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1.
Chandrashekhar D Kamat Jessica E Thorpe Satyendra S Shenoy Antonio Ceriello Dixy E Green Linda A Warnke Michael A Ihnat 《BMC cardiovascular disorders》2007,7(1):1-13
Background
Cardiovascular diseases (CVD) are the leading cause of death and the third cause of disability in Europe. Prevention programmes should include interventions aimed at a reduction of medical risk factors (hypertension, hypercholesterol, hyperglycemia, overweight and obesity) as well as behavioural risk factors (sedentary lifestyle, high fat intake and low fruit and vegetable intake, smoking). The aim of this study is to investigate the effects of a multifaceted, multidisciplinary electronic prevention programme on cardiovascular risk factors.Methods/Design
In a randomized controlled trial, one group will receive a maximal intervention (= intervention group). The intervention group will be compared to the control group receiving a minimal intervention. An inclusion of 350 patients in total, with a follow-up of 3 years is foreseen. The inclusion criteria are age between 25–65 and insured by the Onderlinge Ziekenkas, insuring for guaranteed income in case of illness for self-employed. The maximal intervention group receives several prevention consultations by their general practitioner (GP) using a new type of cardiovascular risk calculator with personalised feedback on behavioural risk factors. These patients receive a follow-up with intensive support of health behaviour change via different methods, i.e. a tailored website and personal advice of a multidisciplinary team (psychologist, physiotherapist and dietician). The aim of this strategy is to reduce cardiovascular risk factors according to the guidelines. The primary outcome measures will be cardiovascular risk factors. The secondary outcome measures are cardiovascular events, quality of life, costs and incremental cost effectiveness ratios. The control group receives prevention consultations using a new type of cardiovascular risk calculator and general feedback.Discussion
This trial incorporates interventions by GPs and other health professionals aiming at a reduction of medical and behavioural cardiovascular risk factors. An assessment of clinical, psychological and economical outcome measures will be performed.Trial registration
ISRCTN23940498 相似文献2.
3.
David C Crossman Allison C Morton Julian P Gunn John P Greenwood Alistair S Hall Keith AA Fox Andrew J Lucking Marcus D Flather Belinda Lees Claire E Foley 《Trials》2008,9(1):1-14
Background
Point of care testing (PoCT) may be a useful adjunct in the management of chronic conditions in general practice (GP). The provision of pathology test results at the time of the consultation could lead to enhanced clinical management, better health outcomes, greater convenience and satisfaction for patients and general practitioners (GPs), and savings in costs and time. It could also result in inappropriate testing, increased consultations and poor health outcomes resulting from inaccurate results. Currently there are very few randomised controlled trials (RCTs) in GP that have investigated these aspects of PoCT.Design/Methods
The Point of Care Testing in General Practice Trial (PoCT Trial) was an Australian Government funded multi-centre, cluster randomised controlled trial to determine the safety, clinical effectiveness, cost effectiveness and satisfaction of PoCT in a GP setting. The PoCT Trial covered an 18 month period with the intervention consisting of the use of PoCT for seven tests used in the management of patients with diabetes, hyperlipidaemia and patients on anticoagulant therapy. The primary outcome measure was the proportion of patients within target range, a measure of therapeutic control. In addition, the PoCT Trial investigated the safety of PoCT, impact of PoCT on patient compliance to medication, stakeholder satisfaction, cost effectiveness of PoCT versus laboratory testing, and influence of geographic location.Discussion
The paper provides an overview of the Trial Design, the rationale for the research methodology chosen and how the Trial was implemented in a GP environment. The evaluation protocol and data collection processes took into account the large number of patients, the broad range of practice types distributed over a large geographic area, and the inclusion of pathology test results from multiple pathology laboratories. The evaluation protocol developed reflects the complexity of the Trial setting, the Trial Design and the approach taken within the funding provided. The PoCT Trial is regarded as a pragmatic RCT, evaluating the effectiveness of implementing PoCT in GP and every effort was made to ensure that, in these circumstances, internal and external validity was maintained.Trial Registration
12612605000272695 相似文献4.
