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| Name | Class |
|---|---|
| James Cook University, Queensland, Australia | OTHER |
| Göteborg University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ASP-arm | Experimental | This group of primary health care centers get the internal education (ASP). |
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| Control-arm | No Intervention | No intervention at all. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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:
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| 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). |
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pär-Daniel Sundvall, MD PhD | Vastra Gotaland region, Sweden | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| vastra Gotaland region | Borås | Västra Götaland County | 50338 | Sweden |
The data will be summary data for each participating primary health care clinic. The investigators will publish the summary of all clinics but don't intend to show data from single clinics.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 20, 2019 | May 20, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D014069 | Tonsillitis |
| D010612 | Pharyngitis |
| D013290 | Streptococcal Infections |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
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Parallel group randomized controlled trial. Primary health care clinics are randomized. The enrolment number refers to included clinics.
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| Pre intervention 6 Months period compared to the 6 months period prior to follow-up at 18 months |
| 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 |
| D012140 |
| Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |