Discharge Stewardship in Children's Hospitals

NCT05826873 | Active Not Recruiting

• 2 other identifiers: 20-017269R01HS027428-01
• Study Type: interventional
• Target: 1,131
• Locations: 1 country
• Sites: 5

Brief Summary

The goal of this interventional study is to test if a discharge stewardship bundle is effective at reducing inappropriate antibiotic prescriptions at hospital discharge for children with the three common infections: community-acquired pneumonia (CAP), urinary tract infections (UTI), and skin/soft tissue infections (SSTI). The goals of this study are:

• To develop, locally adapt, and implement a discharge stewardship intervention across four geographically diverse children's hospitals.
• To measure the impact of the discharge stewardship intervention on antibiotic prescribing and patient outcome for three common pediatric infections. Families who are enrolled in the study will be asked to:
• complete a one question wellness track on days 3, 7, and 21 after hospital discharge
• complete a brief survey on days 7 and 21 after hospital discharge The study team will conduct interviews with the hospitalists at each of the four participating hospitals to create a "discharge stewardship" bundle. Once the bundle intervention is implemented, the hospitalists will be asked to follow prescribing guidelines for CAP, UTI, and SSTI. They will receive regular group-level feedback reports to show how well they follow the guidelines and motivate the hospitalists to follow the guidelines better.

Conditions

Pneumonia, Bacterial; Pneumonia Childhood; Urinary Tract Infections; Soft Tissue Infections; Skin Infections; Community-acquired Pneumonia

Keywords

Stewardship; Discharge Stewardship; Group-level feedback; Antibiotic; Community-acquired pneumonia; Skin and soft tissue infections; Urinary Tract Infections

Outcome Measures

Primary Outcomes (1)

• Rate of suboptimal prescribing

  The primary objective of this study is to determine the impact of a discharge stewardship intervention on antibiotic prescribing and patient outcomes for three common pediatric infection after developing and implementing the intervention across four geographically diverse children's hospitals. Impact will be measured by the rate of suboptimal prescribing (drug, dose, route, and duration) for CAP, UTI, and SSTI across the four hospitals. Suboptimal prescribing will be measured using data collected from the electronic health record. The discharge prescription data (choice and duration) will be compared to the recommended guidelines to determine if the discharge prescription was on or off guideline.

  up to 3 years

Secondary Outcomes (2)

• Impact of the discharge stewardship intervention on post-discharge treatment failure

  up to 3 years

• Impact of the discharge stewardship intervention on adverse drug events

  up to 3 years

Study Arms (2)

Pediatric Hospitalists

OTHER

Prescribing physicians and hospital employees will be recruited during regularly held staff meetings prior to the data collection period. The study team will briefly introduce the study aims and methods and let the hospitalists know that the study team will be emailing them separately to ask permission for Dr. Szymczak to shadow them. Only those who have agreed will participate in the ethnographic observations. For the interviews and surveys, the study team will recruit respondents via contact made during ethnographic observations. The study team will also utilize a snowball approach by asking respondents if they know of any other staff who might be interested in participating in an interview. Approximately 120 clinicians will participate in the interviews and surveys.

Behavioral: Discharge antibiotic stewardship intervention

Families of hospitalized children

NO INTERVENTION

Families of children who were hospitalized at one of the four participating sites will be approached for consent to participate in the study. Families who consent will complete 2 brief REDCap surveys and a wellness tracker after their child is discharged from the hospital.

Interventions

Discharge antibiotic stewardship intervention BEHAVIORAL

Hospitalists will be provided with group-level, quarterly feedback reports illustrating the number of prescriptions that had the appropriate antibiotic duration and appropriate antibiotic choice for each of the three conditions.

Pediatric Hospitalists

Eligibility Criteria

• Age: 28 Days - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• \>18 year old
• Employed by the hospital as an attending physician, advanced practice provider, resident trainee or other clinical stakeholder (e.g. pharmacist, infectious diseases attending)

You may not qualify if:

• \<18 years old
• Not employed by the hospital
• Subjects less than 18 years
• Diagnosed with either uncomplicated community acquired pneumonia, urinary tract infections, skin/soft tissue infections
• Admitted and discharged from study site
• Subjects \>18 years of age
• Hospital length of stay \>7 days
• Requiring intensive care unit level of care
• \. Parent of ineligible child

Sponsors & Collaborators

• Primary Children's Hospital: collaborator
• St. Louis Children's Hospital: collaborator
• University of Pennsylvania: collaborator
• Agency for Healthcare Research and Quality (AHRQ): collaborator
• Children's Hospital of Philadelphia: lead
• Seattle Children's Hospital: collaborator

Study Sites (5)

St. Louis Children's Hospital

St Louis, Missouri, 63110, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Primary Children's Hospital

Salt Lake City, Utah, 84113, United States

Location

Seattle Children's Hospital

Seattle, Washington, 98105, United States

Location

Related Publications (21)

• Hurst AL, Child J, Pearce K, Palmer C, Todd JK, Parker SK. Handshake Stewardship: A Highly Effective Rounding-based Antimicrobial Optimization Service. Pediatr Infect Dis J. 2016 Oct;35(10):1104-10. doi: 10.1097/INF.0000000000001245.

