## Protocol Section
### Identification Module
**NCT ID:** NCT03464279

**Brief Title:** Use of a Behavioral Economic Intervention to Reduce Antibiotic Prescription for Upper Respiratory Infections

**Official Title:** Use of a Behavioral Economic Intervention to Reduce Antibiotic Prescription for Upper Respiratory Infections

#### Organization Study ID Info
**ID:** IRB #16-000932-004
#### Organization
**Class:** OTHER
**Full Name:** University of California, Los Angeles
### Status Module
#### Completion Date
**Date:** 2018-03-30

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2018-05-02

**Type:** ACTUAL

**Last Update Submit Date:** 2018-04-30

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2018-03-30

**Type:** ACTUAL

#### Start Date
**Date:** 2015-05-29

**Type:** ACTUAL

**Status Verified Date:** 2018-04

#### Study First Post Date
**Date:** 2018-03-14
**Type:** ACTUAL
**Study First Submit Date:** 2018-03-07
**Study First Submit QC Date:** 2018-03-07
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** LAC+USC Medical Center

**Class:** OTHER_GOV

**Name:** Los Angeles County Department of Public Health

#### Lead Sponsor

**Class:** OTHER

**Name:** University of California, Los Angeles

#### Responsible Party

**Investigator Affiliation:** University of California, Los Angeles

**Investigator Full Name:** Catherine A. Sarkisian

**Investigator Title:** Professor in Residence

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** In an effort to implement Choosing Wisely guidelines and decrease patient harm, we will implement and evaluate a clinician audit-feedback and behavioral "nudge" initiative to reduce low-value antibiotics for URIs. Using a quasi-experiment (pre-post) design, antibiotic prescriptions for URI at LAC+USC Urgent Care Center (intervention site) vs. Olive View-UCLA Urgent Care Center (control site) will used to test the effects of behavioral "nudge" on antibiotic prescribing.

**Detailed Description:** National prescription rates for low-value antibiotics for uncomplicated upper respiratory infections (URIs) remain unacceptably high, including at LAC+USC Medical Center-one of the largest safety net medical centers in the U.S. Using a quasi-experiment (pre-post) design, antibiotic prescriptions for URI at LAC+USC Urgent Care Center (intervention site) vs. Olive View-UCLA Urgent Care Center (control site) will be compared. A three-part intervention at LAC+USC consists of (1) the urgent care medical director emailing Choosing Wisely® guidelines and presented journal club to all 16 urgent care clinicians, and then (2) leveraging EHR performance data to provide individual clinicians with case-specific audit-feedback (both via emails and in-person while precepting nurse practitioners) on low-value antibiotic prescribing, and (3) using a behavioral "nudge", urgent care clinicians will sign a large poster committing to avoid prescribing low-value antibiotics for uncomplicated URIs, which will be displayed in the clinic. In contrast, the control site (Urgent Care Center at Olive View-Medical Center) will receive Centers for Disease Control prescription pads for non-antibiotic treatments (e.g., decongestants) that offer patients alternatives to antibiotics, in a broader health system effort to reduce antibiotic prescribing. Patient with URIs (e.g., acute bronchitis, bronchitis NOS, excluding guideline-based red flags such as COPD, HIV) will be identified using electronic health record clinical billable data and low-value antibiotic prescriptions rates per visit will be monitored at both sites. Differences in prescriptions rates will be determined using an interrupted time-series analysis comparing utilization between sites using a repeated measures logistic regression model.

.

### Conditions Module

**Conditions:**

- Antibiotics

- Upper Respiratory Infections

- Safety-Net Hospitals

- Behavioral Economics

- Choosing Wisely

### Design Module

#### Design Info

**Allocation:** NON_RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- PARTICIPANT

**Primary Purpose:** HEALTH_SERVICES_RESEARCH

#### Enrollment Info

**Count:** 2500

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** The intervention Site (Urgent Care Center at LAC+USC Medical Center) will receive a three part intervention consisting of (1) Email Choosing Wisely® guidelines and presented journal club to all 16 urgent care clinicians, (2) leveraging EHR performance data to provide individual clinicians with case-specific audit-feedback (both via emails and in-person while precepting nurse practitioners) on low-value antibiotic prescribing, and (3) using a behavioral "nudge", urgent care clinicians will sign a large poster committing to avoid prescribing low-value antibiotics for uncomplicated URIs displayed in the clinic.

