Ignite Creation Date:
2024-05-06 @ 3:17 PM
Last Modification Date:
2024-10-26 @ 1:47 PM
Study NCT ID:
NCT04588376
Status:
COMPLETED
Last Update Posted:
2020-10-19
First Post:
2020-09-30
Brief Title:
Improving Antibiotic Prescribing for Pediatric Respiratory Infections by Family Physicians With Peer Comparison
Sponsor:
Herb Clegg
Organization:
Forsyth Medical Center
Study Overview
Official Title:
Improving Antibiotic Prescribing for Pediatric Acute Respiratory Tract Infections Cluster Randomized Trial to Evaluate Individual Clinician Compared With Clinic-level Feedback
Status:
COMPLETED
Status Verified Date:
2020-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Findings from an ongoing improvement project to improve antibiotic prescribing for children and adolescents for three acute respiratory tract infections ARTIs upper respiratory tract infection acute bacterial sinusitis and acute otitis media among pediatric and family medicine clinics revealed performance gaps between the two primary care specialties An improvement project was then set up to address the lower performance by family medicine clinics
Literature review revealed that in general quality improvement feedback was more effective if provided to individual clinicians rather than to a group of clinicians but very limited data existed for antibiotic prescribing practices actually comparing individual clinician feedback to group clinic-level feedback
The hypothesis is that individual clinician data feedback is superior to group clinic-level feedback in improving antibiotic prescribing for ARTIs in children and adolescents by family medicine clinicians
The aim is to determine if there are significant differences for antibiotic prescribing for ARTIs and for broad spectrum antibiotic prescribing percentage between an intervention group and a comparator group of family medicine clinics after the intervention starting November 2015 and ending December 2018
A cluster randomized trial was designed for 39 family medicine clinics The intervention group received clinician-level and clinic-level data feedback monthly and the comparator group received clinic-level only feedback monthly
Literature review revealed that in general quality improvement feedback was more effective if provided to individual clinicians rather than to a group of clinicians but very limited data existed for antibiotic prescribing practices actually comparing individual clinician feedback to group clinic-level feedback
The hypothesis is that individual clinician data feedback is superior to group clinic-level feedback in improving antibiotic prescribing for ARTIs in children and adolescents by family medicine clinicians
The aim is to determine if there are significant differences for antibiotic prescribing for ARTIs and for broad spectrum antibiotic prescribing percentage between an intervention group and a comparator group of family medicine clinics after the intervention starting November 2015 and ending December 2018
A cluster randomized trial was designed for 39 family medicine clinics The intervention group received clinician-level and clinic-level data feedback monthly and the comparator group received clinic-level only feedback monthly
Detailed Description:
IntroductionBackground
Findings from an ongoing improvement project to improve antibiotic prescribing for children and adolescents for three acute respiratory tract infections ARTIs upper respiratory tract infection acute bacterial sinusitis and acute otitis media among pediatric and family medicine clinics revealed performance gaps between the two primary care specialties An improvement project was then set up to address the lower performance by family medicine clinics
Literature review revealed that in general quality improvement feedback was more effective if provided to individual clinicians rather than to a group of clinicians but very limited data existed for antibiotic prescribing practices actually comparing individual clinician feedback to group clinic-level feedback
The hypothesis is that individual clinician data feedback is superior to group clinic-level feedback in improving antibiotic prescribing for ARTIs in children and adolescents by family medicine clinicians
The aim is to determine if there are significant differences for antibiotic prescribing for ARTIs and for broad spectrum antibiotic prescribing percentage between an intervention group and a comparator group of family medicine clinics after the intervention starting November 2015 and ending December 2018
Methods
Design
A cluster randomized trial was designed for all 98 family medicine clinics within Novant Health Medical Group In August 2015 retrospective review of data from January 1 2014 was conducted by the antimicrobial stewardship team and the trial was developed Clusters were a subset of clinics identified as under-performing based on not avoiding antibiotics in at least 83 of patients with upper respiratory infection or common cold URI 2013 Healthcare Effectiveness Data Information Set mean in patients 3 months-18 years of age Among these 47 clinics 6 had recorded 20 encounters in the 6 months January-June 2015 for an illness diagnosis of URI and were excluded
The remaining 39 clinics sites in 26 practices 1 practice had 10 clinic sites and a second had 5 sites all others were single site practices agreed to participate and were stratified by size of clinic number of clinics or clinicians as very small small large very large Clinics were then block randomized with selection of half of each stratum for two groups - an intervention group and a comparator group