  PMID: 27254036 BACKGROUND

• Newland JG, Stach LM, De Lurgio SA, Hedican E, Yu D, Herigon JC, Prasad PA, Jackson MA, Myers AL, Zaoutis TE. Impact of a Prospective-Audit-With-Feedback Antimicrobial Stewardship Program at a Children's Hospital. J Pediatric Infect Dis Soc. 2012 Sep;1(3):179-86. doi: 10.1093/jpids/pis054. Epub 2012 Jul 12.

  PMID: 26619405 BACKGROUND

• 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.

  PMID: 23757082 BACKGROUND

• Lovegrove MC, Geller AI, Fleming-Dutra KE, Shehab N, Sapiano MRP, Budnitz DS. US Emergency Department Visits for Adverse Drug Events From Antibiotics in Children, 2011-2015. J Pediatric Infect Dis Soc. 2019 Nov 6;8(5):384-391. doi: 10.1093/jpids/piy066.

  PMID: 30137509 BACKGROUND

• Gerber JS, Ross RK, Bryan M, Localio AR, Szymczak JE, Wasserman R, Barkman D, Odeniyi F, Conaboy K, Bell L, Zaoutis TE, Fiks AG. Association of Broad- vs Narrow-Spectrum Antibiotics With Treatment Failure, Adverse Events, and Quality of Life in Children With Acute Respiratory Tract Infections. JAMA. 2017 Dec 19;318(23):2325-2336. doi: 10.1001/jama.2017.18715.

  PMID: 29260224 BACKGROUND

• Hersh AL, Newland JG, Gerber JS. Pediatric Antimicrobial Discharge Stewardship: An Unmet Need. JAMA Pediatr. 2016 Mar;170(3):191-2. doi: 10.1001/jamapediatrics.2015.3369. No abstract available.

  PMID: 26752682 BACKGROUND

• Olson J, Thorell EA, Hersh AL. Evaluation of Discharge Antibiotic Prescribing at a Freestanding Children's Hospital: Opportunities for Stewardship. J Pediatric Infect Dis Soc. 2019 Dec 27;8(6):563-566. doi: 10.1093/jpids/piy127.

  PMID: 30544150 BACKGROUND

• Yogo N, Haas MK, Knepper BC, Burman WJ, Mehler PS, Jenkins TC. Antibiotic prescribing at the transition from hospitalization to discharge: a target for antibiotic stewardship. Infect Control Hosp Epidemiol. 2015 Apr;36(4):474-8. doi: 10.1017/ice.2014.85.

  PMID: 25782905 BACKGROUND

• Scarpato SJ, Timko DR, Cluzet VC, Dougherty JP, Nunez JJ, Fishman NO, Hamilton KW; CDC Prevention Epicenters Program. An Evaluation of Antibiotic Prescribing Practices Upon Hospital Discharge. Infect Control Hosp Epidemiol. 2017 Mar;38(3):353-355. doi: 10.1017/ice.2016.276. Epub 2016 Nov 28.

  PMID: 27890038 BACKGROUND

• Chavada R, Davey J, O'Connor L, Tong D. 'Careful goodbye at the door': is there role for antimicrobial stewardship interventions for antimicrobial therapy prescribed on hospital discharge? BMC Infect Dis. 2018 May 16;18(1):225. doi: 10.1186/s12879-018-3147-0.

  PMID: 29769028 BACKGROUND

• Olson SC, Smith S, Weissman SJ, Kronman MP. Adverse Events in Pediatric Patients Receiving Long-Term Outpatient Antimicrobials. J Pediatric Infect Dis Soc. 2015 Jun;4(2):119-25. doi: 10.1093/jpids/piu037. Epub 2014 Apr 30.

  PMID: 26407410 BACKGROUND

• Gerber JS, Kronman MP, Ross RK, Hersh AL, Newland JG, Metjian TA, Zaoutis TE. Identifying targets for antimicrobial stewardship in children's hospitals. Infect Control Hosp Epidemiol. 2013 Dec;34(12):1252-8. doi: 10.1086/673982. Epub 2013 Oct 24.