Background
To reduce the spread of antibiotic resistance, there is a pressing need for worldwide implementation of effective interventions to promote more prudent prescribing of antibiotics for acute LRTI. This study is a process analysis of the GRACE/INTRO trial of a multifactorial intervention that reduced antibiotic prescribing for acute LRTI in six European countries. The aim was to understand how the interventions were implemented and to examine effects of the interventions on general practitioners’ (GPs’) and patients’ attitudes.Methods
GPs were cluster randomised to one of three intervention groups or a control group. The intervention groups received web-based training in either use of the C-reactive protein (CRP) test, communication skills and use of a patient booklet, or training in both. GP attitudes were measured before and after the intervention using constructs from the Theory of Planned Behaviour and a Website Satisfaction Questionnaire. Effects of the interventions on patients were assessed by a post-intervention questionnaire assessing patient enablement, satisfaction with the consultation, and beliefs about the risks and need for antibiotics.Results
GPs in all countries and intervention groups had very positive perceptions of the intervention and the web-based training, and felt that taking part had helped them to reduce prescribing. All GPs perceived reducing prescribing as more important and less risky following the intervention, and GPs in the communication groups reported increased confidence to reduce prescribing. Patients in the communication groups who received the booklet reported the highest levels of enablement and satisfaction and had greater awareness that antibiotics could be unnecessary and harmful.Conclusions
Our findings suggest that the interventions should be broadly acceptable to both GPs and patients, as well as feasible to roll out more widely across Europe. There are also some indications that they could help to engender changes in GP and patient attitudes that will be helpful in the longer-term, such as increased awareness of the potential disadvantages of antibiotics and increased confidence to manage LRTI without them. Given the positive effects of the booklet on patient beliefs and attitudes, it seems logical to extend the use of the patient booklet to all patients.5.
James A Karlowsky Mark E Jones Deborah C Draghi Clyde Thornsberry Daniel F Sahm Gregory A Volturo 《Annals of clinical microbiology and antimicrobials》2004,3(1):1-8
Background
Upper respiratory tract infections (URTIs) are among the most frequent reasons for physician office visits in paediatrics. Despite their predominant viral aetiology, URTIs continue to be treated with antimicrobials. We explored general practitioners' (GPs) prescribing behaviour for antimicrobials in children (≤ 16 years) with URTIs in Trinidad, using the guidelines from the Centers for Disease Control and Prevention (CDC) as a reference.Methods
A cross-sectional study was conducted on 92 consenting GPs from the 109 contacted in Central and East Trinidad, between January to June 2003. Using a pilot-tested questionnaire, GPs identified the 5 most frequent URTIs they see in office and reported on their antimicrobial prescribing practices for these URTIs to trained research students.Results
The 5 most frequent URTIs presenting in children in general practice, are the common cold, pharyngitis, tonsillitis, sinusitis and acute otitis media (AOM) in rank order. GPs prescribe at least 25 different antibiotics for these URTIs with significant associations for amoxicillin, co-amoxiclav, cefaclor, cefuroxime, erythromycin, clarithromycin and azithromycin (p < 0.001). Amoxicillin alone or with clavulanate was the most frequently prescribed antibiotic for all URTIs. Prescribing variations from the CDC recommendations were observed for all URTIs except for AOM (50%), the most common condition for antibiotics. Doctors practicing for >30 years were more likely to prescribe antibiotics for the common cold (p = 0.014). Severity (95.7%) and duration of illness (82.5%) influenced doctors' prescribing and over prescribing in general practice was attributed to parent demands (75%) and concern for secondary bacterial infections (70%). Physicians do not request laboratory investigations primarily because they are unnecessary (86%) and the waiting time for results is too long (51%).Conclusions
Antibiotics are over prescribed for paediatric URTIs in Trinidad and amoxicillin with co-amoxiclav were preferentially prescribed. Except for AOM, GPs' prescribing varied from the CDC guidelines for drug and duration. Physicians recognise antibiotics are overused and consider parents expecting antibiotics and a concern for secondary bacterial infections are prescribing pressures. Guidelines to manage URTIs, ongoing surveillance programs for antibiotic resistance, public health education on non-antibiotic strategies, and postgraduate education for rational pharmacotherapy in general practice would decrease inappropriate antibiotic use in URTIs. 相似文献6.
7.
Manfred Hecking Marlies Antlanger Wolfgang Winnicki Thomas Reiter Johannes Werzowa Michael Haidinger Thomas Weichhart Hans-Dietrich Polaschegg Peter Josten Isabella Exner Katharina Lorenz-Turnheim Manfred Eigner Gernot Paul Renate Klauser-Braun Walter H H?rl Gere Sunder-Plassmann Marcus D S?emann 《Trials》2012,13(1):1-12
Background
Governments and donors all over Africa are searching for sustainable, affordable and cost-effective ways to improve the quality of malaria case management. Widespread deficiencies have been reported in the prescribing and counselling practices of health care providers treating febrile patients in both public and private health facilities. Cameroon is no exception with low levels of adherence to national guidelines, the frequent selection of non-recommended antimalarials and the use of incorrect dosages. This study evaluates the effectiveness and cost-effectiveness of introducing two different provider training packages, alongside rapid diagnostic tests (RDTs), designed to equip providers with the knowledge and practical skills needed to effectively diagnose and treat febrile patients. The overall aim is to target antimalarial treatment better and to facilitate optimal use of malaria treatment guidelines.Methods/Design
A 3-arm stratified, cluster randomized trial will be conducted to assess whether introducing RDTs with provider training (basic or enhanced) is more cost-effective than current practice without RDTs, and whether there is a difference in the cost effectiveness of the provider training interventions. The primary outcome is the proportion of patients attending facilities that report a fever or suspected malaria and receive treatment according to malaria guidelines. This will be measured by surveying patients (or caregivers) as they exit public and mission health facilities. Cost-effectiveness will be presented in terms of the primary outcome and a range of secondary outcomes, including changes in provider knowledge. Costs will be estimated from a societal and provider perspective using standard economic evaluation methodologies.Trial Registration
ClinicalTrials.gov: NCT00981877 相似文献8.
Martin P Eccles Jeremy M Grimshaw Graeme MacLennan Debbie Bonetti Liz Glidewell Nigel B Pitts Nick Steen Ruth Thomas Anne Walker Marie Johnston 《Implementation science : IS》2012,7(1):1-13
Background
High-risk prescribing of non-steroidal anti-inflammatory drugs (NSAIDs) and antiplatelet agents accounts for a significant proportion of hospital admissions due to preventable adverse drug events. The recently completed PINCER trial has demonstrated that a one-off pharmacist-led information technology (IT)-based intervention can significantly reduce high-risk prescribing in primary care, but there is evidence that effects decrease over time and employing additional pharmacists to facilitate change may not be sustainable.Methods/design
We will conduct a cluster randomised controlled with a stepped wedge design in 40 volunteer general practices in two Scottish health boards. Eligible practices are those that are using the INPS Vision clinical IT system, and have agreed to have relevant medication-related data to be automatically extracted from their electronic medical records. All practices (clusters) that agree to take part will receive the data-driven quality improvement in primary care (DQIP) intervention, but will be randomised to one of 10 start dates. The DQIP intervention has three components: a web-based informatics tool that provides weekly updated feedback of targeted prescribing at practice level, prompts the review of individual patients affected, and summarises each patient's relevant risk factors and prescribing; an outreach visit providing education on targeted prescribing and training in the use of the informatics tool; and a fixed payment of 350 GBP (560 USD; 403 EUR) up front and a small payment of 15 GBP (24 USD; 17 EUR) for each patient reviewed in the 12 months of the intervention. We hypothesise that the DQIP intervention will reduce a composite of nine previously validated measures of high-risk prescribing. Due to the nature of the intervention, it is not possible to blind practices, the core research team, or the data analyst. However, outcome assessment is entirely objective and automated. There will additionally be a process and economic evaluation alongside the main trial.Discussion
The DQIP intervention is an example of a potentially sustainable safety improvement intervention that builds on the existing National Health Service IT-infrastructure to facilitate systematic management of high-risk prescribing by existing practice staff. Although the focus in this trial is on Non-steroidal anti-inflammatory drugs and antiplatelets, we anticipate that the tested intervention would be generalisable to other types of prescribing if shown to be effective.Trial registration
ClinicalTrials.gov, dossier number: NCT01425502 相似文献9.
