the encounter level and will be estimated two ways: (i) in terms of rate of guideline-recommended antibiotics among selected respiratory diagnoses, and (ii) in terms of rate of antibiotic prescribing among respiratory diagnoses where no prescribing should occur (i.e., rate of "inappropriate" antibiotics).

    Measured: Intervention period is one year

  2. Diagnostic shifting

    The secondary outcome of diagnostic shifting will be measured at the provider level and characterize changes in the types of diagnoses used during respiratory encounters.

    Measured: Intervention period is one year

  3. Patient satisfaction

    As data availability allows, a secondary outcome of patient satisfaction will be measured at the patient encounter level in terms of a validated, patient satisfaction score. Patient satisfaction will be assessed using the "rate your provider" question. This question asks patients to rate their provider on a scale of 1 - 10 (1 being the worst, 10 being the best). Patient satisfaction scores will be explored in patients that receive antibiotics for tier 2 and 3 respiratory conditions and those that do not receive antibiotics for tier 2 and 3 respiratory conditions.

    Measured: Intervention period is one year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 May 2019
  2. Study start1 Jul 2019
  3. Primary completion23 Apr 2023 (estimated)
  4. Study completion23 Apr 2023 (estimated)

Resources

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
Health services research
Allocation
Not applicable
Intervention model
Single group
Model description
This is a before/after study design. Its an implementation science project.
Masking
None (open label)
Enrolment
700,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03932708
Sponsor's protocol ID
1050982
Acronym
SCORE_UC
Status last verified
Mar 2022
First submitted
18 Apr 2019
Last updated
29 Mar 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing CDC Core Elements of Outpatient Stewardship in people with Antibiotic Side Effect and Behavioral Changes, 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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 29 Mar 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Eddie Stenehjem, MD (801-507-7781, eddie.stenehjem@imail.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Antibiotic prescribing for respiratory encounters measured at the encounter level (time frame: Intervention period is one year). 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 29 Mar 2022.

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