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An adaptable implementation package targeting evidence-based indicators in primary care: A pragmatic cluster-randomised evaluation.
Willis, TA, Collinson, M, Glidewell, L, Farrin, AJ, Holland, M, Meads, D, Hulme, C, Petty, D, Alderson, S, Hartley, S, et al
PLoS medicine. 2020;(2):e1003045
Abstract
BACKGROUND In primary care, multiple priorities and system pressures make closing the gap between evidence and practice challenging. Most implementation studies focus on single conditions, limiting generalisability. We compared an adaptable implementation package against an implementation control and assessed effects on adherence to four different evidence-based quality indicators. METHODS AND FINDINGS We undertook two parallel, pragmatic cluster-randomised trials using balanced incomplete block designs in general practices in West Yorkshire, England. We used 'opt-out' recruitment, and we randomly assigned practices that did not opt out to an implementation package targeting either diabetes control or risky prescribing (Trial 1); or blood pressure (BP) control or anticoagulation in atrial fibrillation (AF) (Trial 2). Within trials, each arm acted as the implementation control comparison for the other targeted indicator. For example, practices assigned to the diabetes control package acted as the comparison for practices assigned to the risky prescribing package. The implementation package embedded behaviour change techniques within audit and feedback, educational outreach, and computerised support, with content tailored to each indicator. Respective patient-level primary endpoints at 11 months comprised the following: achievement of all recommended levels of haemoglobin A1c (HbA1c), BP, and cholesterol; risky prescribing levels; achievement of recommended BP; and anticoagulation prescribing. Between February and March 2015, we recruited 144 general practices collectively serving over 1 million patients. We stratified computer-generated randomisation by area, list size, and pre-intervention outcome achievement. In April 2015, we randomised 80 practices to Trial 1 (40 per arm) and 64 to Trial 2 (32 per arm). Practices and trial personnel were not blind to allocation. Two practices were lost to follow-up but provided some outcome data. We analysed the intention-to-treat (ITT) population, adjusted for potential confounders at patient level (sex, age) and practice level (list size, locality, pre-intervention achievement against primary outcomes, total quality scores, and levels of patient co-morbidity), and analysed cost-effectiveness. The implementation package reduced risky prescribing (odds ratio [OR] 0.82; 97.5% confidence interval [CI] 0.67-0.99, p = 0.017) with an incremental cost-effectiveness ratio of £1,359 per quality-adjusted life year (QALY), but there was insufficient evidence of effect on other primary endpoints (diabetes control OR 1.03, 97.5% CI 0.89-1.18, p = 0.693; BP control OR 1.05, 97.5% CI 0.96-1.16, p = 0.215; anticoagulation prescribing OR 0.90, 97.5% CI 0.75-1.09, p = 0.214). No statistically significant effects were observed in any secondary outcome except for reduced co-prescription of aspirin and clopidogrel without gastro-protection in patients aged 65 and over (adjusted OR 0.62; 97.5% CI 0.39-0.99; p = 0.021). Main study limitations concern our inability to make any inferences about the relative effects of individual intervention components, given the multifaceted nature of the implementation package, and that the composite endpoint for diabetes control may have been too challenging to achieve. CONCLUSIONS In this study, we observed that a multifaceted implementation package was clinically and cost-effective for targeting prescribing behaviours within the control of clinicians but not for more complex behaviours that also required patient engagement. TRIAL REGISTRATION The study is registered with the ISRCTN registry (ISRCTN91989345).
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Effectiveness of a muticomponent workout program integrated in an evidence based multimodal program in hyperfrail elderly patients: POWERAGING randomized clinical trial protocol.
