The effectiveness of a noninterruptive alert to increase prescription of take-home naloxone in emergency departments.

OBJECTIVE: Opioid-related overdose (OD) deaths continue to increase. Take-home naloxone (THN), after treatment for an OD in an emergency department (ED), is a recommended but under-utilized practice. To promote THN prescription, we developed a noninterruptive decision support intervention that combined a detailed OD documentation template with a reminder to use the template that is automatically inserted into a provider's note by decision rules. We studied the impact of the combined intervention on THN prescribing in a longitudinal observational study. METHODS: ED encounters involving an OD were reviewed before and after implementation of the reminder embedded in the physicians' note to use an advanced OD documentation template for changes in: (1) use of the template and (2) prescription of THN. Chi square tests and interrupted time series analyses were used to assess the impact. Usability and satisfaction were measured using the System Usability Scale (SUS) and the Net Promoter Score. RESULTS: In 736 OD cases defined by International Classification of Disease version 10 diagnosis codes (247 prereminder and 489 postreminder), the documentation template was used in 0.0% and 21.3%, respectively (P < .0001). The sensitivity and specificity of the reminder for OD cases were 95.9% and 99.8%, respectively. Use of the documentation template led to twice the rate of prescribing of THN (25.7% vs 50.0%, P < .001). Of 19 providers responding to the survey, 74% of SUS responses were in the good-to-excellent range and 53% of providers were Net Promoters. CONCLUSIONS: A noninterruptive decision support intervention was associated with higher THN prescribing in a pre-post study across a multiinstitution health system.

Ethnicity Differences in Sleep Changes Among Prehypertensive Adults Using a Smartphone Meditation App: Dose-Response Trial.

BACKGROUND: African Americans (AAs) experience greater sleep quality problems than non-Hispanic Whites (NHWs). Meditation may aid in addressing this disparity, although the dosage levels needed to achieve such benefits have not been adequately studied. Smartphone apps present a novel modality for delivering, monitoring, and measuring adherence to meditation protocols. OBJECTIVE: This 6-month dose-response feasibility trial investigated the effects of a breathing awareness meditation (BAM) app, Tension Tamer, on the secondary outcomes of self-reported and actigraphy measures of sleep quality and the modulating effects of ethnicity of AAs and NHWs. METHODS: A total of 64 prehypertensive adults (systolic blood pressure <139 mm Hg; 31 AAs and 33 NHWs) were randomized into 3 different Tension Tamer dosage conditions (5,10, or 15 min twice daily). Sleep quality was assessed at baseline and at 1, 3, and 6 months using the Pittsburgh Sleep Quality Index (PSQI) and 1-week bouts of continuous wrist actigraphy monitoring. The study was conducted between August 2014 and October 2016 (IRB #Pro00020894). RESULTS: At baseline, PSQI and actigraphy data indicated that AAs had shorter sleep duration, greater sleep disturbance, poorer efficiency, and worse quality of sleep (range P=.03 to P<.001). Longitudinal generalized linear mixed modeling revealed a dose effect modulated by ethnicity (P=.01). Multimethod assessment showed a consistent pattern of NHWs exhibiting the most favorable responses to the 5-min dose; they reported greater improvements in sleep efficiency and quality as well as the PSQI global value than with the 10-min and 15-min doses (range P=.04 to P<.001). Actigraphy findings revealed a consistent, but not statistically significant, pattern in the 5-min group, showing lower fragmentation, longer sleep duration, and higher efficiency than the other 2 dosage conditions. Among AAs, actigraphy indicated lower sleep fragmentation with the 5-min dose compared with the 10-min and 15-min doses (P=.03 and P<.001, respectively). The 10-min dose showed longer sleep duration than the 5-min and 15-min doses (P=.02 and P<.001, respectively). The 5-min dose also exhibited significantly longer average sleep than the 15-min dose (P=.03). CONCLUSIONS: These findings indicate the need for further study of the potential modulating influence of ethnicity on the impact of BAM on sleep indices and user-centered exploration to ascertain the potential merits of refining the Tension Tamer app with attention to cultural tailoring among AAs and NHWs with pre-existing sleep complaints.