Martin P Eccles Robbie Foy Claire H Bamford Julian C Hughes Marie Johnston Paula M Whitty Nick Steen Jeremy G Grimshaw 《Implementation science : IS》2006,1(1):1-6
Background
Despite the availability of clinical guidelines for the management of low back pain (LBP), there continues to be wide variation in general practitioners' (GPs') referral rates for lumbar spine x-ray (LSX). This study aims to explain variation in GPs' referral rates for LSX from their accounts of the management of patients with low back pain.Methods
Qualitative, semi-structured interviews with 29 GPs with high and low referral rates for LSX in North East England. Thematic analysis used constant comparative techniques.Results
Common and divergent themes were identified among high- and low-users of LSX. Themes that were similar in both groups included an awareness of current guidelines for the use of LSX for patients with LBP and the pressure from patients and institutional factors to order a LSX. Differentiating themes for the high-user group included: a belief that LSX provides reassurance to patients that can outweigh risks, pessimism about the management options for LBP, and a belief that denying LSX would adversely affect doctor-patient relationships. Two specific differentiating themes are considered in more depth: GPs' awareness of their use of lumbar spine radiology relative to others, and the perceived risks associated with LSX radiation.Conclusion
Several key factors differentiate the accounts of GPs who have high and low rates of referral for LSX, even though they are aware of clinical guideline recommendations. Intervention studies that aim to increase adherence to guideline recommendations on the use of LSX by changing the ordering behaviour of practitioners in primary care should focus on these factors. 相似文献10.
Noah M Ivers Karen Tu Jill Francis Jan Barnsley Baiju Shah Ross Upshur Alex Kiss Jeremy M Grimshaw Merrick Zwarenstein 《Implementation science : IS》2010,5(1):1-10
Background
The implementation of new medical knowledge into general practice is a complex process. Blended learning may offer an effective and efficient educational intervention to reduce the knowledge-to-practice gap. The aim of this study was to compare knowledge acquisition about dementia management between a blended learning approach using online modules in addition to quality circles (QCs) and QCs alone.Methods
In this cluster-randomised trial with QCs as clusters and general practitioners (GPs) as participants, 389 GPs from 26 QCs in the western part of Germany were invited to participate. Data on the GPs' knowledge were obtained at three points in time by means of a questionnaire survey. Primary outcome was the knowledge gain before and after the interventions. A subgroup analysis of the users of the online modules was performed.Results
166 GPs were available for analysis and filled out a knowledge test at least two times. A significant increase of knowledge was found in both groups that indicated positive learning effects of both approaches. However, there was no significant difference between the groups. A subgroup analysis of the GPs who self-reported that they had actually used the online modules showed that they had a significant increase in their knowledge scores.Conclusion
A blended learning approach was not superior to a QCs approach for improving knowledge about dementia management. However, a subgroup of GPs who were motivated to actually use the online modules had a gain in knowledge.Trial registration
Current Controlled Trials ISRCTN36550981. 相似文献11.
Background
Previous research indicates that people with osteoarthritis (OA) are not receiving the recommended and optimal treatment. Based on international treatment recommendations for hip and knee OA and previous research, the SAMBA model for integrated OA care in Norwegian primary health care has been developed. The model includes physiotherapist (PT) led patient OA education sessions and an exercise programme lasting 8–12 weeks. This study aims to assess the effectiveness, feasibility, and costs of a tailored strategy to implement the SAMBA model.Methods/design
A cluster randomized controlled trial with stepped wedge design including an effect, process, and cost evaluation will be conducted in six municipalities (clusters) in Norway. The municipalities will be randomized for time of crossover from current usual care to the implementation of the SAMBA model by a tailored strategy. The tailored strategy includes interactive workshops for general practitioners (GPs) and PTs in primary care covering the SAMBA model for integrated OA care, educational material, educational outreach visits, feedback, and reminder material. Outcomes will be measured at the patient, GP, and PT levels using self-report, semi-structured interviews, and register based data. The primary outcome measure is patient-reported quality of care (OsteoArthritis Quality Indicator questionnaire) at 6-month follow-up. Secondary outcomes include referrals to PT, imaging, and referrals to the orthopaedic surgeon as well as participants’ treatment satisfaction, symptoms, physical activity level, body weight, and self-reported and measured lower limb function. The actual exposure to the tailor made implementation strategy and user experiences will be measured in a process evaluation. In the economic evaluation, the difference in costs of usual OA care and the SAMBA model for integrated OA care will be compared with the difference in health outcomes and reported by the incremental cost-effectiveness ratio (ICER).Discussion
The results from the present study will add to the current knowledge on tailored strategies, which aims to improve the uptake of evidence-based OA care recommendations and improve the quality of OA care in primary health care. The new knowledge can be used in national and international initiatives designed to improve the quality of OA care.Trial registration
ClinicalTrials.gov NCT0233365612.