González-Sánchez, M, Cuesta-Vargas, AI, Del Mar Rodríguez González, M, Caro, ED, Núñez, GO, Galán-Mercant, A, Belmonte, JJB
BMC geriatrics. 2019;(1):171
Abstract
BACKGROUND Short-term and mid-term comparison of the efficacy of a multimodal program that incorporates a therapeutic workout program, medication review, diet adjustment and health education, in comparison to the standard medical practice in the improvement of the neuromuscular and physiological condition. Furthermore, it is intended to analyse the maintenance of these effects in a long-term follow-up (12 months) from the onset of the intervention. METHODS A randomized clinical trial of elderly frail patients drawn from the Clinical Management Unit "Tiro de Pichón", Health District of Malaga, will be included in the study (after meeting the inclusion / exclusion criteria) will be randomized in two groups: a control group that will undergo an intervention consistent of medication review + diet adjustment + health education (regular workout recommendations within a complete advice on healthy lifestyles) and an experimental group whose intervention will consist of a multimodal treatment: therapeutic workout program+ medication review+ diet adjustment + health education. The sociodemographic, clinical and tracing variables will be reflected at the beginning of the study. In addition, the follow-up variables will be gathered at the second and sixth months after the beginning of the treatment and at the third and sixth months after the treatment (follow-up). The follow-up variables that will be measured are: body mass index, general health condition, fatigue, frailty, motor control, attention- concentration- memory, motor memory, spatial orientation, grip strength, balance (static, semi-dynamic), gait speed and metabolomics. A descriptive analysis of the sociodemographic variables of the participants will be conducted. One-Factor ANOVA will be used for the Within-Subject analysis and as for the Between-Subject analysis, the outcome variables between both the groups in each moment of the data collection will be compared. DISCUSSION A multimodal program that incorporates a therapeutic workout program, medication review, diet adjustment and health education may be effective treatment to reduce the functional decline in elderly. The results of the study will provide information on the possible strengths and benefits in multimodal program in elderly. TRIAL REGISTRATION ClinicalTrials.gov NCT02772952 registered May 2017.
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Information exchange networks of health care providers and evidence-based cardiovascular risk management: an observational study.
Heijmans, N, van Lieshout, J, Wensing, M
Implementation science : IS. 2017;(1):7
Abstract
BACKGROUND Although a wide range of preventive and clinical interventions has targeted cardiovascular risk management (CVRM), outcomes remain suboptimal. Therefore, the question is what additional determinants of CVRM and outcomes can be identified and addressed to optimize CVRM. In this study, we aimed to identify new perspectives for improving healthcare delivery and explored associations between information exchange networks of health care providers and evidence-based CVRM. METHODS This observational study was performed parallel to a randomized clinical trial which aimed to improve professional performance of practice nurses in the Netherlands. Information exchange on medical policy for CVRM ("general information networks") and CVRM for individual patients ("specific information networks") of 180 health professionals in 31 general practices was measured with personalized questionnaires. Medical record audit was performed concerning 1620 patients in these practices to document quality of care delivery and two risk factors (systolic blood pressure (SBP) and LDL cholesterol level). Hypothesized effects of five network characteristics (density, frequency of contact, centrality of CVRM-coordinators, homophily on positive attitudes for treatment target achievement, and presence of an opinion leader for CVRM) constructed on both general and specific information exchange networks were tested and controlled for practice and patient factors using logistic multilevel analyses. RESULTS Odds for adequate performance were enhanced in practices with an opinion leader for CVRM (OR 2.75, p < .05). Odds for achievement of SBP targets were reduced in practices who had networks with low homophily on positive attitudes for SBP and LDL targets (homophily for SBP targets OR 0.57, p < .05 and OR 0.60, p < .05, homophily for LDL targets OR 0.59, p < .05 and OR 0.61, p < .05 in general and specific information networks, respectively). No effects of network characteristics on cholesterol were found. CONCLUSIONS Delivery of evidence-based CVRM is associated with homophily of clinical attitudes and presence of opinion leaders in primary care teams. These results signal the potential of social networks to be taken into account in further attempts to improve the implementation of evidence-based care for CVRM. Future research is needed to identify and formulate optimal strategies for using opinion leaders to improve CVRM. Future interventions may be more effective if they target a common vision on CVRM within practices.
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The PREDIMED trial, Mediterranean diet and health outcomes: How strong is the evidence?
Guasch-Ferré, M, Salas-Salvadó, J, Ros, E, Estruch, R, Corella, D, Fitó, M, Martínez-González, MA, ,
Nutrition, metabolism, and cardiovascular diseases : NMCD. 2017;(7):624-632
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Abstract
AIMS: To address potential controversies on the health benefits of the Mediterranean diet (MedDiet) after PREDIMED, a randomized trial of MedDiet for primary cardiovascular prevention. We have focused on: a) the PREDIMED study design, b) analysis of PREDIMED data and c) interpretation of its results. DATA SYNTHESIS Regarding the design of the trial, its early termination and between-group differences in the intensity of the intervention are potential causes of concern. The planned duration was 6 years but the trial was prematurely stopped when an interim analysis at 4.8-year provided sufficient evidence of benefit for the two MedDiets. In the MedDiet groups supplemented with extra-virgin olive oil or mixed-nuts, the primary composite endpoint (myocardial infarction, stroke, or cardiovascular death) was reduced by 30% and 28% respectively, as compared with the control group. Final results did not change after taking into account the different intensity of educational efforts during the trial. Other potential doubts related to data analysis (e.g., intention to treat versus a per-protocol approach, and consequences of dropouts) should not be causes of concern. Finally, we addressed alternative interpretations of the effect on all-cause mortality. The protocol-defined primary endpoint was a composite cardiovascular endpoint, not all-cause mortality. To analyze total mortality, we would have needed a much larger sample size and longer follow-up. Therefore, the PREDIMED results cannot be used to draw firm conclusions on MedDiets and all-cause mortality. CONCLUSIONS The PREDIMED study was designed to overcome three major problems of previous nutritional research: a) residual confounding, addressed by using a randomized design; b) single-nutrient approaches, by randomizing an overall dietary pattern; and c) the limitations of assessing only intermediate risk markers, by using hard clinical end-points.
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Randomised controlled feasibility trial of an evidence-informed behavioural intervention for obese adults with additional risk factors.
Sniehotta, FF, Dombrowski, SU, Avenell, A, Johnston, M, McDonald, S, Murchie, P, Ramsay, CR, Robertson, K, Araujo-Soares, V
PloS one. 2011;(8):e23040
Abstract
BACKGROUND Interventions for dietary and physical activity changes in obese adults may be less effective for participants with additional obesity-related risk factors and co-morbidities than for otherwise healthy individuals. This study aimed to test the feasibility and acceptability of the recruitment, allocation, measurement, retention and intervention procedures of a randomised controlled trial of an intervention to improve physical activity and dietary practices amongst obese adults with additional obesity related risk factors. METHOD Pilot single centre open-labelled outcome assessor-blinded randomised controlled trial of obese (Body Mass Index (BMI)≥30 kg/m2) adults (age≥18 y) with obesity related co-morbidities such as type 2 diabetes, impaired glucose tolerance or hypertension. Participants were randomly allocated to a manual-based group intervention or a leaflet control condition in accordance to a 2∶1 allocation ratio. Primary outcome was acceptability and feasibility of trial procedures, secondary outcomes included measures of body composition, physical activity, food intake and psychological process measures. RESULTS Out of 806 potentially eligible individuals identified through list searches in two primary care general medical practices N = 81 participants (63% female; mean-age = 56.56(11.44); mean-BMI = 36.73(6.06)) with 2.35(1.47) co-morbidities were randomised. Scottish Index of Multiple Deprivation (SIMD) was the only significant predictor of providing consent to take part in the study (higher chances of consent for invitees with lower levels of deprivation). Participant flowcharts, qualitative and quantitative feedback suggested good acceptance and feasibility of intervention procedures but 34.6% of randomised participants were lost to follow-up due to overly high measurement burden and sub-optimal retention procedures. Participants in the intervention group showed positive trends for most psychological, behavioural and body composition outcomes. CONCLUSIONS The intervention procedures were found to be acceptable and feasible. Attrition rates were unacceptably high and areas for improvements of trial procedures were identified. TRIAL REGISTRATION Controlled-Trials.com ISRCTN90101501.
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Suboptimal use of evidence-based medical therapy in patients with acute myocardial infarction from the Korea Acute Myocardial Infarction Registry: prescription rate, predictors, and prognostic value.
Lee, JH, Yang, DH, Park, HS, Cho, Y, Jeong, MH, Kim, YJ, Kim, KS, Hur, SH, Seong, IW, Hong, TJ, et al
American heart journal. 2010;(6):1012-9
Abstract
BACKGROUND Only limited data are available for the recent trend of optimal evidence-based medical therapy at discharge after acute myocardial infarction (AMI) in Asia. We evaluated the predictors for the use of optimal evidence-based medical therapy at discharge and the association between discharge medications and 6-month mortality after AMI. METHODS Between November 2005 and January 2008, we evaluated the discharge medications among 9,294 post-MI survivors who did not have any documented contraindications to antiplatelet drugs, beta-blockers, angiotensin-converting enzyme inhibitors (ACE-Is)/angiotensin II receptor blockers (ARBs), or statins in the Korea Acute Myocardial Infarction Registry. Optimal evidence-based medical therapy was defined as the use of all 4 indicated medications. RESULTS Of these patients, 4,684 (50.4%) received all 4 medications at discharge. The discharge prescription rates of antiplatelet drugs, beta-blockers, ACE-Is/ARBs, and statins were 99.0%, 72.7%, 81.5%, and 77.2%, respectively. In multivariate analysis, advanced age, lower systolic blood pressure, higher Killip class at admission, left ventricular systolic dysfunction, higher blood creatinine level, lower total cholesterol levels, and coronary artery bypass grafting during hospitalization were independently associated with less use of optimal evidence-based medical therapy. In contrast, patients who underwent percutaneous coronary intervention were more likely to use optimal medications. In Cox proportional hazards model, optimal evidence-based medical therapy was an independent predictor of 6-month mortality after adjusting clinical characteristics and angiographic and procedural data. CONCLUSIONS The optimal evidence-based medical therapy is prescribed at suboptimal rates, particularly in patients with high-risk features. New educational strategies are needed to increase the use of these secondary preventive medical therapies.