The Institutional Review Board of Novant Health Presbyterian Medical Center granted a waiver of written informed consent An email was sent to the lead physicians for the 41 remaining clinics detailing the protocol and all but two clinics agreed to participate
Intervention
All 39 clinics received the same multifaceted intervention with one exception This intervention included
1 A one-hour in-person educational session in September-October 2015 with the lead clinician clinic administrator and stewardship team physicians describing the project and clinical guidelines for URI ABS and AOM
2 A tip sheet detailing how to improve scores appropriate codes and documentation strategies
3 An after-visit summary for clinicians to give to patients and parents discussing antibiotic use and side effects
4 A presentation of summary results for all pediatric and family medicine clinics for the 3 ARTI metrics to for the six-month period January-June 2015 Clinic comparison performance data were then provided monthly for all 39 clinics
5 Discussion about a new clinical pathway for acute bacterial sinusitis with a request for adoption and implementation
6 A request of each practice to
1 Discuss the guidelines for the three metrics the tip sheet the AVS and baseline performance at the outset
2 Adopt and implement the ABS clinical pathway
3 Review monthly the performance scores for the three metrics The exception was the intervention group received monthly clinician-specific performance data for the three measures while the comparator group received only clinic-level data All family medicine clinics received composite clinic-level data for all family medicine and pediatric clinics so each clinician could view at the clinic level all other clinics performances Clinical decision support was not used
Data Collection
Baseline performance data were collected retrospectively from January 1 2014-October 31 2015 The intervention period was November 1 2015-December 31 2017 A post-intervention period was from January 1-December 31 2018 during which time only clinic-level data were provided monthly to all 39 clinics
Visit-level data included ICD-9 codes and starting in October 2015 ICD-10 codes associated with an encounter IE and listed as a visit diagnosis Antibiotic prescribing was determined by medication orders search in the record associated with the encounter or within 30 days prior if URI diagnosis or within 60 days prior if ABS or AOM diagnosis and 3 days subsequent to the encounter IEs were defined as evaluation and management visits for new patients with codes 99201-99205 and for established patients with codes 99212-99215
Measures
Using guidelines from the American Academy of Pediatrics and the Infectious Diseases Society of America customized clinical quality measures for the 3 ARTIs were developed and validated by selective manual chart review of electronic health records These measures represented the primary outcomes at cluster level and included as numerator appropriate care and denominator IE for each ARTI
A target of 90 for URI was set using the HEDIS 2013 90th percentile and at 80 for ABS and AOM consistent with targets suggested by an outpatient antibiotic use target-setting workgroup
A secondary outcome was broad-spectrum antibiotic prescribing BSAP percentage determined monthly by enumerating all antibiotics given stratifying by narrow and broad spectrum and dividing by the total number of antibiotics prescribed for any condition not limited to the 3 ARTIs For this calculation patients were excluded if their record showed an allergy to an antibiotic listed as narrow or broad spectrum andor one of the listed antibiotics had been given 60 days prior
To determine if code shifting occurred or total antibiotic utilization changed after the intervention began the investigators recorded the mean number of encounters per clinic for the 3 ARTIs and the total of all IEs and antibiotics prescribed for all patients seen for illness in the baseline and intervention periods in both groups
Statistical Analysis
Power will be estimated based on the primary outcomes baseline-to-intervention period change in the proportion of encounters with the appropriate treatment for URI ABS and AOM respectively The numbers of clusters are fixed at 22 for the intervention group and 17 for the comparator group Based on retrospective data from the baseline period the average cluster sizes ie the average numbers of encounters per clinic over 22 months for URI ABS and AOM respectively are 2100 726 and 1292 for the intervention group and 2110 655 and 1336 for the comparator group This provided 85 power to detect a study group difference in mean baseline-to-intervention period change of 04 standard deviations corresponding to a medium effect size with two-sided alpha 005 for intra-cluster correlations ICCs ranging between 001 and 015 The power analysis was performed using PASS 15
The clinic is the unit of analysis for describing changes in clinical decision making The primary outcomes ie the proportion of relevant encounters with appropriate treatment for URI ABS and AOM respectively will be recorded for each clinic during the baseline and intervention periods
