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

ABSTRACT: 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 /].

SUBMITTER: Kessler JB

PROVIDER: S-EPMC6109000 | biostudies-literature | 2018 Sep

REPOSITORIES: biostudies-literature

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

Kessler Judd B JB Troxel Andrea B AB Asch David A DA Mehta Shivan J SJ Marcus Noora N Lim Raymond R Zhu Jingsan J Shrank William W Brennan Troyen T Volpp Kevin G KG

Journal of general internal medicine 20180315 9

<h4>Background</h4>Poor medication adherence is common and limits the effectiveness of treatment.<h4>Objective</h4>To investigate how social supports, automated alerts, and their combination improve medication adherence.<h4>Design</h4>Four-arm, randomized clinical trial with a 6-month intervention.<h4>Participants</h4>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%, a ...[more]

PMID: 29546659

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Project description:ImportanceForgetfulness is a major contributor to nonadherence to chronic disease medications and could be addressed with medication reminder devices.ObjectiveTo compare the effect of 3 low-cost reminder devices on medication adherence.Design, setting, and participantsThis 4-arm, block-randomized clinical trial involved 53 480 enrollees of CVS Caremark, a pharmacy benefit manager, across the United States. Eligible participants were aged 18 to 64 years and taking 1 to 3 oral medications for long-term use. Participants had to be suboptimally adherent to all of their prescribed therapies (with a medication possession ratio of 30% to 80%) in the 12 months before randomization. Participants were stratified on the basis of the medications they were using at randomization: medications for cardiovascular or other nondepression chronic conditions (the chronic disease stratum) and antidepressants (the antidepressant stratum). In each stratum, randomization occurred within blocks defined by whether all of the patient's targeted medications were dosed once daily. Patients were randomized to receive in the mail a pill bottle strip with toggles, digital timer cap, or standard pillbox. The control group received neither notification nor a device. Data were collected from February 12, 2013, through March 21, 2015, and data analyses were on the intention-to-treat population.Main outcomes and measuresThe primary outcome was optimal adherence (medication possession ratio ≥80%) to all eligible medications among patients in the chronic disease stratum during 12 months of follow-up, ascertained using pharmacy claims data. Secondary outcomes included optimal adherence to cardiovascular medications among patients in the chronic disease stratum as well as optimal adherence to antidepressants.ResultsOf the 53 480 participants, mean (SD) age was 45 (12) years and 56% were female. In the primary analysis, 15.5% of patients in the chronic disease stratum assigned to the standard pillbox, 15.1% assigned to the digital timer cap, 16.3% assigned to the pill bottle strip with toggles, and 15.1% assigned to the control arm were optimally adherent to their prescribed treatments during follow-up. There was no statistically significant difference in the odds of optimal adherence between the control and any of the devices (standard pillbox: odds ratio [OR], 1.03 [95% CI, 0.95-1.13]; digital timer cap: OR, 1.00 [95% CI, 0.92-1.09]; and pill bottle strip with toggles: OR, 0.94 [95% CI, 0.85-1.04]). In direct comparisons, the odds of optimal adherence were higher with a standard pillbox than with the pill bottle strip (OR, 1.10 [95% CI, 1.00-1.21]). Secondary analyses yielded similar results.Conclusions and relevanceLow-cost reminder devices did not improve adherence among nonadherent patients who were taking up to 3 medications to treat common chronic conditions. The devices may have been more effective if coupled with interventions to ensure consistent use or if targeted to individuals with an even higher risk of nonadherence.Trial registrationclinicaltrials.gov Identifier: NCT02015806.

Project description:BackgroundPatient characteristics are associated with adherence, which has implications for planning clinical research or designing payment systems that reward superior outcomes. It is unclear to what extent clinician efforts to improve adherence can attenuate these associations.MethodsTo identify factors predicting visit and medication adherence in settings designed to optimize adherence, we did a retrospective analysis of participants in the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT). ALLHAT recruited participants at 632 sites in North America, Puerto Rico, and the U.S. Virgin Islands for random assignment to antihypertensive treatment with amlodipine, chlorthalidone, or lisinopril. Site investigators reported clinic characteristics at the time they applied to participate in the study and research coordinators used standardized methods to measure patient characteristics. We defined adequate visit adherence as attending at least 80 % of scheduled visits; adequate medication adherence was defined as taking 80 % or more of the randomly assigned medication at all study visits.ResultsThe 31,250 ALLHAT participants eligible for the visit adherence analysis attended 78.5 % of scheduled study visits; 68.9 % attended more than 80 % of scheduled visits. Clinic setting was predictive of both forms of adherence; adherence was worst at private clinics; clinics that enrolled more study participants had superior adherence. Adjusting for clinic characteristics and clinical factors, women, younger participants, Blacks and smokers were less likely to have adequate visit adherence. Among the 28,967 participants eligible for the medication adherence analysis, 21,261 (73.4 %) reported adequate medication adherence. In adjusted analyses, younger and less educated participants, Blacks, and smokers were less likely to report adequate adherence.ConclusionsParticipant demographics were associated with adherence despite strenuous efforts to optimize adherence. Our results could inform decisions by researchers planning trials and policymakers designing payment systems.Trial registrationNCT00000542 . Registered 27 October 1999.