Exploratory Analysis of the Impact of an mHealth Medication Adherence Intervention on Tacrolimus Trough Concentration Variability: Post Hoc Results of a Randomized Controlled Trial.

BACKGROUND: Medication nonadherence is a leading cause of late allograft loss in kidney transplantation (KT). Tacrolimus trough coefficient of variation (CV), measured using the coefficient of variation, is strongly correlated with acute rejection, graft function, and graft loss. OBJECTIVE: The objective of this study was to determine if this mobile health (mHealth) intervention aimed at improving medication adherence in a nonadherent KT population would affect high intrapatient tacrolimus variability. METHODS: A 6-month, prospective, parallel-arm, randomized controlled clinical trial was conducted to determine the effects of an mHealth intervention on tacrolimus CV. Intervention arm participants utilized an electronic medication tray and an mHealth app to monitor home-based adherence. Tailored motivational reinforcement messages were delivered to promote competence for adherence. Tacrolimus CV was measured using a 12-month rolling average, assessed at monthly intervals (6-month intervention period and 6 months after completion of the study); 80 were included, 40 in each arm. RESULTS: At baseline, tacrolimus CV was similar between arms (37% ± 15% intervention, 37% ± 13% control, P = 0.894). Patients randomized to the intervention had a significant reduction in mean 12-month tacrolimus CVs (P = 0.046) and a significant improvement in the proportion achieving low tacrolimus CV (tacrolimus CV < 40%; P = 0.001), as compared with the control arm. CONCLUSION AND RELEVANCE: High tacrolimus CV is a risk factor for acute rejection and graft loss; these results offer the potential promise of improved medication adherence and clinical outcomes through the use of innovative technology.

Impact of 12-Month Smartphone Breathing Meditation Program upon Systolic Blood Pressure among Non-Medicated Stage 1 Hypertensive Adults.

(1) Background: Hypertension (HTN) affects ~50% of adults and is a major risk factor for stroke and cardiovascular disease. In 2017, the SPRINT trial outcomes led to lowering of HTN cutoffs by the American College of Cardiology (ACC) and American Heart Association (AHA). The Joint National Committee (JNC8) and National High BP Education Program recommend that lifestyle modifications be used as first-line HTN treatment. Chronic stress is a risk factor for HTN and cardiovascular disease. A recently completed 12 month randomized controlled trial (RCT) of a breathing meditation smart phone app (Tension Tamer, TT) involving JNC8 designated pre-HTN adults provided an opportunity to examine its impact upon individuals now classified as having stage 1 HTN. The TT app captures continuous real-time heart rate (HR) from a user's fingertip placed over a video camera lens during sessions. Users receive immediate feedback graphs after each session, showing their HR changes. They also receive motivational and social reinforcement SMS text messages the following day based upon levels of adherence. We conducted ancillary analyses of a 2-arm, 12-month, small-scale efficacy RCT among a subgroup of our total sample of participants, who are now classified as having stage 1 non-medicated systolic HTN. Primary outcome was change in resting systolic blood pressure (SBP). Secondary outcomes were change in resting diastolic blood pressure, adherence to the TT protocol, and perceived stress levels. (2) Methods: 30 adults (mean age: 45.0 years; 15 males; 16 White; 14 Black) with ACC/AHA 2017 defined systolic HTN (130-139 mmHg) on 3 consecutive sessions (mean SBP: 132.6 mmHg) were randomly assigned to TT or lifestyle education program delivered via smartphone (SPCTL). Each group received a twice-daily dosage schedule of TT or walking (month 1: 15 min; months 2 and 3: 10 min; months 4-12: 5 min). (3) Results: Mixed modeling results revealed a significant group x time effect for SBP (p<.01). The TT group showed greater SBP reductions at months 3 (-8.0 vs. -1.9), 6 (-10.0 vs. -0.7), and 12: (-11.6 vs. -0.4 mmHg; all p-values <0.04). (4) Conclusion: The TT app was beneficial in reducing SBP levels among adults with stage 1 systolic HTN. The TT app may be a promising, scalable first-line tactic for stage 1 HTN. Preparations are underway for an efficacy RCT involving uncontrolled stage 1 HTN patients.

