Comparison of Pharmacy Claims and Electronic Pill Bottles for Measurement of Medication Adherence Among Myocardial Infarction Patients.

BACKGROUND: Medication adherence after myocardial infarction remains low. Pharmacy claims have typically been used to measure medication adherence, but electronic pill bottles may offer additional information. OBJECTIVE: The main objectives of this study were to compare the association of adherence measured by prescription claims and remote monitoring technologies with cardiovascular events. RESEARCH DESIGN: This study was a secondary analysis of a remote monitoring intervention to increase medication adherence in myocardial infarction patients. SUBJECTS: In total, 682 myocardial infarction patients were randomized to the intervention group with both medical and pharmacy benefits. MEASURES: Pharmacy claims adherence was measured using proportion of days covered (PDC) and GlowCap adherence (GC) was measured as the proportion of days the pill bottle was opened. We compared the association of PDC and GC adherence for statins with time to first vascular readmission or death and assessed model fit using Akaike information criterion and Bayesian information criterion and the likelihood ratio test. RESULTS: Higher PDC was significantly associated with a lower hazard rate for vascular readmissions or death (hazard ratio=0.435; P=0.009). There was also an association between GC adherence and vascular readmissions or death (hazard ratio=0.313; P≤0.001). Adding the GC adherence variable to the model using only PDC improved the model fit (likelihood ratio test, P=0.001), as well as vice versa (P=0.050). CONCLUSIONS: Pharmacy claims data provide useful but not complete data for medication adherence monitoring. New wireless technologies have the potential to provide additional data about clinical outcomes.

Electronic Pill Bottles or Bidirectional Text Messaging to Improve Hypertension Medication Adherence (Way 2 Text): a Randomized Clinical Trial.

BACKGROUND: Poor medication adherence contributes to inadequate control of hypertension. However, the value of adherence monitoring is unknown. OBJECTIVE: To evaluate the impact of monitoring adherence with electronic pill bottles or bidirectional text messaging on improving hypertension control. DESIGN: Three-arm pragmatic randomized controlled trial. PATIENTS: One hundred forty-nine primary care patients aged 18-75 with hypertension and text messaging capabilities who were seen at least twice in the prior 12 months with at least two out-of-range blood pressure (BP) measurements, including the most recent visit. INTERVENTIONS: Patients were randomized in a 1:2:2 ratio to receive (1) usual care, (2) electronic pill bottles for medication adherence monitoring (pill bottle), and (3) bidirectional text messaging for medication adherence monitoring (bidirectional text). MAIN MEASURES: Change in systolic BP during the final 4-month visit compared with baseline. KEY RESULTS: At the 4-month follow-up visit, mean (SD) change values in systolic blood pressure were - 4.7 (23.4) mmHg in usual care, - 4.3 (21.5) mmHg in the pill bottle arm, and - 4.6 (19.8) mmHg in the text arm. There was no significant change in systolic blood pressure between control and the pill bottle arm (p = 0.94) or the text messaging arm (p = 1.00), and the two intervention arms did not differ from each other (p = 0.93). CONCLUSIONS: Despite good measured adherence, neither feedback with electronic pill bottles nor bidirectional text messaging about medication adherence improved blood pressure control. Adherence to prescribed medications was not improved enough to affect BP control or it was not the primary driver of poor control. TRIAL REGISTRATION: clinicaltrials.gov (NCT02778542).

Partners and Alerts in Medication Adherence: A Randomized Clinical Trial.

