INTRODUCTION: The CONDUIT-HID intervention integrates patients' electronic blood pressure measurements directly into the clinical EHR using Microsoft HealthVault as an intermediary data store. The goal of this paper is to describe generalizable categories of patient and technical challenges encountered in the development and implementation of this inexpensive, commercial off-the-shelf consumer health informatics intervention, examples of challenges within each category, and how the example challenges were resolved prior to conducting an RCT of the intervention. METHODS: The research team logged all challenges and mediation strategies during the technical development of the intervention, conducted home visits to observe patients using the intervention, and conducted telephone calls with patients to understand challenges they encountered. We then used these data to iteratively refine the intervention. RESULTS: The research team identified a variety of generalizable categories of challenges associated with patients uploading data from their homes, patients uploading data from clinics because they did not have or were not comfortable using home computers, and patients establishing the connection between HealthVault and the clinical EHR. Specific challenges within these categories arose because: (1) the research team had little control over the device and application design, (2) multiple vendors needed to coordinate their actions and design changes, (3) the intervention use cases were not anticipated by the device and application designers, (4) PHI accessed on clinic computers needed to be kept secure, (5) the research team wanted the data in the clinical EHR to be valid and reliable, (6) patients needed the ability to share only the data they wanted, and (7) the development of some EHR functionalities were new to the organization. While these challenges were varied and complex, the research team was able to successfully resolve each one prior to the start of the RCT. CONCLUSIONS: By identifying these generalizable categories of challenges, we aim to help others proactively search for and remedy potential challenges associated with their interventions, rather than reactively responding to problems as they arise. We posit that this approach will significantly increase the likelihood that these types of interventions will be successful.

OBJECTIVE: To examine various strategies for the identification of adverse drug events (ADEs) among older persons in the ambulatory clinical setting. DESIGN: A cohort study of Medicare enrollees (n = 31,757 per month) receiving medical care from a large multispecialty group practice during a 12-month observation period (July 1, 1999 through June 30, 2000). MEASUREMENTS: Possible drug-related incidents occurring in the ambulatory clinical setting were detected using signals from multiple sources. RESULTS: During the tracking period, there were 1,523 identified ADEs, of which 421 (28%) were considered preventable. Across all sources, 23,917 signals were found; 12,791 (53%) were potential incidents that led to review of a patient's medical record and 2,266 (9%) were presented to physician reviewers. Although the positive predictive value (PPV) for reports from providers was high compared with other sources (54%), only 11% of the ADEs and 6% of the preventable ADEs were identified through this source. PPVs for other sources ranged from a low of 4% for administrative incident reports to a high of 12% for free-text review of electronic notes. Computer-generated signals were the source for 31% of the ADEs and 37% of the preventable ADEs. Electronic notes were the source for 39% of the ADEs and 29% of the preventable ADEs. There was little overlap in the ADEs identified across all sources. CONCLUSION: Our findings emphasize the limitations of voluntary reporting by health care providers as the principal means for detection of ADEs and suggest that multiple strategies are required to detect ADEs in geriatric ambulatory patients.

OBJECTIVE: To evaluate how well hypertension is managed in HMO patients and to assess opportunities for improvement. STUDY DESIGN: Retrospective cohort study. PATIENTS AND METHODS: The study population included HMO members (age 45-84 years) who had at least 1 ambulatory encounter with an ICD-9-CM diagnosis code of essential hypertension during the first 6 months of 1999. Medical records were reviewed to obtain information on blood pressure measurements, sex, age, coexisting medical conditions, smoking status, and changes made to the antihypertensive drug regimen. RESULTS: We identified 681 members with 3347 encounters related to hypertension management during 1999. Overall, 74 (11%) patients were at target blood pressure for all visits and 260 (38%) were at target blood pressure for at least 50% of the visits; 222 (33%) patients were not at target blood pressure for any visit. A history of coronary artery disease or cerebrovascular disease was associated with better blood pressure control (defined as being at goal levels during at least 50% of visits), while being older (age > or = 75) or having diabetes mellitus was associated with poorer control. Medication regimen intensifications occurred in 10% of visits with systolic blood pressure levels of 140-149 mm Hg, compared with 45% of visits with levels of > or = 180 mm Hg. Medication regimen intensifications occurred in 21% of visits with diastolic blood pressure levels of 90-99 mm Hg and 43% of visits with levels of > or = 100 mm Hg. CONCLUSION: Efforts are required to reduce "therapeutic inertia," particularly in patients with modestly elevated systolic blood pressure levels.

