Clinical trial NCT03408704: Antimicrobial Stewardship Program (ASP) in Patients With a Sore Throat
Official title: The Effectiveness of an Antimicrobial Stewardship Program (ASP) in Primary Health Care in the Management of Patients With a Sore Throat
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tonsillitis
Streptococcus Pharyngitis
Sore Throat
Pharyngitis
Pharyngitis Bacterial
Keywords: Streptococcus Pyogenes Infection
Randomized Controlled Trial
Lead sponsor: Vastra Gotaland Region
Sponsor class: OTHER_GOV
Collaborators: name: James Cook University, Queensland, Australia
name: Göteborg University
First posted: 2018-01-24
Enrollment: 49
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel group randomized controlled trial. Primary health care clinics are randomized. The enrolment number refers to included clinics.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed description: 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 6 months before and after implementation of the ASP. The ASP consists of educational meetings at the clinic for medical practitioners and nurses being informed about current guidelines, seeing their clinics adherence to the guidelines as well as discussing cases.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* None

Primary outcomes:
measure: The effect of an ASP on the change in proportion of positive RADT among patients prescribed AB - 6m
timeFrame: Pre intervention 6 Months period compared to the 6 months period prior to follow-up at 6 months
measure: The effect of an ASP on the change in proportion of positive RADT among patients prescribed AB - 12m
timeFrame: Pre intervention 6 Months period compared to the 6 months period prior to follow-up at 12 months
measure: The effect of an ASP on the change in proportion of positive RADT among patients prescribed AB - 18m
timeFrame: Pre intervention 6 Months period compared to the 6 months period prior to follow-up at 18 months
Secondary outcomes:
measure: The effect of an ASP on the change in proportion of negative RADT given AB - 6m
timeFrame: Pre intervention 6 Months period compared to the 6 months period prior to follow-up at 6 months
measure: The effect of an ASP on the change in proportion of negative RADT given AB - 12m
timeFrame: Pre intervention 6 Months period compared to the 6 months period prior to follow-up at 12 months
measure: The effect of an ASP on the change in proportion of negative RADT given AB - 18m
timeFrame: Pre intervention 6 Months period compared to the 6 months period prior to follow-up at 18 months
measure: The effect of an ASP on the change in proportion of recommended AB prescribed - 6m
timeFrame: Pre intervention 6 Months period compared to the 6 months period prior to follow-up at 6 months
measure: The effect of an ASP on the change in proportion of recommended AB prescribed - 12m
timeFrame: Pre intervention 6 Months period compared to the 6 months period prior to follow-up at 12 months
measure: The effect of an ASP on the change in proportion of recommended AB prescribed - 18m
timeFrame: Pre intervention 6 Months period compared to the 6 months period prior to follow-up at 18 months
measure: The effect of an ASP on the change in proportion of patients where CRP is requested - 6m
timeFrame: Pre intervention 6 Months period compared to the 6 months period prior to follow-up at 6 months
measure: The effect of an ASP on the change in proportion of patients where CRP is requested - 12m
timeFrame: Pre intervention 6 Months period compared to the 6 months period prior to follow-up at 12 months
measure: The effect of an ASP on the change in proportion of patients where CRP is requested - 18m
timeFrame: Pre intervention 6 Months period compared to the 6 months period prior to follow-up at 18 months
measure: Proportion of patients given AB for a sore throat with no throat swab taken
timeFrame: Pre intervention 6 Months period
measure: Proportion of patients with pharyngotonsillitis where a throat swab is taken and sent for a culture
timeFrame: Pre intervention 6 Months period
measure: Proportion of patients with pharyngotonsillitis where a test for mononucleosis is taken
timeFrame: Pre intervention 6 Months period
Other outcomes:
Locations:
city: Borås
country: Sweden
facility: vastra Gotaland region
state: Vastra Gotaland
Study officials:
affiliation: Vastra Gotaland region, Sweden
name: Pär-Daniel Sundvall, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: