Reducing Antibiotic Prescribing in Family Practice
17 de septiembre de 2019 actualizado por: Rita Mangione-Smith, Seattle Children's Hospital
Dialogue Around Respiratory Illness Treatment for Family Practice (DART -FP)
Antibiotic prescribing for childhood acute respiratory tract infections (ARTIs), including acute otitis media (AOM), pharyngitis, sinusitis, bronchitis, and upper respiratory infection (URI), is common in the United States (US).
In the outpatient setting, more than 50% of children diagnosed with ARTIs receive antibiotic prescriptions.
Considering that the estimated US prevalence of pediatric bacterial ARTIs is 27% (with the remainder of ARTIs caused by viruses) this represents a substantial degree of antibiotic overuse nationwide.
Another troubling trend in antibiotic prescribing for ARTIs in children is the increased reliance on broad-spectrum, second-line agents for bacterial ARTIs.
Unwarranted use of antibiotics, especially broad-spectrum agents, has been associated with increased resistance among several strains of bacteria that commonly cause ARTIs, posing risks to both individuals and communities.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Descripción detallada
Provider-parent communication during ARTI visits often drives unwarranted antibiotic prescribing. Dr. Mangione-Smith (proposed principal investigator) and colleagues developed a quality improvement (QI) intervention for pediatric providers called the Dialogue Around Respiratory Illness Treatment (DART) program. The DART QI program is a multifaceted, web-based intervention that is delivered asynchronously over a 9-month period and takes a total of 2 hours to complete. DART's content is based on over a decade of observational research conducted by Mangione-Smith et al focused on optimizing provider-parent communication during pediatric ARTI visits in order to reduce unnecessary antibiotic prescribing while still maintaining parent satisfaction with care.[cites] The DART program also includes content related to evidence-based antibiotic prescribing with a particular focus on reducing the use of second-line, broad-spectrum antibiotics for bacterial ARTIs.
Under funding from the Eunice Kennedy National Institute for Child Health and Human Development (NICHD), the investigators recently conducted a trial of the DART QI program with 55 providers from 20 practices belonging to one of two pediatric practice-based research networks: the Pediatric Research in Office Settings (PROS) and NorthShore University Health System networks. Exposure to the DART QI program resulted in an proportional decrease from for overall antibiotic prescribing rates for ARTIs and a proportional decrease from for the use of second-line antibiotics for bacterial ARTIs comparing the baseline to the post-intervention periods.
The DART QI Program represents a new, innovative tool to address antibiotic over-use for ARTIs in the pediatric outpatient setting. However, it is unclear whether the program will be effective when disseminated to the family practice clinical setting where 23% of children receive their acute illness care nationally. It is also unclear how exposure to the communication strategies outlined in the DART QI program may influence provider-patient communication during adult encounters for ARTI.
Tipo de estudio
Intervencionista
Inscripción (Anticipado)
180
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Rita Mangione-Smith, MD, MPH
- Número de teléfono: 206-884-8242
- Correo electrónico: Rita.Mangione-Smith@seattlechildrens.org
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
6 meses y mayores (Niño, Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Children or adults with acute respiratory tract infections (ARTIs) defined as bacterial (acute otitis media [AOM], pharyngitis, and sinusitis) or viral (bronchitis and viral upper respiratory infection [URI]) based on their common etiologies.
- Seven months old and older
Exclusion Criteria:
1. 0 - 6 months old
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: Intervention Group Providers
DART QI Program Participation
|
Antibiotic prescribing data will be collected at multiple time points both before and after the initiation of the intervention.
|
|
Sin intervención: Control Group Providers
Usual Care
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Overall antibiotic prescribing rates for pediatric and adult ARTIs.
Periodo de tiempo: The primary outcomewill be collected for all participating providers (both intervention and control) during a 30-month period beginning with baseline data collection.
|
The primary outcome of overall antibiotic prescribing rates for ARTIs will be assessed by calculating the number of eligible ARTI visits occurring within a measurement period (measure denominator) where antibiotics were prescribed (numerator).
