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Clinical Trials/NCT03408704
NCT03408704
Completed
Not Applicable

The Effectiveness of an Antimicrobial Stewardship Program (ASP) in Primary Health Care in the Management of Patients With a Sore Throat

Vastra Gotaland Region1 site in 1 country49 target enrollmentJanuary 17, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Tonsillitis
Sponsor
Vastra Gotaland Region
Enrollment
49
Locations
1
Primary Endpoint
The effect of an ASP on the change in proportion of positive RADT among patients prescribed AB - 18m
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 17, 2018
End Date
February 28, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Vastra Gotaland Region
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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

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

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).

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

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

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).

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

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

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).

Secondary Outcomes

  • 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 - 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 - 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 - 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 patients where CRP is requested - 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 - 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 recommended AB prescribed - 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 patients where CRP is requested - 6m(Pre intervention 6 Months period compared to the 6 months period prior to follow-up at 6 months)
  • Proportion of patients with pharyngotonsillitis where a test for mononucleosis is taken(Pre intervention 6 Months period)
  • The effect of an ASP on the change in proportion of patients where CRP is requested - 12m(Pre intervention 6 Months period compared to the 6 months period prior to follow-up at 12 months)
  • Proportion of patients given AB for a sore throat with no throat swab taken(Pre intervention 6 Months period)
  • Proportion of patients with pharyngotonsillitis where a throat swab is taken and sent for a culture(Pre intervention 6 Months period)

Study Sites (1)

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