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A cluster randomised controlled trial of educational prompts in diabetes care: study protocol.

ABSTRACT: BACKGROUND: Laboratory services have a central role in supporting screening, diagnosis, and management of patients. The increase in chronic disease management in primary care for conditions such as diabetes mellitus requires regular monitoring of patients' biochemical parameters. This process offers a route for improving the quality of care that patients receive by using test results as a vehicle for delivering educational messages as well as the test result itself. AIM: To develop and evaluate the effectiveness of a quality improvement initiative to improve the care of patients with diabetes using test report reminders. DESIGN: A programme of four cluster randomised controlled trials within one population of general practices. PARTICIPANTS: General practices in Newcastle-upon-Tyne, UK. INTERVENTION: Brief educational messages added to paper and electronic general practice laboratory test reports introduced over two phases. Phase One messages, attached to Haemoglobin A1c (HbA1c) reports, targeted glycaemic and cholesterol control. Phase Two messages, attached to albumin:creatinine ratio (ACR) reports, targeted blood pressure (BP) control and foot inspection. OUTCOMES: General practice mean levels of HbA1c and cholesterol (Phase One) and diastolic and systolic BP and proportions of patients having undergone foot inspections (Phase Two); number of tests requested.

SUBMITTER: Foy R

PROVIDER: S-EPMC1973073 | biostudies-literature | 2007

REPOSITORIES: biostudies-literature

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A cluster randomised controlled trial of educational prompts in diabetes care: study protocol.

Foy Robbie R Hawthorne Gillian G Gibb Ian I Eccles Martin P MP Steen Nick N Hrisos Susan S White Trevor T Croal Bernard L BL Grimshaw Jeremy M JM

Implementation science : IS 20070724

<h4>Background</h4>Laboratory services have a central role in supporting screening, diagnosis, and management of patients. The increase in chronic disease management in primary care for conditions such as diabetes mellitus requires regular monitoring of patients' biochemical parameters. This process offers a route for improving the quality of care that patients receive by using test results as a vehicle for delivering educational messages as well as the test result itself.<h4>Aim</h4>To develop ...[more]

PMID: 17650309

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Project description:IntroductionDiabetes management in primary care remains suboptimal in China, despite its inclusion in the essential public health service (EPHS). We aimed to evaluate the effectiveness of a mobile health (mHealth) based and three-tiered diabetes management system in diverse Chinese contexts.Methods and analysisThis is a cluster randomised controlled trial, named road to hierarchical diabetes management at primary care (ROADMAP). 19 008 patients with type 2 diabetes (T2D) were recruited from primary care clinics in 864 communities across 144 counties/districts of 24 provinces. Eligible participants were adult patients diagnosed with T2D and registered for diabetes management in communities. Patients within the same communities (clusters) were randomly allocated into the intervention or control arm for 1 year in a 2:1 ratio. The control arm patients received usual care as EPHS packaged: at least four blood glucose (BG) and blood pressure (BP) tests, and lifestyle and medication instruction, yearly, from primary care providers. The intervention arm patients received at least two BG and one BP tests, monthly, and lifestyle and treatment instruction from a three-tiered contracted team. A mHealth platform, Graded ROADMAP, enabled test results uploading and sharing, and patient referral within the team. The intervention participants will be further divided into basic or intensive intervention group according to whether they were actively using the Your Doctor App. The primary outcome is the BG control rate with glycated haemoglobin (HbA1c)<7.0%. Secondary outcomes include control rates and changes of ABC (HbA1c, BP and low-density lipoprotein cholesterol) and fasting BG, hypoglycaemia episodes and health-related quality of life (EuroQol (EQ-5D)).Ethics and disseminationThe trial has been approved by the Institutional Review Board at Shanghai Sixth People's Hospital. Findings on the intervention effectiveness will be disseminated through peer-reviewed journals, conference presentations and other relevant mechanisms.Trial registration numberChiCTR-IOC-17011325.