This outcome will be assessed separately for the eligible pediatric (6 months to 17 years-old) and adult (> 18 years-old) patients.
|
The primary outcomewill be collected for all participating providers (both intervention and control) during a 30-month period beginning with baseline data collection.
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
First-line antibiotic prescribing rates for pediatric and adult bacterial ARTIs.
Periodo de tiempo: The secondary outcome will be collected for all participating providers (both intervention and control) during a 30-month period beginning with baseline data collection.
|
The secondary outcome of first-line antibiotic prescribing rates for bacterial ARTIs will be assessed by calculating the number of eligible bacterial ARTI visits occurring within a measurement period (measure denominator) where first-line antibiotics were prescribed (numerator).
This outcome will be assessed separately for the eligible pediatric (6 months to 17 years-old) and adult (> 18 years-old) patients.
|
The secondary outcome will be collected for all participating providers (both intervention and control) during a 30-month period beginning with baseline data collection.
|
|
Net cost of delivering the DART QI program
Periodo de tiempo: This outcome will be collected for all participating providers (both intervention and control) during a 30-month period beginning with baseline data collection.
|
The net cost of delivering the intervention will be calculated as the difference between the total costs (sum of antibiotic prescription, intervention delivery, and return visit utilization costs) in the intervention and control groups.
|
This outcome will be collected for all participating providers (both intervention and control) during a 30-month period beginning with baseline data collection.
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Rita Mangione-Smith, MD, MPH, Seattle Children's
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Davis DA, Thomson MA, Oxman AD, Haynes RB. Changing physician performance. A systematic review of the effect of continuing medical education strategies. JAMA. 1995 Sep 6;274(9):700-5. doi: 10.1001/jama.274.9.700.
- Fleming-Dutra KE, Hersh AL, Shapiro DJ, Bartoces M, Enns EA, File TM Jr, Finkelstein JA, Gerber JS, Hyun DY, Linder JA, Lynfield R, Margolis DJ, May LS, Merenstein D, Metlay JP, Newland JG, Piccirillo JF, Roberts RM, Sanchez GV, Suda KJ, Thomas A, Woo TM, Zetts RM, Hicks LA. Prevalence of Inappropriate Antibiotic Prescriptions Among US Ambulatory Care Visits, 2010-2011. JAMA. 2016 May 3;315(17):1864-73. doi: 10.1001/jama.2016.4151.
- Little P, Stuart B, Francis N, Douglas E, Tonkin-Crine S, Anthierens S, Cals JW, Melbye H, Santer M, Moore M, Coenen S, Butler C, Hood K, Kelly M, Godycki-Cwirko M, Mierzecki A, Torres A, Llor C, Davies M, Mullee M, O'Reilly G, van der Velden A, Geraghty AW, Goossens H, Verheij T, Yardley L; GRACE consortium. Effects of internet-based training on antibiotic prescribing rates for acute respiratory-tract infections: a multinational, cluster, randomised, factorial, controlled trial. Lancet. 2013 Oct 5;382(9899):1175-82. doi: 10.1016/S0140-6736(13)60994-0. Epub 2013 Jul 31.
- Cabral C, Horwood J, Hay AD, Lucas PJ. How communication affects prescription decisions in consultations for acute illness in children: a systematic review and meta-ethnography. BMC Fam Pract. 2014 Apr 8;15:63. doi: 10.1186/1471-2296-15-63.
- Costelloe C, Metcalfe C, Lovering A, Mant D, Hay AD. Effect of antibiotic prescribing in primary care on antimicrobial resistance in individual patients: systematic review and meta-analysis. BMJ. 2010 May 18;340:c2096. doi: 10.1136/bmj.c2096.
- Goossens H, Ferech M, Vander Stichele R, Elseviers M; ESAC Project Group. Outpatient antibiotic use in Europe and association with resistance: a cross-national database study. Lancet. 2005 Feb 12-18;365(9459):579-87. doi: 10.1016/S0140-6736(05)17907-0.