BACKGROUND: Poor medication adherence is common and limits the effectiveness of treatment. OBJECTIVE: To investigate how social supports, automated alerts, and their combination improve medication adherence. DESIGN: Four-arm, randomized clinical trial with a 6-month intervention. PARTICIPANTS: A total of 179 CVS health employees or adult dependents with CVS Caremark prescription coverage, a current daily statin prescription, a medication possession ratio less than 80%, and Internet access. INTERVENTIONS: Participants were randomly assigned to control, social support (partner), automated adherence alert messages (alert), or both social support and alerts (partner + alert). Participants in the social support arms were asked to name a medication adherence partner (MAP) to help them take their medication. Participants in the alert arms were sent emails, text messages, or automated phone calls if they had failed to adhere on the previous day and on one or both of the 2 days before that. In partner + alert, both participants and fully enrolled MAPs received alerts. MAIN MEASURES: Adherence measured by wireless pill bottle opening. KEY RESULTS: Compared to 36.0% adherence in control, adherence was significantly greater in the alert arm (52.9%, difference vs. control of 17.0%, 95% CI for difference 6.3 to 27.6%, P = 0.002) and the partner + alert arm (54.5%, difference vs. control of 18.6%, 95% CI for difference 6.6 to 30.5%, P = 0.003). Adherence in the partner arm was not statistically significantly greater than control (43.2%, difference vs. control of 7.2%, 95% CI of difference - 5.2% to 19.5%, P = 0.25). There were no statistically significant differences among the three treatment arms. Fewer participants invited a MAP in the partner + alert arm than the partner arm (P = 0.02). CONCLUSIONS: Automated alerts were effective at improving medication adherence. Assigning a medication adherence partner did not statistically significantly affect adherence rates. TRIAL REGISTRATION: ClinicalTrials.gov Number NCT01890018 [ https://clinicaltrials.gov /].

Prior experiences of racial discrimination and racial differences in health care system distrust.

PURPOSE: Factors contributing to racial differences in health care system distrust (HCSD) are currently unknown. Proposed potential contributing factors are prior experiences of racial discrimination and racial residential segregation. METHODS: Random digit dialing survey of 762 African American and 1267 white adults living in 40 US metropolitan statistical areas. Measures included the Revised Health Care System Distrust scale, the Experiences of Discrimination scale, metrics of access to care, sociodemographic characteristics, and the level of racial residential segregation in the city (using the isolation index). RESULTS: In unadjusted analyses, African Americans had higher levels of HCSD, particularly values distrust, and greater experiences of discrimination. Experience of discrimination was also strongly associated with HCSD. Adjusting for sociodemographic characteristics, health care access, and residential segregation had little effect on the association between African American race and overall HCSD or values distrust. In contrast, adjusting for experiences of racial discrimination reversed the association so that distrust was lower among African Americans than whites (odds ratio 0.53; 95% confidence interval, 0.33-0.85 for the overall measure). The Sobel test for mediation was strongly significant (P<0.001). CONCLUSIONS: Higher HCSD among African Americans is explained by a greater burden of experiences of racial discrimination than whites. Reasons for higher distrust among whites after adjusting for experiences of racial discrimination are not known. Efforts to eliminate racial discrimination and restore trust given prior discrimination are needed.

The influence of health care policies and health care system distrust on willingness to undergo genetic testing.

PURPOSE: As the potential role of genetic testing in disease prevention and management grows, so does concern about differences in uptake of genetic testing across social and racial groups. Characteristics of how genetic tests are delivered may influence willingness to undergo testing and, if they affect population subgroups differently, alter disparities in testing. METHODS: Conjoint analysis study of the effect of 3 characteristics of genetic test delivery (ie, attributes) on willingness to undergo genetic testing for cancer risk. Data were collected using a random digit dialing survey of 128 African American and 209 white individuals living in the United States. Measures included conjoint scenarios, the Revised Health Care System Distrust Scale (including the values and competence subscales), health insurance coverage, and sociodemographic characteristics. The 3 attributes studied were disclosure of test results to the health insurer, provision of the test by a specialist or primary care doctor, and race-specific or race-neutral marketing. RESULTS: In adjusted analyses, disclosure of test results to insurers, having to get the test from a specialist, and race-specific marketing were all inversely associated with willingness to undergo the genetic test, with the greatest effect for the disclosure attribute. Racial differences in willingness to undergo testing were not statistically significant (P=0.07) and the effect of the attributes on willingness to undergo testing did not vary by patient race. However, the decrease in willingness to undergo testing with insurance disclosure was greater among individuals with high values distrust (P=0.03), and the decrease in willingness to undergo testing from specialist access was smaller among individuals with high competence distrust (P=0.03). CONCLUSIONS: Several potentially modifiable characteristics of how genetic tests are delivered are associated with willingness to undergo testing. The effect of 2 of these characteristics vary according to the level of health care system distrust, suggesting that policy decisions about delivery of genetic testing may influence differences in uptake across patient subgroups defined by levels of distrust rather than by race.