Project description:INTRODUCTION:Childhood vaccination programmes have been established in all Organisation for Economic Co-operation and Development (OECD) countries; however, measles, mumps and rubella (MMR) as well as diphtheria, tetanus, pertussis and polio (Tdap-IPV) vaccination rates are not optimal in adolescents. Education in combination with easy access vaccination may be a promising approach to improve vaccination rates. We aim at improving MMR and Tdap-IPV rates in a school setting in the context of a planned cluster randomised controlled trial (cRCT), the present paper describes the detailed protocol of this trial. METHODS AND ANALYSIS:We will conduct a school-based cRCT, where schools will be randomised to either an educational condition addressing knowledge, risk communication and enhancing self-efficacy regarding vaccination or a low-intensity information condition. In both conditions, a bus equipped with medical staff and materials, will be delivering MMR and Tdap-IPV vaccine directly after the intervention. Schools in the city centre of Berlin, Germany, will be stratified by percentage of migration and type of school. Primary outcome is the number of students who receive vaccination in the bus. Secondary outcomes are knowledge and self-efficacy. An estimated sample size of 355 school classes with approximately 25 students per class is required. The planned analyses will take the nested structure of students, classes and schools into account. ETHICS AND DISSEMINATION:The study will be performed according to the principles of Good Clinical Practice and the Declaration of Helsinki. Approval was obtained by the local ethics committee. Parents of all students will be informed in advance. Their written consent will be obtained, in case students are underage. For dissemination, we will engage with governmental organisations to create potential of our educational unit to be included in future public health prevention schemes. TRIAL REGISTRATION NUMBER:ISRCTN18026662;Pre-results.

Project description:BackgroundThe prevalence of gestational diabetes mellitus (GDM) is rising rapidly in many low- and middle-income countries (LMICs). Most women with GDM in LMICs are undiagnosed and/or inadequately managed due to a lack of knowledge and skills about GDM on the part of both providers and patients. Following contextual analysis, we developed an educational/behavioural intervention for GDM delivered through a package of culturally tailored films. This trial aims to evaluate whether the intervention can improve the timely detection and management of GDM in two LMIC settings.MethodsTwo independent cluster randomised controlled trials, one each to be conducted in Uganda and India. Thirty maternity facilities in each country have been recruited to the study and randomised in a 1:1 ratio to the intervention and control arms. The intervention comprises of three interconnected sets of films with the following aims: to improve knowledge of GDM guidelines and skills of health providers, to raise awareness of GDM screening among pregnant women and their families, and to improve confidence and skills in self-management among those diagnosed with GDM. In facilities randomised to the intervention arm, a GDM awareness-raising film will be shown in antenatal care waiting rooms, and four films for pregnant women with GDM will be shown in group settings and made available for viewing on mobile devices. Short films for doctors and nurses will be presented at professional development meetings. Data will be collected on approximately 10,000 pregnant women receiving care at participating facilities, with follow-up at 32 weeks gestational age and 6 weeks postnatally. Women who self-report a GDM diagnosis will be invited for a clinic visit at 34 weeks. Primary outcomes are (a) the proportion of women who report a GDM diagnosis by 32 weeks of pregnancy and (b) glycaemic control (fasting glucose and HbA1C) in women with GDM at ~34 weeks of pregnancy. The secondary outcome is a composite measure of GDM-related adverse perinatal-neonatal outcome.DiscussionScreening and management of GDM are suboptimal in most LMICs. We hypothesise that a scalable film-based intervention has the potential to improve the timely detection and management of GDM in varied LMIC settings.Trial registrationClinicalTrials.gov NCT03937050 , registered on 3 May 2019. Clinical Trials Registry India CTRI/2020/02/023605 , registered on 26 February 2020.

Project description:BackgroundChronic obstructive pulmonary disease (COPD) is a common cause of morbidity and mortality worldwide. It is often undiagnosed and insufficiently managed. Effective forms of continuing medical education (CME) for primary care physicians (PCPs) are necessary to ensure the implementation of guidelines in clinical practice and, thus, improve patients' health.MethodsIn this study, we will measure the effects of CME by Case Method and compare them against those of traditional lectures and no CME at all through an unblinded, cluster randomised controlled trial (CRCT). Thirty-three primary health care centres (PHCCs) in Stockholm, Sweden, with a total of 180 PCPs will be involved. Twenty-two primary PHCCs, will be cluster-randomised into: an intervention group who will receive CME by Case Method (n = 11) and a control group who will receive traditional lectures (n = 11). The remaining PHCCs (n = 11) will be a reference group and will receive no CME. From the intervention and control groups, 460 randomly selected patients with COPD in GOLD stages 2 and 3 will participate, while no patients will be recruited from the reference group. For the patients, smoking status, actual treatment and urgent visits to a health provider due to airway problems will be registered. For the PCPs, professional competence (i.e. knowledge and management skills) in COPD, will be measured using a questionnaire based on current guidelines and guideline implementation problems in clinical practice which has previously been described by the authors. Data will be collected at baseline and at follow-up, which will be after 1.5 years for the patients, and 1 year for the PCPs. Statistical methods for individual-level and cluster-level analyses will be used.DiscussionCOPD is considered a particularly complex clinical challenge involving managing multimorbidity, symptom adaptation, and lifestyle problematisation. Case Method in CME for PCPs may contribute to a better understanding of the impact of COPD on patients' lives and, thus, improve their management of it. The present study is expected to contribute scientific knowledge about indicators for an effective CME in COPD that is tailor-made to primary care physicians.Trial registrationClinicalTrials.gov, identifier: NCT02213809 . Registered on 10 August 2014. Protocol version: Issue date: May 2014.

