The Center for Pediatric Clinical Effectiveness (CPCE) at The Children’s Hospital of Philadelphia supports outstanding pilot research studies designed to produce evidence for what works best for treating, diagnosing, and preventing disease. Winners chosen for the fall round of the CPCE’s Pilot Grant Program will focus on two projects that aim to have an impact on clinical decision-making.
Maya Dewan, MD, MPH, a fellow in CHOP’s Department of Anesthesiology and Critical Care Medicine, will evaluate a low-cost intervention with the goal of reducing the rates of unnecessary alarm signals. It has been well-established that alarm fatigue is a growing threat to patient safety, but little research has been done that focuses on approaches to solve the problem of excessive alarms in the pediatric setting.
“Often when you’re in the pediatric intensive care unit (PICU), you’re overwhelmed by the amount of noise,” Dr. Dewan said. “You’ll go into a sick patient’s room, and sometimes it’s even hard for you to communicate or hear someone speaking because everything is beeping in the room.”
The barrage of alarms also can be stressful for families, Dr. Dewan added. She recalled sitting at 2 a.m. beside a concerned mother who was fixated on her child’s monitors and would jump at every blip.
Physiologic alarms display heart rate, respiratory rate, blood pressure, and oxygen saturation and are important tools to alert clinicians to signs of instability and prevent cardiac and respiratory arrest. In CHOP’s PICU, patients average 100 to 110 crisis and warning alarms per day, yet the majority are false, which can interrupt patient care and reduce nurses’ trust in the alarms.
“We decided to devise an intervention that could safely decrease alarms that are unnecessary,” Dr. Dewan said. “But our goal isn’t just to get rid of the false alarms. We want to ensure that the alarms you hear are true and people respond to them faster. If you filter out the false alarms, maybe we’ll pay more attention and identify kids who are getter sicker sooner.”
Preliminary data show that 25 percent to 30 percent of the crisis and warning alarms in CHOP’s PICU are caused by just 4 percent to 8 percent of patients who are mainly low acuity and require less complicated care. On a daily basis, Dr. Dewan and her study team will identify one or two low-acuity patients in the PICU who have high physiologic monitor alarm rates. During safety huddles — brief, structured conversations with physicians, nurses, and other staff to mitigate safety risks — they will review the alarm data and determine if the patients could benefit from adjustment of the alarm parameters. Patients recognized during the safety huddles as eligible for intervention will be discussed further during rounds, when their physicians will decide if safe tailoring of alarm limits is warranted.
“We wanted to individualize the approach for every patient,” Dr. Dewan said. “And we didn’t want to take away any of the autonomy of the providers at the bedside who know the patient best.”
Dr. Dewan was excited to receive funding from the CPCE, which will pay for research assistance to help launch the project by early spring. She expects the pilot study to include about 200 intervention patients over a six-month period and anticipates that their alarm rates will decrease by at least 10 percent when compared to control patients.
If the huddle intervention is shown to be safe and effective in the PICU, the next step would be to integrate the data-driven approach into the workflow throughout the hospital. The data they collect eventually could be used to support application for funding from the National Institutes of Health to evaluate the intervention’s effectiveness in a multicenter study of PICUs across the U.S.
Nephrology fellow Aadil Kakajiwala, MBBS, is equally as thrilled to have been chosen by the CPCE to conduct a research project that will focus on the variability in measures of mineral metabolism in pediatric end-stage kidney disease. Chronic kidney disease (CKD) is associated with nearly universal disturbances in metabolism of calcium, phosphate, parathyroid hormone, and vitamin D that present multiple obstacles to children’s bone and cardiovascular health, nutrition, and growth. As part of his training at CHOP, Dr. Kakajiwala spent six months getting to know the young patients who visited the pediatric hemodialysis center, usually three times a week.
As part of the standard of care, the patients were monitored monthly for calcium, phosphate, parathyroid hormone. These measurements aided clinicians in making adjustments to the patients’ medications and growth hormone therapy. Dr. Kakajiwala and his mentors, including Michelle Denburg, MD, MSCE, an attending physician in the Division of Nephrology, suspect that flux in these parameters may occur often in children on dialysis, so they planned a pilot study to investigate if more frequent assessment of mineral homeostasis could help clinicians to assess bone health more closely.
“Our concern is that patients on dialysis have vitamin D and parathyroid hormone levels that are variable, and they need a lot of fine-tuning and management,” Dr. Kakajiwala said. “What we want to show from this study is whether we need to check these levels more than just every month, with the intention that we can intervene quicker and not lead to any bone or cardiovascular issues.”
As a major goal of the study is to see how decision-making would differ based on serial measures, the study will not alter usual care in any way except that an extra 3 mL of blood will be drawn pre-dialysis twice weekly from about 10 study participants over a 12-week period during the winter season. The study team will collect, store, and then analyze the blood samples, also taking note of any medication changes that were made based on the usual monthly laboratory results.
The investigators will determine how many times an intervention would have been made based on the weekly results. Dr. Kakajiwala noted that a similar study of adults showed that almost 25 percent to 40 percent of the time, the physician would have made changes to the patient’s care plan.
Dr. Kakajiwala is especially thankful for the guidance from Dr. Denburg, an assistant professor of pediatrics for the Perelman School of Medicine at the University of Pennsylvania, during his application for the CPCE grant.
“With Dr. Denburg’s expertise in chronic kidney disease and metabolic bone health, and my passion for the dialysis patients, I think this is going to be a fantastic study,” Dr. Kakajiwala said.
The CPCE accepts proposals for its pilot grant program twice a year, and promising projects undergo at least two rounds of reviews to determine that they fully meet the selection criteria. Read more about the program’s winners chosen in spring 2014: http://www.research.chop.edu/blog/investigators-excited-receive-cpce-pilot-grant-awards/