Sonja Melman Ellen NC Schoorel Carmen Dirksen Anneke Kwee Luc Smits Froukje de Boer Madelaine Jonkers Mallory D Woiski Ben Willem J Mol Johannes PR Doornbos Harry Visser Anjoke JM Huisjes Martina M Porath Friso MC Delemarre Simone MI Kuppens Robert Aardenburg Ivo MA Van Dooren Francis PJM Vrouenraets Frans TH Lim Gunilla Kleiverda Paulien CM van der Salm Karin de Boer Marko J Sikkema Jan G Nijhuis Rosella PMG Hermens Hubertina CJ Scheepers 《Implementation science : IS》2013,8(1):1-8
Background
Caesarean section (CS) rates are rising worldwide. In the Netherlands, the most significant rise is observed in healthy women with a singleton in vertex position between 37 and 42 weeks gestation, whereas it is doubtful whether an improved outcome for the mother or her child was obtained. It can be hypothesized that evidence-based guidelines on CS are not implemented sufficiently. Therefore, the present study has the following objectives: to develop quality indicators on the decision to perform a CS based on key recommendations from national and international guidelines; to use the quality indicators in order to gain insight into actual adherence of Dutch gynaecologists to guideline recommendations on the performance of a CS; to explore barriers and facilitators that have a direct effect on guideline application regarding CS; and to develop, execute, and evaluate a strategy in order to reduce the CS incidence for a similar neonatal outcome (based on the information gathered in the second and third objectives).Methods
An independent expert panel of Dutch gynaecologists and midwives will develop a set of quality indicators on the decision to perform a CS. These indicators will be used to measure current care in 20 hospitals with a population of 1,000 women who delivered by CS, and a random selection of 1,000 women who delivered vaginally in the same period. Furthermore, by interviewing healthcare professionals and patients, the barriers and facilitators that may influence the decision to perform a CS will be measured. Based on the results, a tailor-made implementation strategy will be developed and tested in a controlled before-and-after study in 12 hospitals (six intervention, six control hospitals) with regard to effectiveness, experiences, and costs.Discussion
This study will offer insight into the current CS care and into the hindering and facilitating factors influencing obstetrical policy on CS. Furthermore, it will allow definition of patient categories or situations in which a tailor-made implementation strategy will most likely be meaningful and cost effective, without negatively affecting the outcome for mother and child.Trial registration
http://www.clinicaltrials.gov: NCT01261676 相似文献13.
Background
The recent development and publication of evidence-based clinical practice guidelines (CPGs) for acute low back pain (LBP) has resulted in evidence-based recommendations that, if implemented, have the potential to improve the quality and safety of care for acute LBP. While a strategy has been specified for dissemination of the CPG for acute LBP in Australia, there is no accompanying plan for active implementation. Evidence regarding the cost-effectiveness of active implementation of CPGs for acute LBP is sparse. The IMPLEMENT study will consider the incremental benefits and costs of progressing beyond development and dissemination to implementation.Methods/design
Cost-effectiveness and cost-utility analyses alongside the IMPLEMENT cluster randomised controlled trial (CRCT) from a societal perspective to quantify the additional costs (savings) and health gains associated with a targeted implementation strategy as compared with access to the CPG via dissemination only.Discussion
The protocol provided here registers our intent to conduct an economic evaluation alongside the IMPLEMENT study, facilitates peer-review of proposed methods and provides a transparent statement of planned analyses.Trial registration
Australian New Zealand Clinical Trials Registry ACTRN012606000098538 相似文献14.
