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A randomized trial of an intervention to improve use and adherence to effective coronary heart disease prevention strategies.

ABSTRACT: Efficacious strategies for the primary prevention of coronary heart disease (CHD) are underused, and, when used, have low adherence. Existing efforts to improve use and adherence to these efficacious strategies have been so intensive that they are impractical for clinical practice.We conducted a randomized trial of a CHD prevention intervention (including a computerized decision aid and automated tailored adherence messages) at one university general internal medicine practice. After obtaining informed consent and collecting baseline data, we randomized patients (men and women age 40-79 with no prior history of cardiovascular disease) to either the intervention or usual care. We then saw them for two additional study visits over 3 months. For intervention participants, we administered the decision aid at the primary study visit (1 week after baseline visit) and then mailed 3 tailored adherence reminders at 2, 4, and 6 weeks. We assessed our outcomes (including the predicted likelihood of angina, myocardial infarction, and CHD death over 10 years (CHD risk) and self-reported adherence) between groups at 3 month follow-up. Data collection occurred from June 2007 through December 2009. All study procedures were IRB approved.We randomized 160 eligible patients (81 intervention; 79 control) and followed 96% to study conclusion. Mean predicted CHD risk at baseline was 11.3%. The intervention increased self-reported adherence to chosen risk reducing strategies by 25 percentage points (95% CI 8% to 42%), with the biggest effect for aspirin. It also changed predicted CHD risk by -1.1% (95% CI -0.16% to -2%), with a larger effect in a pre-specified subgroup of high risk patients.A computerized intervention that involves patients in CHD decision making and supports adherence to effective prevention strategies can improve adherence and reduce predicted CHD risk.

SUBMITTER: Sheridan SL

PROVIDER: S-EPMC3268742 | biostudies-literature | 2011 Dec

REPOSITORIES: biostudies-literature

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A randomized trial of an intervention to improve use and adherence to effective coronary heart disease prevention strategies.

Sheridan Stacey L SL Draeger Lindy B LB Pignone Michael P MP Keyserling Thomas C TC Simpson Ross J RJ Rimer Barbara B Bangdiwala Shrikant I SI Cai Jianwen J Gizlice Ziya Z

BMC health services research 20111205

<h4>Background</h4>Efficacious strategies for the primary prevention of coronary heart disease (CHD) are underused, and, when used, have low adherence. Existing efforts to improve use and adherence to these efficacious strategies have been so intensive that they are impractical for clinical practice.<h4>Methods</h4>We conducted a randomized trial of a CHD prevention intervention (including a computerized decision aid and automated tailored adherence messages) at one university general internal m ...[more]

PMID: 22141447

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Project description:BackgroundThe treatment of many chronic illnesses involves long-term pharmaceutical therapy, but it is an ongoing challenge to find effective ways to improve medication adherence to promote good health outcomes. Cardioprotective medications can prevent the enlargement of harmful clots, cardiovascular symptoms, and poor therapeutic outcomes, such as uncontrolled high blood pressure and hyperlipidemia, for patients with coronary heart disease. Poor adherence to cardioprotective medications, however, has been reported as a global health concern among patients with coronary heart disease, and it is particularly a concern in China.ObjectiveThis study aimed to evaluate the efficacy of a mobile health (mHealth) intervention using 2 mobile apps to improve medication adherence and health outcomes.MethodsA randomized, placebo-controlled, 2-arm parallel study was conducted in a major university-affiliated medical center located in Chengdu, China. Participants were recruited by flyers and health care provider referrals. Each participant was observed for 90 days, including a 60-day period of mHealth intervention and a 30-day period of nonintervention follow-up. The study coordinator used WeChat and Message Express to send educational materials and reminders to take medication, respectively. Participants used WeChat to receive both the educational materials and reminders. Participants in the control group only received educational materials. This study received ethics approval from the Duke Health Institutional Review Board (Pro00073395) on May 5, 2018, and was approved by West China Hospital (20170331180037). Recruitment began on May 20, 2018. The pilot phase of this study was registered on June 8, 2016, and the current, larger-scale study was retrospectively registered on January 11, 2021 (ClinicalTrials.gov).ResultsWe recruited 230 patients with coronary heart disease. Of these patients, 196 completed the baseline survey and received the intervention. The majority of participants were married (181/196, 92.4%), male (157/196, 80.1%), and lived in urban China (161/196, 82.1%). Participants' average age was 61 years, and half were retired (103/191, 53.9%). More than half the participants (121/196, 61.7%) were prescribed at least 5 medications. The mean decrease in medication nonadherence score was statistically significant at both 60 days (t179=2.04, P=.04) and 90 days (t155=3.48, P<.001). Systolic blood pressure and diastolic blood pressure decreased in the experimental group but increased in the control group. The mean decrease in diastolic blood pressure was statistically significant at both 60 days (t160=2.07, P=.04) and 90 days (t164=2.21, P=.03). The mean decrease in systolic blood pressure was significantly different in the groups at 90 days (t165=3.12, P=.002).ConclusionsThe proposed mHealth intervention can improve medication adherence and health outcomes, including systolic blood pressure and diastolic blood pressure.Trial registrationClinicalTrials.gov NCT02793830; https://clinicaltrials.gov/ct2/show/NCT02793830 and ClinicalTrials.gov NCT04703439; https://clinicaltrials.gov/ct2/show/NCT04703439.

Project description:BackgroundMobile health technologies have the potential to improve the reach and delivery of interventions for promoting long-term secondary prevention of coronary heart disease.ObjectiveThis study aims to determine the effectiveness of an SMS text messaging intervention (Text4HeartII) for improving adherence to medication and lifestyle changes over and above usual care in people with coronary heart disease at 24 and 52 weeks.MethodsA two-arm, parallel, randomized controlled trial was conducted in New Zealand. Participants with a recent acute coronary syndrome were randomized to receive usual cardiac services alone (control, n=153) or a 24-week SMS text message program for supporting self-management plus usual cardiac services (n=153). The primary outcome was adherence to medication at 24 weeks, defined as a medication possession ratio of 80% or more for aspirin, statin, and antihypertensive therapy. Secondary outcomes included medication possession ratio at 52 weeks, self-reported medication adherence, adherence to healthy lifestyle behaviors, and health-related quality of life at 24 and 52 weeks.ResultsParticipants were predominantly male (113/306, 80.3%) and European New Zealanders (210/306, 68.6%), with a mean age of 61 years (SD 11 years). Groups were comparable at baseline. National hospitalization and pharmacy dispensing records were available for all participants; 92% (282/306, 92.1%) of participants completed a 24-week questionnaire and 95.1% (291/306) of participants completed a 52-week questionnaire. Adherence with 3 medication classes were lower in the intervention group than in the control group (87/153, 56.8% vs 105/153, 68.6%, odds ratio 0.60, 95% CI 0.38-0.96; P=.03) and 52 weeks (104/153, 67.9% vs 83/153, 54.2%; odds ratio 0.56, 95% CI 0.35-0.89; P=.01). Self-reported medication adherence scores showed the same trend at 52 weeks (mean difference 0.3; 95% CI 0.01-0.59; P=.04). Moreover, self-reported adherence to health-related behaviors was similar between groups.ConclusionsText4HeartII did not improve dispensed medication or adherence to a favorable lifestyle over and above usual care. This finding contrasts with previous studies and highlights that the benefits of text interventions may depend on the context in which they are used.Trial registrationAustralian New Zealand Clinical Trials Registry ACTRN12616000422426; http://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=370398.International registered report identifier (irrid)RR2-10.1186/s13063-018-2468-z.

Project description:BackgroundCoronary heart disease (CHD) is the leading cause of cardiovascular mortality worldwide, yet implementation of evidence-based strategies for secondary prevention remains suboptimal.ObjectiveThis study aimed to evaluate the feasibility, specifically the usability and acceptability, and estimate the preliminary effectiveness of a mobile health (mHealth) intervention targeting both physicians and patients to improve adherence to evidence-based medications and lifestyle modifications.MethodsWe conducted a 12-week pre-post interventional pilot study at two sites in Shanghai and Hainan, China. Physicians used the app designed in this study to prescribe evidence-based medicines and record patient information. Eligible and consenting patients received automatic text messages or voice calls 4 to 5 times per week for 12 weeks on medication adherence and healthy behaviors. Interviews were conducted among 10 physicians and 24 patients at the two sites for their thoughts on medication adherence and feedback on the usability and acceptability. Questions on usability and acceptability were also asked in a patient follow-up survey. With regard to estimating effectiveness, the primary outcome was medication adherence (as estimated by the Morisky Green Levine Scale) at 12 weeks. Secondary outcomes included physical activity, smoking status, fruits and vegetables consumption, and facility visit frequency.ResultsInterview findings and patient survey showed the good usability and acceptability of the intervention. Among 190 patients who completed the intervention, there was a significant increase in medication adherence (odds ratio [OR] 1.80, 95% CI 1.14-2.85). The study also showed decrease of smokers' percentage (-5%, P=.05), increase of daily vegetables consumption frequency (+0.3/day, P=.01), and community health care center visit frequency (+3 in 3 months, P=.04). The following site-specific differences were noted: medication adherence appeared to increase in Hainan (OR 14.68, 95% CI 5.20-41.45) but not in Shanghai (OR 0.61, 95% CI 0.33-1.12).ConclusionsOur study demonstrated that the intervention was feasible in both a tertiary care center and an urban community health center in China. Preliminary results from pre-post comparison suggest the possibility that provider and patient-linked mHealth interventions may improve medication adherence and lifestyle modifications among CHD patients, especially in resource-scarce settings. Randomized controlled trials are needed to verify the findings.

