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Randomized trial of telephone outreach to improve medication adherence and metabolic control in adults with diabetes.

ABSTRACT: Medication nonadherence is a major obstacle to better control of glucose, blood pressure (BP), and LDL cholesterol in adults with diabetes. Inexpensive effective strategies to increase medication adherence are needed.In a pragmatic randomized trial, we randomly assigned 2,378 adults with diabetes mellitus who had recently been prescribed a new class of medication for treating elevated levels of glycated hemoglobin (A1C) ?8% (64 mmol/mol), BP ?140/90 mmHg, or LDL cholesterol ?100 mg/dL, to receive 1) one scripted telephone call from a diabetes educator or clinical pharmacist to identify and address nonadherence to the new medication or 2) usual care. Hierarchical linear and logistic regression models were used to assess the impact on 1) the first medication fill within 60 days of the prescription; 2) two or more medication fills within 180 days of the prescription; and 3) clinically significant improvement in levels of A1C, BP, or LDL cholesterol.Of the 2,378 subjects, 89.3% in the intervention group and 87.4% in the usual-care group had sufficient data to analyze study outcomes. In intent-to-treat analyses, intervention was not associated with significant improvement in primary adherence, medication persistence, or intermediate outcomes of care. Results were similar across subgroups of patients defined by age, sex, race/ethnicity, and study site, and when limiting the analysis to those who completed the intended intervention.This low-intensity intervention did not significantly improve medication adherence or control of glucose, BP, or LDL cholesterol. Wide use of this strategy does not appear to be warranted; alternative approaches to identify and improve medication adherence and persistence are needed.

SUBMITTER: O'Connor PJ

PROVIDER: S-EPMC4751474 | biostudies-literature | 2014 Dec

REPOSITORIES: biostudies-literature

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Randomized trial of telephone outreach to improve medication adherence and metabolic control in adults with diabetes.

O'Connor Patrick J PJ Schmittdiel Julie A JA Pathak Ram D RD Harris Ronald I RI Newton Katherine M KM Ohnsorg Kris A KA Heisler Michele M Sterrett Andrew T AT Xu Stanley S Dyer Wendy T WT Raebel Marsha A MA Thomas Abraham A Schroeder Emily B EB Desai Jay R JR Steiner John F JF

Diabetes care 20141014 12

<h4>Objective</h4>Medication nonadherence is a major obstacle to better control of glucose, blood pressure (BP), and LDL cholesterol in adults with diabetes. Inexpensive effective strategies to increase medication adherence are needed.<h4>Research design and methods</h4>In a pragmatic randomized trial, we randomly assigned 2,378 adults with diabetes mellitus who had recently been prescribed a new class of medication for treating elevated levels of glycated hemoglobin (A1C) ≥8% (64 mmol/mol), BP ...[more]

PMID: 25315207

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Project description:BackgroundSimple nudges such as reminders and feedback reports to either a patient or a partner may facilitate improved medication adherence.ObjectiveTo test the impact of a pill bottle used to monitor adherence, deliver a daily alarm, and generate weekly medication adherence feedback reports on statin adherence.DesignThree-month, three-arm randomized clinical trial (ClinicalTrials.gov identifier: NCT02480530).ParticipantsOne hundred and twenty-six veterans with known coronary artery disease and poor adherence (medication possession ratio <80 %).InterventionPatients were randomized to one of three groups: (1) a control group (n = 36) that received a pill-monitoring device with no alarms or feedback; (2) an individual feedback group (n = 36) that received a daily alarm and a weekly medication adherence feedback report; and (3) a partner feedback group (n = 54) that received an alarm and a weekly feedback report that was shared with a friend, family member, or a peer. The intervention continued for 3 months, and participants were followed for an additional 3 months after the intervention period.Main measuresAdherence as measured by pill bottle. Secondary outcomes included change in LDL (mg/dl), patient activation, and social support.Key resultsDuring the 3-month intervention period, medication adherence was higher in both feedback arms than in the control arm (individual feedback group 89 %, partner feedback group 86 %, control group 67 %; p < 0.001 and = 0.001). At 6 months, there was no difference in medication adherence between either of the feedback groups and the control (individual feedback 60 %, partner feedback 52 %, control group 54 %; p = 0.75 and 0.97).ConclusionsDaily alarms combined with individual or partner feedback reports improved statin medication adherence. While neither an individual feedback nor partner feedback strategy created a sustainable medication adherence habit, the intervention itself is relatively easy to implement and low cost.

