Data Quality Assessment and Multi-Organizational Reporting: Tools to Enhance Network Knowledge.

OBJECTIVE: Multi-organizational research requires a multi-organizational data quality assessment (DQA) process that combines and compares data across participating organizations. We demonstrate how such a DQA approach complements traditional checks of internal reliability and validity by allowing for assessments of data consistency and the evaluation of data patterns in the absence of an external "gold standard." METHODS: We describe the DQA process employed by the Data Coordinating Center (DCC) for Kaiser Permanente's (KP) Center for Effectiveness and Safety Research (CESR). We emphasize the CESR DQA reporting system that compares data summaries from the eight KP organizations in a consistent, standardized manner. RESULTS: We provide examples of multi-organization comparisons from DQA to confirm expectations about different aspects of data quality. These include: 1) comparison of direct data extraction from the electronic health records (EHR) and 2) comparison of non-EHR data from disparate sources. DISCUSSION: The CESR DCC has developed codes and procedures for efficiently implementing and reporting DQA. The CESR DCC approach is to 1) distribute DQA tools to empower data managers at each organization to assess their data quality at any time, 2) summarize and disseminate findings to address data shortfalls or document idiosyncrasies, and 3) engage data managers and end-users in an exchange of knowledge about the quality and its fitness for use. CONCLUSION: The KP CESR DQA model is applicable to networks hoping to improve data quality. The multi-organizational reporting system promotes transparency of DQA, adds to network knowledge about data quality, and informs research.

Difference in Effectiveness of Medication Adherence Intervention by Health Literacy Level.

CONTEXT: There is little research investigating whether health information technologies, such as interactive voice recognition, are effective ways to deliver information to individuals with lower health literacy. OBJECTIVE: Determine the extent to which the impact of an interactive voice recognition-based intervention to improve medication adherence appeared to vary by participants' health literacy level. DESIGN: Promoting Adherence to Improve Effectiveness of Cardiovascular Disease Therapies (PATIENT) was a randomized clinical trial designed to test the impact, compared with usual care, of 2 technology-based interventions that leveraged interactive voice recognition to promote medication adherence. A 14% subset of participants was sent a survey that included questions on health literacy. This exploratory analysis was limited to the 833 individuals who responded to the survey and provided data on health literacy. MAIN OUTCOME MEASURES: Adherence to statins and/or angiotensin-converting enzyme inhibitors and/or angiotensin II receptor blockers. RESULTS: Although intervention effects did not differ significantly by level of health literacy, the data were suggestive of differential intervention effects by health literacy level. CONCLUSIONS: The differences in intervention effects for high vs low health literacy in this exploratory analysis are consistent with the hypothesis that individuals with lower health literacy may derive greater benefit from this type of intervention compared with individuals with higher health literacy. Additional studies are needed to further explore this finding.

Improving Adherence to Cardiovascular Therapies: An Economic Evaluation of a Randomized Pragmatic Trial.

OBJECTIVE: Preplanned economic analysis of a pragmatic trial using electronic-medical-record-linked interactive voice recognition (IVR) reminders for enhancing adherence to cardiovascular medications (i.e., statins, angiotensin-converting enzyme inhibitors [ACEIs], and angiotensin receptor blockers [ARBs]). METHODS: Three groups, usual care (UC), IVR, and IVR plus educational materials (IVR+), with 21,752 suboptimally adherent patients underwent follow-up for 9.6 months on average. Costs to implement and deliver the intervention (from a payer perspective) were tracked during the trial. Medical care costs and outcomes were ascertained using electronic medical records. RESULTS: Per-patient intervention costs ranged from $9 to $17 for IVR and from $36 to $47 for IVR+. For ACEI/ARB, the incremental cost-effectiveness ratio for each percent adherence increase was about 3 times higher with IVR+ than with IVR ($6 and $16 for IVR and IVR+, respectively). For statins, the incremental cost-effectiveness ratio for each percent adherence increase was about 7 times higher with IVR+ than with IVR ($6 and $43 for IVR and IVR+, respectively). Considering potential cost offsets from reduced cardiovascular events, the probability of breakeven was the highest for UC, but the IVR-based interventions had a higher probability of breakeven for subgroups with a baseline low-density lipoprotein (LDL) level of more than 100 mg/dl and those with two or more calls. CONCLUSIONS: We found that the use of an automated voice messaging system to promote adherence to ACEIs/ARBs and statins may be cost-effective, depending on a decision maker's willingness to pay for unit increase in adherence. When considering changes in LDL level and downstream medical care offsets, UC is the optimal strategy for the general population. However, IVR-based interventions may be the optimal choice for those with elevated LDL values at baseline.