Project description:ObjectiveTo determine whether electronic health record alerts for acute kidney injury would improve patient outcomes of mortality, dialysis, and progression of acute kidney injury.DesignDouble blinded, multicenter, parallel, randomized controlled trial.SettingSix hospitals (four teaching and two non-teaching) in the Yale New Haven Health System in Connecticut and Rhode Island, US, ranging from small community hospitals to large tertiary care centers.Participants6030 adult inpatients with acute kidney injury, as defined by the Kidney Disease: Improving Global Outcomes (KDIGO) creatinine criteria.InterventionsAn electronic health record based "pop-up" alert for acute kidney injury with an associated acute kidney injury order set upon provider opening of the patient's medical record.Main outcome measuresA composite of progression of acute kidney injury, receipt of dialysis, or death within 14 days of randomization. Prespecified secondary outcomes included outcomes at each hospital and frequency of various care practices for acute kidney injury.Results6030 patients were randomized over 22 months. The primary outcome occurred in 653 (21.3%) of 3059 patients with an alert and in 622 (20.9%) of 2971 patients receiving usual care (relative risk 1.02, 95% confidence interval 0.93 to 1.13, P=0.67). Analysis by each hospital showed worse outcomes in the two non-teaching hospitals (n=765, 13%), where alerts were associated with a higher risk of the primary outcome (relative risk 1.49, 95% confidence interval 1.12 to 1.98, P=0.006). More deaths occurred at these centers (15.6% in the alert group v 8.6% in the usual care group, P=0.003). Certain acute kidney injury care practices were increased in the alert group but did not appear to mediate these outcomes.ConclusionsAlerts did not reduce the risk of our primary outcome among patients in hospital with acute kidney injury. The heterogeneity of effect across clinical centers should lead to a re-evaluation of existing alerting systems for acute kidney injury.Trial registrationClinicalTrials.gov NCT02753751.

Project description:BACKGROUND:Harnessing supportive influences in close relationships is an innovative and potentially effective strategy to improve sun protection behaviors. OBJECTIVE:This pilot randomized controlled clinical trial evaluates the feasibility and impact of Sun Safe Partners Online, a web-based, couples-focused intervention to improve sun protection behavior. METHODS:A total of 75 couples reporting suboptimal levels of sun protection recruited from Facebook advertisements were randomized to receive a web-based intervention called Sun Safe Partners Online or a Generic Online Sun Safety Information intervention. Sun Safe Partners Online had 4 individual-focused modules and 4 couples-focused modules. Feasibility was assessed by study enrollment, engagement, follow-up survey completion, and intervention evaluation. Participants completed baseline and a 1-month postintervention survey assessing sun protection and exposure, along with individual and relationship attitudes about the importance of sun protection. RESULTS:Using Facebook as a recruitment strategy resulted in rapid enrollment and higher acceptance than for the prior telephone and print trial. The follow-up survey completion was higher in the Generic Online condition (100%) than in the Sun Safe Partners Online condition (87.2%). Engagement in Sun Safe Partners Online was high, with more than two-thirds of participants completing all modules. Evaluations of Sun Safe Partners Online content and features as well as ease of navigation were excellent. Sun Safe Partners Online showed small effects on sun protection behaviors and sun exposure on weekends compared with the Generic Online intervention and moderate effect size increases in the Sun Safe Partners Online condition. CONCLUSIONS:This study uses a novel approach to facilitate engagement in sun protection by harnessing the influence of relationships among spouses and cohabiting partners. A couples-focused intervention may hold promise as a means to improve sun protection behaviors beyond interventions focused solely on individuals by leveraging the concern, collaboration, and support among intimate partners and addressing relationship-based barriers to sun protection. TRIAL REGISTRATION:ClinicalTrials.gov NCT04549675; https://clinicaltrials.gov/ct2/show/NCT04549675.

Project description:Importance:Medication nonadherence accounts for up to half of uncontrolled hypertension. Smartphone applications (apps) that aim to improve adherence are widely available but have not been rigorously evaluated. Objective:To determine if the Medisafe smartphone app improves self-reported medication adherence and blood pressure control. Design, Setting, and Participants:This was a 2-arm, randomized clinical trial (Medication Adherence Improvement Support App For Engagement-Blood Pressure [MedISAFE-BP]). Participants were recruited through an online platform and were mailed a home blood pressure cuff to confirm eligibility and to provide follow-up measurements. Of 5577 participants who were screened, 412 completed consent, met inclusion criteria (confirmed uncontrolled hypertension, taking 1 to 3 antihypertensive medications), and were randomized in a ratio of 1:1 to intervention or control. Interventions:Intervention arm participants were instructed to download and use the Medisafe app, which includes reminder alerts, adherence reports, and optional peer support. Main Outcomes and Measures:Co-primary outcomes were change from baseline to 12 weeks in self-reported medication adherence, measured by the Morisky medication adherence scale (MMAS) (range, 0-8, with lower scores indicating lower adherence), and change in systolic blood pressure. Results:Participants (n = 411; 209 in the intervention group and 202 controls) had a mean age of 52.0 years and mean body mass index, calculated as weight in kilograms divided by height in meters squared, of 35.5; 247 (60%) were female, and 103 (25%) were black. After 12 weeks, the mean (SD) score on the MMAS improved by 0.4 (1.5) among intervention participants and remained unchanged among controls (between-group difference: 0.4; 95% CI, 0.1-0.7; P = .01). The mean (SD) systolic blood pressure at baseline was 151.4 (9.0) mm Hg and 151.3 (9.4) mm Hg, among intervention and control participants, respectively. After 12 weeks, the mean (SD) systolic blood pressure decreased by 10.6 (16.0) mm Hg among intervention participants and 10.1 (15.4) mm Hg among controls (between-group difference: -0.5; 95% CI, -3.7 to 2.7; P = .78). Conclusions and Relevance:Among individuals with poorly controlled hypertension, patients randomized to use a smartphone app had a small improvement in self-reported medication adherence but no change in systolic blood pressure compared with controls. Trial Registration:clinicaltrials.gov Identifier: NCT02727543.

Dataset Information

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

Publications

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

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