Project description:Background P2Y12 inhibitor medications are critical following percutaneous coronary intervention (PCI); however, adherence remains suboptimal. Our objective was to assess the effectiveness of a multifaceted intervention to improve P2Y12 inhibitor adherence following PCI. Methods and Results This was a modified stepped wedge trial of 52 eligible hospitals, of which 15 were randomly selected and agreed to participate (29 hospitals declined, and 8 eligible hospitals were not contacted). At each intervention hospital, patient recruitment occurred for 6 months and enrolled patients were followed up for 1 year after PCI. Three control groups were used: patients at intervention hospitals undergoing PCI (1) before the intervention period (preintervention); (2) after the intervention period (postintervention); or (3) at the 8 hospitals not contacted (concurrent controls). The intervention consisted of 4 components: (1) P2Y12 inhibitor delivered to patients' bedside after PCI; (2) education on importance of P2Y12 inhibitors; (3) automated reminder telephone calls to refill medication; and (4) outreach to patients if they delayed refilling P2Y12 inhibitor. The primary outcomes were as follows: (1) proportion of patients with delays filling P2Y12 inhibitor at hospital discharge and (2) proportion of patients who were adherent in the year after PCI using pharmacy refill data. Primary analysis compared intervention with preintervention control patients. There were 1377 (intent-to-treat) potentially eligible patients, of whom 803 (per protocol) were approached at intervention sites versus 5910 preintervention, 2807 postintervention, and 4736 concurrent control patients. In the intent-to-treat analysis, intervention patients were less likely to delay filling P2Y12 at hospital discharge (-3.4%; 98.3% CI, -1.2% to -5.6%) and more likely to be adherent to P2Y12 (4.1%; 98.3% CI, 1.0%-7.1%) at 1 year, but had more clinical events (3.2%; 98.3% CI, 2.3%-4.1%) driven by repeated PCI compared with preintervention patients. In post hoc analysis looking at myocardial infarction, stroke, and death, intervention patients had lower event rates compared with preintervention patients (-1.7%; 98.3% CI, -2.3% to -1.1%). Conclusions A 4-component intervention targeting P2Y12 inhibitor adherence was difficult to implement. The intervention produced mixed results. It improved P2Y12 adherence, but there was also an increase in repeat PCI. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT01609842.

Project description:BackgroundAdherence to antiplatelet medications is critical to prevent life threatening complications (ie, stent thrombosis) after percutaneous coronary interventions (PCIs), yet rates of nonadherence range from 21-57% by 12 months. Mobile interventions delivered via text messaging or mobile apps represent a practical and inexpensive strategy to promote behavior change and enhance medication adherence.ObjectiveThe Mobile4Meds study seeks to determine whether text messaging or a mobile app, compared with an educational website control provided to all Veterans, can improve adherence to antiplatelet therapy among patients following acute coronary syndrome (ACS) or PCI. The three aims of the study are to: (1) determine preferences for content and frequency of text messaging to promote medication adherence through focus groups; (2) identify the most patient-centered app that promotes adherence, through a content analysis of all commercially available apps for medication adherence and focus groups centered on usability; and (3) compare adherence to antiplatelet medications in Veterans after ACS/PCI via a randomized clinical trial (RCT).MethodsWe will utilize a mixed-methods design that uses focus groups to achieve the first and second aims (N=32). Patients will be followed for 12 months after being randomly assigned to one of three arms: (1) customized text messaging, (2) mobile app, or (3) website-control groups (N=225). Medication adherence will be measured with electronic monitoring devices, pharmacy records, and self-reports.ResultsEnrollment for the focus groups is currently in progress. We expect to enroll patients for the RCT in the beginning of 2018.ConclusionsDetermining the efficacy of mobile technology using a Veteran-designed protocol to promote medication adherence will have a significant impact on Veteran health and public health, particularly for individuals with chronic diseases that require strict medication adherence.Trial registrationClinicalTrials.gov NCT03022669.

Project description:Coronary heart disease (CHD) is one of the leading causes of morbidity and mortality worldwide, and more efforts should be made to reduce the risk of cardiovascular events. This study aimed to investigate the impact of clinical pharmacist intervention on the prognosis of acute coronary syndrome (ACS) in Chinese patients with CHD. Two hundred and forty patients who had ACS were recruited. Participants were randomly assigned to the intervention group (n = 120) or the control group (n = 120). The intervention group received a medication assessment and education by the clinical pharmacist at discharge and telephone follow-ups at 1 week and 1 and 3 months after discharge. The control group received usual care. The primary outcomes of this study were the proportion of patients who had major adverse cardiovascular events (MACEs), including mortality, nonfatal myocardial infarction (MI), stroke, and unplanned cardiac-related rehospitalizations within 6 and 12 months after hospital discharge. Secondary outcome was self-reported medication adherence to evidence-based medications for CHD (antiplatelets, statins, β-blockers, and angiotensin-converting enzyme inhibitors or angiotensin receptor blockers). Of 240 enrolled patients, 238 (98.3%) completed 6-month follow-up, and 235 (97.9%) completed 12-month follow-up. There were no significant differences between intervention and control groups in the percentages of patients who incurred MACEs within the 6-month follow-up (3.3% vs 7.6%, respectively, P = 0.145) or 12-month follow-up (10.9% vs 12.1%, respectively, P = 0.783). Significant improvements were found in the prescribing rates of β-blockers and all four classes of medications at discharge in the intervention group compared with the control group (P = 0.001 and P = 0.009, respectively). There was no significant difference between the intervention and control groups in the use of all four classes of medications at the 6-month follow-up (48.3% vs 45.8%, respectively, P = 0.691) and 12-month follow-up (47.9% vs 46.6%, respectively, P = 0.836). The use of β-blockers was nonsignificantly higher in the intervention group than in the control group at the 6-month follow-up (74.2% vs. 64.4%, P = 0.103) and 12-month follow-up (74.8% vs 63.8%, P = 0.068). Clinical pharmacist intervention had no significant effects on reduction in cardiovascular events among patients with CHD. Further studies with larger sample sizes and longer time frames for both intervention and follow-up are needed to validate the role of the clinical pharmacist in the morbidity and mortality of CHD. Clinical Trial Registration: chictr.org.cn, identifier ChiCTR-IOR-16007716.

Project description:BackgroundIn the treatment of coronary heart disease, secondary prevention goals are still often unmet and poor adherence to prescribed drugs has been suggested as one of the reasons. We aimed to investigate whether pharmaceutical care by a pharmacist at the cardiology clinic trained in motivational interviewing improves clinical outcomes and patient adherence.MethodsThis was a prospective, randomized, controlled, outcomes-blinded trial designed to compare pharmaceutical care follow-up with standard care. After standard follow-up at the cardiology clinic, patients in the intervention group were seen by a clinical pharmacist two to five times as required over seven months. Pharmacists were trained to use motivational interviewing in the consultations and they tailored their support to each patient's clinical needs and beliefs about medicines. The primary study end-point was the proportion of patients who reached the treatment goal for low-density lipoprotein cholesterol by 12 months after discharge. The key secondary outcome was patient adherence to lipid-lowering therapy at 15 months after discharge, and other secondary outcomes were the effects on patient adherence to other preventive drugs, systolic blood pressure, disease-specific quality of life, and healthcare use.Results316 patients were included. The proportion of patients who reached the target for low-density lipoprotein cholesterol were 37.0% in the intervention group and 44.2% in the control group (P = .263). More intervention than control patients were adherent to cholesterol-lowering drugs (88 vs 77%; P = .033) and aspirin (97 vs 91%; P = .036) but not to beta-blocking agents or renin-angiotensin-aldosterone system inhibitors.ConclusionsOur intervention had no positive effects on risk factors for CHD, but it increased patient adherence. Further investigation of the intervention process is needed to explore the difference in results between patient adherence and medication effects. Longer follow-up of healthcare use and mortality will determine if the increased adherence per se eventually will have a meaningful effect on patient health.Trial registrationClinicalTrials.gov NCT02102503, 03/04/2014 retrospectively registered.

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A randomized trial of an intervention to improve use and adherence to effective coronary heart disease prevention strategies.

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A randomized trial of an intervention to improve use and adherence to effective coronary heart disease prevention strategies.

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