Improving adherence to cardiovascular disease medications with information technology.

OBJECTIVES: Evaluate the utility of 2 electronic medical record (EMR)-linked, automated phone reminder interventions for improving adherence to cardiovascular disease medications. STUDY DESIGN: A 1-year, parallel arm, pragmatic clinical trial in which 21,752 adults were randomized to receive either usual care (UC) or 1 of 2 interventions in the form of interactive voice recognition calls-regular (IVR) or enhanced (IVR+). The interventions used automated phone reminders to increase adherence to cardiovascular disease medications. The primary outcome was medication adherence; blood pressure and lipid levels were secondary outcomes. METHODS: The study took place in 3 large health maintenance organizations. We enrolled participants who were 40 years or older, had diabetes mellitus or atherosclerotic cardiovascular disease, and were suboptimally adherent. IVR participants received automated phone calls when they were due or overdue for a refill. IVR+ participants received these phone calls, plus personalized reminder letters, live outreach calls, EMR-based feedback to their primary care providers, and additional mailed materials. RESULTS: Both interventions significantly increased adherence to statins and angiotensin-converting enzyme inhibitors/angiotensin receptor blockers (ACEIs/ARBs) compared with UC (1.6 to 3.7 percentage points). Adherence to ACEIs/ARBs was also significantly higher for IVR+ relative to IVR participants. These differences persisted across subgroups. Among statin users, IVR+ participants had significantly lower low-density lipoprotein (LDL) levels at follow-up compared with UC (Δ = -1.5; 95% CI, -2.7 to -0.2 mg/dL); this effect was seen mainly in those with baseline LDL levels ≥ 100 mg/dL (Δ = -3.6; 95% CI, -5.9 to -1.3 mg/dL). CONCLUSIONS: Technology-based tools, in conjunction with an EMR, can improve adherence to chronic disease medications and measured cardiovascular disease risk factors.

Design of the Prevention of Adult Caries Study (PACS): a randomized clinical trial assessing the effect of a chlorhexidine dental coating for the prevention of adult caries.

BACKGROUND: Dental caries is one of the primary causes of tooth loss among adults. It is estimated to affect a majority of Americans aged 55 and older, with a disproportionately higher burden in disadvantaged populations. Although a number of treatments are currently in use for caries prevention in adults, evidence for their efficacy and effectiveness is limited. METHODS/DESIGN: The Prevention of Adult Caries Study (PACS) is a multicenter, placebo-controlled, double-blind, randomized clinical trial of the efficacy of a chlorhexidine (10% w/v) dental coating in preventing adult caries. Participants (n = 983) were recruited from four different dental delivery systems serving four diverse communities, including one American Indian population, and were randomized to receive either chlorhexidine or a placebo treatment. The primary outcome is the net caries increment (including non-cavitated lesions) from baseline to 13 months of follow-up. A cost-effectiveness analysis also will be considered. DISCUSSION: This new dental treatment, if efficacious and approved for use by the Food and Drug Administration (FDA), would become a new in-office, anti-microbial agent for the prevention of adult caries in the United States. TRIAL REGISTRATION NUMBER: NCT00357877.