Preventing Home Medication Administration Errors.

Medication administration errors that take place in the home are common, especially when liquid preparations are used and complex medication schedules with multiple medications are involved; children with chronic conditions are disproportionately affected. Parents and other caregivers with low health literacy and/or limited English proficiency are at higher risk for making errors in administering medications to children in their care. Recommended strategies to reduce home medication errors relate to provider prescribing practices; health literacy-informed verbal counseling strategies (eg, teachback and showback) and written patient education materials (eg, pictographic information) for patients and/or caregivers across settings (inpatient, outpatient, emergency care, pharmacy); dosing-tool provision for liquid medication measurement; review of medication lists with patients and/or caregivers (medication reconciliation) that includes prescription and over-the-counter medications, as well as vitamins and supplements; leveraging the medical home; engaging adolescents and their adult caregivers; training of providers; safe disposal of medications; regulations related to medication dosing tools, labeling, packaging, and informational materials; use of electronic health records and other technologies; and research to identify novel ways to support safe home medication administration.

Association of care in a medical home and health care utilization among children with sickle cell disease.

OBJECTIVE: Sickle cell disease (SCD) is marked by high utilization of medical services. The aim of this study was to determine whether having a patient-centered medical home (PCMH) is associated with a reduction in emergency care (ED) utilization or hospitalizations among children with SCD. METHODS: We collected and analyzed data from parents of 150 children, ages 1 to 17 years, who received care within a large children's hospital. The primary dependent variables were rates of parent-reported ED visits and hospitalizations. The principal independent variable was parent-reported experience with an overall PCMH or its four individual components (regular provider, comprehensive care, family-centered care, and coordinated care). Multivariate negative binomial regression, yielding incident rate ratios (IRR), was used for analysis. RESULTS: Children who received comprehensive care had half the rate of ED visits (IRR 0.51, 95% confidence interval, 0.33-0.78) and nearly half the rate of hospitalizations (IRR 0.56, 95% confidence interval, 0.33-0.93) compared to children without comprehensive care. No other component of the PCMH was significantly associated with ED visits or hospitalizations. Children reported to have excellent/very good/good health status had lower odds of ED visits and hospitalizations compared to those reported to be in fair/poor condition. CONCLUSIONS: Children with SCD reported to experience comprehensive care had lower rates of ED encounters and hospitalizations after controlling for demographics and health status. The overall findings highlight that the provision of comprehensive care--having a usual source of care and no problems with referrals--may provide a strategy for improving pediatric SCD care.

Pain and other non-neurological adverse events in children with sickle cell anemia and previous stroke who received hydroxyurea and phlebotomy or chronic transfusions and chelation: results from the SWiTCH clinical trial.

To compare the non-neurological events in children with sickle cell anemia (SCA) and previous stroke enrolled in SWiTCH. The NHLBI-sponsored Phase III multicenter randomized clinical trial stroke with transfusions changing to hydroxyurea (SWiTCH) (ClinicalTrials.gov NCT00122980) compared continuation of chronic blood transfusion/iron chelation to switching to hydroxyurea/phlebotomy for secondary stroke prevention and management of iron overload. All randomized children were included in the analysis (intention to treat). The Fisher's Exact test was used to compare the frequency of subjects who experienced at least one SCA-related adverse event (AE) or serious adverse event (SAE) in each arm and to compare event rates. One hundred and thirty three subjects, mean age 13 ± 3.9 years (range 5.2-19.0 years) and mean time of 7 years on chronic transfusion at study entry, were randomized and treated. Numbers of subjects experiencing non-neurological AEs were similar in the two treatment arms, including SCA-related events, SCA pain events, and low rates of acute chest syndrome and infection. However, fewer children continuing transfusion/chelation experienced SAEs (P = 0.012), SCA-related SAEs (P = 0.003), and SCA pain SAEs (P = 0.016) as compared to children on the hydroxyurea/phlebotomy arm. The timing of phlebotomy did not influence SAEs. Older age at baseline predicted having at least 1 SCA pain event. Patients with recurrent neurological events during SWiTCH were not more likely to experience pain. In children with SCA and prior stroke, monthly transfusions and daily iron chelation provided superior protection against acute vaso-occlusive pain SAEs when compared to hydroxyurea and monthly phlebotomy.

