Effectiveness of home blood pressure monitoring, Web communication, and pharmacist care on hypertension control: a randomized controlled trial.

CONTEXT: Treating hypertension decreases mortality and disability from cardiovascular disease, but most hypertension remains inadequately controlled. OBJECTIVE: To determine if a new model of care that uses patient Web services, home blood pressure (BP) monitoring, and pharmacist-assisted care improves BP control. DESIGN, SETTING, AND PARTICIPANTS: A 3-group randomized controlled trial, the Electronic Communications and Home Blood Pressure Monitoring study was based on the Chronic Care Model. The trial was conducted at an integrated group practice in Washington state, enrolling 778 participants aged 25 to 75 years with uncontrolled essential hypertension and Internet access. Care was delivered over a secure patient Web site from June 2005 to December 2007. INTERVENTIONS: Participants were randomly assigned to usual care, home BP monitoring and secure patient Web site training only, or home BP monitoring and secure patient Web site training plus pharmacist care management delivered through Web communications. MAIN OUTCOME MEASURES: Percentage of patients with controlled BP (<140/90 mm Hg) and changes in systolic and diastolic BP at 12 months. RESULTS: Of 778 patients, 730 (94%) completed the 1-year follow-up visit. Patients assigned to the home BP monitoring and Web training only group had a nonsignificant increase in the percentage of patients with controlled BP (<140/90 mm Hg) compared with usual care (36% [95% confidence interval {CI}, 30%-42%] vs 31% [95% CI, 25%-37%]; P = .21). Adding Web-based pharmacist care to home BP monitoring and Web training significantly increased the percentage of patients with controlled BP (56%; 95% CI, 49%-62%) compared with usual care (P < .001) and home BP monitoring and Web training only (P < .001). Systolic BP was decreased stepwise from usual care to home BP monitoring and Web training only to home BP monitoring and Web training plus pharmacist care. Diastolic BP was decreased only in the pharmacist care group compared with both the usual care and home BP monitoring and Web training only groups. Compared with usual care, the patients who had baseline systolic BP of 160 mm Hg or higher and received home BP monitoring and Web training plus pharmacist care had a greater net reduction in systolic BP (-13.2 mm Hg [95% CI, -19.2 to -7.1]; P < .001) and diastolic BP (-4.6 mm Hg [95% CI, -8.0 to -1.2]; P < .001), and improved BP control (relative risk, 3.32 [95% CI, 1.86 to 5.94]; P<.001). CONCLUSION: Pharmacist care management delivered through secure patient Web communications improved BP control in patients with hypertension. Trial Registration clinicaltrials.gov Identifier: NCT00158639.

Electronic communications and home blood pressure monitoring (e-BP) study: design, delivery, and evaluation framework.

BACKGROUND: Randomized controlled trials have provided unequivocal evidence that treatment of hypertension decreases mortality and major disability from cardiovascular disease; however, blood pressure remains inadequately treated in most affected individuals. This large gap continues despite the facts that more than 90% of adults with hypertension have health insurance, and hypertension is the leading cause of visits to the doctor. New approaches are needed to improve hypertension care. OBJECTIVES: The Electronic Communications and Home Blood Pressure Monitoring (e-BP) study is a three-arm randomized controlled trial designed to determine whether care based on the Chronic Care Model and delivered over the Internet improves hypertension care. The primary study outcomes are systolic, diastolic, and blood pressure control; secondary outcomes are medication adherence, patient self-efficacy, satisfaction and quality of life, and healthcare utilization and costs. METHODS: Hypertensive patients receiving care at Group Health medical centers are eligible if they have uncontrolled blood pressure on two screening visits and access to the Web and an e-mail address. Study participants are randomly assigned to three intervention groups: (a) usual care; (b) home blood pressure monitoring receipt and proficiency training on its use and the Group Health secure patient website (with secure e-mail access to their healthcare provider, access to a shared medical record, prescription refill and other services); or (c) this plus pharmacist care management (collaborative care management between the patient, the pharmacist, and the patient's physician via a secure patient website and the electronic medical record). CONCLUSION: We will determine whether a new model of patient-centered care that leverages Web communications, self-monitoring, and collaborative care management improves hypertension control. If this model proves successful and cost-effective, similar interventions could be used to improve the care of large numbers of patients with uncontrolled hypertension.

Healthy steps in an integrated delivery system: child and parent outcomes at 30 months.

