Consumers As Partners: An Honest Approach to Patient Engagement


November / December 2006

Consumers As Partners

An Honest Approach to Patient Engagement

In October 2006, the U.S. Department of Health and Human Services approved a new parent education campaign developed by the Centers of Disease Prevention & Control’s (CDC) National Center for Birth Defects and Developmental Disabilities together with a broad coalition of stakeholders interested in safe neonatal healthcare. Entitled Did you know that jaundice can sometimes lead to brain damage in newborns?, the program is a victory for consumers and providers who want more direct, less-carefully-worded patient information about preventable adverse outcomes, especially when they can take actions themselves to help minimize risk.

There are lessons to be learned from the journey of the parents who worked tirelessly with CDC, Joint Commission on Accreditation of Healthcare Organizations (JCAHO), Partnership for Patient Safety (p4ps), the HCA system, the Healthy Mothers Healthy Babies Coalition, March of Dimes, and others for 6 years to bring this campaign to fruition. Reluctance to caution patients about serious adverse outcomes for fear of alarming them is not a patient-centered approach, as born out by focus group research informing this campaign. Indeed, fear can be a gift when coupled with education about concrete actions patients and their lay caregivers can take as part of the healthcare team.

The Formation of Parents of Infants and Children with Kernicterus
In October of 2000, in large part because of a news story in USA Today (Appleby & Davis, 2000), a group of eight mothers with something in common found each other. Each was the parent of a healthy newborn who had sustained brain damage during the first week of life because of the systemic failure to diagnose or treat hyperbilirubinemia that had reached critical levels. Each mom had read the leading prenatal books — which were uniformly silent on the dangers of jaundice — and believed herself to be an educated consumer doing everything that could be done to protect her child. And, following the adverse outcome experienced by her child, each had been led in some way to think it was a freak accident that just did not happen anymore in the U.S. healthcare system.

In fact, the moms were an early warning system with a message for any neonatal safety advocate ready to listen. There was a hole in the safety net. The brain injury caused by severe neonatal hyperbilirubinemia, known as kernicterus, was re-emerging in the U.S. healthcare system in the 1990s after having been largely eradicated.

Within a couple of weeks the mothers — soon to become Parents of Infants and Children with Kernicterus (PICK) — were on airplanes to Chicago to visit the American Academy of Pediatrics (AAP) and share the concern that they were but the tip of a geographically scattered “iceberg” of needlessly injured babies and devastated families. Their fundamental question: Why didn’t we know that jaundice could harm our babies?

Kernicterus, A Never Event
Kernicterus is a condition affecting newborns that leads to severe disabling brain damage or death. It is caused by a number of factors contributing to hyperbilirubinemia and, while it is preventable with techniques currently available, it appears to be increasing internationally (Donaldson, 2005). A University of Pennsylvania-based registry of voluntary reports lists 90 cases in the United States from 1984 to 1996 (Brown & Johnson, 1996). The Centers for Disease Control and Prevention (CDC, 2005) reported 82 cases of kernicterus in New Jersey alone from 1992 to 2001, a rate of 7.5 cases per 100,000 live births. Under-reporting is likely, due to the lack of national surveillance initiatives, the fact that kernicterus is typically diagnosed well after discharge from the birthing hospital, and the reality that many kernicterus cases are sealed by confidentiality agreements in the litigation settlement process, at least in the United States. For example, there are no kernicterus cases in the JCAHO database of sentinel events other than the ones reported by consumers.

Better data is available from a number of epidemiologic studies done in recent years as well as international surveillance. Although the United States does not participate, the incidence of severe/hazardous hyperbilirubinemia and bilirubin encephalopathy is tracked by a number of countries through the International Network of Paediatric Surveillance Units. A 2004 report from the Canadian Paediatric Surveillance Program indicates a rate of severe hyperbilirubinemia (>425 umol/L) of 21.8/ 100,000. Two hundred and fifty-nine cases were reported in the 2-year study. In the United Kingdom, in the 2 years prior to May 2005, 14 cases of kernicterus were reported (Donaldson, 2005). Recently, two large U.S. healthcare systems published the results of large bilirubin screening studies of newborns. Both Hospital Corporation of America (HCA) (151,996 neonates studied) and Intermountain Health Care (IHC) (101,272 neonates studied) found higher rates of severe (>25 mg/dcl) or hazardous (>30 mg/dcl) hyperbilirubinemia than anticipated (Hospital Corporation of America, 2005; Eggert et al., 2006). Both systems implemented universal pre-discharge bilirubin screening programs as a result of their baseline studies and immediately achieved significantly reduced numbers of babies at risk as well as dramatically reduced neonatal re-admission.