To assess the influence of the intervention on clinical decision making a generalized linear mixed model GLMM will be analyzed for each outcome using PROC GLIMMIX in SAS The response variable in the models is yn where y the number of appropriate treatment occurrences and n the total number of relevant encounters and the response distribution is specified as binomial with a logit link The independent variables are the study group intervention comparator time period baseline intervention a study-group-by-time interaction term and clinic size very small small large and very large used as the stratification variable in the randomization The models include a random intercept term for clinic to account for relatedness of clinical decisions made in the same clinic The p-value for the interaction term will be used to assess significance between the intervention and comparator groups on the baseline-to-intervention period change
The overall alpha level is pre-specified at 005 To account for multiple testing Holms Step-Down procedure will be used to adjust p-values where the family of inferences includes those for the three primary outcomes and the secondary outcome BSAP In the case of a significant interaction effect the pre-intervention and post-intervention outcome will be compared for the intervention and comparator groups respectively using pre-specified contrasts generated from the GLMM Odds ratios corresponding to these contrasts will be calculated along with 95 confidence intervals that are Bonferroni-corrected at the α2 0025 level to further adjust for multiple comparisons For each outcome variable the ICC will be calculated using the level-2 ie random intercept variance from the GLMM and a level-1 variance component assumed to be π23 329 for a logistic random intercept model
Analysis of the secondary outcome BSAP percentage will be conducted using the steps described for the primary outcomes All analyses will be performed using SAS
Findings from an ongoing improvement project to improve antibiotic prescribing for children and adolescents for three acute respiratory tract infections ARTIs upper respiratory tract infection acute bacterial sinusitis and acute otitis media among pediatric and family medicine clinics revealed performance gaps between the two primary care specialties An improvement project was then set up to address the lower performance by family medicine clinics
Literature review revealed that in general quality improvement feedback was more effective if provided to individual clinicians rather than to a group of clinicians but very limited data existed for antibiotic prescribing practices actually comparing individual clinician feedback to group clinic-level feedback
The hypothesis is that individual clinician data feedback is superior to group clinic-level feedback in improving antibiotic prescribing for ARTIs in children and adolescents by family medicine clinicians
The aim is to determine if there are significant differences for antibiotic prescribing for ARTIs and for broad spectrum antibiotic prescribing percentage between an intervention group and a comparator group of family medicine clinics after the intervention starting November 2015 and ending December 2018
Methods
Design
A cluster randomized trial was designed for all 98 family medicine clinics within Novant Health Medical Group In August 2015 retrospective review of data from January 1 2014 was conducted by the antimicrobial stewardship team and the trial was developed Clusters were a subset of clinics identified as under-performing based on not avoiding antibiotics in at least 83 of patients with upper respiratory infection or common cold URI 2013 Healthcare Effectiveness Data Information Set mean in patients 3 months-18 years of age Among these 47 clinics 6 had recorded 20 encounters in the 6 months January-June 2015 for an illness diagnosis of URI and were excluded
The remaining 39 clinics sites in 26 practices 1 practice had 10 clinic sites and a second had 5 sites all others were single site practices agreed to participate and were stratified by size of clinic number of clinics or clinicians as very small small large very large Clinics were then block randomized with selection of half of each stratum for two groups - an intervention group and a comparator group
The Institutional Review Board of Novant Health Presbyterian Medical Center granted a waiver of written informed consent An email was sent to the lead physicians for the 41 remaining clinics detailing the protocol and all but two clinics agreed to participate
Intervention
All 39 clinics received the same multifaceted intervention with one exception This intervention included
1 A one-hour in-person educational session in September-October 2015 with the lead clinician clinic administrator and stewardship team physicians describing the project and clinical guidelines for URI ABS and AOM
2 A tip sheet detailing how to improve scores appropriate codes and documentation strategies
3 An after-visit summary for clinicians to give to patients and parents discussing antibiotic use and side effects
4 A presentation of summary results for all pediatric and family medicine clinics for the 3 ARTI metrics to for the six-month period January-June 2015 Clinic comparison performance data were then provided monthly for all 39 clinics
5 Discussion about a new clinical pathway for acute bacterial sinusitis with a request for adoption and implementation
6 A request of each practice to
1 Discuss the guidelines for the three metrics the tip sheet the AVS and baseline performance at the outset
2 Adopt and implement the ABS clinical pathway
3 Review monthly the performance scores for the three metrics The exception was the intervention group received monthly clinician-specific performance data for the three measures while the comparator group received only clinic-level data All family medicine clinics received composite clinic-level data for all family medicine and pediatric clinics so each clinician could view at the clinic level all other clinics performances Clinical decision support was not used