- Quan H, Sundararajan V, Halfon P, Fong A, Burnand B, Luthi JC, Saunders LD, Beck CA, Feasby TE, Ghali WA. Coding algorithms for defining comorbidities in ICD-9-CM and ICD-10 administrative data. Med Care. 2005 Nov;43(11):1130-9. doi: 10.1097/01.mlr.0000182534.19832.83.
- Moher D, Hopewell S, Schulz KF, Montori V, Gotzsche PC, Devereaux PJ, Elbourne D, Egger M, Altman DG; Consolidated Standards of Reporting Trials Group. CONSORT 2010 Explanation and Elaboration: Updated guidelines for reporting parallel group randomised trials. J Clin Epidemiol. 2010 Aug;63(8):e1-37. doi: 10.1016/j.jclinepi.2010.03.004. Epub 2010 Mar 25. Erratum In: J Clin Epidemiol. 2012 Mar;65(3):351.
- Grijalva CG, Nuorti JP, Griffin MR. Antibiotic prescription rates for acute respiratory tract infections in US ambulatory settings. JAMA. 2009 Aug 19;302(7):758-66. doi: 10.1001/jama.2009.1163.
- Vaz LE, Kleinman KP, Raebel MA, Nordin JD, Lakoma MD, Dutta-Linn MM, Finkelstein JA. Recent trends in outpatient antibiotic use in children. Pediatrics. 2014 Mar;133(3):375-85. doi: 10.1542/peds.2013-2903. Epub 2014 Feb 2.
- Deyo RA, Cherkin DC, Ciol MA. Adapting a clinical comorbidity index for use with ICD-9-CM administrative databases. J Clin Epidemiol. 1992 Jun;45(6):613-9. doi: 10.1016/0895-4356(92)90133-8.
- Hersh AL, Shapiro DJ, Pavia AT, Shah SS. Antibiotic prescribing in ambulatory pediatrics in the United States. Pediatrics. 2011 Dec;128(6):1053-61. doi: 10.1542/peds.2011-1337. Epub 2011 Nov 7.
- Kronman MP, Zhou C, Mangione-Smith R. Bacterial prevalence and antimicrobial prescribing trends for acute respiratory tract infections. Pediatrics. 2014 Oct;134(4):e956-65. doi: 10.1542/peds.2014-0605. Epub 2014 Sep 15.
- Chung A, Perera R, Brueggemann AB, Elamin AE, Harnden A, Mayon-White R, Smith S, Crook DW, Mant D. Effect of antibiotic prescribing on antibiotic resistance in individual children in primary care: prospective cohort study. BMJ. 2007 Sep 1;335(7617):429. doi: 10.1136/bmj.39274.647465.BE. Epub 2007 Jul 26.
- Michaelidis CI, Fine MJ, Lin CJ, Linder JA, Nowalk MP, Shields RK, Zimmerman RK, Smith KJ. The hidden societal cost of antibiotic resistance per antibiotic prescribed in the United States: an exploratory analysis. BMC Infect Dis. 2016 Nov 8;16(1):655. doi: 10.1186/s12879-016-1990-4.
- Centers for Disaese Control and Prevention Antibiotic resistance threats in the United States, 2013. 2013; http://www.cdc.gov/drugresistance/threat Accessed July 25, 2018.
- Shapiro DJ, Hicks LA, Pavia AT, Hersh AL. Antibiotic prescribing for adults in ambulatory care in the USA, 2007-09. J Antimicrob Chemother. 2014 Jan;69(1):234-40. doi: 10.1093/jac/dkt301. Epub 2013 Jul 25.
- Mangione-Smith R, McGlynn EA, Elliott MN, McDonald L, Franz CE, Kravitz RL. Parent expectations for antibiotics, physician-parent communication, and satisfaction. Arch Pediatr Adolesc Med. 2001 Jul;155(7):800-6. doi: 10.1001/archpedi.155.7.800.
- Mangione-Smith R, Elliott MN, Stivers T, McDonald LL, Heritage J. Ruling out the need for antibiotics: are we sending the right message? Arch Pediatr Adolesc Med. 2006 Sep;160(9):945-52. doi: 10.1001/archpedi.160.9.945.
