Antimicrobial Stewardship Program (ASP) in Patients With a Sore Throat

NCT03408704 | Completed

• 1 other identifier: U1111-1207-9573
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators have developed an antibiotic stewardship program (ASP) to increase adherence to the Swedish guidelines for managing patients with a sore throat. This is a randomized controlled trial where primary health care centers are randomised to get the ASP or not. The adherence to the Swedish guidelines are measured in all participating centers.

Conditions

Tonsillitis; Streptococcus Pharyngitis; Sore Throat; Pharyngitis; Pharyngitis Bacterial

Keywords

Streptococcus Pyogenes Infection; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (3)

• The effect of an ASP on the change in proportion of positive RADT among patients prescribed AB - 6m

  The effect of an antibiotic stewardship program (ASP) on the proportion of patients prescribed antibiotics (J01 excluding methenamine) for a sore throat where a rapid antigen detection test (RADT) to detect Group A Streptococcus (GAS) is taken and is positive. Change from a 6 month period before initiation of the intervention (baseline) is compared with a time period of 6 months prior to the follow up date. The change from baseline to follow-up in all primary health care centres (PHCC) in the intervention group is compared to the corresponding change in PHCC in the control group (ASP group versus control group) using linear regression where adjustment will also be made for: the number of enlisted patients at baseline, location in cities versus small villages, Adjusted Clinical Group (ACG), Care-need index (CNI) and type of PHCC (private/public).

  Pre intervention 6 Months period compared to the 6 months period prior to follow-up at 6 months

• The effect of an ASP on the change in proportion of positive RADT among patients prescribed AB - 12m

  The effect of an antibiotic stewardship program (ASP) on the proportion of patients prescribed antibiotics (J01 excluding methenamine) for a sore throat where a rapid antigen detection test (RADT) to detect Group A Streptococcus (GAS) is taken and is positive. Change from a 6 month period before initiation of the intervention (baseline) is compared with a time period of 6 months prior to the follow up date. The change from baseline to follow-up in all primary health care centres (PHCC) in the intervention group is compared to the corresponding change in PHCC in the control group (ASP group versus control group) using linear regression where adjustment will also be made for: the number of enlisted patients at baseline, location in cities versus small villages, Adjusted Clinical Group (ACG), Care-need index (CNI) and type of PHCC (private/public).

  Pre intervention 6 Months period compared to the 6 months period prior to follow-up at 12 months

• The effect of an ASP on the change in proportion of positive RADT among patients prescribed AB - 18m

  The effect of an antibiotic stewardship program (ASP) on the proportion of patients prescribed antibiotics (J01 excluding methenamine) for a sore throat where a rapid antigen detection test (RADT) to detect Group A Streptococcus (GAS) is taken and is positive. Change from a 6 month period before initiation of the intervention (baseline) is compared with a time period of 6 months prior to the follow up date. The change from baseline to follow-up in all primary health care centres (PHCC) in the intervention group is compared to the corresponding change in PHCC in the control group (ASP group versus control group) using linear regression where adjustment will also be made for: the number of enlisted patients at baseline, location in cities versus small villages, Adjusted Clinical Group (ACG), Care-need index (CNI) and type of PHCC (private/public).

  Pre intervention 6 Months period compared to the 6 months period prior to follow-up at 18 months

Secondary Outcomes (12)

• The effect of an ASP on the change in proportion of negative RADT given AB - 6m

  Pre intervention 6 Months period compared to the 6 months period prior to follow-up at 6 months

• The effect of an ASP on the change in proportion of negative RADT given AB - 12m

  Pre intervention 6 Months period compared to the 6 months period prior to follow-up at 12 months

• The effect of an ASP on the change in proportion of negative RADT given AB - 18m

  Pre intervention 6 Months period compared to the 6 months period prior to follow-up at 18 months

• The effect of an ASP on the change in proportion of recommended AB prescribed - 6m

  Pre intervention 6 Months period compared to the 6 months period prior to follow-up at 6 months

• The effect of an ASP on the change in proportion of recommended AB prescribed - 12m

  Pre intervention 6 Months period compared to the 6 months period prior to follow-up at 12 months

Study Arms (2)

ASP-arm

EXPERIMENTAL

This group of primary health care centers get the internal education (ASP).

Other: ASP

Control-arm

NO INTERVENTION

No intervention at all.

Interventions

ASP OTHER

It consists of one educational session where doctors and staff at the center discuss current guidelines around management of patients attending for a sore throat. At the education the following is discussed: 1. The Swedish guidelines 2. Example of cases 3. Statistics from previous 6 month showing how well this clinic adheres to the Swedish guidelines.

ASP-arm

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Being a primary health care center in the Vastra Gotaland region, Sweden accepting participation

You may not qualify if:

• None

Sponsors & Collaborators

• Vastra Gotaland Region: lead
• James Cook University, Queensland, Australia: collaborator
• Göteborg University: collaborator

Study Sites (1)

vastra Gotaland region

Borås, Västra Götaland County, 50338, Sweden

Location

MeSH Terms

Conditions

Tonsillitis; Pharyngitis; Streptococcal Infections

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Pharyngeal Diseases; Stomatognathic Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses

Study Officials

• Pär-Daniel Sundvall, MD PhD

  Vastra Gotaland region, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Parallel group randomized controlled trial. Primary health care clinics are randomized. The enrolment number refers to included clinics.

Study Record Dates

• First Submitted: January 17, 2018
• First Posted: January 24, 2018
• Study Start: January 17, 2018
• Primary Completion: February 28, 2022
• Study Completion: February 28, 2022
• Last Updated: June 6, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)