OBJECTIVES: To gather information on patient-level factors associated with risk of adverse drug events (ADEs) that may allow focus of prevention efforts on patients at high risk. DESIGN: Nested case-control study. SETTING: Large multispecialty group practice in New England. PARTICIPANTS: All Medicare enrollees cared for by a multispecialty group practice during 1 year (N=30,397 person-years from July 1, 1999, through June 30, 2000). For each patient with an ADE, a control was randomly selected. MEASUREMENTS: Data were abstracted from medical records on age, sex, comorbidities, and medication use at the time of the event. RESULTS: ADEs were identified in 1,299 older adults. Independent risk factors included being female and aged 80 and older. There were dose-response associations with the Charlson Comorbidity Index and number of scheduled medications. Patients taking anticoagulants, antidepressants, antibiotics, cardiovascular drugs, diuretics, hormones, and corticosteroids were at increased risk. In the analysis of preventable ADEs, the dose-response relationship with comorbidity and number of medications remained. Patients taking nonopioid analgesics (predominantly nonsteroidal antiinflammatory drugs and acetaminophen), anticoagulants, diuretics, and anti-seizure medications were at increased risk. CONCLUSION: Prevention efforts to reduce ADEs should be targeted toward older adults with multiple medical conditions or taking multiple medications, nonopioid analgesics, anticoagulants, diuretics, and antiseizure medications.

CONTEXT: Adverse drug events, especially those that may be preventable, are among the most serious concerns about medication use in older persons cared for in the ambulatory clinical setting. OBJECTIVE: To assess the incidence and preventability of adverse drug events among older persons in the ambulatory clinical setting. DESIGN, SETTING, AND PATIENTS: Cohort study of all Medicare enrollees (30 397 person-years of observation) cared for by a multispecialty group practice during a 12-month study period (July 1, 1999, through June 30, 2000), in which possible drug-related incidents occurring in the ambulatory clinical setting were detected using multiple methods, including reports from health care providers; review of hospital discharge summaries; review of emergency department notes; computer-generated signals; automated free-text review of electronic clinic notes; and review of administrative incident reports concerning medication errors. MAIN OUTCOME MEASURES: Number of adverse drug events, severity of the events (classified as significant, serious, life-threatening, or fatal), and whether the events were preventable. RESULTS: There were 1523 identified adverse drug events, of which 27.6% (421) were considered preventable. The overall rate of adverse drug events was 50.1 per 1000 person-years, with a rate of 13.8 preventable adverse drug events per 1000 person-years. Of the adverse drug events, 578 (38.0%) were categorized as serious, life-threatening, or fatal; 244 (42.2%) of these more severe events were deemed preventable compared with 177 (18.7%) of the 945 significant adverse drug events. Errors associated with preventable adverse drug events occurred most often at the stages of prescribing (n = 246, 58.4%) and monitoring (n = 256, 60.8%), and errors involving patient adherence (n = 89, 21.1%) also were common. Cardiovascular medications (24.5%), followed by diuretics (22.1%), nonopioid analgesics (15.4%), hypoglycemics (10.9%), and anticoagulants (10.2%) were the most common medication categories associated with preventable adverse drug events. Electrolyte/renal (26.6%), gastrointestinal tract (21.1%), hemorrhagic (15.9%), metabolic/endocrine (13.8%), and neuropsychiatric (8.6%) events were the most common types of preventable adverse drug events. CONCLUSIONS: Adverse drug events are common and often preventable among older persons in the ambulatory clinical setting. More serious adverse drug events are more likely to be preventable. Prevention strategies should target the prescribing and monitoring stages of pharmaceutical care. Interventions focused on improving patient adherence with prescribed regimens and monitoring of prescribed medications also may be beneficial.