Navdeep Sahota Rob Lloyd Anita Ramakrishna Jean A Mackay Jeanette C Prorok Lorraine Weise-Kelly Tamara Navarro Nancy L Wilczynski R Brian Haynes 《Implementation science : IS》2011,6(1):1-14
Background
There is a need to find innovative approaches for translating best practices for chronic disease care into daily primary care practice routines. Primary care plays a crucial role in the prevention and management of cardiovascular disease. There is, however, a substantive care gap, and many challenges exist in implementing evidence-based care. The Improved Delivery of Cardiovascular Care (IDOCC) project is a pragmatic trial designed to improve the delivery of evidence-based care for the prevention and management of cardiovascular disease in primary care practices using practice outreach facilitation.Methods
The IDOCC project is a stepped-wedge cluster randomized control trial in which Practice Outreach Facilitators work with primary care practices to improve cardiovascular disease prevention and management for patients at highest risk. Primary care practices in a large health region in Eastern Ontario, Canada, were eligible to participate. The intervention consists of regular monthly meetings with the Practice Outreach Facilitator over a one- to two-year period. Starting with audit and feedback, consensus building, and goal setting, the practices are supported in changing practice behavior by incorporating chronic care model elements. These elements include (a) evidence-based decision support for providers, (b) delivery system redesign for practices, (c) enhanced self-management support tools provided to practices to help them engage patients, and (d) increased community resource linkages for practices to enhance referral of patients. The primary outcome is a composite score measured at the level of the patient to represent each practice's adherence to evidence-based guidelines for cardiovascular care. Qualitative analysis of the Practice Outreach Facilitators' written narratives of their ongoing practice interactions will be done. These textual analyses will add further insight into understanding critical factors impacting project implementation.Discussion
This pragmatic, stepped-wedge randomized controlled trial with both quantitative and process evaluations demonstrates innovative methods of implementing large-scale quality improvement and evidence-based approaches to care delivery. This is the first Canadian study to examine the impact of a large-scale multifaceted cardiovascular quality-improvement program in primary care. It is anticipated that through the evaluation of IDOCC, we will demonstrate an effective, practical, and sustainable means of improving the cardiovascular health of patients across Canada.Trial Registration
ClinicalTrials.gov: NCT00574808 相似文献15.
Cathal?A.?Cadogan Cristín?Ryan Jill?J.?Francis Gerard?J.?Gormley Peter?Passmore Ngaire?Kerse Carmel?M.?Hughes
Background
The use of multiple medicines (polypharmacy) is increasingly common in older people. Ensuring that patients receive the most appropriate combinations of medications (appropriate polypharmacy) is a significant challenge. The quality of evidence to support the effectiveness of interventions to improve appropriate polypharmacy is low. Systematic identification of mediators of behaviour change, using the Theoretical Domains Framework (TDF), provides a theoretically robust evidence base to inform intervention design. This study aimed to (1) identify key theoretical domains that were perceived to influence the prescribing and dispensing of appropriate polypharmacy to older patients by general practitioners (GPs) and community pharmacists, and (2) map domains to associated behaviour change techniques (BCTs) to include as components of an intervention to improve appropriate polypharmacy in older people in primary care.Methods
Semi-structured interviews were conducted with members of each healthcare professional (HCP) group using tailored topic guides based on TDF version 1 (12 domains). Questions covering each domain explored HCPs’ perceptions of barriers and facilitators to ensuring the prescribing and dispensing of appropriate polypharmacy to older people. Interviews were audio-recorded and transcribed verbatim. Data analysis involved the framework method and content analysis. Key domains were identified and mapped to BCTs based on established methods and discussion within the research team.Results
Thirty HCPs were interviewed (15 GPs, 15 pharmacists). Eight key domains were identified, perceived to influence prescribing and dispensing of appropriate polypharmacy: ‘Skills’, ‘Beliefs about capabilities’, ‘Beliefs about consequences’, ‘Environmental context and resources’, ‘Memory, attention and decision processes’, ‘Social/professional role and identity’, ‘Social influences’ and ‘Behavioural regulation’. Following mapping, four BCTs were selected for inclusion in an intervention for GPs or pharmacists: ‘Action planning’, ‘Prompts/cues’, ‘Modelling or demonstrating of behaviour’ and ‘Salience of consequences’. An additional BCT (‘Social support or encouragement’) was selected for inclusion in a community pharmacy-based intervention in order to address barriers relating to interprofessional working that were encountered by pharmacists.Conclusions
Selected BCTs will be operationalised in a theory-based intervention to improve appropriate polypharmacy for older people, to be delivered in GP practice and community pharmacy settings. Future research will involve development and feasibility testing of this intervention.16.