Project description:Scalable self-management interventions are necessary to address suboptimal diabetes control, especially among minority populations. The study tested the effectiveness of a telephone behavioral intervention in improving glycemic control among adults with diabetes in the New York City A1c Registry.RCT comparing a telephone intervention to print-only intervention in the context of the A1c Registry program.Nine hundred forty-one adults with diabetes and hemoglobin A1c (A1c) >7% from a low-income, predominantly Latino population in the South Bronx were recruited from the A1c Registry.All study participants were mailed print diabetes self-management materials at baseline and modest lifestyle incentives quarterly. Only the telephone participants received four calls from health educators evenly spaced over 1 year if baseline A1c was >7%-9%, or eight calls if baseline A1c was >9%. Medication adherence was the main behavioral focus and, secondarily, nutrition and exercise.Primary outcome was difference between two study arms in change in A1c from baseline to 1 year. Secondary outcomes included diabetes self-care activities, including self-reported medication adherence. Data were collected in 2008-2012 and analyzed in 2012-2014.Participants were predominantly Latino (67.7%) or non-Latino black (28%), with 69.7% foreign-born and 55.1% Spanish-speaking. Among 694 (74%) participants with follow-up A1c, mean A1c decreased by 0.9 (SD=0.1) among the telephone group compared with 0.5 (SD=0.1) among the print-only group, a difference of 0.4 (95% CI=0.09, 0.74, p=0.01). The intervention had significant effect when baseline A1c was >9%. Both groups experienced similar improvements in self-care activities, medication adherence, and intensification.A telephone intervention delivered by health educators can be a clinically effective tool to improve diabetes control in diverse populations, specifically for those with worse metabolic control identified using a registry. This public health approach could be adopted by health systems supported by electronic record capabilities. CLINICALTRIALS.NCT00797888.

Project description:IntroductionThe exact pathway linking health literacy, self-efficacy, medication adherence, and glycemic control for type 2 diabetes remains unclear. Understanding the relationship between patient factors, medication adherence, and lower glycated hemoglobin (HbA1c) may help patients better manage their disease. This study examined the association of health literacy and medication self-efficacy with self-reported diabetes medication adherence, and the association of health literacy, medication self-efficacy, and self-reported diabetes medication adherence with HbA1c of patients with type 2 diabetes.MethodsThis cross-sectional study utilized a face-to-face questionnaire at two family medicine clinics in a Midwestern state among 174 patients; subjects enrolled were at least 20 years old with diagnosed type 2 diabetes, prescribed at least one oral diabetes medicine, and understood English. Questionnaires were administered to assess the participants': health literacy, using the Newest Vital Sign six-item questionnaire (NVS); self-efficacy for medication use, using the 13-item Self-Efficacy for Appropriate Medication Use Scale; and self-report medication adherence, using the eight-item Morisky Medication Adherence Scale. HbA1c values were obtained from participants' electronic medical records. Multiple linear regressions were used to explore the association of health literacy and medication self-efficacy with both medication adherence and HbA1c level after controlling for all other covariates.ResultsSelf-reported health status (β = 0.17, p = 0.015) and medication self-efficacy (β = 0.53, p < 0.001) were positively associated with diabetes medication adherence. Health literacy was neither associated with diabetes medication adherence (β = -0.04, p = 0.586) nor HbA1c (β = -0.06, p = 0.542). Lower diabetes medication adherence (β = -0.26, p = 0.008) and higher number of prescribed medications (β = 0.28, p = 0.009) were correlated with higher HbA1c.ConclusionHealth literacy, as measured by the NVS, does not correlate with medication adherence or glycemic control among patients with type 2 diabetes. Interventions to improve patients' self-efficacy of medication use may improve diabetes medication adherence.

Project description:BACKGROUND:The efficacy of smartphone apps for improving medication adherence in type 2 diabetes is not well studied in Asian populations. OBJECTIVE:This study aimed to determine the feasibility, acceptability, and clinical outcomes of using a smartphone app to improve medication adherence in a multiethnic Asian population with type 2 diabetes. METHODS:We block randomized 51 nonadherent and digitally literate patients with type 2 diabetes between the ages of 21 and 75 years into two treatment arms (control: usual care; intervention: usual care+Medisafe app) and followed them up for 12 weeks. Recruitment occurred at a public tertiary diabetes specialist outpatient center in Singapore. The intervention group received email reminders to complete online surveys monthly, while the control group only received an email reminder(s) at the end of the study. Barriers to medication adherence and self-appraisal of diabetes were assessed using the Adherence Starts with Knowledge-12 (ASK-12) and Appraisal of Diabetes Scale (ADS) questionnaires at baseline and poststudy in both groups. Perception toward medication adherence and app usage, attitude, and satisfaction were assessed in the intervention group during and after the follow-up period. Sociodemographic data were collected at baseline. Clinical data (ie, hemoglobin A1c, body mass index, low-density lipoprotein, high-density lipoprotein, and total cholesterol levels) were extracted from patients' electronic medical records. RESULTS:A total of 51 (intervention group: 25 [49%]; control group: 26 [51%]) participants were randomized, of which 41 (intervention group: 22 [88.0%]; control group: 19 [73.1%]) completed the poststudy survey. The baseline-adjusted poststudy ASK-12 score was significantly lower in the intervention group than in the control group (mean difference: 4.7, P=.01). No changes were observed in the clinical outcomes. The average 12-week medication adherence rate of participants tracked by the app was between 38.3% and 100% in the intervention group. The majority (>80%) of the participants agreed that the app was easy to use and made them more adherent to their medication. CONCLUSIONS:Our feasibility study showed that among medication-nonadherent patients with type 2 diabetes, a smartphone app intervention was acceptable, improved awareness of medication adherence, and reduced self-reported barriers to medication adherence, but did not improve clinical outcomes in a developed Asian setting.