**Intervention Names:**

- Behavioral: Nudge using Behavioral Economic Interventions

**Label:** Intervention Site

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** The control site (Urgent Care Center at Olive View-Medical Center) will receive broader health system efforts to reduce antibiotic prescribing consisting of Center for Disease Control prescription pads for non-antibiotic treatments (e.g., decongestants) that offer patients alternatives to antibiotics.

**Intervention Names:**

- Behavioral: Standard Practices to Reduce Health System Antibiotic Prescription

**Label:** Control Site

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Intervention Site

**Name:** Nudge using Behavioral Economic Interventions

**Type:** BEHAVIORAL

#### Intervention 2

**Arm Group Labels:**

- Control Site

**Name:** Standard Practices to Reduce Health System Antibiotic Prescription

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** Changes in inappropriate antibiotic prescriptions rates per visit before and after implementation of intervention at both sites

**Measure:** Change in Low-value antibiotic prescriptions rates per visit

**Time Frame:** 1 year

#### Secondary Outcomes

**Description:** Change frequency of proportion of antibiotic appropriate diagnoses before intervention and after at both sites.

**Measure:** Coding Shift (ie, a shift in use of diagnostic codes to conditions that are more antibiotic appropriate) in URI diagnosis

**Time Frame:** 1 year

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* all patient receiving treatment for Upper Respiratory Infections (defined by ICD codes EHR billable codes) at both LAC+USC Medical Center Urgent Care or Olive View-UCLA Medical Center

Exclusion Criteria:

* Patients not receiving treatment for Upper Respiratory Infections at both LAC+USC Medical Center Urgent Care or Olive View-UCLA Medical Center

**Healthy Volunteers:** True

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Los Angeles

**Country:** United States

**Facility:** Los Angeles County +University of Southern California (LAC+USC) Medical Center

**State:** California

**Zip:** 90033

### References Module

#### References

**Citation:** Meeker D, Knight TK, Friedberg MW, Linder JA, Goldstein NJ, Fox CR, Rothfeld A, Diaz G, Doctor JN. Nudging guideline-concordant antibiotic prescribing: a randomized clinical trial. JAMA Intern Med. 2014 Mar;174(3):425-31. doi: 10.1001/jamainternmed.2013.14191.

**PMID:** 24474434

**Citation:** Gonzales R, Steiner JF, Lum A, Barrett PH Jr. Decreasing antibiotic use in ambulatory practice: impact of a multidimensional intervention on the treatment of uncomplicated acute bronchitis in adults. JAMA. 1999 Apr 28;281(16):1512-9. doi: 10.1001/jama.281.16.1512.

**PMID:** 10227321

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000020969

- Term: Disease Attributes

- ID: D000010335

- Term: Pathologic Processes

- ID: D000012140

- Term: Respiratory Tract Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

### Condition Browse Module - Browse Leaves

- ID: M10283

- Name: Infections

- Relevance: HIGH

- As Found: Infection

- ID: M6368

- Name: Communicable Diseases

- Relevance: HIGH

- As Found: Infection

- ID: M14978

- Name: Respiratory Tract Infections

- Relevance: HIGH

- As Found: Upper Respiratory Infection

- ID: M22700

- Name: Disease Attributes

- Relevance: LOW

- As Found: Unknown

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000007239

- Term: Infections

- ID: D000003141

- Term: Communicable Diseases

- ID: D000012141

- Term: Respiratory Tract Infections

### Intervention Browse Module - Ancestors

- ID: D000000890

- Term: Anti-Infective Agents

### Intervention Browse Module - Browse Branches

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: VaCoAg

- Name: Vasoconstrictor Agents

- Abbrev: CNSSti

- Name: Central Nervous System Stimulants

- Abbrev: Resp

- Name: Respiratory System Agents

- Abbrev: HB

- Name: Herbal and Botanical

### Intervention Browse Module - Browse Leaves

- ID: M4222

- Name: Anti-Bacterial Agents

- Relevance: HIGH

- As Found: Initial

- ID: M4224

- Name: Antibiotics, Antitubercular

- Relevance: LOW

- As Found: Unknown

- ID: M12478

- Name: Nicotine

- Relevance: LOW

- As Found: Unknown

- ID: M7966

- Name: Ephedrine

- Relevance: LOW

- As Found: Unknown

- ID: M27586

- Name: Pseudoephedrine

- Relevance: LOW

- As Found: Unknown

- ID: M4214

- Name: Anti-Infective Agents

- Relevance: LOW

- As Found: Unknown

- ID: T242

- Name: Olive

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000000900

- Term: Anti-Bacterial Agents

### Misc Info Module

- Version Holder: 2024-05-24