'When I have these kits I have confidence' - HIV self-testing provides agency for women in their sexual decision-making.

Oral fluid-based HIV self-testing (HIVST) has emerged as a promising approach to increasing HIV testing coverage, particularly among high-risk populations. Understanding the experiences of women using self-tests and offering them to their sexual partners (secondary distribution) is crucial for determining the potential of HIVST. Qualitative in-depth interviews were conducted among 32 women at high risk of HIV infection, including women who engage in transactional sex, who participated in a cluster randomised trial of a secondary distribution strategy in western Kenya. Interviews explored how women used self-tests within relationships and how this affected their sexual decision-making. Three key themes emerged: women used HIVST to assess risk prior to engaging in sex with partners; HIVST provided women with increased agency to engage in or end relationships; and women appreciated these benefits and urged expanded access to self-tests. HIVST has the potential to support HIV prevention objectives in settings with high prevalence of HIV.Trial registration: ClinicalTrials.gov identifier: NCT03135067.

Planning and commitment prompts to encourage reporting of HIV self-test results: A cluster randomized pragmatic trial in Tshwane District, South Africa.

Reporting of HIV self-test results to encourage linkage to HIV care for those who receive a positive test result is a common challenge faced by HIV self-testing programs. The impact of self-testing programs is diminished if individuals who obtain a self-test do not use the test or seek confirmatory testing and initiate HIV treatment following a positive result. We conducted a cluster randomized trial of two interventions designed to increase reporting of HIV self-test results: a "plan and commit" intervention that leveraged insights from behavioral economics, and an enhanced usual care version of the standard HIV self-test community distribution protocol that promoted the importance of reporting results. The trial was conducted at community distribution sites for HIV self-tests in Tshwane Metropolitan Municipality, Gauteng Province, South Africa. The primary outcome was reporting of self-test results via a WhatsApp messaging system. We recruited 1,478 participants at 13 distribution sites over 24 days. In the plan and commit condition, 63/731 participants (8.7%) reported their test results via WhatsApp, compared to 59/747 participants (7.9%) in the enhanced usual care condition (n.s., p = 0.61). During the study period, 101/3,199 individuals (3.1%) who received a self-test under the standard protocol reported test results via WhatsApp, a significant difference across the three arms (p < .00001). Our results suggest that boosting the reporting of self-test results can be done solely through increasing the salience of the importance of reporting and a clear explanation of the procedure for reporting results. Trial Registration: ClinicalTrials.gov: NCT03898557.

Adoption of HIV pre-exposure prophylaxis among women at high risk of HIV infection in Kenya.

In 2017, Kenya became one of the first African countries to provide pre-exposure prophylaxis (PrEP) in its national HIV prevention plan. We sought to characterize factors associated with PrEP uptake and persistence among a cohort of women at risk of HIV infection during the early stages of PrEP scale-up in Kenya. HIV-negative women ≥18 years with ≥2 sexual partners in the past 4 weeks were recruited as part of an ongoing cluster randomized trial of an HIV self-testing intervention. PrEP use was assessed at baseline and at 6- and 12-month follow-up visits. Between June 2017 and August 2018, 2,086 were enrolled and had complete baseline data. 138 (6.6%) reported PrEP use during the first year of the study. Although PrEP use increased, persistence on PrEP was low, and less than half of individuals reported continuing PrEP at follow-up visits. In multivariate analyses, PrEP use was associated with recent STIs, having an HIV-positive primary partner, having regular transactional sex in the past 12 months, and being a female sex worker. In the early stages of PrEP scale-up in Kenya, uptake increased modestly among women with risk factors for HIV infection, but overall uptake and persistence was low.

Incentives to promote accessing HIV care and viral suppression among HIV self-screening test users who obtain a reactive result.

