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Educational intervention to improve effectiveness in treatment and control of patients with high cardiovascular risk in low-resource settings in Argentina: study protocol of a cluster randomised controlled trial.

ABSTRACT: INTRODUCTION:Hypercholesterolaemia is estimated to cause 2.6 million deaths annually and one-third of the cases of ischaemic heart disease. In Argentina, the prevalence of hypercholesterolaemia increased between 2005 and 2013 from 27.9% to 29.8%. Only one out of four subjects with a self-reported diagnosis of coronary heart disease is taking statins. Since 2014, statins (simvastatin 20?mg) are part of the package of drugs provided free-of-charge for patients according to cardiovascular disease (CVD) risk stratification. The goal of this study is to test whether a complex intervention targeting physicians and pharmacist assistants improves treatment and control of hypercholesterolaemia among patients with moderate-to-high cardiovascular risk in Argentina. METHODS AND ANALYSIS:This is a cluster trial of 350 patients from 10 public primary care centres in Argentina to be randomised to either the intervention or usual care. The study is designed to have 90% statistical power to detect a 0.7?mmol/L reduction in low-density lipoproteins cholesterol from baseline to 12?months. The physician education programme consists of a 2-day initial intensive training and certification workshop followed by educational outreach visits (EOVs) conducted at 3, 6 and 9?months from the outset of the study. An on-site training to pharmacist assistants during the first EOV is performed at each intervention clinic. In addition, two intervention support tools are used: an app installed in physician's smartphones to serve as a decision aid to improve prescription of statins according to patient's CVD risk and a web-based platform tailored to send individualised SMS messages to patients. ETHICS AND DISSEMINATION:Ethical approval was obtained from an independent ethics committee. Results of this study will be presented to the Ministry of Health of Argentina for potential dissemination and scale-up of the intervention programme to the entire national public primary care network in Argentina. TRIAL REGISTRATION NUMBER:NCT02380911.

SUBMITTER: Gulayin P

PROVIDER: S-EPMC5293870 | biostudies-literature | 2017 Jan

REPOSITORIES: biostudies-literature

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Educational intervention to improve effectiveness in treatment and control of patients with high cardiovascular risk in low-resource settings in Argentina: study protocol of a cluster randomised controlled trial.

Gulayin Pablo P Irazola Vilma V Lozada Alfredo A Chaparro Martin M Santero Marilina M Gutierrez Laura L Poggio Rosana R Beratarrechea Andrea A Rubinstein Adolfo A

BMJ open 20170131 1

<h4>Introduction</h4>Hypercholesterolaemia is estimated to cause 2.6 million deaths annually and one-third of the cases of ischaemic heart disease. In Argentina, the prevalence of hypercholesterolaemia increased between 2005 and 2013 from 27.9% to 29.8%. Only one out of four subjects with a self-reported diagnosis of coronary heart disease is taking statins. Since 2014, statins (simvastatin 20 mg) are part of the package of drugs provided free-of-charge for patients according to cardiovascular d ...[more]

PMID: 28143840

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Project description:Background The control of hypertension is low in low- and middle-income countries like India. We evaluated the effects of a nurse-facilitated educational intervention in improving the control rate of hypertension among school teachers in India. Methods and Results This was a cluster-randomized controlled trial involving 92 schools in Kerala, which were randomly assigned equally into a usual care group and an intervention group. Participants were 402 school teachers (mean age, 47 years; men, 29%) identified with hypertension. Participants in both study groups received a leaflet containing details of a healthy lifestyle and the importance of regular intake of antihypertensive medication. In addition, the intervention participants received a nurse-facilitated educational intervention on hypertension control for 3 months. The primary outcome was hypertension control. Key secondary outcomes included systolic blood pressure, diastolic blood pressure, and the proportion of participants taking antihypertensive medications. For the primary outcome, we used mixed-effects logistic regression models. Two months after a 3-month educational intervention, a greater proportion of intervention participants (49.0%) achieved hypertension control than the usual care participants (38.2%), with an odds ratio of 1.89 (95% CI, 1.06-3.35), after adjusting for baseline hypertension control. The odds of taking antihypertensive medications were 1.6 times higher in the intervention group compared with the usual care group (odds ratio, 1.62; 95% CI, 1.08-2.45). The reduction in mean systolic blood pressure was significantly greater in the intervention group by 4.2 mm Hg (95% CI, -7.2 to -1.1) than in the usual care group. Conclusions A nurse-facilitated educational intervention was effective in improving the control and treatment rates of hypertension as well as reducing systolic blood pressure among schoolteachers with hypertension. Registration URL: https://www.ctri.nic.in; Unique Identifier: CTRI/2018/01/011402.

Project description:ImportanceHypertension is highly prevalent in low- and middle-income countries, and it is an important preventable risk factor for cardiovascular diseases (CVDs). Understanding the economic benefits of a hypertension control program is valuable to decision-makers.ObjectiveTo evaluate the long-term cost-effectiveness of a multicomponent hypertension management program compared with usual care among patients with hypertension receiving care in public clinics in Argentina from a health care system perspective.Design, setting, and participantsThis economic evaluation used a Markov model to estimate the cost-effectiveness of a hypertension management program among adult patients with uncontrolled hypertension in a low-income setting. Patient-level data (743 individuals for multicomponent intervention; 689 for usual care) from the Hypertension Control Program in Argentina trial (HCPIA) were used to estimate treatment effects and the risk of CVD. Three health states were included in each strategy: (1) low risk of CVD, (2) high risk of CVD, and (3) death. The total time horizon was the lifetime, and each cycle lasted 6 months.Main outcomes and measuresModel inputs were based on trial data and other published sources. Cost and utilities were discounted at a rate of 5% annually. The incremental cost-effectiveness ratio (ICER) between the multicomponent intervention and usual care was calculated using the difference in costs in 2017 international dollars (INT $) divided by the difference in effectiveness in quality-adjusted life-years (QALYs). One-way sensitivity analysis and probabilistic sensitivity analysis were performed to assess the uncertainty and robustness of the results.ResultsIn the original trial, the 743 participants in the intervention group (349 [47.0%] men) had a mean (SD) age of 56.2 (12.0) years, and the 689 participants in the control group (311 [45.1%] men) had a mean (SD) age of 56.2 (11.7) years. In the base-case analysis, the HCPIA program yielded 8.42 discounted QALYs and accrued INT $3096 discounted costs, while usual care yielded 8.29 discounted QALYs and accrued INT $2473 discounted costs. The ICER for the HCPIA program was INT $4907/QALY gained. The model results remained robust in sensitivity analyses, and the model was most sensitive to parameters of program costs.Conclusions and relevanceIn this study, the HCPIA multicomponent intervention vs usual care was a cost-effective strategy to improve hypertension management and reduce the risk of associated CVD among patients with hypertension who received services at public clinics in Argentina. This intervention program is likely transferable to other settings in Argentina or other lower- and middle-income countries.

Project description:BackgroundWeb-based lifestyle interventions at the workplace have the potential to promote health and work productivity. However, the sustainability of effects is often small, which could be enhanced by adding face-to-face contacts, so-called 'blended care'. Therefore, this study evaluates the effects of a blended workplace health promotion intervention on health and work outcomes among employees with increased cardiovascular risk.MethodsIn this multicentre cluster-randomised controlled trial (PerfectFit), 491 workers in 18 work units from military, police, and a hospital with increased cardiovascular risk were randomised into two intervention groups. The limited intervention (n = 213; 9 clusters) consisted of a web-based Health Risk Assessment with advice. In the extensive intervention (n = 271; 8 clusters), coaching sessions by occupational health physicians using motivational interviewing were added. One cluster dropped out after randomisation but before any inclusion of subjects. Primary outcome was self-rated health. Secondary outcomes were body weight, body mass index (BMI), work productivity, and health behaviours. Follow-up measurements were collected at 6 and 12 months. Effect sizes were determined in mixed effects models.ResultsAt 12 months, the extensive intervention was not statistically different from the limited intervention for self-rated health (4.3%; 95%CI -5.3-12.8), BMI (- 0.81; 95%CI -1.87-0.26) and body weight (- 2.16; 95%CI -5.49-1.17). The within-group analysis showed that in the extensive intervention group body weight (- 3.1 kg; 95% CI -2.0 to - 4.3) was statistically significantly reduced, whereas body weight remained stable in the limited intervention group (+ 0.2 kg; 95% CI -1.4 to 1.8). In both randomised groups productivity loss and physical activity increased and excessive alcohol use decreased significantly at 12 months.ConclusionsThere were no effects on self-rated health, body weight, and BMI. However, within the group with web-based tailored Health Risk Assessment including personalized advice body weight reduced significantly. Adding motivational coaching is promising to reduce body weight.Trial registrationRetrospectively registered at the Netherlands Trial Registry with number NTR4894 , at Nov 14 2014.

Project description:OBJECTIVE:Test effectiveness of an educational intervention for general practitioners (GPs) on quality of life and depression outcomes for patients. DESIGN:Double-blind, cluster randomised controlled trial. SETTING:General practices in Australia between 2007 and 2010. PARTICIPANTS:General practices were randomly allocated to the waitlist (n=37) or intervention (n=66) group, in a ratio of 1:2. A total of 2030 (1478 intervention; 552 waitlist) community-dwelling participants aged 75 years or older were recruited via 168 GPs (113 intervention; 55 waitlist). INTERVENTIONS:A practice-based academic detailing intervention led by a peer educator that included: (1) training in use of the GP assessment of cognition dementia screening instrument; (2) training in diagnosis and management based on Royal Australian College of General Practitioners Dementia Guidelines; (3) addressing GPs' barriers to dementia diagnosis; and (4) a business case outlining a cost-effective dementia assessment approach. OUTCOME MEASURES:Primary outcome measures were patient quality of life and depression; secondary outcome measures were: (1) sensitivity and specificity of GP identification of dementia; (2) referral to medical specialists and/or support services; (3) patient satisfaction with care; and (4) carer quality of life, depression and satisfaction with care. RESULTS:The educational intervention had no significant effect on patient quality of life or depression scores after 12 months. There were however improvements in secondary outcome measures including sensitivity of GP judgement of dementia (p=0.002; OR 6.0, 95% CI 1.92 to 18.73), satisfaction with GP communication for all patients (p=0.024; mean difference 2.1, 95% CI 0.27 to 3.93) and for patients with dementia (p=0.007; mean difference 7.44, 95% CI 2.02 to 12.86) and enablement of carers (p=0.0185; mean difference 24.77, 95% CI 4.15 to 45.40). CONCLUSION:Practice-based academic detailing did not improve patient quality of life or depression scores but did improve detection of dementia in primary care and patient satisfaction with GP communication. TRIAL REGISTRATION NUMBER:ACTRN12607000117415; Pre-results.

Project description:OBJECTIVES:To improve maternal health services in rural areas, the Palestinian Ministry of Health launched a midwife-led continuity model in the West Bank in 2013. Midwives were deployed weekly from governmental hospitals to provide antenatal and postnatal care in rural clinics. We studied the intervention's impact on use and quality indicators of maternal services after 2?years' experience. DESIGN:A non-randomised intervention design was chosen. The study was based on registry data only available at cluster level, 2?years before (2011and2012) and 2?years after (2014and2015) the intervention. SETTING:All 53 primary healthcare clinics in Nablus and Jericho regions were stratified for inclusion. PRIMARY AND SECONDARY OUTCOMES:Primary outcome was number of antenatal visits. Important secondary outcomes were number of referrals to specialist care and number of postnatal home visits. Differences in changes within the two groups before and after the intervention were compared by using mixed effect models. RESULTS:14 intervention clinics and 25 control clinics were included. Number of antenatal visits increased by 1.16 per woman in the intervention clinics, while declined by 0.39 in the control clinics, giving a statistically significant difference in change of 1.55 visits (95%?CI 0.90 to 2.21). A statistically significant difference in number of referrals was observed between the groups, giving a ratio of rate ratios of 3.65 (2.78-4.78) as number of referrals increased by a rate ratio of 3.87 in the intervention group, while in the control the rate ratio was only 1.06.Home visits increased substantially in the intervention group but decreased in the control group, giving a ratio of RR 97.65 (45.20 - 210.96) CONCLUSION: The Palestinian midwife-led continuity model improved use and some quality indicators of maternal services. More research should be done to investigate if the model influenced individual health outcomes and satisfaction with care. TRIAL REGISTRATION NUMBER:NCT03145571; Results.

Project description:ObjectivesTo evaluate the impact of a multicomponent intervention (Stand More AT (SMArT) Work) designed to reduce sitting time on short (three months), medium (six months), and longer term (12 months) changes in occupational, daily, and prolonged sitting, standing, and physical activity, and physical, psychological, and work related health.DesignCluster two arm randomised controlled trial.SettingNational Health Service trust, England.Participants37 office clusters (146 participants) of desk based workers: 19 clusters (77 participants) were randomised to the intervention and 18 (69 participants) to control.InterventionsThe intervention group received a height adjustable workstation, a brief seminar with supporting leaflet, workstation instructions with sitting and standing targets, feedback on sitting and physical activity at three time points, posters, action planning and goal setting booklet, self monitoring and prompt tool, and coaching sessions (month 1 and every three months thereafter). The control group continued with usual practice.Main outcome measuresThe primary outcome was occupational sitting time (thigh worn accelerometer). Secondary outcomes were objectively measured daily sitting, prolonged sitting (?30 minutes), and standing time, physical activity, musculoskeletal problems, self reported work related health (job performance, job satisfaction, work engagement, occupational fatigue, sickness presenteeism, and sickness absenteeism), cognitive function, and self reported psychological measures (mood and affective states, quality of life) assessed at 3, 6, and 12 months. Data were analysed using generalised estimating equation models, accounting for clustering.ResultsA significant difference between groups (in favour of the intervention group) was found in occupational sitting time at 12 months (-83.28 min/workday, 95% confidence interval -116.57 to -49.98, P=0.001). Differences between groups (in favour of the intervention group compared with control) were observed for occupational sitting time at three months (-50.62 min/workday, -78.71 to -22.54, P<0.001) and six months (-64.40 min/workday, -97.31 to -31.50, P<0.001) and daily sitting time at six months (-59.32 min/day, -88.40 to -30.25, P<0.001) and 12 months (-82.39 min/day, -114.54 to -50.26, P=0.001). Group differences (in favour of the intervention group compared with control) were found for prolonged sitting time, standing time, job performance, work engagement, occupational fatigue, sickness presenteeism, daily anxiety, and quality of life. No differences were seen for sickness absenteeism.ConclusionsSMArT Work successfully reduced sitting time over the short, medium, and longer term, and positive changes were observed in work related and psychological health.Trial registrationCurrent Controlled Trials ISRCTN10967042.

Project description:We conducted a cluster randomized trial testing the effectiveness of an intervention to increase the use of osteoporosis medications in high-risk patients receiving home health care. The trial did not find a significant difference in medication use in the intervention arm.This study aims to test an evidence implementation intervention to improve the quality of care in the home health care setting for patients at high risk for fractures.We conducted a cluster randomized trial of a multimodal intervention targeted at home care for high-risk patients (prior fracture or physician-diagnosed osteoporosis) receiving care in a statewide home health agency in Alabama. Offices throughout the state were randomized to receive the intervention or to usual care. The primary outcome was the proportion of high-risk home health patients treated with osteoporosis medications. A t test of difference in proportions was conducted between intervention and control arms and constituted the primary analysis. Secondary analyses included logistic regression estimating the effect of individual patients being treated in an intervention arm office on the likelihood of a patient receiving osteoporosis medications. A follow-on analysis examined the effect of an automated alert built into the electronic medical record that prompted the home health care nurses to deploy the intervention for high-risk patients using a pre-post design.There were 11 offices randomized to each of the treatment and control arms; these offices treated 337 and 330 eligible patients, respectively. Among the offices in the intervention arm, the average proportion of eligible patients receiving osteoporosis medications post-intervention was 19.1 %, compared with 15.7 % in the usual care arm (difference in proportions 3.4 %, 95 % CI, -2.6 to 9.5 %). The overall rates of osteoporosis medication use increased from 14.8 % prior to activation of the automated alert to 17.6 % afterward, a nonsignificant difference.The home health intervention did not result in a significant improvement in use of osteoporosis medications in high-risk patients.

Project description:BackgroundTo understand better the success of self-management interventions and to enable tailoring of such interventions at specific subgroups of patients, the nurse-led Activate intervention is developed targeting one component of self-management (physical activity) in a heterogeneous subgroup (patients at risk of cardiovascular disease) in Dutch primary care.AimThe aim of this study was to evaluate the effectiveness of the Activate intervention and identifying which patient-related characteristics modify the effect.MethodsA two-armed cluster-randomised controlled trial was conducted comparing the intervention with care as usual. The intervention consisted of four nurse-led behaviour change consultations within a 3-month period. Data were collected at baseline, 3 months and 6 months. Primary outcome was the daily amount of moderate to vigorous physical activity at 6 months. Secondary outcomes included sedentary behaviour, self-efficacy for physical activity, patient activation for self-management and health status. Prespecified effect modifiers were age, body mass index, level of education, social support, depression, patient provider relationship and baseline physical activity.ResultsThirty-one general practices (n = 195 patients) were included (intervention group n = 93; control group n = 102). No significant between-group difference was found for physical activity (mean difference 2.49 minutes; 95% confidence interval -2.1; 7.1; P = 0.28) and secondary outcomes. Patients with low perceived social support (P = 0.01) and patients with a low baseline activity level (P = 0.02) benefitted more from the intervention.ConclusionThe Activate intervention did not improve patients' physical activity and secondary outcomes in primary care patients at risk of cardiovascular disease. To understand the results, the intervention fidelity and active components for effective self-management require further investigation.Trial registration: ClinicalTrials.gov NCT02725203.

Project description:BackgroundFostering a culture of safety is an essential step in ensuring patient safety and quality in primary care. We aimed to evaluate the effectiveness of an educational intervention to improve the safety culture in the family and community medicine teaching units in an Atlantic European Region.MethodsRandomized study conducted in family and community medicine teaching units in Galicia (Spain). Participants were all fourth-year residents and their tutors (N = 138). Those who agreed to participate were randomized into one of two groups (27 tutors/26 residents in the intervention group, 23 tutors/ 23 residents in the control one).All were sent the Survey on Patient Safety Culture. After that, the intervention group received specific training in safety; they also recorded incidents over 15 days, documented them following a structured approach, and had feedback on their performance. The control group did not receive any action. All participants completed the same survey four months later. Outcome measures were the changes in safety culture as quantified by the results variables of the Survey: Patient Safety Grade and Number of events reported. We conducted bivariate and adjusted analyses for the outcome measures. To explore the influence of participants' demographic characteristics and their evaluation of the 12 dimensions of the safety culture, we fitted a multivariate model for each outcome.ResultsTrial followed published protocol. There were 19 drop outs. The groups were comparable in outcome and independent variables at start. The experiment did not have any effect on Patient safety grade (- 0.040) in bivariate analysis. The odds of reporting one to two events increased by 1.14 (0.39-3.35), and by 13.75 (2.41-354.37) the odds of reporting 3 or more events. Different dimensions had significant independent effects on each outcome variable.ConclusionA educational intervention in family and community medicine teaching units may improve the incidents reported. The associations observed among organizational dimensions and outcomes evidence the complexity of patient safety culture measurement and, also, show the paths for improvement. In the future, it would be worthwhile to replicate this study in teaching units from different settings and with different health professionals engaged.Trial registrationIt was retrospectively registered with ( ISRCTN41911128 , 31/12/2010).

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Educational intervention to improve effectiveness in treatment and control of patients with high cardiovascular risk in low-resource settings in Argentina: study protocol of a cluster randomised controlled trial.

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Educational intervention to improve effectiveness in treatment and control of patients with high cardiovascular risk in low-resource settings in Argentina: study protocol of a cluster randomised controlled trial.

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