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Multifactorial intervention to prevent recurrent cardiovascular events in patients 75 years or older: the Drugs and Evidence-Based Medicine in the Elderly (DEBATE) study: a randomized, controlled trial.
Strandberg, TE, Pitkala, KH, Berglind, S, Nieminen, MS, Tilvis, RS
American heart journal. 2006;(3):585-92
Abstract
OBJECTIVE We aimed to examine whether better use of preventive methods and treatments of cardiovascular disease would reduce recurrent events in home-dwelling patients 75 years or older. METHODS This was a randomized, controlled trial (a practical clinical trial, the DEBATE), conducted in 2000 to 2003 in Helsinki, Finland. We recruited 400 vascular patients with mean age of 80 years from the community, and they were randomly assigned to the intervention group (n = 199) where both nonpharmacological and pharmacological cardiovascular treatments were optimized by a geriatrician according to current guidelines. The control group (n = 201) received the usual care. Main outcome measures were major cardiovascular disease events and total mortality and changes in risk factors and medications. RESULTS The groups were balanced at baseline. Mean duration of follow-up was 3.4 years. At 3 years, drug treatments had become more evidence-based in the intervention group. Consequently, total and low-density lipoprotein cholesterol levels (P < .0001) and systolic (P = .005) and diastolic (P = .009) blood pressure were significantly improved in the intervention group. However, neither primary end points (52 and 53 events in the intervention and control groups, respectively) nor total mortality (36 and 35 deaths) were significantly different between the two groups. No special adverse effects were encountered. CONCLUSION It was possible and safe to institute evidence-based cardiovascular treatments and improve risk factors in patients 75 years or older in a pragmatic setting. During 3.4 years, however, this was not converted to clinical benefits.
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Secondary prevention of cardiovascular disease: a randomised trial of training in information management, evidence-based medicine, both or neither: the PIER trial.
Langham, J, Tucker, H, Sloan, D, Pettifer, J, Thom, S, Hemingway, H
The British journal of general practice : the journal of the Royal College of General Practitioners. 2002;(483):818-24
Abstract
BACKGROUND Sub-optimal management of cardiovascular disease (CVD) patients is widespread in primary and secondary care, with risk factors frequently unrecorded or untreated. AIM: To investigate the effectiveness of educational interventions developed in primary care, on recording, prescribing and control of risk factors among all patients recorded by their general practitioner as having CVD. DESIGN OF STUDY Factorial, duster-randomised controlled trial. SETTING Primary care teams representing the range of practice development in a geographically defined area in inner London. METHOD Participating practices were randomly allocated to one of the four intervention groups: information, evidence, both or neither. Interventions were tailored to suit individual practice needs. At a mean of 19 months after baseline, and three months after the end of intervention, practices carried out the follow-up assessment of recording, treatment, and control of risk factors in the same CVD patients. RESULTS Adequate recording of all three risk factors, found inapproximately a third of patients at baseline, increased non-significantly by 10.5% (95% confidence interval [CI] = 3.9 to 24.9) in the information (versus not information) group and by 6.6% (95% [CI] = 8.9 to 22.0) in the evidence (versus not evidence) group. Factorial improvements in prescribing and control of risk factors tended not to be significant. Adequate recording of an three risk factors showed the greatest improvement in the information plus evidence group (19.9% increase, P for heterogeneity across the four groups < or = 0.001). Mean change from baseline to follow-up within the four intervention groups suggested improvements in the combined information plus evidence group in cholesterol recording (22.5% increase), prescribing of lipid lowering drugs (4.4% increase) and mean cholesterol (0.7 mmol/l decrease). CONCLUSIONS Adequate risk factor recording did not differ between the information (versus not information) or the evidence (versus not evidence) intervention groups. Combined training in information systems and evidence-based medicine should be considered in the design of future interventions, to improve secondary prevention of CVD.