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Completed

NCT Number: NCT03408704

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

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.

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Key information

Conditions

Tonsillitis Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Otorhinolaryngologic Diseases Pharyngeal Diseases Pharyngitis Pharyngitis Bacterial Respiratory Tract Diseases Respiratory Tract Infections Sore Throat Stomatognathic Diseases Streptococcal Infections Streptococcus Pharyngitis

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

vastra Gotaland region

Borås, Västra Götaland County, 50338, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None

Treatment and study plan

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:

  • The Swedish guidelines
  • Example of cases
  • Statistics from previous 6 month showing how well this clinic adheres to the Swedish guidelines.

Primary outcomes

  1. 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).

  2. 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).

  3. 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).

Secondary outcomes

  1. The effect of an ASP on the change in proportion of negative RADT given 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 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).

  2. The effect of an ASP on the change in proportion of negative RADT given 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 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).

  3. The effect of an ASP on the change in proportion of negative RADT given 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 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).

  4. The effect of an ASP on the change in proportion of recommended AB prescribed - 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 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).

  5. The effect of an ASP on the change in proportion of recommended AB prescribed - 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 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).

  6. The effect of an ASP on the change in proportion of recommended AB prescribed - 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 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).

  7. The effect of an ASP on the change in proportion of patients where CRP is requested - 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 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).

  8. The effect of an ASP on the change in proportion of patients where CRP is requested - 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 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).

  9. The effect of an ASP on the change in proportion of patients where CRP is requested - 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 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).

  10. Proportion of patients given AB for a sore throat with no throat swab taken

    Time frame: Pre intervention 6 Months period

    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.

  11. Proportion of patients with pharyngotonsillitis where a throat swab is taken and sent for a culture

    Time frame: Pre intervention 6 Months period

    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.

  12. Proportion of patients with pharyngotonsillitis where a test for mononucleosis is taken

    Time frame: Pre intervention 6 Months period

    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.

Sponsors and collaborators

Lead sponsor

Vastra Gotaland Region

Other Gov

Collaborators

  • Göteborg University
  • James Cook University, Queensland, Australia

Registry information

Official study title

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

Acronym: ASP-Throat

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Jan 24, 2018
Registry last updated
Jun 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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