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.

A safety app to respond to dating violence for college women and their friends: the MyPlan study randomized controlled trial protocol.

BACKGROUND: Research demonstrates high rates of physical and sexual victimization of women by intimate partners on college campuses (Black et al. 2001). College women in abusive relationships must weigh complex factors (health, academics, economics, and social stigma) during critical decision-making regarding the relationship. Rather than access formal support systems (e.g., campus security, administrators, counselors), research indicates abused college women most often turn to informal networks; specifically friends (Perspect Psychiatr Care 41:162-171, 2005), who often lack the knowledge or resources to provide effective support (Nurs Res 54(4):235-242, 2005). Decision aids have been shown to assist with health-related decisions by improving knowledge, creating realistic expectations, and resolving decisional conflict (Cochrane Database Syst Rev 1:1-332, 2014). METHODS/DESIGN: This study is a randomized controlled trial testing the effectiveness of an interactive safety decision aid web-based and smartphone application (App) for abused college women and their friends. Three hundred female college students experiencing abuse and three hundred friends of female college students experiencing abuse will be recruited in Maryland and Oregon and randomized to either the intervention safety decision aid, accessible by website or smartphone App, or a usual safety planning control website/App. The intervention App allows users to enter information on: a) relationship health; b) safety priorities; and c) severity of violence/danger in relationship. The App uses this information to provide personalized safety planning information and resources. Self-reported outcome measures for abused college women on safety seeking behaviors, decisional conflict, IPV exposure and mental health will be collected at baseline, six, and 12-months post-baseline via the study App/website. Outcomes measured for friends are IPV awareness, confidence to intervene, supportive behaviors and decisional conflict. Protocols for safely recruiting, retaining and collecting data from abused women via web/App are discussed. DISCUSSION: This trial may provide important information on the impact of an App and web-based safety planning tool on college women's decisional conflict and safety behavior use when making difficult safety decisions. This study is the first, to our knowledge, to test an intervention that engages friends of abused college women. The trial may also inform researchers on the feasibility of safely conducting research with abused women using online recruitment and enrollment methods and collecting data via an App or website. TRIAL REGISTRATION: Clinicaltrials.gov ID: NCT02236663.

Comparison of pharmacy-based measures of medication adherence.

BACKGROUND: Pharmacy databases are commonly used to assess medication usage, and a number of measures have been developed to measure patients' adherence to medication. An extensive literature now supports these measures, although few studies have systematically compared the properties of different adherence measures. METHODS: As part of an 18-month randomized clinical trial to assess the impact of automated telephone reminders on adherence to inhaled corticosteroids (ICS) among 6903 adult members of a managed care organization, we computed eight pharmacy-based measures of ICS adherence using outpatient pharmacy dispensing records obtained from the health plan's electronic medical record. We used simple descriptive statistics to compare the relative performance characteristics of these measures. RESULTS: Comparative analysis found a relative upward bias in adherence estimates for those measures that require at least one dispensing event to be calculated. Measurement strategies that require a second dispensing event evidence even greater upward bias. These biases are greatest with shorter observation times. Furthermore, requiring a dispensing to be calculated meant that these measures could not be defined for large numbers of individuals (17-32 % of participants in this study). Measurement strategies that do not require a dispensing event to be calculated appear least vulnerable to these biases and can be calculated for everyone. However they do require additional assumptions and data (e.g., pre-intervention dispensing data) to support their validity. CONCLUSIONS: Many adherence measures require one, or sometimes two, dispensings in order to be defined. Since such measures assume all dispensed medication is used as directed, they have a built in upward bias that is especially pronounced when they are calculated over relatively short timeframes (< 9 months). Less biased measurement strategies that do not require a dispensing event are available, but require additional data to support their validity. TRIAL REGISTRATION: The study was funded by grant R01HL83433 from the National Heart, Lung and Blood Institute (NHLBI) and is filed as study NCT00414817 in the clinicaltrials.gov database.

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 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.

Maximizing acceptability and usefulness of an automated telephone intervention: Lessons from a developmental mixed-methods approach.

The objective was to describe the utility of mixed methods to inform the development of an automated telephone intervention to improve patients' compliance with asthma medication. As part of intervention development for a larger trial, we conducted 15 focus groups (n = 53) to design and develop calls, and to identify factors influencing intervention acceptability and usefulness. We piloted four call types and interviewed 64 participants to further improve call content and receptivity to the intervention. Feedback led to several changes to the intervention scripts and eventual calls, and an initial pilot led us to drop one of the calls. During the pilot, we reached 43 percent of target participants; 74 percent of those stayed on the call until it ended. This process provided key insights about automated calls, and may have broader applicability for the development of automated interventions designed to help patients manage a variety of chronic conditions.

Use of health information technology to improve medication adherence.

OBJECTIVES: To evaluate the effectiveness of an intervention based on health information technology (HIT) that used speech recognition software to promote adherence to inhaled corticosteroids (ICS) among individuals with asthma who were members of a large health maintenance organization. STUDY DESIGN: Pragmatic randomized clinical trial. METHODS: Adults with asthma enrolled in a large managed care organization (N = 8517) were randomized to receive either usual care or an interactive voice recognition (IVR) intervention designed to prompt medication refills and improve ICS adherence. The primary outcome was ICS adherence as measured by modified medication possession ratio calculated from the electronic medical record (EMR). Secondary measures included survey- and EMR-based measures of asthma morbidity. RESULTS: Our primary analyses found that ICS adherence increased modestly but significantly for participants in the intervention group relative to those in the usual care group ( Δ= 0.02, 95% confidence interval 0.01-0.03), with a baseline adherence of 0.42 in both groups. No difference was observed in asthma morbidity measures. In post hoc analyses of participants receiving 2 or more direct IVR contacts or detailed messages, the intervention effect was more marked. The overall effect was triple that observed in the primary analyses (0.06 vs 0.02), and significant differences were observed between groups in asthma control. CONCLUSIONS: An HIT-based adherence intervention shows potential for supporting medication adherence in patients with chronic diseases such as asthma. However, additional research is needed to determine how best to enhance the reach and effectiveness of such interventions.