Clinical Decision Support and PalivizumabA Means to Protect from Respiratory Syncytial Virus
07 August 2015
accepted: 08 November 2015
19 December 2017 (online)
Background and Objectives: Palivizumab can reduce hospitalizations due to respiratory syncytial virus (RSV), but many eligible infants fail to receive the full 5-dose series. The efficacy of clinical decision support (CDS) in fostering palivizumab receipt has not been studied. We sought a comprehensive solution for identifying eligible patients and addressing barriers to palivizumab administration.
Methods: We developed workflow and CDS tools targeting patient identification and palivizumab administration. We randomized 10 practices to receive palivizumab-focused CDS and 10 to receive comprehensive CDS for premature infants in a 3-year longitudinal cluster-randomized trial with 2 baseline and 1 intervention RSV seasons.
Results: There were 356 children eligible to receive palivizumab, with 194 in the palivizumab-focused group and 162 in the comprehensive CDS group. The proportion of doses administered to children in the palivizumab-focused intervention group increased from 68.4% and 65.5% in the two baseline seasons to 84.7% in the intervention season. In the comprehensive intervention group, proportions of doses administered declined during the baseline seasons (from 71.9% to 62.4%) with partial recovery to 67.9% during the intervention season. The palivizumab-focused group improved by 19.2 percentage points in the intervention season compared to the prior baseline season (p < 0.001), while the comprehensive intervention group only improved 5.5 percentage points (p = 0.288). The difference in change between study groups was significant (p = 0.05).
Conclusions: Workflow and CDS tools integrated in an EHR may increase the administration of palivizumab. The support focused on palivizumab, rather than comprehensive intervention, was more effective at improving palivizumab administration.
- 1 Shay DK, Holman RC, Newman RD. et al. Bronchiolitis-associated hospitalizations among US children, 1980–1996. JAMA 1999; 282 (15) 1440-1446.
- 2 Boyce TG, Mellen BG, Mitchel Jr EF. et al. Rates of hospitalization for respiratory syncytial virus infection among children in Medicaid. The Journal of Pediatrics 2000; 137 (Suppl. 06) 865-870.
- 3 American Academy of Pediatrics.. Respiratory Syncytial Virus. In: Pickering LK, Baker CJ, Kimberlin DW, Long SS. editors. Red Book: 2012 Report of the Committee on Infectious Diseases. Elk Grove Village, IL: 2012. pp. 609-618.
- 4 Hall CB, Weinberg GA, Iwane MK. et al. The burden of respiratory syncytial virus infection in young children. N Engl J Med 2009; 360 (Suppl. 06) 588-598.
- 5 The IMpact-RSV Study Group.. Palivizumab, a Humanized Respiratory Syncytial Virus Monoclonal Antibody, Reduces Hospitalization From Respiratory Syncytial Virus Infection in High-risk Infants. Pediatrics 1998; 102 (03) 531-537.
- 6 Parnes C, Guillermin J, Habersang R. et al. Palivizumab prophylaxis of respiratory syncytial virus disease in 2000–2001: results from The Palivizumab Outcomes Registry. Pediatr Pulmonol 2003; 35 (06) 484-489.
- 7 Committee on Infectious Diseases.. Policy Statement-Modified recommendations for use of palivizumab for prevention of respiratory syncytial virus infections. Pediatrics 2009; 124 (06) 1694-1701.
- 8 Andabaka T, Nickerson JW, Rojas-Reyes MX. et al. Monoclonal antibody for reducing the risk of respiratory syncytial virus infection in children. Cochrane Database Syst Rev 2013; 4: CD006602.
- 9 Anderson LJ, Dormitzer PR, Nokes DJ. et al. Strategic priorities for respiratory syncytial virus (RSV) vaccine development. Vaccine 2013; 31 (Suppl. 02) B209-B215.
- 10 Hampp C. Cost-effectiveness of Respiratory Syncytial Virus Prophylaxis in Various Indications. Arch Pediatr Adolesc Med 2011; 165 (06) 498.
- 11 Committee on Infectious Diseases and Bronchiolitis Guidelines Committee.. Updated guidance for palivizumab prophylaxis among infants and young children at increased risk of hospitalization for respiratory syncytial virus infection. Pediatrics 2014; 134 (02) 415-420.
