The American Journal of Managed Care November 2009
Randomized Trial of an Electronic Asthma Monitoring System Among New York City Children
Children who used an electronic monitoring system had as many emergency department visits and hospitalizations for asthma as children who used a paper diary.
Objectives: To test the efficacy of an electronic asthma monitoring system (AMS) to reduce pediatric emergency department (ED) visits and hospitalizations for asthma.
Study Design: Randomized clinical trial. Methods: Families of pediatric patients with asthma aged 8 to 17 years were recruited at 6 medical centers. Children were randomly assigned to the American Medical Alert Corporation pediatric AMS or a paper diary. The numbers of and costs associated with ED visits and hospitalizations for the 2 groups in the year following randomization were compared using t tests of statistical significance.
Results: Of 59 children recruited to the trial, 29 were randomized to the AMS and 30 to the diary. The 2 groups were similar in demographic and clinical characteristics. During their study year, 24 AMS group members logged on a mean (SD) of 211.0 (117.3) days; 13 diary group members provided data on a mean (SD) of 136.6 (128.0) days. During the 32 months that the study was in progress, the case managers logged on a mean (SD) of 171.0 (97.2) days. Overall, 35 children had at least 1 ED visit, but only 7 children were hospitalized. The 2 groups had no statistically significant differences in the numbers of or charges associated with ED visits or hospitalizations.
Conclusion: Electronic devices are being developed to make chronic disease management easier for patients and their families, but they should not be adopted without careful study, including randomized trials, to ascertain their use, costs, and benefits.
(Am J Manag Care. 2009;15(11):809-814)
In a randomized trial, children with asthma who used an electronic asthma monitoring system had as many emergency department visits and hospitalizations as children who used a paper diary.
- Clinical trial methods can be a valuable aid to decision making about reimbursement for costly new technologies.
- Case managers are typically busy dealing with urgent conditions and needy patients. Expecting them to log on to a Web site on a daily basis without a prompt may be unrealistic.
- Whether adding a prompt would yield better results for the electronic system can be determined but would require further research.
Asthma is the most common chronic disease in children. Despite intensive asthma control efforts during the past decade, the disease is the number one cause of emergency department (ED) visits and hospitalizations. Asthma impairs the quality of life of patients and families in the short term, and frequent absences from school may limit the aspirations of children with poorly controlled asthma, as well as their potential contributions to society in the long term. For patients with more than mild asthma with infrequent exacerbations, treatment involves daily use of a controller medication, usually an inhalable corticosteroid, plus rescue medication for use during exacerbations.1 Good outcomes for patients with asthma rely on effective patient education, regular and correct use of medications, and early recognition of symptoms requiring medication or medical attention. Poor outcomes in the treatment of asthma may be attributed in part to suboptimal patient adherence to the asthma action plan (treatment plan), ineffective communication between patient and physician,2 and inadequate or nonexistent asthma action plans.3,4 To assess adherence to the treatment plan, physicians often ask their patients to keep an asthma diary, but compliance with diaries is generally poor. Sharek et al5 studied children who averaged 0.41 hospitalizations and 3.5 ED asthma “sick” visits in the 2 months before enrollment in the study. They found that, among parents of 119 disadvantaged inner-city children with moderate-to-severe asthma, compliance with an asthma diary was 64%. However, new technologies offer the prospect of improving adherence,6 information about adherence,7 or both.
In New York City, approximately 300,000 children (17%) have been diagnosed as having asthma at some time in their lives.8 The prevalence of asthma is highest among the low-income neighborhoods of the South Bronx, East Harlem, and Central Harlem. Children who live in those neighborhoods are almost 3 times as likely to be hospitalized for asthma as those in higher-income neighborhoods in part because of inadequate control of their condition.8
The hospitals of the New York City Health and Hospitals Corporation (HHC) are primary providers of healthcare for low-income children in New York City. In 2002, more than 20,000 pediatric visits to HHC EDs and urgent clinics carried a primary diagnosis of asthma (6% of all pediatric ED visits and 35% of urgent outpatient visits). Since 1997, pediatric ED visits and hospitalizations have declined somewhat,9 but better asthma management seems achievable and may reduce the economic and human costs of this chronic condition.
In 2002, in an attempt to reduce the ED and hospitalization rates among his most difficult pediatric patients with asthma,10 the director of pediatrics at HHC’s Coney Island Hospital provided the Health Buddy, a computerized device developed by the American Medical Alert Corporation (AMAC [Oceanside, NY]) and programmed with their pediatric asthma monitoring system (AMS), to 69 children aged 8 to 16 years who had been diagnosed as having moderate-to-severe asthma. The patients had had a mean of 2.4 ED visits per month and 1 hospitalization every 7 weeks during the previous winter. Based on the prior winter’s data from Coney Island Hospital, the children were expected to have 2 to 3 ED visits per month and 3 to 4 hospitalizations during the 6-month study period from October 2002 to March 2003. In fact, only 1 child had an ED visit and was hospitalized (W. Seigel, MD, and M. Rutstein, RN, oral communication, July 2003). These results stimulated considerable interest in the new technology. We initiated a randomized controlled trial to test the hypothesis that among children with moderate-to-severe asthma those assigned to use the AMS would have fewer ED visits and hospitalizations than those assigned to use a paper diary.