Introduction: Achieving viral suppression in people with HIV is crucial in ending the AIDS epidemic. Among users of HIV self-screening tests, low rates of linkage to care and early retention in care are key obstacles to achieving viral suppression. This study sought to evaluate the efficacy of financial incentives in supporting HIV case management. Methods: Young adults within the inner city of Johannesburg, South Africa and surrounding areas who used HIV self-tests, were able to use WhatsApp to communicate with study personnel, reported a reactive or invalid result, and were confirmed to by HIV-positive were enrolled in the study. Participants were randomised to an intervention arm that received reminders and financial rewards for engaging in care, or to a control arm that received the standard of care. The primary outcome was HIV viral load at six months. Results: Among 2,388 HIV self-test kits that were distributed, 1757/2,388 (73,58%) recipients were able to use their phones to send photos to study personnel. 142/1,757 (8,08%) of these recipients reported reactive or invalid results. Upon confirmatory testing, 99/142 (69,71%) participants were identified as being HIV-positive and were enrolled in the study. 2 (1,41%) participants received an HIV negative result, and 41(28,87%) participants were either lost to follow-up or did not complete the confirmatory testing step. 20/99 (20,2%) from the intervention arm and 18/99 (18,18%) from the control arm completed the study (i.e., attended a 6 month follow up and participated in the exit interview). 29/99 (29,29%) were virally suppressed by at 6 months. Of those achieving viral suppression 15 (51,72%) were from the intervention arm. Conclusion: Financial incentives and reminders were not effective in promoting engagement with HIV care and viral suppression in this setting.

Health and Economic Outcomes Associated With COVID-19 in Women at High Risk of HIV Infection in Rural Kenya.

Importance: COVID-19 lockdowns may affect economic and health outcomes, but evidence from low- and middle-income countries remains limited. Objective: To assess the economic security, food security, health, and sexual behavior of women at high risk of HIV infection in rural Kenya during the COVID-19 pandemic. Design, Setting, and Participants: This survey study of women enrolled in a randomized trial in a rural county in Kenya combined results from phone interviews, conducted while social distancing measures were in effect between May 13 and June 29, 2020, with longitudinal, in-person surveys administered between September 1, 2019, and March 25, 2020. Enrolled participants were HIV-negative and had 2 or more sexual partners within the past month. Surveys collected information on economic conditions, food security, health status, and sexual behavior. Subgroup analyses compared outcomes by reliance on transactional sex for income and by educational attainment. Data were analyzed between May 2020 and April 2021. Main Outcomes and Measures: Self-reported income, employment hours, numbers of sexual partners and transactional sex partners, food security, and COVID-19 prevention behaviors. Results: A total of 1725 women participated, with a mean (SD) age of 29.3 (6.8) years and 1170 (68.0%) reporting sex work as an income source before the COVID-19 pandemic. During the pandemic, participants reported experiencing a 52% decline in mean (SD) weekly income, from $11.25 (13.46) to $5.38 (12.51) (difference, -$5.86; 95% CI, -$6.91 to -$4.82; P < .001). In all, 1385 participants (80.3%) reported difficulty obtaining food in the past month, and 1500 (87.0%) worried about having enough to eat at least once. Reported numbers of sexual partners declined from a mean (SD) total of 1.8 (1.2) partners before COVID-19 to 1.1 (1.0) during (difference, -0.75 partners; 95% CI, -0.84 to -0.67 partners; P < .001), and transactional sex partners declined from 1.0 (1.1) to 0.5 (0.8) (difference, -0.57 partners; 95% CI, -0.64 to -0.50 partners; P < .001). In subgroup analyses, women reliant on transactional sex for income were 18.3% (95% CI, 11.4% to 25.2%) more likely to report being sometimes or often worried that their household would have enough food than women not reliant on transactional sex (P < .001), and their reported decline in employment was 4.6 hours (95% CI, -7.9 to -1.2 hours) greater than women not reliant on transactional sex (P = .008). Conclusions and Relevance: In this survey study, COVID-19 was associated with large reductions in economic security among women at high risk of HIV infection in Kenya. However, shifts in sexual behavior may have temporarily decreased their risk of HIV infection.

The effect of providing women sustained access to HIV self-tests on male partner testing, couples testing, and HIV incidence in Kenya: a cluster-randomised trial.