Project description:BackgroundComplex medication regimens are highly prevalent in residential aged care facilities (RACFs). Strategies to reduce unnecessary complexity may be valuable because complex medication regimens can be burdensome for residents and are costly in terms of nursing time. The aim of this study is to investigate application of a structured process to simplify medication administration in RACFs.MethodsSImplification of Medications Prescribed to Long-tErm care Residents (SIMPLER) is a non-blinded, matched-pair, cluster randomised controlled trial of a single multidisciplinary intervention to simplify medication regimens. Trained study nurses will recruit English-speaking, permanent residents from eight South Australian RACFs. Medications taken by residents in the intervention arm will be assessed once using a structured tool (the Medication Regimen Simplification Guide for Residential Aged CarE) to identify opportunities to reduce medication regimen complexity (e.g. by administering medications at the same time, or through the use of longer-acting or combination formulations). Residents in the comparison group will receive routine care. Participants will be followed for up to 36 months after study entry. The primary outcome measure will be the total number of charted medication administration times at 4 months after study entry. Secondary outcome measures will include time spent administering medications, medication incidents, resident satisfaction, quality of life, falls, hospitalisation and mortality. Individual-level analyses that account for clustering will be undertaken to determine the impact of the intervention on the study outcomes.DiscussionEthical approval has been obtained from the Monash University Human Research Ethics Committee and the aged care provider organisation. Research findings will be disseminated through conference presentations and peer-reviewed publications. SIMPLER will enable an improved understanding of the burden of medication use in RACFs and quantify the impact of regimen simplification on a range of outcomes important to residents and care providers.Trial registrationAustralian New Zealand Clinical Trials Registry, ACTRN12617001060336 . Retrospectively registered on 20 July 2017.

Project description:IntroductionHeart failure (HF) is a common chronic disease that increases in prevalence with age. It is associated with high hospitalisation rates, poor quality of life and high mortality. Management is complex with most interactions occurring in primary care. Disease management programmes implemented during or after an HF hospitalisation have been shown to reduce hospitalisation and mortality rates. Evidence for integrated disease management (IDM) serving the primary care HF population has been investigated but is less conclusive. The aim of this study is to evaluate the efficacy of IDM, focused on, optimising medication, self-management and structured follow-up, in a high-risk primary care HF population.Methods and analysis100 family physician clusters will be recruited in this Canadian primary care multicentre cluster randomised controlled trial. Physicians will be randomised to IDM or to care as usual. The IDM programme under evaluation will include case management, medication management, education, and skills training delivered collaboratively by the family physician and a trained HF educator. The primary outcome will measure the combined rate (events/patient-years) of all-cause hospitalisations, emergency department visits and mortality over a 12-month follow-up. Secondary outcomes include other health service utilisation, quality of life, knowledge assessments and acute HF episodes. Two to three HF patients will be recruited per physician cluster to give a total sample size of 280. The study has 90% power to detect a 35% reduction in the primary outcome. The difference in primary outcome between IDM and usual care will be modelled using a negative binomial regression model adjusted for baseline, clustering and for individuals experiencing multiple events.Ethics and disseminationThe study has obtained approval from the Research Ethics Board at the University of Western Ontario, London, Canada (ID 114089). Findings will be disseminated through local reports, presentations and peer-reviewed publications.Trial registration numberNCT04066907.

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A cluster randomised controlled trial of educational prompts in diabetes care: study protocol.

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A cluster randomised controlled trial of educational prompts in diabetes care: study protocol.

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