The medical home experience among children with sickle cell disease.

BACKGROUND: While a large body of research documents acute care services for children with sickle cell disease (SCD), little is known about the primary care experiences of this population. The goal of this study was to determine to what extent children with SCD experienced care consistent with a patient-centered medical home (PCMH). PROCEDURE: We collected and analyzed data from 150 children, ages 1-17 years, who received care within a large children's hospital. The primary dependent variable was access to a PCMH or its four individual components (regular provider, comprehensive care, family-centered care, and coordinated care) as determined by parental report. Multivariate logistic regression was conducted to investigate associations between socio-demographic variables and having access to a PCMH. RESULTS: Only 11% (16/150) of children qualified as having a PCMH, achieving the required thresholds in all four components. Approximately half of children had access to two or fewer components. Over 90% of children were reported to have a personal provider. Two-thirds of children had access to comprehensive care. Almost 60% of children were reported to receive family-centered care. Only 20% of children had access to coordinated care. No consistent associations were found between socio-demographic variables and having access to a PCMH or its individual components. CONCLUSIONS: Within our study sample, children with SCD experienced multiple deficiencies in having access to a PCMH, particularly with respect to care coordination. However, further studies with larger samples are needed to determine associations between socio-demographic variables and having a PCMH.

High resource hospitalizations among children with vaso-occlusive crises in sickle cell disease.

BACKGROUND: Vaso-occlusive crises (VOCs) contribute to frequent hospitalizations among children with sickle cell disease (SCD). The objective of this study was to identify factors associated with high resource utilization during hospitalizations for VOC. PROCEDURE: We analyzed pediatric discharges 0-18 years of age with a primary diagnosis of SCD with crisis from the 2006 Kids' Inpatient Database, a nationally representative sample of pediatric hospital discharges. High resource hospitalizations were defined as those in the highest decile for total charges. We conducted sample-weighted regression analyses to determine associations between independent variables (patient demographics, hospital characteristics, illness severity) and high resource use. RESULTS: There were 9,893 (0.371%) discharges for children with VOCs. Median total hospitalization charges were $10,691. In multivariate analysis, children 15-18 years of age (odds ratio [OR] 3.39, 95% confidence interval [CI] 2.54-4.53), 10-14 years of age (OR 2.72, 95% CI 2.07-3.59), and 5-9 years of age (OR 1.74, 95% CI 1.30-2.34) had higher odds of high resource hospitalizations compared to children 0-4 years of age. Care in a children's hospital had three times the odds of high resource use compared to care in a general hospital. Discharges with secondary diagnoses including pneumonia (OR 2.46, 95% CI 1.96-3.09) and constipation (OR 1.78, 95% CI 1.31-2.40) were also associated with high resource use. CONCLUSIONS: Older age and secondary diagnoses were associated with high resource use during VOC hospitalizations. These findings suggest the need to improve adherence to comprehensive care among older children to prevent VOCs and standardize protocols to manage VOC complications.

Healthcare utilization and expenditures for low income children with sickle cell disease.

BACKGROUND: While multiple studies have examined the healthcare burden of sickle cell disease (SCD) in adults, few have specifically focused on healthcare utilization and expenditures in children. The objective of this study was to characterize the healthcare utilization and costs associated with the care of low-income children with SCD in comparison to other children of similar socioeconomic status. PROCEDURE: For the study period, 2004-2007, we conducted a retrospective, cross-sectional descriptive analysis of administrative claims data from a managed care plan exclusively serving low-income children with Medicaid and the State Children's Health Insurance Plan (SCHIP). Patient demographics, continuity of insurance coverage, healthcare utilization, and expenditures were collected for all children enrolled with SCD and the general population within the health plan for comparison. RESULTS: On average, 27% of members with SCD required inpatient hospitalization and 39% utilized emergency care in a given calendar year. Both values were significantly higher than those of the general health plan population (P < 0.0001). Across the study period, 63% of members with SCD averaged one well child check per year and 10% had a minimum of one outpatient visit per year to a hematologist for comprehensive specialty care. CONCLUSIONS: Low-income children with SCD demonstrate significantly higher healthcare utilization for inpatient care, emergency center care, and home health care compared to children with similar socio-demographic characteristics. A substantial proportion of children with SCD may fail to meet minimum guidelines for outpatient primary and hematology comprehensive care.

