Publications

BACKGROUND

Health information technology can enhance self-management and quality of life for patients with chronic disease and overcome healthcare barriers for patients with limited English proficiency. After a randomized controlled trial of a multilingual automated telephone self-management support program (ATSM) improved patient-centered dimensions of diabetes care in safety net clinics, we collaborated with a nonprofit Medicaid managed care plan to translate research into practice, offering ATSM as a covered benefit and augmenting ATSM to promote medication activation. This paper describes the protocol of the Self-Management Automated and Real-Time Telephonic Support Project (SMARTSteps).

METHODS/DESIGN

This controlled quasi-experimental trial used a wait-list variant of a stepped wedge design to enroll 362 adult health plan members with diabetes who speak English, Cantonese, or Spanish and receive care at 4 publicly-funded clinics. Through language-stratified randomization, participants were assigned to four intervention statuses: SMARTSteps-ONLY, SMARTSteps-PLUS, or wait-list for either intervention. In addition to usual primary care, intervention participants received 27 weekly calls in their preferred language with rotating queries and response-triggered education about self-care, medication adherence, safety concerns, psychological issues, and preventive services. Health coaches from the health plan called patients with out-of-range responses for collaborative goal setting and action planning. SMARTSteps-PLUS also included health coach calls to promote medication activation, adherence and intensification, if triggered by ATSM-reported non-adherence, refill non-adherence from pharmacy claims, or suboptimal cardiometabolic indicators. Wait-list patients crossed-over to SMARTSteps-ONLY or -PLUS at 6 months. For participants who agreed to structured telephone interviews at baseline and 6 months (n = 252), primary outcomes will be changes in quality of life and functional status with secondary outcomes of 6-month changes in self-management behaviors/efficacy and patient-centered processes of care. We will also evaluate 6-month changes in cardiometabolic (HbA1c, blood pressure, and LDL) and utilization indicators for all participants.

DISCUSSION

Outcomes will provide evidence regarding real-world implementation of ATSM within a Medicaid managed care plan serving safety net settings. The evaluation trial will provide insight into translating and scaling up health information technology interventions for linguistically and culturally diverse vulnerable populations with chronic disease.

TRIAL REGISTRATION

ClinicalTrials.gov: NCT00683020.

AIMS

The interval between the T-wave's peak and end (Tpe), an electrocardiographic (ECG) index of ventricular repolarization, has been proposed as an indicator of arrhythmic risk. We aimed to clarify the clinical usefulness of Tpe for risk stratification.

METHODS AND RESULTS

We evaluated 327 patients with left ventricular ejection fraction (LVEF) ≤ 35% (75% male, LVEF 23 ± 7%). All patients had an implanted implantable cardioverter-defibrillator (ICD). Clinical data and ECGs were analysed at baseline. Prospective follow-up for the endpoints of appropriate ICD therapy and mortality was conducted via periodic device interrogation, chart review, and the Social Security Death Index. During device clinic follow-up of 17 ± 12 months, 59 (18%) patients had appropriate ICD therapy, and during mortality follow-up of 30 ± 13 months, 67 (21%) patients died. A longer Tpe(c) predicted appropriate ICD therapy, death, and the combination of appropriate ICD therapy or death (P< 0.01 for each endpoint). On multivariable analysis correcting for other univariable predictors, Tpe(c) remained predictive of ICD therapy [hazard ratio (HR) per 10 ms increase: 1.16, P= 0.02], all-cause mortality (HR per 10 ms: 1.14, P= 0.03), and the composite endpoint of ICD therapy or death (HR per 10 ms: 1.16, P< 0.01).

CONCLUSIONS

In patients with left ventricular systolic dysfunction and an implanted ICD, Tpe(c) independently predicts both ventricular tachyarrhythmia and overall mortality.

BACKGROUND

Artesunate-amodiaquine (AS&AQ) is a widely used artemisinin combination therapy (ACT) for falciparum malaria. A comprehensive appreciation of its effects on haematology vs other anti-malarials is needed in view of potential safety liabilities.

METHODS

Individual-patient data analysis conducted on a database from seven randomized controlled trials conducted in sub-Saharan African comparing AS&AQ to reference treatments in uncomplicated falciparum malaria patients of all ages. Haematologic values (white cells total and neutrophil counts, haemoglobin/haematocrit, platelets) were analysed as both continuous and categorical variables for their occurrence, (severity grade 1-4) and changes during follow-up. Risks and trends were calculated using multivariate logistic random effect models.

RESULTS

4,502 patients (72% < 5 years old), from 13 sites in nine countries with 28-day follow-up were treated with AS&AQ (45%) or a comparator (other forms of ACT accounted for 27%, other combination 12%, mono-therapies 16%). Pre-treatment leucopaenia (3%) and neutropaenia (6%) were infrequent; anaemia was common (39%). The treatment-emergent adverse events incidence (TEAE = condition not present or less severe pre-treatment) was 11% for neutropaenia, 6% for thrombocytopaenia with AS&AQ and not different from treatment groups; anaemia was higher with AS&AQ (20%) or other forms of ACT (22%) than in non-artemisinin groups (4%, p = 0.001). Multivariate analysis showed that the risk of anaemia, thrombocytopaenia, and leucopaenia decreased with follow-up time, while neutropaenia increased; the risk of anaemia and thrombocytopaenia increased with higher baseline parasitaemia and parasitological reappearance. White cells total count was not a good surrogate for neutropaenia. No systematic significant difference between treatments was detected. Older patients were at lower risks.

CONCLUSION

The effects of AS&AQ on haematologic parameters were not different from those of other anti-malarial treatments used in sub-Saharan Africa. This analysis provides the basis for a broader evaluation of haematology following anti-malarial treatment. Continuing monitoring of haematologic safety on larger databases is required.