- Mangione-Smith R, Zhou C, Robinson JD, Taylor JA, Elliott MN, Heritage J. Communication practices and antibiotic use for acute respiratory tract infections in children. Ann Fam Med. 2015 May-Jun;13(3):221-7. doi: 10.1370/afm.1785.
- Gerber JS, Prasad PA, Fiks AG, Localio AR, Grundmeier RW, Bell LM, Wasserman RC, Keren R, Zaoutis TE. Effect of an outpatient antimicrobial stewardship intervention on broad-spectrum antibiotic prescribing by primary care pediatricians: a randomized trial. JAMA. 2013 Jun 12;309(22):2345-52. doi: 10.1001/jama.2013.6287.
- Merriam SB, Cafrrarella RS. Learing in Adulthood. San Francisco, CA: Jossey-Bass; 2008.
- Butler CC, Simpson SA, Dunstan F, Rollnick S, Cohen D, Gillespie D, Evans MR, Alam MF, Bekkers MJ, Evans J, Moore L, Howe R, Hayes J, Hare M, Hood K. Effectiveness of multifaceted educational programme to reduce antibiotic dispensing in primary care: practice based randomised controlled trial. BMJ. 2012 Feb 2;344:d8173. doi: 10.1136/bmj.d8173.
- Stivers T. Non-antibiotic treatment recommendations: delivery formats and implications for parent resistance. Soc Sci Med. 2005 Mar;60(5):949-64. doi: 10.1016/j.socscimed.2004.06.040.
- Pace WD, Cifuentes M, Valuck RJ, Staton EW, Brandt EC, West DR. An electronic practice-based network for observational comparative effectiveness research. Ann Intern Med. 2009 Sep 1;151(5):338-40. doi: 10.7326/0003-4819-151-5-200909010-00140. Epub 2009 Jul 28.
- Ajzen I, Madden TJ. Prediction of goal-directed behavior: attitudes, intentions, and perceived behavioral control. Journal lof Experimental Social Psychology. 1986;22:453-474.
- Simon TD, Cawthon ML, Stanford S, Popalisky J, Lyons D, Woodcox P, Hood M, Chen AY, Mangione-Smith R; Center of Excellence on Quality of Care Measures for Children with Complex Needs (COE4CCN) Medical Complexity Working Group. Pediatric medical complexity algorithm: a new method to stratify children by medical complexity. Pediatrics. 2014 Jun;133(6):e1647-54. doi: 10.1542/peds.2013-3875. Epub 2014 May 12.
- Simon TD, Haaland W, Hawley K, Lambka K, Mangione-Smith R. Development and Validation of the Pediatric Medical Complexity Algorithm (PMCA) Version 3.0. Acad Pediatr. 2018 Jul;18(5):577-580. doi: 10.1016/j.acap.2018.02.010. Epub 2018 Feb 26.
- Gelman A, Hillman J. Data analysis using regression and multilevel/hierarchical models. Cambridge: Cambridge University Press; 2007.
- Goldstein H. Multilevel statistical models. 4th ed: Wiley; 2010.
- Raudenbush SW, Bryk AS. Heirarchical linear models: applications and data analysis methods. 2nd ed: Sage; 2002.
- Wright DR, Taveras EM, Gillman MW, Horan CM, Hohman KH, Gortmaker SL, Prosser LA. The cost of a primary care-based childhood obesity prevention intervention. BMC Health Serv Res. 2014 Jan 29;14:44. doi: 10.1186/1472-6963-14-44.
- Xu X, Grossetta Nardini HK, Ruger JP. Micro-costing studies in the health and medical literature: protocol for a systematic review. Syst Rev. 2014 May 21;3:47. doi: 10.1186/2046-4053-3-47.
- Drummond MF, Sculpher MJ, Torrance GW, O'Brien BJ, Stodart GL. Methods of economic evaluation of health care programmes. 3rd ed. New York: Oxford University Press; 2005.
