Christopher P Bonafide1,2,3,4, Rui Xiao5, Amanda C Schondelmeyer6,7,8, Amy R Pettit9, Patrick W Brady7,8,10, Christopher P Landrigan11,12, Courtney Benjamin Wolk13,14,15, Zuleyha Cidav14,16, Halley Ruppel17,16,18, Naveen Muthu19, Nathaniel J Williams20,21, Enrique Schisterman5, Canita R Brent22, Kimberly Albanowski22, Rinad S Beidas13,14,15,23,24,25,26. 1. Section of Hospital Medicine, Children's Hospital of Philadelphia, Children's Hospital of Philadelphia Hub for Clinical Collaboration, 3500 Civic Center Blvd, Philadelphia, PA, 19104, USA. bonafide@chop.edu. 2. Center for Pediatric Clinical Effectiveness, Children's Hospital of Philadelphia, 2716 South Street, Philadelphia, PA, 19146, USA. bonafide@chop.edu. 3. Department of Pediatrics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, USA. bonafide@chop.edu. 4. Penn Implementation Science Center at the Leonard Davis Institute of Health Economics (PISCE@LDI), University of Pennsylvania, Philadelphia, USA. bonafide@chop.edu. 5. Department of Biostatistics, Epidemiology, and Informatics, Perelman School of Medicine, University of Pennsylvania, 206 Blockley Hall, 423 Guardian Drive, Philadelphia, PA, 19104-6021, USA. 6. Department of Pediatrics, University of Cincinnati, Cincinnati, OH, 45229, USA. 7. Division of Hospital Medicine, Cincinnati Children's Hospital Medical Center, Cincinnati, USA. 8. James M. Anderson Center for Health Systems Excellence, Cincinnati Children's Hospital Medical Center, 3333 Burnet Ave ML 9016, Cincinnati, OH, 45229, USA. 9. Independent Consultant, Boston, USA. 10. Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, USA. 11. Division of General Pediatrics, Boston Children's Hospital, Enders 1, 300 Longwood Ave, Boston, MA, 02115, USA. 12. Department of Pediatrics, Harvard Medical School, Boston, MA, USA. 13. Penn Implementation Science Center at the Leonard Davis Institute of Health Economics (PISCE@LDI), University of Pennsylvania, Philadelphia, USA. 14. Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, 3535 Market Street, Philadelphia, PA, 19104, USA. 15. Department of Medical Ethics and Health Policy, Perelman School of Medicine, Philadelphia, USA. 16. Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, PA, USA. 17. Center for Pediatric Clinical Effectiveness, Children's Hospital of Philadelphia, 2716 South Street, Philadelphia, PA, 19146, USA. 18. Department of Family and Community Health, School of Nursing, University of Pennsylvania, Philadelphia, USA. 19. Department of Biomedical and Health Informatics, Children's Hospital of Philadelphia, 2716 South Street, Philadelphia, PA, 19146, USA. 20. School of Social Work, Boise State University, 1910 W. University Drive, Boise, ID, 83725, USA. 21. Institute for the Study of Behavioral Health and Addiction, Boise State University, Boise, USA. 22. Section of Hospital Medicine, Children's Hospital of Philadelphia, Children's Hospital of Philadelphia Hub for Clinical Collaboration, 3500 Civic Center Blvd, Philadelphia, PA, 19104, USA. 23. Department of Medicine, Perelman School of Medicine, University of Pennsylvania, 3600 Civic Center Boulevard, 8th Floor, Philadelphia, PA, 19104, USA. 24. Penn Medicine Nudge Unit, University of Pennsylvania Health System, Philadelphia, USA. 25. Center for Health Incentives and Behavioral Economics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, USA. 26. Department of Medical Social Sciences, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.