Development of the Public Education Campaign
Beginning with that AAP meeting in 2000, PICK initiated an energetic campaign to put kernicterus “back in the history books.” Unschooled in the ways standards of care are formulated and healthcare risks are managed, the moms simply issued a call to action and invited engagement from any stakeholder partner with an interest in keeping babies safe. Although questions were raised about frequency and whether there was an evidentiary basis for concluding kernicterus was re-emerging, JCAHO and CDC were shocked to hear of any cases at all and quickly responded. Other organizations followed their leadership. From October 2000 to date, Kernicterus prevention has been the subject of:


  • JCAHO Sentinel Event Alerts in 2001 and 2004.
  • A CDC Morbidity and Mortality Weekly Report in 2001 on the reemergence of this injury.
  • A National Association of Neonatal Nurses position statement in 2003.
  • Inclusion in the National Quality Forum’s list of Serious Reportable Events in Healthcare (a.k.a. “never events”) 2003, which have now been adopted by law or regulation in five states (NQF, 2004).
  • A 2005 Annual Report of the Chief Medical Officer on the “state of public health” in the United Kingdom (Donaldson).
  • An Association of Women’s Health, Obstetric and Neonatal Nurses Clinical Position Statement on the importance of Universal Bilirubin Screening and the inadequacy of visual assessment (2005).


In addition, the AAP updated their clinical practice guidelines in 2004, which stress the importance of universal systemic assessment while the newborn is in the hospital, close monitoring and follow-up upon discharge, and prompt intervention upon diagnosis. Based on the AAP guidelines and the accumulating research, a best practice emerging in the United States includes a cost-effective pre-discharge serum bilirubin test. Test results are compared with an age-specific nomogram that places infants into low, intermediate, or high-risk categories for developing clinically significant hyperbilirubinemia (Bhutani et al., 1999).

The Importance of Patient Education
A wake-up call for PICK was the realization that despite these initiatives from public health authorities, change in practice is slow in coming, and babies continue to be put at risk in the United States. Clearly there is systemic risk in the very transition from the care of obstetrician and hospital to parent and pediatrician in the first week of life. Safety improvement barriers include:


  • Commonly held beliefs among pediatricians that kernicterus is no longer a problem or is too rare to merit modification of traditional reliance on visual assessment of jaundice.
  • Variation in the implementation of protocol-based bilirubin testing.
  • Fears of alarming patients by informing them of the risk of “brain damage” and/or discomfort about having to respond to patients who are overly-concerned about remote risks (Newman, 2003).
  • Delayed or failed follow-up by parents.


PICK, CDC, and their partners determined to strengthen the safety net through parental education. Accordingly, the Did you know that jaundice can sometimes lead to brain damage in newborns?campaign identifies key opportunities for patient and family engagement, including:


  • Education of expectant parents about the fact that jaundice can lead to brain damage, whether or not it is deemed to be rare by population-based measures.
  • Asking about a serum bilirubin testing prior to discharge.
  • Making and keeping the follow-up appointment with a pediatrician within 48 hours after discharge.


The campaign consists of posters, brochures, tent cards, fact sheets, and an educational video. Alternative print pieces depict babies of differing skin color. Campaign materials were developed by media firm Captains of Industry, based on strong indicators in focus group research that parents want to know about the risks of brain damage to infants, even if such risks are rare. The kit will be piloted and evaluated throughout New Jersey in conjunction with the UMDNJ-Robert Wood Johnson Medical School Kernicterus Research and Prevention Center, as well as at St. Alphonsus Regional Medical Center in Boise, ID. It also will be integrated into the obstetrics safety programs of the HCA system and Northwest Physicians Mutual Insurance Company. For more information on participating in the campaign, visit

Lessons Learned
Like healthcare services delivery, patient education materials must be patient-centered if they are to be effective. To be effective, they should be developed based on patient research including, although not limited to, the experiences of patients who have suffered harm (Entwistle et al., 2005). A key insight is that population-based frequency statistics have much less significance for consumers than providers, especially when the risks are easily preventable. Parents typically want to guard against even remote risks and welcome messages that communicate risk in a way that gets their attention.

Martin Hatlie is president of Partnership for Patient Safety (p4ps), a patient-centered initiative dedicated to advancing the reliability of healthcare systems worldwide, and co-editor of The Patient Safety Handbook (Jones & Bartlett 2003). Previously, Hatlie was a lobbyist for the American Medical Association (AMA) focusing on tort reform. In 1997, he coordinated the AMA’s launch of the National Patient Safety Foundation and served as its founding executive director, and in 2003, Hatlie co-founded Consumers Advancing Patient Safety (CAPS) and serves on its board. He also serves on the Sentinel Event Advisory Group of the Joint Commission on Accreditation of Healthcare Organizations, the Steering Group of the Patients for Patient Safety work strand of the WHO World Alliance for Patient Safety, and the Advisory Board of Parents of Infants and Children with Kernicterus. Formerly, he has served on the governing boards of the Anesthesia Patient Safety Foundation and the American Tort Reform Association. Hatlie is a member of the Editorial Advisory Board for Patient Safety & Quality Healthcare and may be contacted at

Karen Dixon is a co-founder, current president of Parents of Infants and Children with Kernicterus (PICK), and the mother of a 17-year-old son with kernicterus. Dixon is an assistant professor in the Department of Neurobiology at the University of Alabama at Birmingham. Her research on kernicterus is to better characterize the natural history of the disorder with the goal to improve the quality of life of individuals with kernicterus. She is the assistant program director of the Civitan International Research Center at the Alabama University Center of Excellence on Develop-mental Disabilities. She is a member of the Executive Committee for the External Partners Group of the CDC’s National Center on Birth Defects and Developmental Disabilities. Dixon sits on several advisory boards and councils in Alabama that serve individuals with develop-mental disabilities. Dixon can be contacted at

Susan Sheridan’s introduction to safety issues — and her motivation to make a difference — came through grave medical errors, which led to her son’s permanent disability fromÝkernicterus in 1995 and her husband’s death in 2002 from failure to communicate a diagnosis of cancer. She is co-founder of Parents of Infants and Children with Kernicterus (PICK), a nonprofit devoted to preventing kernicterus and realizing the full potential of people who have it, and co-founder of Consumers Advancing Patient Safety (CAPS), a 501(c)(3) organization dedicated to fostering the role of consumer as proactive partner. She also chairs the Patients for Patient Safety track of the World Alliance for Patient Safety, launched by the World Health Organization (WHO) in 2004. Sheridan is a member of PSQH’s Editorial Advisory Board and may be contacted at


Appleby, J., Davis, R. (2000, October 11). Was it medical negligence, or bad luck? Judge, jury differ on boy’s disability. USA Today.

Donaldson, L. (2005). On the state of the public health: Annual report of the Chief Medical Officer. United Kingdom, Department of Health, 32-37. 04/13/73/71/04137371.pdf.

Brown, A. K. & Johnson, L. (1996). Loss of concern about jaundice and the reemergence of kernicterus in full-term infants in the era of managed care. In A. A. Fanaroff & M. H. Klaus (Eds.). The year book of neonatal and perinatal medicine (pp. 17‚28). Philadelphia: Mosby Yearbook.

Centers for Disease Control and Prevention (CDC), National Center on Birth Defects and Developmental Disabilities. (2005). Kernicterus research. ncbddd/dd/kernicterus/ker_research.htm.

Canadian Paediatric Society. (2004). Canadian Paediatric Surveillance Program. 2004 Results, 40-44. CPSP/About/2004Results.pdf.

Hospital Corporation of America’s screening of newborns preventing brain damage caused by severe jaundice. (2005). Link: /kernicterus_results.pdf.

Eggert, L. D., Wiedmeier, S. E., Wilson, J., & Christensen, R. D. (2006). The effect of instituting a prehospital-discharge newborn bilirubin screening program in an 18-hospital health system. Pediatrics, 117(5), 855-862.

Joint Commission on Accreditation of Healthcare Organizations (JCAHO). (2001, April 1). Kernicterus threatens healthy newborns. Sentinel Event Alert, Issue 18.

Joint Commission on Accreditation of Healthcare Organizations (JCAHO). (2004, August 31). Revised guidance to help prevent kernicterus. Sentinel Event Alert, Issue 31. http://www.

Centers for Disease Control and Prevention (CDC). (2001, June 15). Kernicterus in full-term infants — United States, 1994‚1998, MMWR Weekly, 50(23), 491-494. Link:

National Association of Neonatal Nurses. (2003). Prevention of bilirubin encephalopathy and kernicterus in newborns, Position Statement #3040.

National Quality Forum (NQF). (2004). Serious reportable events in healthcare.

Association of Women’s Health, Obstetric and Neonatal Nurses. (2005). Universal screening for hyperbilirubinemia. http://www.awhonn. org/awhonn/?pg=875-4730-17990.

Subcommittee on Hyperbilirubinemia. Management of hyperbilirubinemia in the newborn infant 35 or more weeks of gestation. Pediatrics, 114(1), 297-316.

Bhutani, V. K. et al. (1999). Predictive ability of a predischarge hour-specific serum bilirubin for subsequent significant hyperbilirubinemia in healthy term and near-term infants. Pediatrics, 103(1), 6-14.

Newman, T. B. (2003). The power of stories over statistics. British Medical Journal, 327, 1424-1427.

Entwistle, V. A., Mello, M. M., & Brennan, T. A. (2005). Advising patients about patient safety: current initiatives risk shifting responsibility. Joint Commission Journal on Quality and Patient Safety, 31(9), 483-494.