- Jenkins TC, Irwin A, Coombs L, Dealleaume L, Ross SE, Rozwadowski J, Webster B, Dickinson LM, Sabel AL, Mackenzie TD, West DR, Price CS. Effects of clinical pathways for common outpatient infections on antibiotic prescribing. Am J Med. 2013 Apr;126(4):327-335.e12. doi: 10.1016/j.amjmed.2012.10.027.
- Pihlajamaki M, Kotilainen P, Kaurila T, Klaukka T, Palva E, Huovinen P; Finnish Study Group for Antimicrobial Resistance (FiRe-Network). Macrolide-resistant Streptococcus pneumoniae and use of antimicrobial agents. Clin Infect Dis. 2001 Aug 15;33(4):483-8. doi: 10.1086/322735. Epub 2001 Jul 20.
- Brennan-Krohn T, Ozonoff A, Sandora TJ. Adherence to guidelines for testing and treatment of children with pharyngitis: a retrospective study. BMC Pediatr. 2018 Feb 9;18(1):43. doi: 10.1186/s12887-018-0988-z.
- Hersh AL, Shapiro DJ, Pavia AT, Fleming-Dutra KE, Hicks LA. Geographic Variability in Diagnosis and Antibiotic Prescribing for Acute Respiratory Tract Infections. Infect Dis Ther. 2018 Mar;7(1):171-174. doi: 10.1007/s40121-017-0181-y. Epub 2017 Dec 22.
- Gerber JS, Prasad PA, Russell Localio A, Fiks AG, Grundmeier RW, Bell LM, Wasserman RC, Keren R, Zaoutis TE. Variation in Antibiotic Prescribing Across a Pediatric Primary Care Network. J Pediatric Infect Dis Soc. 2015 Dec;4(4):297-304. doi: 10.1093/jpids/piu086. Epub 2014 Oct 30.
- Barnett ML, Linder JA. Antibiotic prescribing for adults with acute bronchitis in the United States, 1996-2010. JAMA. 2014 May 21;311(19):2020-2. doi: 10.1001/jama.2013.286141. No abstract available.
- Hersh AL, Fleming-Dutra KE, Shapiro DJ, Hyun DY, Hicks LA; Outpatient Antibiotic Use Target-Setting Workgroup. Frequency of First-line Antibiotic Selection Among US Ambulatory Care Visits for Otitis Media, Sinusitis, and Pharyngitis. JAMA Intern Med. 2016 Dec 1;176(12):1870-1872. doi: 10.1001/jamainternmed.2016.6625. No abstract available.
- Tyrstrup M, Melander E, Hedin K, Beckman A, Molstad S. Children with respiratory tract infections in Swedish primary care; prevalence of antibiotic resistance in common respiratory tract pathogens and relation to antibiotic consumption. BMC Infect Dis. 2017 Sep 4;17(1):603. doi: 10.1186/s12879-017-2703-3.
- Stivers T, Mangione-Smith R, Elliott MN, McDonald L, Heritage J. Why do physicians think parents expect antibiotics? What parents report vs what physicians believe. J Fam Pract. 2003 Feb;52(2):140-8.
- Basu, A. Estimating costs and valuations of non-health benefits. 2nd ed. New York: Oxford University Press; 2017.
- Drummond MF, Sculpher MJ, Claxton K, Stoddart GL, Torrance GW. Methods for Economic Evaluation of Health Care Programmes. New York: Oxford University Press; 2015.
- Tang S. Profile of Pediatric Visits 2004-2007. American Academy of Pediatrics, 2010.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Anticipado)
1 de julio de 2022
Finalización primaria (Anticipado)
1 de enero de 2025
Finalización del estudio (Anticipado)
1 de junio de 2026
Fechas de registro del estudio
Enviado por primera vez
6 de septiembre de 2018
Primero enviado que cumplió con los criterios de control de calidad
14 de septiembre de 2018
Publicado por primera vez (Actual)
18 de septiembre de 2018
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
19 de septiembre de 2019
Última actualización enviada que cumplió con los criterios de control de calidad
17 de septiembre de 2019
Última verificación
1 de septiembre de 2019
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 371934
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .