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* Pediatric and Adolescent Unit, Behavioral Research and Mental Health Section, Genetics and Epidemiology Section, Joslin Diabetes Center, Harvard Medical School, Boston, Massachusetts
Department of Medicine, Children’s Hospital of Boston, Harvard Medical School, Boston, Massachusetts
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ABSTRACT |
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 TOP ABSTRACT METHODSRESULTSDISCUSSIONCONCLUSIONSREFERENCES |
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Methods. We performed a 2-year prospective, randomized clinical trial in 299 youths with type 1 diabetes, aged 7 to 16 years, comparing 3 treatment programs (Care Ambassador [CA], Care Ambassador plus psychoeducational modules [CA+], and standard multidisciplinary diabetes care [SC]). The study was conducted in a large metropolitan US city from April 1997 through April 2000. Number of medical visits, frequency of hypoglycemic events, hospital/emergency department (ED) utilization, and glycosylated hemoglobin A1c were assessed during follow-up.
Results. During the 2-year study period, both the CA and CA+ groups had significantly more routine visits (mean [standard deviation]: 7.3 [2.06] and 7.5 [2.02], respectively) compared with the SC group (5.4 [2.62]). The CA+ intervention group had significantly reduced rates of short-term adverse outcomes compared with the other 2 groups; 25% fewer total hypoglycemic events, 60% fewer severe hypoglycemic events, and 40% fewer hospitalizations and ED visits. "High-risk" youths in the CA+ group (baseline glycosylated hemoglobin A1c 
8.7%) were 3.4-fold (1.57–7.41) more likely to improve their glycemic control compared with those at high risk in the other 2 groups.
Conclusions. For youths with type 1 diabetes, the CA and CA+ interventions increased visit frequency. Youths in the CA+ intervention had reduced rates of hypoglycemia and hospital/ED utilization with estimated annual cost savings of $80 000 to $90 000. The CA+ intervention compared with the other 2 groups improved glycemic control in "high-risk" youths. Nonmedical case management incorporating psychoeducational modules seems to be a cost-effective approach to improving outcomes in youths with diabetes.
Key Words: type 1 diabetes • pediatrics • case management • HbA1c • adverse outcomes
Abbreviations: DCCT, Diabetes Control and Complications Trial • HbA1c, glycosylated hemoglobin A1c • CA, Care Ambassador • ED, emergency department • CA+, Care Ambassador plus psychoeducational modules • SC, standard care
Diabetes is a common chronic disease that is both serious and costly. Although diabetes affects approximately 6% of the US population (17 million people), it accounts for approximately 15% of US health care expenditures.1–6 Hospitalization is the major cost driver, amounting to 40% of the total costs.1,2,4 Previous studies have shown that these costs are not equally divided among all patients but that rates of hospitalization and costs of care are higher when metabolic control is poor, chronic complications have developed, and access to care and "health literacy" (a patient’s ability to read, comprehend, and act on medical instructions) are limited.7–10
Adolescents with diabetes experience poor glycemic control and acute complications more frequently than adults, as was clearly demonstrated in the Diabetes Control and Complications Trial (DCCT).11,12 Although the adults and adolescents who were enrolled in the trial benefited equally from intensive insulin therapy with a reduction in the occurrence and progression of microvascular complications, the adolescents were unable to achieve equivalent levels of glycemic control. Adolescents in conventionally and intensively treated groups each experienced mean glycosylated hemoglobin A1c (HbA1c) levels approximately 1% higher than their adult counterparts in the trial.12 Previous studies have attributed poor glycemic control among adolescents to their changing physiology (pubertal growth and development) and to behavioral and adherence issues.12–16 The challenge of achieving optimal glycemic control in this age group underscores the need for the design, implementation, and evaluation of affordable, efficacious, and translatable interventions aimed at optimizing glycemic control and reducing acute complications.17,18
Diabetes is a highly complex disease to manage. The child with diabetes and his or her family are expected to perform a multitude of tasks, both medical and nonmedical. The medical expectations include frequent monitoring of blood glucose; multiple daily injections of insulin or continuous insulin infusion via a pump; careful meal planning with respect to timing, quality, and quantity of food ingested; attention to physical activity; and interpretation of blood glucose levels. The nonmedical challenges include scheduling and attending appointments with the diabetes health care team, disclosing and discussing medical needs with others (school personnel, coaches, and friends), obtaining diabetes supplies, paying bills, and dealing with insurance issues in addition to the burden of care associated with living with a chronic disease. Given the rigors of such a demanding regimen, a diabetes intervention model is likely to be most effective when built from a synthesis of several complementary approaches, such as enhancing coping skills and parent-child teamwork.19,20
One approach that has been applied to reduce the rate and length of hospitalizations among patients with established complications is case management.8,21–24 In recent years, such programs have proliferated, and previous work has demonstrated their effectiveness in decreasing resource use in selected chronic diseases such as congestive heart failure.25–27 Aggressive case management of established high-risk patients, however, is a secondary or tertiary preventive mechanism; ie, these patients have established complications and only palliative therapy remains. As a primary prevention, diabetes treatment programs should rather aim to optimize glycemic control and reduce the risk for both acute and chronic complications. In a previous pilot study, we found that use of a low-intensity, nonmedical case manager called a "Care Ambassador" (CA), assigned to monitor clinic attendance and assist families with issues such as appointment scheduling and confirmation, improved metabolic outcomes and significantly reduced the occurrence of acute complications such as hospital/emergency department (ED) use.28 In a second related study, an intervention targeting parent involvement around diabetes management tasks, highlighting the importance of family support, education, and positive nonjudgmental communication, was also shown to improve metabolic control.29
In the present study, we sought to merge these 2 separate lines of previous investigation. Our goal was to evaluate the CA intervention when integrated into routine pediatric diabetes office visits and to determine whether this intervention supplemented by psychoeducational modules further improved outcomes.
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METHODS |
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TOPABSTRACTMETHODSRESULTSDISCUSSIONCONCLUSIONSREFERENCES |
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Of the 301 patients initially randomized, 2 (1 in the CA and 1 in the CA+ intervention) discontinued study participation and thus were excluded from our analyses. One of the patients was excluded because of complicating psychosocial/medical issues related to her general care. The second subject attended the initial visit but then decided to discontinue study participation. The final study sample included 299 patients: 108 in the SC group, 94 in the CA group, and 97 in the CA+ group. Of note, no patients were receiving pump therapy at the start of the study (pump use was not a routine therapeutic modality at the time). By the study’s end, a total of 6 patients had started pump therapy, involving patients from each of the 3 study groups.
For participants in the CA and CA+ groups, a research assistant conducted a structured joint (patient and parent) interview at each quarterly routine medical visit to gather demographic information and to collect data concerning frequency and severity of hypoglycemia and recent hospital or ED utilization. Patients who were randomized to SC were contacted annually by telephone for ascertainment of these medical outcomes. These interviews lasted approximately 5 to 10 minutes. Each child and a parent also completed our questionnaire entitled the Blood Glucose Monitoring/Health Information Survey at 12 and 24 months, which provided a self-report of adherence behaviors and health outcomes.30 An interval history including assessment of outcomes and a physical examination were also completed for all patients at each visit by a clinician who was blinded to group assignment. These data were extracted from the medical record. The interrater reliability of data extraction from chart review exhibited >95% concordance.
CA Condition
The intervention for the families in the CA condition focused on helping patients and their families receive ambulatory diabetes care as prescribed by the patient’s usual diabetes health care team. A CA assisted the families with their appointment scheduling and confirmation and helped them with questions concerning billing or insurance by directing the families to the appropriate personnel. The primary task of the CA was to monitor the clinic attendance of intervention patients and provide telephone or written outreach to families after missed or canceled appointments. The 3 CAs, who were funded by a research grant, were college graduates who had no formal medical education and were trained by the research and medical staff; they provided no prescriptive advice. Rather, they encouraged the patients and their families to seek medical advice from their health care team in a timely manner. In this respect, they were comparable to the office personnel usually found in a medical setting. The CA spent approximately 5 to 10 minutes with each family per clinic visit and an estimated 10 to 15 minutes per family between clinic visits for scheduling and confirmation of follow-up appointments.
CA+ Condition
The intervention for the families in the CA+ condition supplemented the above CA intervention with psychoeducational modules. The written teaching modules were created by the authors and addressed 8 issues pertaining to diabetes care that included understanding HbA1c, factors affecting blood sugars, the "blame and shame" cycle, a team approach to diabetes care, blood glucose monitoring, carbohydrate counting, research trends, and a summary (see Table 2). The CAs implemented these modules at each visit with a scripted protocol to ensure consistency of intervention delivery.
