Reducing Antibiotic Prescribing in Family Practice
17 września 2019 zaktualizowane przez: 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.
Przegląd badań
Status
Jeszcze nie rekrutacja
Warunki
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Interwencyjne
Zapisy (Oczekiwany)
180
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Kontakt w sprawie studiów
- Nazwa: Rita Mangione-Smith, MD, MPH
- Numer telefonu: 206-884-8242
- E-mail: Rita.Mangione-Smith@seattlechildrens.org
Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
6 miesięcy i starsze (Dziecko, Dorosły, Starszy dorosły)
Akceptuje zdrowych ochotników
Nie
Płeć kwalifikująca się do nauki
Wszystko
Opis
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 studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Aktywny komparator: 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.
|
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Brak interwencji: Control Group Providers
Usual Care
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Overall antibiotic prescribing rates for pediatric and adult ARTIs.
Ramy czasowe: 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.
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
First-line antibiotic prescribing rates for pediatric and adult bacterial ARTIs.
Ramy czasowe: 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.
|
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Net cost of delivering the DART QI program
Ramy czasowe: 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.
|
Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Śledczy
- Główny śledczy: Rita Mangione-Smith, MD, MPH, Seattle Children's
Publikacje i pomocne linki
Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.
Publikacje ogólne
- 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.
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Oczekiwany)
1 lipca 2022
Zakończenie podstawowe (Oczekiwany)
1 stycznia 2025
Ukończenie studiów (Oczekiwany)
1 czerwca 2026
Daty rejestracji na studia
Pierwszy przesłany
6 września 2018
Pierwszy przesłany, który spełnia kryteria kontroli jakości
14 września 2018
Pierwszy wysłany (Rzeczywisty)
18 września 2018
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
19 września 2019
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
17 września 2019
Ostatnia weryfikacja
1 września 2019
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 371934
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
NIE
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .
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