search
Back to results

Discharge Stewardship in Children's Hospitals (DISCO)

Primary Purpose

Pneumonia, Bacterial, Pneumonia Childhood, Urinary Tract Infections

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Discharge antibiotic stewardship intervention
Sponsored by
Children's Hospital of Philadelphia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Pneumonia, Bacterial focused on measuring Stewardship, Discharge Stewardship, Group-level feedback, Antibiotic, Community-acquired pneumonia, Skin and soft tissue infections, Urinary Tract Infections

Eligibility Criteria

28 Days - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Clinician Inclusion Criteria >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) Clinician Exclusion Criteria <18 years old Not employed by the hospital Patient Inclusion Criteria 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 Patient Exclusion Criteria Subjects >18 years of age Hospital length of stay >7 days Requiring intensive care unit level of care Parent Inclusion Criteria 1. Parent of eligible child Parent Exclusion Criteria 1. Parent of ineligible child

Sites / Locations

  • St. Louis Children's Hospital
  • Children's Hospital of Philadelphia
  • University of Pennsylvania
  • Primary Children's Hospital
  • Seattle Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

No Intervention

Arm Label

Pediatric Hospitalists

Families of hospitalized children

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Impact of the discharge stewardship intervention on post-discharge treatment failure
Using a quasi-experimental design, the study team will assess the rate and trajectory of post-discharge treatment failure for CAP, UTI, and SSTI via patient report (post-discharge REDCap surveys)
Impact of the discharge stewardship intervention on adverse drug events
Using a quasi-experimental design, the study team will assess the rate and trajectory of adverse drug events for CAP, UTI, and SSTI via patient report (post-discharge REDCap surveys)

Full Information

First Posted
April 12, 2023
Last Updated
May 9, 2023
Sponsor
Children's Hospital of Philadelphia
Collaborators
Seattle Children's Hospital, Primary Children's Hospital, St. Louis Children's Hospital, University of Pennsylvania, Agency for Healthcare Research and Quality (AHRQ)
search