  PMID: 24225609 BACKGROUND

• Caplinger C, Crane K, Wilkin M, Bohan J, Remington R, Madaras-Kelly K. Evaluation of a protocol to optimize duration of pneumonia therapy at hospital discharge. Am J Health Syst Pharm. 2016 Dec 15;73(24):2043-2054. doi: 10.2146/ajhp160011. Epub 2016 Nov 2.

  PMID: 27806937 BACKGROUND

• Yogo N, Shihadeh K, Young H, Calcaterra SL, Knepper BC, Burman WJ, Mehler PS, Jenkins TC. Intervention to Reduce Broad-Spectrum Antibiotics and Treatment Durations Prescribed at the Time of Hospital Discharge: A Novel Stewardship Approach. Infect Control Hosp Epidemiol. 2017 May;38(5):534-541. doi: 10.1017/ice.2017.10. Epub 2017 Mar 6.

  PMID: 28260538 BACKGROUND

• Laible BR, Nazir J, Assimacopoulos AP, Schut J. Implementation of a pharmacist-led antimicrobial management team in a community teaching hospital: use of pharmacy residents and pharmacy students in a prospective audit and feedback approach. J Pharm Pract. 2010 Dec;23(6):531-5. doi: 10.1177/0897190009358775. Epub 2010 Mar 31.

  PMID: 21507858 BACKGROUND

• Thampi N, Shah PS, Nelson S, Agarwal A, Steinberg M, Diambomba Y, Morris AM. Prospective audit and feedback on antibiotic use in neonatal intensive care: a retrospective cohort study. BMC Pediatr. 2019 Apr 11;19(1):105. doi: 10.1186/s12887-019-1481-z.

  PMID: 30975119 BACKGROUND

• Brehaut JC, Colquhoun HL, Eva KW, Carroll K, Sales A, Michie S, Ivers N, Grimshaw JM. Practice Feedback Interventions: 15 Suggestions for Optimizing Effectiveness. Ann Intern Med. 2016 Mar 15;164(6):435-41. doi: 10.7326/M15-2248. Epub 2016 Feb 23.

  PMID: 26903136 BACKGROUND

• Meeker D, Linder JA, Fox CR, Friedberg MW, Persell SD, Goldstein NJ, Knight TK, Hay JW, Doctor JN. Effect of Behavioral Interventions on Inappropriate Antibiotic Prescribing Among Primary Care Practices: A Randomized Clinical Trial. JAMA. 2016 Feb 9;315(6):562-70. doi: 10.1001/jama.2016.0275.

  PMID: 26864410 BACKGROUND

• Charani E, Ahmad R, Rawson TM, Castro-Sanchez E, Tarrant C, Holmes AH. The Differences in Antibiotic Decision-making Between Acute Surgical and Acute Medical Teams: An Ethnographic Study of Culture and Team Dynamics. Clin Infect Dis. 2019 Jun 18;69(1):12-20. doi: 10.1093/cid/ciy844.

  PMID: 30445453 BACKGROUND

• Pronovost P, Needham D, Berenholtz S, Sinopoli D, Chu H, Cosgrove S, Sexton B, Hyzy R, Welsh R, Roth G, Bander J, Kepros J, Goeschel C. An intervention to decrease catheter-related bloodstream infections in the ICU. N Engl J Med. 2006 Dec 28;355(26):2725-32. doi: 10.1056/NEJMoa061115.

  PMID: 17192537 BACKGROUND

• Szymczak, J.E. and J. Newland (2018) "The Social Determinants of Antimicrobial Prescribing: Implications for Antimicrobial Stewardship." In: Barlam, TF, MM Neuhauser, PD Tamma and K. Trivedi, eds. Practical Implementation of an Antimicrobial Stewardship Program. Cambridge, UK: Cambridge University Press. Chapter 3

  BACKGROUND

MeSH Terms

Conditions

Pneumonia, Bacterial; Urinary Tract Infections; Soft Tissue Infections; Cellulitis; Community-Acquired Pneumonia

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Skin Diseases, Infectious; Suppuration; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Community-Acquired Infections

Study Officials

• Jeffrey S Gerber, MD, PhD

  Associate Professor, Pediatrics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Mixed methods implementation science study with a multicenter, quasi-experimental interrupted time-series design.

Study Record Dates

• First Submitted: April 12, 2023
• First Posted: April 24, 2023
• Study Start: June 10, 2020
• Primary Completion: December 16, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: January 9, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)