Project description:Background/objectiveAs pharmacists work to ensure reimbursement for chronic disease management services on the national level, evidence of their impact on important health metrics, such as medication adherence, is needed. However, summative evidence is lacking on the effectiveness of pharmacists to improve medication adherence in older adults. The objective was to assess the effectiveness of pharmacist-led interventions on medication adherence in older adults (65+ years).Design/setting/participantsUsing a systematic review and meta-analytic approach, a comprehensive search of publications in PubMed, Scopus, CINAHL, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, and Google Scholar was conducted through April 2, 2020 for randomized clinical trials of pharmacist-led interventions to improve medication adherence in older adults. A standardized mean difference effect size (Cohen's d) was calculated for medication adherence in each study. Study effect sizes were pooled using a random-effects model, with effect sizes weighted by inverse of its total variance.MeasurementsMedication adherence using any method of measurement.ResultsAmong 40 unique randomized trials of pharmacist-led interventions with data from 8822 unique patients (mean age, range: 65-85 years), the mean effect size was 0.57 (k = 40; 95% Confidence Interval [CI]: 0.38-0.76). When two outlier studies were excluded from the analysis, the mean effect size reduced to 0.41 (k = 38; 95% CI: 0.27-0.54). A sensitivity analysis of medication adherence outcome by time point resulted in a mean effect size of 0.64 at 3 months (k = 12; 95% CI: 0.32-0.97), 0.30 at 6 months (k = 13; 95% CI: 0.11-0.48), 0.22 at 12 months (k = 12; 95% CI: 0.08-0.37), and 0.36 for outcome time points beyond 12 months (k = 5; 95% CI: 0.02-0.70).ConclusionThis meta-analysis found a significant improvement in medication adherence among older adults receiving pharmacist-led interventions. Implementation of pharmacist-led interventions supported by Medicare reimbursement could ensure older adults' access to effective medication adherence support.

Project description:BackgroundDespite the demonstrated need to increase screening mammography utilization and strong evidence that mail and telephone outreach to women can increase screening, most managed care organizations have not adopted comprehensive outreach programs. The uncertainty about optimum strategies and cost effectiveness have retarded widespread acceptance. While 70% of women report getting a mammogram within the prior 2 years, repeat mammography rates are less than 50%. This 5-year study is conducted though a Central Massachusetts healthcare plan and affiliated clinic. All women have adequate health insurance to cover the test.Methods/designThis randomized study compares 3 arms: reminder letter alone; reminder letter plus reminder call; reminder letter plus a second reminder and booklet plus a counselor call. All calls provide women with the opportunity to schedule a mammogram in a reasonable time. The invention period will span 4 years and include repeat attempts. The counselor arm is designed to educate, motivate and counsel women in an effort to alleviate PCP burden.All women who have been in the healthcare plan for 24 months and who have a current primary care provider (PCP) and who are aged 51-84 are randomized to 1 of 3 arms. Interventions are limited to women who become ≥ 18 months from a prior mammogram. Women and their physicians may opt out of the intervention study.Measurement of completed mammograms will use plan billing records and clinic electronic records. The primary outcome is the proportion of women continuously enrolled for ≥ 24 months who have had ≥ 1 mammogram in the last 24 months. Secondary outcomes include the number of women who need repeat interventions. The cost effectiveness analysis will measure all costs from the provider perspective.DiscussionSo far, 18,509 women aged 51-84 have been enrolled into our tracking database and were randomized into one of three arms. At baseline, 5,223 women were eligible for an intervention. We anticipate that the outcome will provide firm data about the maximal effectiveness as well as the cost effectiveness of the interventions both for increasing the mammography rate and the repeat mammography rate.Trial registrationhttp://clinicaltrials.gov/NCT01332032.

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Randomized trial of telephone outreach to improve medication adherence and metabolic control in adults with diabetes.

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Randomized trial of telephone outreach to improve medication adherence and metabolic control in adults with diabetes.

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