- 12 Frogel MP, Stewart DL, Hoopes M. et al. A systematic review of compliance with palivizumab administration for RSV immunoprophylaxis. J Manag Care Pharm 2010; 16 (01) 46-58.
- 13 Anderson KS, Mullally VM, Fredrick LM. et al. Compliance with RSV prophylaxis: Global physicians’ perspectives. Patient Prefer Adherence 2009; 3: 195-203.
- 14 Frogel M, Nerwen C, Cohen A. et al. Prevention of hospitalization due to respiratory syncytial virus: results from the Palivizumab Outcomes Registry. J Perinatol 2008; 28 (Suppl. 07) 511-517.
- 15 Afghani B, Ngo T, Leu S-Y. et al. The effect of an interventional program on adherence to the American Academy of Pediatrics guidelines for palivizumab prophylaxis. Pediatr Infect Dis J 2006; 25 (11) 1019-1024.
- 16 Berner ES. Clinical decision support systems: state of the art. AHRQ Publication No. 09–0069-EF. Rockville, MD: Agency for Healthcare Research and Quality; 2009: 1-26.
- 17 Fiks AG, Grundmeier RW, Biggs LM. et al. Impact of Clinical Alerts Within an Electronic Health Record on Routine Childhood Immunization in an Urban Pediatric Population. Pediatrics 2007; 120 (04) 707-714.
- 18 Fiks AG, Hunter KF, Localio AR. et al. Impact of Electronic Health Record-Based Alerts on Influenza Vaccination for Children With Asthma. Pediatrics 2009; 124 (01) 159-169.
- 19 Fiks AG, Grundmeier RW, Mayne S. et al. Effectiveness of Decision Support for Families, Clinicians, or Both on HPV Vaccine Receipt. Pediatrics 2013; 131 (06) 1114-1124.
- 20 Lundeen K, Pfeiffenberger T, Jacobson Vann J. et al. Evaluation of a novel web-based prior approval application for palivizumab prophylaxis of respiratory syncytial virus in a state Medicaid program. J Manag Care Pharm 2013; 19 (02) 115-124.
- 21 Shiffman RN, Karras BT, Agrawal A. et al. GEM: A Proposal for a More Comprehensive Guideline Document Model Using XML. Journal of the American Medical Informatics Association 2000; 7 (05) 488-498.
- 22 Karavite D, Fiks AG, Grundmeier RW. Developing Guideline Based Clinical Decision Support for Premature Infant Care. medicine.yale.edu . [cited 2014 Aug 20]. Available from: http://medicine.yale.edu/cmiglides/localize/555_148593_CHOPImpGuide4.5.13.pdf
- 23 Harris PA, Taylor R, Thielke R. et al. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. Journal of Biomedical Informatics 2009; 42 (02) 377-381.
- 24 Bracht M, Basevitz D, Cranis M. et al. Identifying and ensuring optimal care for all children at risk of developing serious respiratory syncytial virus disease: a Canadian nurses’ perspective. Neonatal Netw 2012; 31 (06) 369-386.
- 25 Shojania KG, Jennings A, Mayhew A. et al. The effects of on-screen, point of care computer reminders on processes and outcomes of care. Cochrane Database Syst Rev 2009 (3): CD001096.
- 26 Goldstein MK, Hoffman BB, Coleman RW. et al. Patient safety in guideline-based decision support for hypertension management: ATHENA DSS. Journal of the American Medical Informatics Association 2002; 9: S11-S16.
- 27 van der Sijs H, Aarts J, Vulto A. et al. Overriding of drug safety alerts in computerized physician order entry. Journal of the American Medical Informatics Association 2006; 13 (Suppl. 02) 138-147.
- 28 Synagis (palivizumab) for intramuscular injection. Gaithersburg, MD: Medimmune; 2014. Mar. Package Insert.
- 29 Centers for Medicare & Medicaid Services.. EHR Incentive Programs: Stage 2. [cited 2014 Nov 10]. Available from: http://www.cms.gov/Regulations-and-Guidance/Legislation/EHRIncentivePrograms Stage_2.html
- 30 Center for Disease Control & Prevention.. National Vital Statistics System –Birth Data. cdc.gov. [cited 2015 Feb 20]. Available from: http://www.cdc.gov/nchs/births.htm