Abstract
BACKGROUND: Methods of sustaining the deimplementation of overused medical practices (i.e., practices not supported by evidence) are understudied. In pediatric hospital medicine, continuous pulse oximetry monitoring of children with the common viral respiratory illness bronchiolitis is recommended only under specific circumstances. Three national guidelines discourage its use for children who are not receiving supplemental oxygen, but guideline-discordant practice (i.e., overuse) remains prevalent. A 6-hospital pilot of educational outreach with audit and feedback resulted in immediate reductions in overuse; however, the best strategies to optimize sustainment of deimplementation success are unknown. METHODS: The Eliminating Monitor Overuse (EMO) trial will compare two deimplementation strategies in a hybrid type III effectiveness-deimplementation trial. This longitudinal cluster-randomized design will be conducted in Pediatric Research in Inpatient Settings (PRIS) Network hospitals and will include baseline measurement, active deimplementation, and sustainment phases. After a baseline measurement period, 16-19 hospitals will be randomized to a deimplementation strategy that targets unlearning (educational outreach with audit and feedback), and the other 16-19 will be randomized to a strategy that targets unlearning and substitution (adding an EHR-integrated clinical pathway decision support tool). The primary outcome is the sustainment of deimplementation in bronchiolitis patients who are not receiving any supplemental oxygen, analyzed as a longitudinal difference-in-differences comparison of overuse rates across study arms. Secondary outcomes include equity of deimplementation and the fidelity to, and cost of, each deimplementation strategy. To understand how the deimplementation strategies work, we will test hypothesized mechanisms of routinization (clinicians developing new routines supporting practice change) and institutionalization (embedding of practice change into existing organizational systems). DISCUSSION: The EMO trial will advance the science of deimplementation by providing new insights into the processes, mechanisms, costs, and likelihood of sustained practice change using rigorously designed deimplementation strategies. The trial will also advance care for a high-incidence, costly pediatric lung disease. TRIAL REGISTRATION: ClinicalTrials.gov, NCT05132322 . Registered on November 10, 2021.
BACKGROUND: Methods of sustaining the deimplementation of overused medical practices (i.e., practices not supported by evidence) are understudied. In pediatric hospital medicine, continuous pulse oximetry monitoring of children with the common viral respiratory illness bronchiolitis is recommended only under specific circumstances. Three national guidelines discourage its use for children who are not receiving supplemental oxygen, but guideline-discordant practice (i.e., overuse) remains prevalent. A 6-hospital pilot of educational outreach with audit and feedback resulted in immediate reductions in overuse; however, the best strategies to optimize sustainment of deimplementation success are unknown. METHODS: The Eliminating Monitor Overuse (EMO) trial will compare two deimplementation strategies in a hybrid type III effectiveness-deimplementation trial. This longitudinal cluster-randomized design will be conducted in Pediatric Research in Inpatient Settings (PRIS) Network hospitals and will include baseline measurement, active deimplementation, and sustainment phases. After a baseline measurement period, 16-19 hospitals will be randomized to a deimplementation strategy that targets unlearning (educational outreach with audit and feedback), and the other 16-19 will be randomized to a strategy that targets unlearning and substitution (adding an EHR-integrated clinical pathway decision support tool). The primary outcome is the sustainment of deimplementation in bronchiolitis patients who are not receiving any supplemental oxygen, analyzed as a longitudinal difference-in-differences comparison of overuse rates across study arms. Secondary outcomes include equity of deimplementation and the fidelity to, and cost of, each deimplementation strategy. To understand how the deimplementation strategies work, we will test hypothesized mechanisms of routinization (clinicians developing new routines supporting practice change) and institutionalization (embedding of practice change into existing organizational systems). DISCUSSION: The EMO trial will advance the science of deimplementation by providing new insights into the processes, mechanisms, costs, and likelihood of sustained practice change using rigorously designed deimplementation strategies. The trial will also advance care for a high-incidence, costly pediatric lung disease. TRIAL REGISTRATION: ClinicalTrials.gov, NCT05132322 . Registered on November 10, 2021.
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