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

Pharyngitis Clinical Trial

— ASP-Throat  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03408704
• Other study ID #: U1111-1207-9573
• Status: Completed
• Phase: N/A
• Start date: January 17, 2018
• Est. completion date: February 28, 2022

Study information

• Verified date: February 2022
• Source: Vastra Gotaland Region
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: February 28, 2022
• Est. primary completion date: February 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Pharyngitis
• Pharyngitis Bacterial
• Sore Throat
• Streptococcus Pharyngitis
• Tonsillitis

Intervention

Other:
• ASP
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.

Locations

Country	Name	City	State
Sweden	vastra Gotaland region	Borås	Vastra Gotaland

Sponsors (3)

Lead Sponsor	Collaborator
Vastra Gotaland Region	Göteborg University, James Cook University, Queensland, Australia

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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