A critical assessment of transcranial doppler screening rates in a large pediatric sickle cell center: opportunities to improve healthcare quality.

BACKGROUND: Transcranial Doppler ultrasound (TCD) has been demonstrated to be a powerful predictor of stroke risk due to sickle cell disease (SCD) in pediatric populations. Little is known about how this healthcare innovation has disseminated into preventive care for SCD. The objective of this study was to determine TCD screening rates and modifiable patient barriers in children with SCD. PROCEDURE: We retrospectively assessed the screening of 207 children with SCD at the Texas Children's Sickle Cell Center over a 3-year period (2004-2006). Demographics, adherence to comprehensive care visits, severity of disease, and distance from the sickle cell center were obtained from computerized medical record databases. Screenings cancelled or missed by patients were extracted from a computerized order entry system. RESULTS: The average yearly screening rate for eligible patients was 45%. The average yearly cancellation rate by patients was 20%. Patient with private insurance were three times more likely to be compliant with ordered screenings than patients with Medicaid (P = 0.0077). Patients adherent to hematology comprehensive care visits more likely underwent ordered screenings than those who were not (P = 0.0386). When given at least one opportunity per year, providers, on average, ordered TCD screening 74% of the time when it was indicated. CONCLUSIONS: Despite evidence that routine screening to assess stroke risk is vital to the preventive care of SCD, implementation of this healthcare technology may be slow to disseminate due to patient and provider related factors.

Patient-reported outcomes of deferasirox (Exjade, ICL670) versus deferoxamine in sickle cell disease patients with transfusional hemosiderosis. Substudy of a randomized open-label phase II trial.

BACKGROUND/AIMS: There is increasing evidence demonstrating the value of transfusions in sickle cell disease (SCD). However, resultant iron overload can be life threatening if untreated. Chelation therapy with deferoxamine requires parenteral infusions that can negatively impact quality of life and adherence to treatment. METHODS: As part of a phase II trial, SCD patient-reported outcomes were evaluated. One hundred and ninety-five patients were randomized (2:1) to receive oral deferasirox (5-30 mg/kg/day) or deferoxamine (20-50 mg/kg, 5 days per week); 121 had previously received deferoxamine. RESULTS: At each time point, significantly more patients who had previously received deferoxamine were 'satisfied/very satisfied' with deferasirox, or found treatment to be 'convenient/very convenient' compared with deferoxamine (p < 0.001). In these patients, fewer hours were lost from daily activities with deferasirox than deferoxamine treatment. Most patients (77%) preferred deferasirox, and more were willing to continue taking deferasirox than deferoxamine at end-of-study (84 vs. 11%, respectively). CONCLUSIONS: Patients with SCD are therefore more satisfied with deferasirox, which has a lower impact on daily activities than deferoxamine. Given the high levels of satisfaction, it is likely that quality of life will be improved. These results also suggest that treatment adherence with deferasirox may be better than with deferoxamine, which should lead to improved long-term outcomes.

A randomised comparison of deferasirox versus deferoxamine for the treatment of transfusional iron overload in sickle cell disease.

Deferasirox is a once-daily, oral iron chelator developed for treating transfusional iron overload. Preclinical studies indicated that the kidney was a potential target organ of toxicity. As patients with sickle cell disease often have abnormal baseline renal function, the primary objective of this randomised, open-label, phase II trial was to evaluate the safety and tolerability of deferasirox in comparison with deferoxamine in this population. Assessment of efficacy, as measured by change in liver iron concentration (LIC) using biosusceptometry, was a secondary objective. A total of 195 adult and paediatric patients received deferasirox (n = 132) or deferoxamine (n = 63). Adverse events most commonly associated with deferasirox were mild, including transient nausea, vomiting, diarrhoea, abdominal pain and skin rash. Abnormal laboratory studies with deferasirox were occasionally associated with mild non-progressive increases in serum creatinine and reversible elevations in liver function tests. Discontinuation rates from deferasirox (11.4%) and deferoxamine (11.1%) were similar. Over 1 year, similar dose-dependent LIC reductions were observed with deferasirox and deferoxamine. Once-daily oral deferasirox has acceptable tolerability and appears to have similar efficacy to deferoxamine in reducing iron burden in transfused patients with sickle cell disease.