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SC Condition
Similar to the other 2 study groups, families that were randomly assigned to the SC condition participated in a brief interview and completed the questionnaires at the end of years 1 and 2. In contrast to the CA and CA+ groups, a CA did not assist patients and families in the SC group with appointment scheduling, confirmation, or billing/insurance questions. Telephone or written outreach to families after missed or canceled appointments was not made by the research staff. Families in the SC condition did not receive the psychoeducational materials.
Measure of Process of Care
We assessed the process of diabetes care by the number of medical visits made to our specialty center by the participants in each of the 3 study groups.
Measures of Outcomes of Care
We assessed outcomes of diabetes care using 3 separate measures: glycemic control, frequency of hypoglycemia, and hospitalization/ED utilization. With respect to glycemic control, each patient’s HbA1c was measured using high-performance liquid chromatography at baseline and at each follow-up clinic visit standardized to the DCCT assay (reference range: 4%–6%; Tosoh Medics, Inc, Foster City, CA). For capturing the full impact of the intervention, at the end of the 2 years, a mean of each patient’s HbA1c values from the second year of study was calculated to yield a cumulative measure of glycemic control. This measure was similar to the cumulative index of glycemic exposure that predicted the risk of complications in the DCCT.11,31 An HbA1c difference was also calculated by subtracting each patient’s mean HbA1c during year 2 from the baseline HbA1c value. The HbA1c difference yielded a measure of worsening, stable, or improving glycemic control over the entire 2-year study period.
The second measure used to assess outcomes of diabetes care was the occurrence of clinically significant hypoglycemic events. The DCCT standard definition of severe hypoglycemia was used.11,12 A hypoglycemic event with neurologic impairment included a low blood sugar that required parenteral administration of glucagon or intravenous dextrose for successful treatment. A second category of severe hypoglycemia included a low blood sugar that responded to oral intake with the help of another person. The frequency of these significant events was ascertained retrospectively by patient interviews, chart reviews, and interval questionnaires. Frequency of hypoglycemia was not based on either meter downloads or patient logbooks. The numbers of months for which each patient contributed data were summed, and the clinical outcomes were tallied as the number of events per 100 patient-years.
The third measure used to assess outcomes of diabetes care was the need for hospitalization or ED use. Hospitalizations included admissions for diabetic ketoacidosis, severe hypoglycemia refractory to outpatient management, other diabetes-related problems (eg, major treatment adjustments, diabetes complicating an intercurrent illness), and problems not directly pertaining to diabetes. As stated above, the frequency of these events was ascertained by patient interviews, chart reviews, and interval questionnaires. Outcomes were tallied as the number of events per 100 patient-years.
Statistical Analysis
Statistical analysis of the data was performed with SAS software (Release 6.12; SAS Institute, Cary, NC). Means ± standard deviations are presented unless otherwise indicated. Rates of clinically significant outcomes were calculated by summing the number of events that occurred during follow-up. The 3 study groups (SC, CA, CA+) were compared. For evaluating the impact of the CA intervention, the CA and CA+ groups were compared against the SC group. For evaluating the impact of the psychoeducational component of the CA+ intervention, the CA+ group was compared against the SC and CA groups combined. Analyses included t tests, 
2, and multivariate analyses to control for potentially confounding variables such as age, duration of diabetes, and sex. P < .05 was considered significant.
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RESULTS |
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TOPABSTRACTMETHODSRESULTSDISCUSSIONCONCLUSIONSREFERENCES |
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Impact of CA Intervention on Frequency of Medical Visits
During the 24-month follow-up, 14 total patients (8 SC, 1 CA, 5 CA+) had only 1 visit over the course of study. As shown in Fig 1, the distribution of visits in the CA and CA+ groups is unimodal, with a median of 8 visits, compared with the random distribution of visits in the SC group. The CA group had a mean of 7.3 visits (2.06), and the CA+ group had a mean of 7.5 visits (2.02) compared with 5.4 visits (2.62) for the SC group (P = .0001, SC vs other 2 groups combined). The difference in the number of visits attended by the patients in the CA and CA+ groups was not significant (P = .48). Only 4 (4%) patients in the CA group and 6 (6%) patients in the CA+ group compared with 24 (22%) patients in the SC group had 
3 visits per year (2 = 57.17; df = 6; P = .001). In a multivariate analysis, assignment to a CA was the main predictor (P < .01) of visit frequency independent of patient’s age, duration of diabetes, sex, and glycemic control.