BACKGROUND: HIV self-testing can overcome barriers to HIV testing, but its potential as an HIV prevention strategy for women in sub-Saharan Africa has not been assessed. We examined whether sustained provision of self-tests to women promotes testing among sexual partners and reduces HIV incidence. METHODS: We conducted a pair-matched cluster-randomised trial in 66 community clusters in Siaya County, Kenya. Clusters were communities with a high prevalence of transactional sex, including beach communities along Lake Victoria and inland communities with hotspots for transactional sex such as bars and hotels. Within clusters, we recruited HIV-negative women aged 18 years or older with two or more sexual partners within the past 4 weeks. In each of the 33 cluster pairs, we randomly assigned clusters to an intervention and comparison group. In intervention clusters, we provided participants with multiple self-tests at regular intervals and encouraged secondary distribution of self-tests to sexual partners. In comparison clusters, we provided participants referral cards for facility-based testing. Follow-up visits and HIV testing occurred at 6-month intervals for up to 24 months. The primary outcome of HIV incidence among all participants who contributed at least one HIV test was analysed using discrete-time mixed effects models. This study is registered with ClinicalTrials.gov, NCT03135067. FINDINGS: Between June 4, 2017, and Aug 31, 2018, we enrolled 2090 participants (1033 in the 33 intervention clusters and 1057 in the 33 comparison clusters). Participants' median age was 25 years (IQR 22-31) and 1390 (66·6%) of 2086 participants reported sex work as an income source. 1840 participants completed the 18-month follow-up and 570 participants completed the 24-month follow up, which ended on March 25, 2020, with a median follow-up duration of 17·6 months. HIV incidence was not significantly different between the intervention and comparison groups (1·2 vs 1·0 per 100 person-years; hazard ratio 1·2, 95% CI 0·6-2·3, p=0·64). Social harms related to study participation occurred in three participants (two in the intervention group and one in the comparison group). INTERPRETATION: Sustained provision of multiple self-tests to women at high risk of HIV infection in Kenya enabled secondary distribution of self-tests to sexual partners but did not affect HIV incidence. FUNDING: National Institute of Mental Health; Center for Health Incentives and Behavioral Economics; National Institute of Allergies and Infectious Diseases; University of Pennsylvania Center for AIDS Research.

Brief Report: Financial Incentives and Real-Time Adherence Monitoring to Promote Daily Adherence to HIV Treatment and Viral Suppression Among People Living With HIV: A Pilot Study.

BACKGROUND: Interventions to promote medication adherence and viral suppression are needed among HIV-positive individuals. We aimed to determine the feasibility, acceptability, and preliminary impact of daily financial incentives linked to real-time adherence monitoring among treatment-experienced individuals. METHODS: At an HIV clinic in Philadelphia, we conducted a pilot randomized trial among treatment-experienced HIV-positive adults with unsuppressed viral loads (>400 copies/mL). Participants randomized to the intervention group were eligible for daily lottery-based financial rewards dependent on antiretroviral therapy (ART) adherence, measured by a wireless-enabled electronic pill bottle. Participants also received a financial incentive for achieving viral suppression at 3 months. The control group received the standard of care. We measured acceptance and feasibility through follow-up survey at 3 months, viral suppression at 3 months, and adherence. RESULTS: Among 29 participants, 28 (93%) completed 3-month follow-up, and 24 (83%) completed a 3-month laboratory visit. Electronic pill bottles were highly acceptable to participants, with most strongly agreeing that they worked well, were reliable, and easy to use. Among those who received the intervention, 77% were very satisfied with their experience. Among those who completed the 3-month laboratory visit, viral suppression was achieved by 40% in the intervention group and 29% in the control group. ART adherence ≥80% was achieved by 36% and 25% in the intervention and control groups, respectively. CONCLUSIONS: Daily financial incentives coupled with real-time adherence monitoring are a promising strategy to support ART adherence among HIV-positive individuals who are not virally suppressed. This novel approach warrants testing in a larger trial.

Male partner testing and sexual behaviour following provision of multiple HIV self-tests to Kenyan women at higher risk of HIV infection in a cluster randomized trial.