"Smartphone Medication Adherence Saves Kidneys" for Kidney Transplantation Recipients: Protocol for a Randomized Controlled Trial.

BACKGROUND: Kidney transplant recipients' poor medication adherence and poor control of comorbidities, particularly hypertension, are risk factors for graft rejection, graft loss, and death. Few randomized controlled trials (RCTs) have been successful in improving sustained medication adherence and blood pressure control among kidney transplantation recipients. We provide rationale for an RCT evaluating a mobile health medical self-management system for kidney transplantation recipients called Smartphone Medication Adherence Saves Kidneys (SMASK). OBJECTIVE: Our objective is to determine whether SMASK is efficacious in improving medication adherence and sustaining blood pressure control among kidney transplantation recipients with uncontrolled hypertension and poor medication adherence compared to an enhanced standard care. METHODS: This two-arm, 6-month, phase II single-site efficacy RCT will involve 80 kidney transplantation recipients. Participants will be randomly assigned to the SMASK intervention arm or control arm. SMASK includes multilevel components: automated reminders from an electronic medication tray; tailored text messages and motivational feedback, guided by the self-determination theory; and automated summary reports for providers. Evaluations will be conducted preintervention, at 3 and 6 months, and posttrial at 12 months. Specific aims are to test the hypotheses that compared to standard care, the SMASK cohort will demonstrate significantly improved changes at 3, 6, and 12 months in the primary outcome variables medication adherence (proportion with electronic monitor-derived score >0.90) and blood pressure control (proportion meeting and sustaining adherence to the Kidney Disease Improving Global Outcomes [KDIGO] guidelines for blood pressure control); the secondary outcome variables provider adherence to KDIGO guidelines, measured by timing of medication changes and changes in self-determination theory constructs; and the exploratory outcome variables estimated glomerular filtration rate, variability in calcineurin inhibitor trough levels, and proportion of patients meeting and sustaining the 24-hour ambulatory blood pressure below 130/80 mm Hg. After the 6-month evaluation, interviews with a random sample of SMASK subjects (n=20) and health care providers (n=3-5) will assess user reactions including acceptability, usability, and aids/barriers to sustainability. Data from the RCT and interviews will be triangulated to further refine and optimize SMASK and prepare for a multisite effectiveness RCT. RESULTS: The SMASK project received funding from National Institute of Diabetes and Digestive and Kidney Diseases in June 2016, obtained institutional review board approval in April 2016, and began data collection in July 2016. As of July 2018, we completed enrollment with a total of 80 participants. CONCLUSIONS: This study will provide data regarding the efficacy of SMASK to improve medication adherence and blood pressure control in a cohort of hypertensive kidney transplant recipients. An efficacious SMASK intervention will pave the way for a larger, multicenter, effectiveness RCT powered sufficiently to evaluate clinical events in a real-world setting and with the potential to demonstrate improved outcomes at lower cost than standard care. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/13351.

Impact of a Culturally Tailored mHealth Medication Regimen Self-Management Program upon Blood Pressure among Hypertensive Hispanic Adults.