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There was no significant difference in the follow-up mean HbA1c values between the 3 study groups. However, many participants in the study had entry HbA1c values that were below the value at which the risk for complications increases dramatically (8%–9%).7,31–34 Such patients may not benefit as much from the additional support and education provided by the intervention as would patients in less optimal control. Therefore, we chose to analyze the data by including only those patients with entry HbA1c 8.7% (the median HbA1c at entry for the study population). The 42 patients in the CA+ group and the 86 patients in the SC plus CA groups who met this criterion had similar entry mean HbA1c levels (ie, high-risk patients were similar in the 3 groups).
After 24 months of follow-up, the 42 patients in the CA+ group with entry HbA1c values 8.7% had a mean HbA1c value of 9.34% (1.13). For the 86 patients in the comparison group (SC plus CA), the mean HbA1c value was significantly higher at 9.93% (1.33; P = .01, CA+ vs other 2 groups combined).
Figure 2 shows the distribution of the change in glycemic control (
HbA1c) after 24 months of follow-up for these "high-risk" patients. In the CA+ group, there was a trend toward improved glycemic control with 69% of participants experiencing a decrease in mean HbA1c during the period of study. No such trend was seen in the comparison group (SC plus CA), in which 60% of patients showed an increase in mean HbA1c during the study. The relative risk of worsening glycemic control in "high-risk" patients in the comparison group (SC plus CA) was 3.4-fold that in the CA+ group (1.57–7.41; P = .002).
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DISCUSSION |
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TOPABSTRACTMETHODSRESULTSDISCUSSIONCONCLUSIONSREFERENCES |
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7 visits during the 2 years of follow-up and thus were in keeping with the American Diabetes Association’s recommendations for routine ambulatory care at 3- to 4-month intervals for patients with type 1 diabetes.36 Only 34% of patients in the SC group followed these same guidelines, although they, too, were followed in a tertiary care center. Furthermore, 4 times as many SC patients had infrequent (3 visits) as did patients in the CA plus CA+ groups. Simply increasing clinic visit frequency was not sufficient to reduce the rate of acute complications. However, incorporating a psychoeducational component into the CA intervention decreased adverse outcomes such as hospital/ED use and hypoglycemic events. This was evidenced by a 40% reduction in the annual rate of hospitalization and ED use and a 60% reduction in the annual rate of severe hypoglycemia requiring parenteral treatment in the CA+ group compared with the other 2 groups combined. Our study is in keeping with earlier research that has shown that family-based behavioral procedures such as goal-setting, positive reinforcement, supportive parental communication, and shared responsibility for diabetes management result in improved outcomes.19,29,37–40
Although the psychoeducational interventions reduced complication rates, they failed to improve glycemic control in the CA+ group when viewed as a whole. A beneficial effect was seen, however, in patients with baseline HbA1c 8.7%. These "high-risk" patients in the CA+ group were 3 times more likely to improve their glycemic control than "high-risk" patients in the comparison group (SC plus CA). This was a key finding as there continues to be a call in the diabetes community for efficacious and translatable interventions targeting high-risk patients at the extremes of the HbA1c distribution.40,41 These data also suggest, however, that a more intensive intervention may be necessary to have a significant impact on glycemic control in patients if glycemic goals <8% are targeted. In an environment challenged by the need for cost containment, one might target high-risk patients to gain the greatest short- and long-term benefits from improvements in control.
