Appl Clin Inform 2015; 06(04): 769-784
DOI: 10.4338/ACI-2015-08-RA-0096
Research Article
Schattauer GmbH

Clinical Decision Support and Palivizumab

A Means to Protect from Respiratory Syncytial Virus
L.H. Utidjian
1   Departments of Pediatrics, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania
3   Department of Biomedical and Health, The Children’s Hospital of Philadelphia, Philadelphia, Pennsylvania
,
A. Hogan
1   Departments of Pediatrics, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania
,
J. Michel
3   Department of Biomedical and Health, The Children’s Hospital of Philadelphia, Philadelphia, Pennsylvania
,
A.R. Localio
2   Departments of Biostatics and Epidemiology, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania
,
D. Karavite
3   Department of Biomedical and Health, The Children’s Hospital of Philadelphia, Philadelphia, Pennsylvania
,
L. Song
4   Healthcare Analytics Unit, The Children’s Hospital of Philadelphia, Philadelphia, Pennsylvania
,
M.J. Ramos
3   Department of Biomedical and Health, The Children’s Hospital of Philadelphia, Philadelphia, Pennsylvania
,
A.G. Fiks
1   Departments of Pediatrics, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania
3   Department of Biomedical and Health, The Children’s Hospital of Philadelphia, Philadelphia, Pennsylvania
,
S. Lorch
1   Departments of Pediatrics, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania
,
R.W. Grundmeier
1   Departments of Pediatrics, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania
3   Department of Biomedical and Health, The Children’s Hospital of Philadelphia, Philadelphia, Pennsylvania
› Author Affiliations
Further Information

Correspondence to:

Levon Utidjian
3535 Market St, Suite 1024, Room 1080
Department of Biomedical and Health Informatics
The Children’s Hospital of Philadelphia
Philadelphia, PA 19104
Phone: 215–300–4248   

Publication History

received: 07 August 2015

accepted: 08 November 2015

Publication Date:
19 December 2017 (online)

 

Summary

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.


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Conflicts of interest

Dr. Grundmeier and Dr. Fiks are co-inventors of the Care Assistant decision support framework, which was used to implement portions of the intervention evaluated in this manuscript. No patent or licensing agreement exists for this technology and the invention has generated no revenue. As co-inventors of the Care Assistant, Dr. Grundmeier and Dr. Fiks may have a perceived conflict of interest. However, statisticians on the study team who have no conflicts of interest reviewed all study data and analyses.

  • References

  • 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

Correspondence to:

Levon Utidjian
3535 Market St, Suite 1024, Room 1080
Department of Biomedical and Health Informatics
The Children’s Hospital of Philadelphia
Philadelphia, PA 19104
Phone: 215–300–4248   

  • References

  • 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