INTRODUCTION: Without significant increases in uptake of HIV testing among men, it will be difficult to reduce HIV incidence to disease elimination levels. Secondary distribution of HIV self-tests by women to their male partners is a promising approach for increasing male testing that is being implemented in several countries. Here, we examine male partner and couples testing outcomes and sexual decision making associated with this approach in a cluster randomized trial. METHODS: We examined data from women at higher risk of HIV participating in the intervention arm of an ongoing pair-matched cluster randomized trial in Kenya. HIV-negative women ≥18 years who self-reported ≥2 partners in the past month were eligible. Participants received self-tests at enrolment and three-monthly intervals. They were encouraged to offer tests to sexual partners with whom they anticipated condomless sex. At six months, we collected data on self-test distribution, male partner and couples testing, and testing and sexual behaviour in the three most recent transactional sex encounters. We used descriptive analyses and generalized estimating equation models to understand how sexual behaviour was influenced by self-test distribution. RESULTS: From January 2018 to April 2019, 921/1057 (87%) participants completed six-month follow-up. Average age was 28 years, 65% were married, and 72% reported income through sex work. Participants received 7283 self-tests over six months, a median of eight per participant. Participants offered a median three self-tests to sexual partners. Of participants with a primary partner, 94% offered them a self-test. Of these, 97% accepted the test. When accepted, couples testing was reported among 91% of participants. Among 1954 transactional sex encounters, 64% included an offer to self-test. When offered self-tests were accepted by 93% of partners, and 84% who accepted conducted couples testing. Compared to partners with an HIV-negative result, condom use was higher when men had a reactive result (56.3% vs. 89.7%, p < 0.01), were not offered a self-test (56.3% vs. 62.0%, p = 0.02), or refused to self-test (56.3% vs. 78.3, p < 0.01). CONCLUSIONS: Providing women with multiple self-tests facilitated male partner and couples testing, and led to safer sexual behaviour. These findings suggest secondary distribution is a promising approach for reaching men and has HIV prevention potential. Clinical Trial Number: NCT03135067.

Effect of Remote Monitoring on Discharge to Home, Return to Activity, and Rehospitalization After Hip and Knee Arthroplasty: A Randomized Clinical Trial.

Importance: Hip and knee arthroplasty are the most common inpatient surgical procedures for Medicare beneficiaries in the US, with substantial variation in cost and quality. Whether remote monitoring incorporating insights from behavioral science might help improve outcomes and increase value of care remains unknown. Objective: To evaluate the effect of activity monitoring and bidirectional text messaging on the rate of discharge to home and clinical outcomes in patients receiving hip or knee arthroplasty. Design, Setting, and Participants: Randomized clinical trial conducted between February 7, 2018, and April 15, 2019. The setting was 2 urban hospitals at an academic health system. Participants were patients aged 18 to 85 years scheduled to undergo hip or knee arthroplasty with a Risk Assessment and Prediction Tool score of 6 to 8. Interventions: Eligible patients were randomized evenly to receive usual care (n = 153) or remote monitoring (n = 147). Those in the intervention arm who agreed received a wearable activity monitor to track step count, messaging about postoperative goals and milestones, pain score tracking, and connection to clinicians as needed. Patients assigned to receive monitoring were further randomized evenly to remote monitoring alone or remote monitoring with gamification and social support. Remote monitoring was offered before surgery, began at hospital discharge, and continued for 45 days postdischarge. Main Outcomes and Measures: The primary outcome was discharge status (home vs skilled nursing facility or inpatient rehabilitation). Prespecified secondary outcomes included change in average daily step count and rehospitalizations. Results: A total of 242 patients were analyzed (124 usual care, 118 intervention); median age was 66 years (interquartile range, 58-73 years); 78.1% were women, 45.5% were White, 43.4% were Black; and 81.4% in the intervention arm agreed to receive monitoring. There was no significant difference in the rate of discharge to home between the usual care arm (57.3%; 95% CI, 48.5%-65.9%) and the intervention arm (56.8%; 95% CI, 47.9%-65.7%) and no significant increase in step count in those receiving remote monitoring plus gamification and social support compared with remote monitoring alone. There was a statistically significant reduction in rehospitalization rate in the intervention arm (3.4%; 95% CI, 0.1%-6.7%) compared with the usual care arm (12.2%; 95% CI, 6.4%-18.0%) (P = .01). Conclusions and Relevance: In this study, the remote monitoring program did not increase rate of discharge to home after hip or knee arthroplasty, and gamification and social support did not increase activity levels. There was a significant reduction in rehospitalizations among those receiving the intervention, which may have resulted from goal setting and connection to the care team. Trial Registration: ClinicalTrials.gov Identifier: NCT03435549.