Data Collection
Baseline performance data were collected retrospectively from January 1 2014-October 31 2015 The intervention period was November 1 2015-December 31 2017 A post-intervention period was from January 1-December 31 2018 during which time only clinic-level data were provided monthly to all 39 clinics
Visit-level data included ICD-9 codes and starting in October 2015 ICD-10 codes associated with an encounter IE and listed as a visit diagnosis Antibiotic prescribing was determined by medication orders search in the record associated with the encounter or within 30 days prior if URI diagnosis or within 60 days prior if ABS or AOM diagnosis and 3 days subsequent to the encounter IEs were defined as evaluation and management visits for new patients with codes 99201-99205 and for established patients with codes 99212-99215
Measures
Using guidelines from the American Academy of Pediatrics and the Infectious Diseases Society of America customized clinical quality measures for the 3 ARTIs were developed and validated by selective manual chart review of electronic health records These measures represented the primary outcomes at cluster level and included as numerator appropriate care and denominator IE for each ARTI
A target of 90 for URI was set using the HEDIS 2013 90th percentile and at 80 for ABS and AOM consistent with targets suggested by an outpatient antibiotic use target-setting workgroup
A secondary outcome was broad-spectrum antibiotic prescribing BSAP percentage determined monthly by enumerating all antibiotics given stratifying by narrow and broad spectrum and dividing by the total number of antibiotics prescribed for any condition not limited to the 3 ARTIs For this calculation patients were excluded if their record showed an allergy to an antibiotic listed as narrow or broad spectrum andor one of the listed antibiotics had been given 60 days prior
To determine if code shifting occurred or total antibiotic utilization changed after the intervention began the investigators recorded the mean number of encounters per clinic for the 3 ARTIs and the total of all IEs and antibiotics prescribed for all patients seen for illness in the baseline and intervention periods in both groups
Statistical Analysis
Power will be estimated based on the primary outcomes baseline-to-intervention period change in the proportion of encounters with the appropriate treatment for URI ABS and AOM respectively The numbers of clusters are fixed at 22 for the intervention group and 17 for the comparator group Based on retrospective data from the baseline period the average cluster sizes ie the average numbers of encounters per clinic over 22 months for URI ABS and AOM respectively are 2100 726 and 1292 for the intervention group and 2110 655 and 1336 for the comparator group This provided 85 power to detect a study group difference in mean baseline-to-intervention period change of 04 standard deviations corresponding to a medium effect size with two-sided alpha 005 for intra-cluster correlations ICCs ranging between 001 and 015 The power analysis was performed using PASS 15
The clinic is the unit of analysis for describing changes in clinical decision making The primary outcomes ie the proportion of relevant encounters with appropriate treatment for URI ABS and AOM respectively will be recorded for each clinic during the baseline and intervention periods
To assess the influence of the intervention on clinical decision making a generalized linear mixed model GLMM will be analyzed for each outcome using PROC GLIMMIX in SAS The response variable in the models is yn where y the number of appropriate treatment occurrences and n the total number of relevant encounters and the response distribution is specified as binomial with a logit link The independent variables are the study group intervention comparator time period baseline intervention a study-group-by-time interaction term and clinic size very small small large and very large used as the stratification variable in the randomization The models include a random intercept term for clinic to account for relatedness of clinical decisions made in the same clinic The p-value for the interaction term will be used to assess significance between the intervention and comparator groups on the baseline-to-intervention period change
The overall alpha level is pre-specified at 005 To account for multiple testing Holms Step-Down procedure will be used to adjust p-values where the family of inferences includes those for the three primary outcomes and the secondary outcome BSAP In the case of a significant interaction effect the pre-intervention and post-intervention outcome will be compared for the intervention and comparator groups respectively using pre-specified contrasts generated from the GLMM Odds ratios corresponding to these contrasts will be calculated along with 95 confidence intervals that are Bonferroni-corrected at the α2 0025 level to further adjust for multiple comparisons For each outcome variable the ICC will be calculated using the level-2 ie random intercept variance from the GLMM and a level-1 variance component assumed to be π23 329 for a logistic random intercept model
Analysis of the secondary outcome BSAP percentage will be conducted using the steps described for the primary outcomes All analyses will be performed using SAS
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None