1. Study Identification

Unique Protocol Identification Number
NCT05826873
Brief Title
Discharge Stewardship in Children's Hospitals
Acronym
DISCO
Official Title
Implementing a Discharge Stewardship Bundle to Improve Antibiotic Use at Transition From Hospital to Home
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
June 10, 2020 (Actual)
Primary Completion Date
January 2025 (Anticipated)
Study Completion Date
July 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital of Philadelphia
Collaborators
Seattle Children's Hospital, Primary Children's Hospital, St. Louis Children's Hospital, University of Pennsylvania, Agency for Healthcare Research and Quality (AHRQ)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Pediatric antibiotic stewardship programs (ASPs) in hospital and outpatient settings optimize the use of antibiotics to improve clinical outcomes, decrease adverse drug events, and reduce the emergence of antibiotic resistant bacteria. However, stewardship for patients at the transition from hospital discharge to home, or "discharge stewardship," is an unmet need for several reasons. First, few pediatric stewardship programs perform discharge stewardship. Second, approximately 30% of pediatric patients receive antibiotics at hospital discharge. Third, the majority of antibiotic days prescribed for hospitalized patients occur after discharge. Fourth, up to half of discharge antibiotic prescriptions are suboptimal, which includes choosing the wrong drug, dose, route, or duration of therapy. This project will use an implementation science framework to develop, implement, and test the effectiveness of a multifaceted discharge stewardship intervention for hospitalized children with the three most common indications for antibiotic prescribing in hospitalized children - community acquired pneumonia (CAP), urinary tract infections (UTI), and skin/soft tissue infections (SSTI) - at four children's hospitals to establish a foundation for future expansion to additional target populations. Antibiotic choice, dose, route, and duration of therapy will be addressed. Aim 1 is to develop, locally adapt, and implement a discharge stewardship intervention across the four participating sites. The integrated Promoting Action on Research Implementation in Health Services (i-PARIHS) framework will guide a rapid formative evaluation to identify contextual factors likely to facilitate or hinder the implementation of a discharge stewardship intervention at each site. Based on these results, local facilitators will work to develop and implement a discharge stewardship intervention comprised of consensus driven clinical prescribing guidelines for CAP, UTI, and SSTI plus quarterly feedback of prescribing data based on these guidelines. Aim 2 is to measure the impact of the discharge stewardship intervention on antibiotic prescribing (the primary outcome) and patient-centered balancing measures (post-discharge treatment failure and adverse events). This project will form the foundation for future dissemination of discharge stewardship to a broader array of patient populations. Investigators on this proposal form the leadership of the Sharing Antimicrobial Reports for Pediatric Stewardship (SHARPS) Collaborative, a network comprised of more than 60 children's hospitals across North America that is uniquely positioned to adopt antimicrobial stewardship interventions designed to target prescribing at hospital discharge.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Mixed methods implementation science study with a multicenter, quasi-experimental interrupted time-series design.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
5720 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pediatric Hospitalists
Arm Type
Other
Arm Description
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.
Arm Title
Families of hospitalized children
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Discharge antibiotic stewardship intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Rate of suboptimal prescribing
Description
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.
Time Frame
up to 3 years
Secondary Outcome Measure Information:
Title
Impact of the discharge stewardship intervention on post-discharge treatment failure
Description
Using a quasi-experimental design, the study team will assess the rate and trajectory of post-discharge treatment failure for CAP, UTI, and SSTI via patient report (post-discharge REDCap surveys)
Time Frame
up to 3 years
Title
Impact of the discharge stewardship intervention on adverse drug events
Description
Using a quasi-experimental design, the study team will assess the rate and trajectory of adverse drug events for CAP, UTI, and SSTI via patient report (post-discharge REDCap surveys)
Time Frame
up to 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
28 Days
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Clinician Inclusion Criteria >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) Clinician Exclusion Criteria <18 years old Not employed by the hospital Patient Inclusion Criteria 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 Patient Exclusion Criteria Subjects >18 years of age Hospital length of stay >7 days Requiring intensive care unit level of care Parent Inclusion Criteria 1. Parent of eligible child Parent Exclusion Criteria 1. Parent of ineligible child
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey S Gerber, MD, PhD
Organizational Affiliation
Associate Professor, Pediatrics
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Louis Children's Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Primary Children's Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84113
Country
United States
Facility Name
Seattle Children's Hospital
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
This study was initiated prior to the NIH Data Management and Sharing Policy update that was released on January 25, 2023.
Citations:
PubMed Identifier
27254036
Citation
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.
Results Reference
background
PubMed Identifier
26619405
Citation
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.
Results Reference
background
PubMed Identifier
23757082
Citation
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.
Results Reference
background
PubMed Identifier
30137509
Citation
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.
Results Reference
background
PubMed Identifier
29260224
Citation
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.
Results Reference
background
PubMed Identifier
26752682
Citation
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.
Results Reference
background
PubMed Identifier
30544150
Citation
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.
Results Reference
background
PubMed Identifier
25782905
Citation
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.
Results Reference
background
PubMed Identifier
27890038
Citation
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.
Results Reference
background
PubMed Identifier
29769028
Citation
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.
Results Reference
background
PubMed Identifier
26407410
Citation
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.
Results Reference
background
PubMed Identifier
24225609
Citation
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.
Results Reference
background
PubMed Identifier
27806937
Citation
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.
Results Reference
background
PubMed Identifier
28260538
Citation
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.
Results Reference
background
PubMed Identifier
21507858
Citation
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.
Results Reference
background
PubMed Identifier
30975119
Citation
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.
Results Reference
background
PubMed Identifier
26903136
Citation
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.
Results Reference
background
PubMed Identifier
26864410
Citation
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.
Results Reference
background
PubMed Identifier
30445453
Citation
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.
Results Reference
background
PubMed Identifier
17192537
Citation
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. Erratum In: N Engl J Med. 2007 Jun 21;356(25):2660.
Results Reference
background
Citation
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
Results Reference
background

Learn more about this trial

Discharge Stewardship in Children's Hospitals

We'll reach out to this number within 24 hrs