Background: Uncontrolled hypertension (HTN) and medication nonadherence are more prominent among Hispanics compared to non-Hispanic whites and African Americans. Advances in wireless health technology enable real-time monitoring of medication adherence (MA) and blood pressure (BP), facilitating timely patient⁻provider communication including tailored reinforcement/motivational feedback to patients and quicker titration changes by providers. The purpose of the current study was to conduct a 9-month smartphone-enabled efficacy trial addressing MA and BP control among Hispanic adults with uncontrolled HTN and poor MA. Methods: The research design was a 9-month, two-arm efficacy trial including an experimental (Smartphone Med Adherence Stops Hypertension, SMASH) group and an enhanced standard care (ESC) group. SMASH participants utilized a SMASH app which interfaced with a Bluetooth-enabled BP monitor for BP self-monitoring and an electronic medication tray. The ESC participants received text messages including links to PDFs and brief video clips containing healthy lifestyle tips for attention control. Results: Participants were 54 Hispanic adults (mean age: 46.5 years) with uncontrolled HTN. They were randomly assigned to either the SMASH (n = 26) or ESC group (n = 28). At baseline, no participants had controlled systolic BP (SBP). Baseline group averages for SBP between the SC and SMASH groups did not differ (150.7 and 152.3 mmHg, respectively; p = 0.53). At the 1, 3, 6, and 9-month time points, SBP averages were significantly lower in the SMASH versus SC groups (month 1: 125.3 vs. 140.6; month 3: 120.4 vs. 137.5, month 6: 121.2 vs. 145.7 mmHg; month 9: 121.8 vs. 145.7, respectively; all p-values <0.01). At months 3, 6, and 9 there was a significant difference between the percentage of participants meeting the 7th Joint National Committee cutoffs for SBP control in the SC and SMASH groups (month 3: 62.5 vs. 92.0%; month 6: 57.9 and 94.4%, month 9: 27.8 and 92.3%, respectively; all p-values ≤0.01). Average medical regimen adherence, as indicated by timestamped medication intake and BP monitoring for the SMASH group, ranged from 89.1 to 95.2% across the 9-month trial. Conclusion: Our findings indicate that our culturally tailored smartphone-enabled medical regimen self-management program may be an effective solution for the promotion of MA, resulting in statistically and clinically significant reductions in SBP among Hispanic adults with uncontrolled HTN.

Meditation smartphone application effects on prehypertensive adults' blood pressure: Dose-response feasibility trial.

OBJECTIVE: Essential hypertension (EH) is the most common chronic disease in the United States and a major cause of morbidity and mortality. Lifestyle interventions (e.g., diet, exercise, stress management) to reduce blood pressure (BP) are often complex with varying effectiveness. Breathing awareness meditation (BAM) is a stress management strategy with encouraging effects on BP, though widespread dissemination is hampered by the lack of an easy-to-use methodology to train and monitor BAM practices. A smartphone application (Tension Tamer [TT]) that implements BAM and tracks adherence has shown promise in addressing these gaps. This 6-month dose-response feasibility trial evaluated effects of the app on BP to further optimize BAM user guidelines. METHODS: Sixty-four adults with prehypertension were randomized to complete TT-guided BAM sessions for 5-, 10-, or 15-min intervals twice daily over 6 months. Continuous heart rate readings derived from the phone's video camera via reflective photoplethysmography were used as feedback and as an index of time-stamped adherence. Outcomes (resting BP, HR) were collected at baseline, 1-, 3-, and 6-months. RESULTS: Mixed modeling results showed a significant time effect for systolic BP (SBP) with a dose-response effect at Months 3 and 6. Adherence declined over time and was lowest in the 15-min dose condition, though SBP reductions were maintained. Generally, adherence was negatively associated with dose as the study progressed. CONCLUSIONS: Smartphone-implemented BAM appears to reduce SBP and can be a low-cost method to reach large populations. (PsycINFO Database Record

Formative evaluation on cultural tailoring breathing awareness meditation smartphone apps to reduce stress and blood pressure.