MetroPlus Health Plan, a wholly owned subsidiary of HHC and its primary managed care plan, covers more than 105,000 children, mainly through Medicaid. We conducted the study among MetroPlus Health Plan member children receiving care for asthma at the following 6 HHC medical centers: Bellevue Medical Center, Elmhurst Hospital Center, Harlem Hospital Center, Jacobi Medical Center, North Central Bronx Hospital, and Woodhull Medical and Mental Health Center. Together these hospitals receive approximately 3000 emergent visits per year from children aged 8 to 17 years with a primary diagnosis of asthma.
The AMAC System
The AMAC electronic monitoring systems are used to assist patients with self-management of various chronic conditions, including congestive heart failure and diabetes mellitus. The pediatric AMS is installed in patients’ homes to help them track their status with respect to their condition, to remind them to take their medication as prescribed, to instruct them to consult their provider when necessary, and to keep their case manager apprised of their status. The AMS uses patient dialogues written for a fourthgrade reading level but is considered interpretable by most children at least 8 years old. The hardware is a hand-sized electronic device with 4 keys and cords that plug into an electrical outlet and a telephone jack. It operates toll free.
Daily at a predetermined time, the device beeps and invites the child to answer a short list of questions (varied from encounter to encounter) about his or her asthma symptoms and use of medications since the last check. If the responses to these questions indicate that the child is having an asthma exacerbation, the system responds with appropriate instructions. The data are uploaded to a central site, where a clinician or case manager is responsible for reviewing them; he or she may then telephone the home to assess the child’s status, adjust the child’s medications if necessary, or have the child come in to see the physician.
Questions and answers are designed to identify symptoms early. Additional trivia questions are designed to keep children engaged while they learn about managing their condition.
The Paper Diary
The diaries (see eAppendix available at www.ajmc.com) were designed to replicate, to the extent that paper could do so, the questions and information that the AMS used. However, the primary purpose of the AMS was not data collection but facilitation of asthma self-management. The diaries provided the control group with a tool that, although commonly used for the same purpose, lacked the electronic reminder features of the AMS. We viewed it as a kind of placebo. For each month, a cover sheet contained instructions for self-monitoring of peak expiratory flow, definitions of asthma zones, and the names of the child’s controller and rescue medications. On subsequent pages were questions about whether the child had gone to school, how the day had gone, the morning and evening peak expiratory flows, medication use, any symptoms, and what the child had done about the symptoms. Columns for each day of the week contained “Ys” for yes, “Ns” for no, or emoticons to be circled as appropriate. Each day’s column was a different color. Each child received a large white 3-ring binder with 12 tabs (labeled for each month of the study year) and a cover sheet and five 1-week diary pages per tab. In a pocket of the binder were 12 addressed and postage-paid envelopes in which each month’s diaries could be mailed to the case managers. The binders were attractively personalized with the child’s name.
Patients aged 8 to 17 years who had 2 or more ED visits or 1 hospitalization with a primary diagnosis of asthma at 1 of 6 participating HHC medical centers in the year before recruitment were invited to participate in the trial. Continuous eligibility in MetroPlus Health Plan was not a requirement for participation in the study. The study was approved by the institutional review boards of the participating hospitals and Columbia University.
After giving their informed consent (via parent or guardian) and assent, participating children were randomly assigned to receive the AMS or to be control subjects. All study materials were made available in English and Spanish. In a few cases, interpreters translated the consent and assent forms into other languages for the parents.
Each hospital assigned a clinical case manager to be responsible for daily review of and, if appropriate, response to the information that the AMS automatically sent to a passwordprotected Web site every night. Upon enrolling a child, the case manager sent the child’s contact information to MetroPlus Health Plan, which held the randomization codes and forwarded the information to AMAC staff or the diary health educators, depending on the randomization assignment.
The AMAC staff or the diary health educators then arranged to visit the child, to bring the AMS or diary, and to train the child in its use. All children were taught the definitions of the green, yellow, and red zones commonly used in asthma action plans.
All training included instruction in the correct use of the peak expiratory flow monitor, determination of the child’s personal best and yellow and red zone ranges, and directions to monitor peak expiratory flow and to use the AMS or diary daily. All participating facilities used uniform clinical protocols for managing pediatric patients with asthma. All study participants received appropriate standard care during their trial participation. AMAC trained the case managers and set up access to the AMS Web site for the patients on their computers. Case managers were instructed to contact patients and to arrange for them to see their provider when they entered the red zone.
Upon enrollment, all study participants completed a demographic and behavioral questionnaire. The primary outcomes of interest were ED visits for asthma, hospitalizations for asthma, and their costs. These data were obtained from the MetroPlus Health Plan member utilization database.
Children in the AMS and diary groups were compared with respect to demographic characteristics and asthma status at baseline. X2 tests were used to assess the statistical significance of differences between the 2 groups. The mean numbers of and charges for ED visits and hospitalizations in the year following enrollment were compared between groups using t tests and X2 tests.
From August 2004 through April 2006, a total of 59 subjects were recruited (Table 1), of whom 29 were randomized to the AMS and 30 to the diary. The groups did not differ with respect to sex (30 girls and 29 boys), age at baseline (age range, 8-15 years for both), race/ethnicity (23 non-Hispanic black, 26 Hispanic, and 10 other or unknown), or recent history of asthma attacks. Overall, 50 subjects had had at least 1 ED visit in the prior year, and 24 subjects had had at least 1 hospitalization.