OBJECTIVE: To test the effects of the Healthy Steps for Young Children program (HS) (which supports parents managing children's developmental and behavioral issues)-with and without a prenatal component-on child health and development, parenting practices, and parental well-being. DESIGN: A concurrent comparison with clinic-level assignment to intervention or usual care status. Nested in the intervention arm, a randomized trial compared HS with and without a prenatal component. SETTING: Five primary care clinics in an integrated delivery system in the Pacific Northwest. PARTICIPANTS: A consecutive sample of 439 pregnant women (80% of eligible) were enrolled. Follow-up data were obtained for 78% when the child was 30 months old. Intervention Families in intervention clinics received HS services, including developmental and behavioral advice and risk factor screening. In addition, those randomized to prenatal services received 3 home visits during pregnancy. MAIN OUTCOME MEASURES: Assessed by telephone interview in the 3 domains of child health and development, parenting practices, and parental well-being. RESULTS: Intervention was associated with positive outcomes in timely well-child care, immunization rates, breastfeeding, television viewing, injury prevention, and discipline strategies. Prenatal initiation of services was associated with larger expressive vocabularies at age 24 months. Mothers who received the intervention reported more depressive symptoms, but there was no increase in the proportion with clinically significant depression. CONCLUSIONS: For members of an integrated delivery system, the HS intervention was associated with positive effects on children's health and parenting practices. There was little evidence of any additional benefit of HS services initiated during the prenatal period.

Expanding developmental and behavioral services for newborns in primary care; Effects on parental well-being, practice, and satisfaction.

BACKGROUND: Healthy Steps (HS) was designed to address, prospectively, behavioral and developmental support needs of young families in pediatric clinical care settings. PrePare (PP) initiates these services prenatally, whereas HS begins services in the postnatal period. Both interventions have universal and risk-directed components. Intervention effects in the first 3 months after birth are reported here. METHODS: A quasi-experimental design was used to allocate 439 participants to intervention or usual care conditions. Within the intervention group, enrollees were randomly assigned to receive HS or PP+HS services. Early outcomes were assessed by telephone survey at 1 week and 3 months postpartum. RESULTS: Mothers in either intervention condition were less likely to report depressive symptoms and more likely to describe themselves as pleased in their role as parents. Intervention families were more likely to continue breastfeeding and more likely to read to their 3-month-old. Knowledge of infant development and recognition of appropriate discipline was greater among intervention recipients. Satisfaction with pediatric care was higher among intervention recipients and the rate of health plan disenrollment was 75% lower at 3 months among those enrolled in the prenatal intervention. No other outcome difference emerged between HS and PP+HS enrollees. CONCLUSIONS: Receipt of either intervention was associated with positive effects on health, safety, and developmentally appropriate parenting, as assessed in early infancy. There were positive effects on health plan disenrollment. No additional benefit could be ascribed to prenatal institution of services. A combination of universal and risk-based support for new parents is recommended, rather than the provision of risk-based services alone.

Expanding developmental and behavioral services for newborns in primary care: program design, delivery, and evaluation framework.

BACKGROUND: Healthy Steps (HS) for Young Children strengthens the healthcare system as a source of developmental and behavioral support for parents. This series of papers presents a study of HS as implemented within a large health maintenance organization that tested the benefit of beginning intervention services during pregnancy with an extension program called "PrePare" (PP). METHODS: The design was a quasi-experimental comparison of intervention families with families receiving usual care. Within the intervention, families were assigned randomly to begin receiving Healthy Steps services prenatally (PP+HS) or shortly after birth (HS). We used a systems model, PRECEDE/PROCEED, for planning, implementation, and process evaluation. Outcomes examined when the infants were aged 3 months included changes in family social support and capacity for parenting, parenting behaviors, and satisfaction and loyalty to the health plan. RESULTS: The sample of 439 families was distributed as follows: usual care (n=136), prenatal initiation of services (PP+HS; n=151), and postnatal Healthy Steps (HS; n=152). Information about program implementation, including provider satisfaction, is provided for the early phases of the study (through age 3 months). The intervention was delivered with fidelity and with minimal disruption to the practice styles of pregnancy providers, most of whom considered the program valuable to their patients. Relative to families in the comparison group, families in the intervention group received more usual care services and more intervention-specific services. CONCLUSIONS: The pregnancy and newborn phases of the intervention were embedded successfully within the existing healthcare delivery system. The program was considered valuable for parents by providers and parents. Participating families received more services and a greater variety of services than families in usual care. Whether these differences result in beneficial outcomes for families or the health plan are topics of the subsequent papers.