Effect of Electronic Reminders, Financial Incentives, and Social Support on Outcomes After Myocardial Infarction: The HeartStrong Randomized Clinical Trial.

Importance: Adherence to medications prescribed after acute myocardial infarction (AMI) is low. Wireless technology and behavioral economic approaches have shown promise in improving health behaviors. Objective: To determine whether a system of medication reminders using financial incentives and social support delays subsequent vascular events in patients following AMI compared with usual care. Design, Setting, and Participants: Two-arm, randomized clinical trial with a 12-month intervention conducted from 2013 through 2016. Investigators were blinded to study group, but participants were not. Design was a health plan-intermediated intervention for members of several health plans. We recruited 1509 participants from 7179 contacted AMI survivors (insured with 5 large US insurers nationally or with Medicare fee-for-service at the University of Pennsylvania Health System). Patients aged 18 to 80 years were eligible if currently prescribed at least 2 of 4 study medications (statin, aspirin, ß-blocker, antiplatelet agent), and were hospital inpatients for 1 to 180 days and discharged home with a principal diagnosis of AMI. Interventions: Patients were randomized 2:1 to an intervention using electronic pill bottles combined with lottery incentives and social support for medication adherence (1003 patients), or to usual care (506 patients). Main Outcomes and Measures: Primary outcome was time to first vascular rehospitalization or death. Secondary outcomes were time to first all-cause rehospitalization, total number of repeated hospitalizations, medication adherence, and total medical costs. Results: A total of 35.5% of participants were female (n = 536); mean (SD) age was 61.0 (10.3) years. There were no statistically significant differences between study arms in time to first rehospitalization for a vascular event or death (hazard ratio, 1.04; 95% CI, 0.71 to 1.52; P = .84), time to first all-cause rehospitalization (hazard ratio, 0.89; 95% CI, 0.73 to 1.09; P = .27), or total number of repeated hospitalizations (hazard ratio, 0.94; 95% CI, 0.60 to 1.48; P = .79). Mean (SD) medication adherence did not differ between control (0.42 [0.39]) and intervention (0.46 [0.39]) (difference, 0.04; 95% CI, -0.01 to 0.09; P = .10). Mean (SD) medical costs in 12 months following enrollment did not differ between control ($29 811 [$74 850]) and intervention ($24 038 [$66 915]) (difference, -$5773; 95% CI, -$13 682 to $2137; P = .15). Conclusions and Relevance: A compound intervention integrating wireless pill bottles, lottery-based incentives, and social support did not significantly improve medication adherence or vascular readmission outcomes for AMI survivors. Trial Registration: clinicaltrials.gov Identifier: NCT01800201.

Building a patient-centered medical home: obtaining the patient's voice.

PURPOSE: Many primary care practices are currently attempting to transform into patient-centered medical homes (PCMHs), but little is known about how patients view aspects of the PCMH or how they define patient-centeredness. METHODS: We conducted 3 focus groups with patients from urban academic internal medicine practices. We asked questions about patients' perceptions of what patient-centered care should be; care quality, teams and access; diabetes self-management; and community connections and services. We used a grounded theory approach to the analysis. RESULTS: The global themes that arose in our focus groups included the desire for timely, clear, and courteous communication; a practice that is structured to facilitate an ongoing relationship with a provider who knows the patient; and a relationship that allows the patient both to trust the provider's guidance and to engage more fully in his or her own care. CONCLUSIONS: Our patients want a provider to know them personally and to take time to listen to their issues. They feel that they cannot access their providers in a timely fashion, find our automated phone systems frustrating, and want more time with their provider. Although the technological and structural implementation of the PCMH requires considerable effort and resources, we cannot neglect the relationships we have with our patients. Patients should be involved in this process of change to ensure we address their concerns and preserve the primary care relationships they value.