BACKGROUND: Chronic stress is an independent risk factor for essential hypertension (EH), cardiovascular disease (CVD), and is sometimes confronted by mal-adaptive coping behaviors (e.g., stress eating, excessive alcohol consumption, etc.). Pre-essential hypertension (preEH) is the leading predictor of future EH status. Breathing awareness meditation (BAM) can result in clinically beneficial blood pressure (BP) reductions, though face-to-face sessions presents barriers to reach those in need. The purpose of this study was to identify if a culturally tailored approach is needed in the design and preferences between groups of preEH African American and White adults toward using a smartphone BAM app, the Tension Tamer (TT) app. METHODS: TT includes audio delivered BAM instructions, real-time heart rate, feedback graphs and motivational reinforcement text messaging. Questionnaires and two focus groups each of African American and White adults, [n=34, mean age =43.1 years, (SD 13.8 years), 44.1% African American] were conducted to understand stress, EH knowledge, app usage along with feedback from a hands-on demonstration of TT. Grounded theory using NVivo 10 was used to develop themes and combined with the questionnaires in the analysis. RESULTS: No racial differences were found in the analysis including app use scenarios, preferences, knowledge, technology use or the attitudes and acceptance toward mobile health (mHealth) programs. Reported stress was high for African Americans [PSS-4: mean 6.87 (SD 3.3) versus mean 4.56 (SD 2.6); P=0.03]. Four main themes were found: (I) stress was pervasive; (II) coping strategies were both positive and negative; (III) BAM training was easy to incorporated; and (IV) tracking stress responses was useful. Responses suggest that additional personalization of app interfaces may drive ownership and adherence to protocols. Measures and reports of heart rate monitoring while in session were favorably viewed with low issues with confidentiality or trust issues on collected session data. CONCLUSIONS: Results suggest that a culturally tailored approach may be unnecessary in the design of BAM apps. Further investigation is warranted for other racial groups, age ranges, and disease conditions.

Sustainability of improvements in medication adherence through a mobile health intervention.

Context-Very few patient-centered, theory-guided programs for medication adherence and blood pressure control have been conducted in kidney transplant recipients. Objective-To evaluate preliminary indications of sustainability of improved blood pressure in kidney transplant recipients 12 months after completion of a 3-month randomized controlled trial of a mobile health pilot program to improve blood pressure and medication adherence. Participants and Design-A total of 18 of the 19 trial participants were contacted and all consented to inclusion in the retrospective analysis of their medical records showing their clinic-recorded systolic blood pressures at 3, 6, and 12 months following participation in the 3-month trial of a medical regimen self-management intervention. Results-A significant group difference in systolic blood pressure was observed longitudinally, indicating that the intervention group, as compared with the standard-care group, exhibited lower clinic-measured systolic blood pressures at the 12-month posttrial follow-up visit (P= .01). At 12-month follow-up, success in establishing and sustaining control of systolic blood pressure (<131 mm Hg) was greater in the intervention group (50%) than in the control group (11%). Conclusion-Patients in the intervention group continued to exhibit lower systolic blood pressure than did patients in the control group 12 months after the trial ended, suggesting that the intervention may have a durable impact on blood pressure control that most likely reflects sustained medication adherence. These findings will aid in the development of an adequately powered randomized controlled trial to address the sustainable impact of the intervention program on medication adherence and blood pressure control.

Attitudes and perceptions of patients on the kidney transplant waiting list toward mobile health-delivered physical activity programs.

CONTEXT: Dialysis patients' lifestyles are associated with low levels of physical activity, increasing the chances of being removed from kidney waiting lists or dying while awaiting transplant because of increased cardiovascular risk factors and deteriorating health conditions. Personalized mobile health (mHealth) delivered programs may support their engagement in healthier lifestyles, maintain transplant eligibility, and reduce premature mortality. OBJECTIVE: To explore barriers and perceptions of physical activity behaviors and gauge interest in using mHealth in a physical activity wellness program for dialysis patients on the kidney transplant waiting list. PARTICIPANTS AND DESIGN: In-depth key informant interviews were conducted with 22 randomly selected dialysis patients during dialysis treatment in an urban Southeastern coastal city. A theory-guided community-based participatory research approach was used to develop the interview content. Constructivist grounded theory guided the data analysis using NVIVO 10 (QSR Int). The 32-item checklist from the Consolidated Criteria for Reporting Qualitative Studies was used in the qualitative reporting. RESULTS: Dialysis patients had a mean age of 46 (SD, 10.7) years, 45% were female, and 82% were African American. Their mean duration on transplant waiting lists was 6.7 (SD 4.3) years, and 73% owned smartphones. After saturation was reached, predominant themes included (1) physical activity was perceived as optional, (2) social support both encouraged and limited physical activity, (3) chronic stress and coping influenced physical activity, (4) spirituality provided strength to engage in physical activity, (5) self-care management practices varied considerably, and (6) high interest (95%) for using mHealth to promote physical activity was found. Patients preferred their home and neighborhood environments to intradialytic settings for engaging in physical activity.