Thomas Grischott Stefan Zechmann Yael Rachamin Stefan Markun Corinne Chmiel Oliver Senn Thomas Rosemann Nicolas Rodondi Stefan Neuner-Jehle 《Implementation science : IS》2018,13(1):155
Background
Inappropriate medication and polypharmacy increase morbidity, hospitalisation rate, costs and mortality in multimorbid patients. At hospital discharge of elderly patients, polypharmacy is often even more pronounced than at admission. However, the optimal discharge strategy in view of sustained medication appropriateness remains unclear. In particular, unreflectingly switching back to the pre-hospitalisation medication must be avoided. Therefore, both the patients and the follow-up physicians should be involved in the discharge process. In this study, we aim to test whether a brief medication review which takes the patients’ priorities into account, combined with a standardised communication strategy at hospital discharge, leads to sustained medication appropriateness and extends readmission times among elderly multimorbid patients.Methods
The study is designed as a two-armed, double-blinded, cluster-randomised trial, involving 42 senior hospital physicians (HPs) with their junior HPs and 2100 multimorbid patients aged 60 years or older.Using a randomised minimisation strategy, senior HPs will be assigned to either intervention or control group. Following instructions of the study team, the senior HPs in the intervention group will teach their junior HPs how to integrate a simple medication review tool combined with a defined communication strategy into their ward’s discharge procedure. The untrained HPs in the control group will provide data on usual care, and their patients will be discharged following usual local routines.Primary outcome is the time until readmission within 6 months after discharge, and secondary outcomes cover readmission rates, number of emergency and GP visits, classes and numbers of drugs prescribed, proportions of potentially inappropriate medications, and the patients’ quality of life after discharge. Additionally, the characteristics of both the HPs as well as the patients will be collected before the intervention. Process evaluation outcomes will be assessed parallel to the ongoing core study using qualitative research methods.Discussion
So far, interventions to reduce polypharmacy are still scarce at the crucial interface between HPs and GPs. To our knowledge, this trial is the first to analyse the combination of a brief deprescribing intervention with a standardised communication strategy at hospital discharge and in the early post-discharge period.Trial registration
ISRCTN, ISRCTN18427377. Registered 11 January 201817.
Karen J Sherman Daniel C Cherkin Andrea J Cook Rene J Hawkes Richard A Deyo Robert Wellman Partap S Khalsa 《Trials》2010,11(1):1-17
Background
In Major Depressive Disorder (MDD), the traditional belief of a delayed onset of antidepressants' effects has lead to the concept of current guidelines that treatment durations should be between 3-8 weeks before medication change in case of insufficient outcome. Post hoc analyses of clinical trials, however, have shown that improvement usually occurs within the first 10-14 days of treatment and that such early improvement (Hamilton Depression Rating Scale [HAMD] decrease ≥20%) has a substantial predictive value for final treatment outcome. Even more important, non-improvement (HAMD decrease <20%) after 14 days of treatment was found to be highly predictive for a poor final treatment outcome.Methods/Design
The EMC trial is a phase IV, multi-centre, multi-step, randomized, observer-blinded, actively controlled parallel-group clinical trial to investigate for the first time prospectively, whether non-improvers after 14 days of antidepressant treatment with an early medication change (EMC) are more likely to attain remission (HAMD-17 ≤7) on treatment day 56 compared to patients treated according to current guideline recommendation (treatment as usual; TAU). In level 1 of the EMC trial, non-improvers after 14 days of antidepressant treatment will be randomised to an EMC strategy or TAU. The EMC strategy for this study schedules a first medication change on day 15; in case of non-improvement between days 15-28, a second medication change will be performed. TAU schedules the first medication change after 28 days in case of non-response (HAMD-17 decrease <50%). Both interventions will last 42 days. In levels 2 and 3, EMC strategies will be compared with TAU strategies in improvers on day 14, who experience a stagnation of improvement during the course of treatment. The trial is supported by the German Federal Ministry of Education and Research (BMBF) and will be conducted in cooperation with the BMBF funded Interdisciplinary Centre Clinical Trials (IZKS) at the University Medical Centre Mainz and at six clinical trial sites in Germany.Discussion
If the EMC strategies lead to significantly more remitters, changes of clinical practice, guidelines for the treatment of MDD as well as research settings can be expected.Trial Registration
Clincaltrials.gov Identifier: NCT00974155; EudraCT: 2008-008280-96. 相似文献18.
