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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Tonsillitis, Streptococcus Pharyngitis, Sore Throat, Pharyngitis, Pharyngitis Bacterial

Intervention / Treatment
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* Other: ASP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Being a primary health care center in the Vastra Gotaland region, Sweden accepting participation Exclusion Criteria: None
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel group randomized controlled trial. Primary health care clinics are randomized. The enrolment number refers to included clinics.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ASP-arm<br>This group of primary health care centers get the internal education (ASP). | Other: ASP<br>* 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: The Swedish guidelines Example of cases Statistics from previous 6 month showing how well this clinic adheres to the Swedish guidelines.<br>|
| No Intervention: Control-arm<br>No intervention at all. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effect of an ASP on the change in proportion of negative RADT given 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 negative being. 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 negative RADT given 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 negative being. 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 negative RADT given 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 negative being. 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 | 
| The effect of an ASP on the change in proportion of recommended AB prescribed - 6m | The effect of an antibiotic stewardship program (ASP) on the proportion of patients prescribed PcV compared to all patients prescribed any antibiotics (J01 excluding methenamine) for a sore throat. 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 recommended AB prescribed - 12m | The effect of an antibiotic stewardship program (ASP) on the proportion of patients prescribed PcV compared to all patients prescribed any antibiotics (J01 excluding methenamine) for a sore throat. 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 recommended AB prescribed - 18m | The effect of an antibiotic stewardship program (ASP) on the proportion of patients prescribed PcV compared to all patients prescribed any antibiotics (J01 excluding methenamine) for a sore throat. 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 | 
| The effect of an ASP on the change in proportion of patients where CRP is requested - 6m | The effect of an antibiotic stewardship program (ASP) on the proportion of patients diagnosed with pharyngotonsillitis where the lab test C-reactive protein (CRP) is requested. 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 patients where CRP is requested - 12m | The effect of an antibiotic stewardship program (ASP) on the proportion of patients diagnosed with pharyngotonsillitis where the lab test C-reactive protein (CRP) is requested. 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 patients where CRP is requested - 18m | The effect of an antibiotic stewardship program (ASP) on the proportion of patients diagnosed with pharyngotonsillitis where the lab test C-reactive protein (CRP) is requested. 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 | 
| Proportion of patients given AB for a sore throat with no throat swab taken | The proportion of patients given a diagnosis of pharyngotonsillitis and prescribed AB (J01 excluding methenamine) where a throat swab is not taken. Descriptive statistics is presented and a group comparison is not made. | Pre intervention 6 Months period | 
| Proportion of patients with pharyngotonsillitis where a throat swab is taken and sent for a culture | The proportion of patients given a diagnosis of pharyngotonsillitis and where a throat swab is taken and send to a microbiologic laboratory for a throat culture. Descriptive statistics is presented and a group comparison is not made. | Pre intervention 6 Months period | 
| Proportion of patients with pharyngotonsillitis where a test for mononucleosis is taken | The proportion of patients given a diagnosis of pharyngotonsillitis and where a test for mononucleosis is taken. Descriptive statistics is presented and a group comparison is not made. | Pre intervention 6 Months period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Streptococcus Pyogenes Infection, Randomized Controlled Trial