As to the issue of costs, it should be noted that our CA intervention involved the training of nonmedical personnel to ensure that routine diabetes follow-up took place. Furthermore, it was these same individuals who implemented the psychoeducational materials in the CA+ intervention, which was associated with immediate improvements in health outcomes with reduced hospital and ED use as well as improved metabolic outcomes in "high-risk" patients. If sustained, then the latter benefits should lead to improved long-term outcomes with the recognized reduced risk of microvascular complications that accompanies lower HbA1c levels.31–33
Each CA carried a caseload of approximately 65 to 70 families and spent approximately 8 hours per week on these activities. Our 3 CAs were equally successful in maintaining medical follow-up for their study patients, suggesting that it was the intervention rather than the individual that succeeded in altering the process of care. We estimate that a single, full-time CA could manage and provide education to approximately 200 patients. With 6 hospitalizations and 14 ED visits prevented per 100 patients per year (see Table 4), we predict that cost savings would be realized within the first year of implementation. Annual savings come from averting approximately 36 hospital days (with an acute hospitalization lasting approximately 3 days at an estimated cost of $2000/d) and 28 ED visits (at $500/visit) for every 200 patients followed by a CA. This amounts to immediate cost savings of $80 000 to $90 000 as a conservative estimate. On average, there were 2 additional outpatient visits per year for CA patients compared with SC patients, with an estimate of $140 in average outpatient charges per visit. In 1 year, the cost savings associated with the reduced hospital and ED use would offset the additional outpatient charges ($56 000 per 200 patients) plus the cost of the CA (1.0 full-time position per 200 patients at approximately $25 000). These estimates of savings are conservative and reflect 1 of the study’s weaknesses as we have no true cost data. In addition, we have not considered the cost savings associated with a decreased number of missed school/work days for these patients and their family members. Any additional cost savings associated with preventing or postponing long-term complications as a result of better glycemic control would take decades to accrue.42–44
One distinct advantage of our study was that we were able to attract and enroll 299 patients with type 1 diabetes and follow them prospectively during a period of 24 months. This was important because, although the CA intervention may affect diabetes management more immediately with a reduction in acute events, psychoeducational interventions that serve to modify behaviors that can have an impact on glycemic control may take longer periods of time to produce observable effects.39,40
Several cautions must be emphasized in discussing the results of this study. Research assistants serving as Care Ambassadors followed patients from all 3 study groups. Therefore, the potential for contamination of the interventions to the SC group existed, which would serve to minimize outcome differences among the 3 groups. Biweekly research meetings stressed the importance of treatment fidelity. Also, although the prospective nature of this study was designed to minimize underreporting of adverse events, it is still possible that we have underestimated rates of adverse events in all categories because of underreporting by parents in interviews and questionnaires and by physicians in medical records. However, we may be selectively underreporting adverse outcomes to a greater extent from participants in the SC group, who had less follow-up. Recall of an adverse event is likely better when queried more proximal to the event itself. Next, the eligibility criteria of this longitudinal intervention research resulted in a very homogeneous group of participating families. This intervention needs to be replicated with a more heterogeneous sample of families. In fact, the beneficial effect may be greater if more "high-risk" patients were included in the study. For example, in a recent study, Rewers et al41 demonstrated that certain identifiable risk factors (underinsurance, the presence of a comorbid psychiatric disorder, higher HbA1c) predicted the rate of acute complications in youths with type 1 diabetes. By targeting an intervention such as ours at children with these known risk factors, it may be possible to prevent or reduce the occurrence of acute diabetes complications.
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CONCLUSIONS |
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TOPABSTRACTMETHODSRESULTSDISCUSSIONCONCLUSIONSREFERENCES |
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ACKNOWLEDGMENTS |
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We acknowledge contributions of the Pediatric Team at the Joslin Diabetes Center: Joan Mansfield, MD; Alyne Ricker, MD; Cindy Pasquarello, RN, BSN, CDE; Kristen Rice, RN, BSN, CDE; Kathleen Walsh, RN, CDE; Louise Crescenzi; and the pediatric endocrine fellows. We also acknowledge the research assistance of Jeanne Antisdel, Julienne Brackett, and Jennifer Dietrich and the computer/statistical expertise of Linda Ficociello.
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FOOTNOTES |
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Reprint requests to (L.B.M.L.) Pediatric and Adolescent Unit, Joslin Diabetes Center, One Joslin Pl, Boston, MA 02215. E-mail: lori.laffel{at}joslin.harvard.edu
Portions of this article were presented at the 60th Annual Meeting and Scientific Sessions of the American Diabetes Association; June 2000; San Antonio, TX.
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REFERENCES |
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TOPABSTRACTMETHODSRESULTSDISCUSSIONCONCLUSIONSREFERENCES |
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