Background
Recent policy and organisational changes within UK primary care have emphasised graduated access to care, speed of access to the first available general practitioner (GP) and care being provided by a range of healthcare professionals. These trends have been strengthened by the current GP contract and Quality and Outcomes Framework (QOF). Concern has been expressed that the potential for personal care is being diminished as a result and that this will reduce quality standards. This paper presents data from a study that explored with patients and GPs what personal care means and whether it has continuing importance to them.Methods
A semi-structured questionnaire was used to interview participants and Framework Analysis supported analysis of emerging themes. Twenty-nine patients, mainly women with young children, and twenty-three GPs were interviewed from seven practices in Lothian, Scotland, ranged by practice size and relative deprivation score.Results and Discussion
Personal care was defined mainly, though not exclusively, as care given within the context of a continuing relationship in which there is an interpersonal connection and the doctor adopts a particular consultation style. Defined in this way, it was reported to have benefits for both health outcomes and patients' experience of care. In particular, such care was thought to be beneficial in attending to the emotions that can be elicited when seeking and receiving health care and in enabling patients to be known by doctors as legitimate seekers of care from the health service. Its importance was described as being dependent upon the nature of the health problem and patients' wider familial and social circumstances. In particular, it was found to provide support to patients in their parenting and other familial caring roles.Conclusion
Personal care has continuing salience to patients and GPs in modern primary care in the UK. Patients equate the experience of care, not just outcomes, with high quality care. As it is mainly conceptualised and experienced as care within the context of a continuing relationship, policies and organisational arrangements that support and give incentives to this must be in place. These preferences are not strongly reflected in the QOF. Specific questions need to be addressed by future audit and research on the impact of the contract on these aspects of service. 相似文献19.
Background
There is a large treatment gap with few community services for people with schizophrenia in low income countries largely due to the shortage of specialist mental healthcare human resources. Community based rehabilitation (CBR), involving lay health workers, has been shown to be feasible, acceptable and more effective than routine care for people with schizophrenia in observational studies. The aim of this study is to evaluate whether a lay health worker led, Collaborative Community Based Care (CCBC) intervention, combined with usual Facility Based Care (FBC), is superior to FBC alone in improving outcomes for people with schizophrenia and their caregivers in India.Methods/Design
This trial is a multi-site, parallel group randomised controlled trial design in India. The trial will be conducted concurrently at three sites in India where persons with schizophrenia will be screened for eligibility and recruited after providing informed consent. Trial participants will be randomly allocated in a 2:1 ratio to the CCBC+FBC and FBC arms respectively using an allocation sequence pre-prepared through the use of permuted blocks, stratified within site. The structured CCBC intervention will be delivered by trained lay community health workers (CHWs) working together with the treating Psychiatrist. We aim to recruit 282 persons with schizophrenia. The primary outcomes are reduction in severity of symptoms of schizophrenia and disability at 12 months. The study will be conducted according to good ethical practice, data analysis and reporting guidelines.Discussion
If the additional CCBC intervention delivered by front line CHWs is demonstrated to be effective and cost-effective in comparison to usually available care, this intervention can be scaled up to expand coverage and improve outcomes for persons with schizophrenia and their caregivers in low income countries.Trial registration
The trial is registered with the International Society for the Registration of Clinical Trials and the allocated unique ID number is ISRCTN 56877013. 相似文献20.
John N Lavis Andrew D Oxman Ray Moynihan Elizabeth J Paulsen 《Implementation science : IS》2008,3(1):1-7