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The improving care in chronic obstructive lung disease study: CAROL improving processes of care and quality of life of COPD patients in primary care: study protocol for a randomized controlled trial.

ABSTRACT: The Swiss health ministry launched a national quality program 'QualiCCare' in 2011 to improve health care for patients with COPD.The aim of this study is to determine whether participation in the COPD quality initiative ('QualiCCare') improves adherence to recommended clinical processes and shows impact on patients' COPD care and on the impact of COPD on a person's life.CAROL is a cluster-randomized controlled trial with randomization on the general practioner (GP) level. Thirty GPs will be randomly assigned to equally sized intervention group or control group.Each GP will approach consecutively and regardless of the reason for the current consultation, patients aged 45 years or older, with a smoking history of ? ten pack-years (PY). Patients with confirmed (by spirometric evaluation) COPD will be included in the study. GPs in the intervention group will receive 'QualiCCare' education, which addresses knowledge, decision-making and behavioural aspects as well as delivery of care according to COPD quality indicators and evidence-based key elements. In the control group, no educational intervention will be applied and COPD patients will be treated as usual. The study period is one year.The primary outcome measure is an aggregated score of relevant clinical processes defining elements in the care of patients with COPD: smoking cessation counseling, influenza vaccination, motivation for physical activity, appropriate pharmacotherapy, patient education and collaborative care. Given a power of 90% and a significance level alpha of 5%, 15 GPs recruiting eight patients each will be necessary in both study arms. With an assumed dropout rate of 20%, 288 patients will need to be included.It is important to develop and implement interventions that add value to COPD care considering quality and efficiency. Care pathways modifying the knowledge and behavior of physicians have the potential for improving care by transferring knowledge to clinical practice.ClinicalTrials.gov: NCT01921556.

SUBMITTER: Steurer-Stey C

PROVIDER: S-EPMC3986912 | biostudies-literature | 2014 Mar

REPOSITORIES: biostudies-literature

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The improving care in chronic obstructive lung disease study: CAROL improving processes of care and quality of life of COPD patients in primary care: study protocol for a randomized controlled trial.

Steurer-Stey Claudia C Markun Stefan S Lana Kaba Dalla KD Frei Anja A Held Ulrike U Wensing Michel M Rosemann Thomas T

Trials 20140327

<h4>Background</h4>The Swiss health ministry launched a national quality program 'QualiCCare' in 2011 to improve health care for patients with COPD.The aim of this study is to determine whether participation in the COPD quality initiative ('QualiCCare') improves adherence to recommended clinical processes and shows impact on patients' COPD care and on the impact of COPD on a person's life.<h4>Methods</h4>CAROL is a cluster-randomized controlled trial with randomization on the general practioner ...[more]

PMID: 24670200

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Project description:IntroductionUp to half of all smokers develop clinically significant chronic obstructive pulmonary disease (COPD). Gaps exist in the implementation and uptake of evidence-based guidelines for managing COPD in primary care. We describe the methodology of a cluster randomised controlled trial (cRCT) evaluating the efficacy and cost-effectiveness of an interdisciplinary model of care aimed at reducing the burden of smoking and COPD in Australian primary care settings.Methods and analysisA cRCT is being undertaken to evaluate an interdisciplinary model of care (RADICALS - Review of Airway Dysfunction and Interdisciplinary Community-based care of Adult Long-term Smokers). General practice clinics across Melbourne, Australia, are identified and randomised to the intervention group (RADICALS) or usual care. Patients who are current or ex-smokers, of at least 10 pack years, including those with an existing diagnosis of COPD, are being recruited to identify 280 participants with a spirometry-confirmed diagnosis of COPD. Handheld lung function devices are being used to facilitate case-finding. RADICALS includes individualised smoking cessation support, home-based pulmonary rehabilitation and home medicines review. Patients at control group sites receive usual care and Quitline referral, as appropriate. Follow-ups occur at 6 and 12?months from baseline to assess changes in quality of life, abstinence rates, health resource utilisation, symptom severity and lung function. The primary outcome is change in St George's Respiratory Questionnaire score of patients with COPD at 6?months from baseline.Ethics and disseminationThis project has been approved by the Monash University Human Research Ethics Committee and La Trobe University Human Ethics Committee (CF14/1018 - 2014000433). Results of the study will be disseminated in peer-reviewed journals and research conferences. If the intervention is successful, the RADICALS programme could potentially be integrated into general practices across Australia and sustained over time.Trial registration numberACTRN12614001155684; Pre-results.

Project description:BackgroundChronic obstructive pulmonary disease (COPD) is a health problem that is becoming increasingly attended-to in Primary Care (PC). However, there is a scarcity of health-care programs and studies exploring the implementation of Clinical Practice Guidelines (CPG). The principal objective of the present study is to evaluate the effectiveness of a combined strategy directed towards health-care professionals and patients to improve the grade of clinical control and the quality-of-life (QoL) of the patients via a feedback on their state-of-health. A training plan for the health-care professionals is based on CPG and health education.Method/designMulti-centred, before-after, quasi experimental, prospective study involving an intervention group and a control group of individuals followed-up for 12 months. The patients receive attention from urban and semi-urban Primary Care Centres (PCC) within the administrative area of the Costa de Ponent (near Barcelona). All the pacients corresponding to the PCC of one sub-area were assigned to the intervention group and patients from the rest of sub-areas to the group control. The intervention includes providing data to the health-care professionals (clinician/nurse) derived from a clinical history and an interview. A course of training focused on aspects of CPG, motivational interview and health education (tobacco, inhalers, diet, physical exercise, physiotherapy). The sample random includes a total of 801 patients (> or = 40 years of age), recorded as having COPD, receiving attention in the PCC or at home, who have had at least one clinical visit, and who provided written informed consent to participation in the study. Data collected include socio-demographic characteristics, drug treatment, exacerbations and hospital admissions, evaluation of inhaler use, tobacco consumption and life-style and health-care resources consumed. The main endpoints are dyspnoea, according to the modified scale of the Medical Research Council (MRC) and the QoL, evaluated with the St George's Respiratory Questionnaire (SGRQ). The variables are obtained at the start and the end of the intervention. Information from follow-up visits focuses on the changes in life-style activities of the patient.DiscussionThis study is conducted with the objective of generating evidence that shows that implementation of awareness programs directed towards health-care professionals as well as patients in the context of PC can produce an increase in the QoL and a decrease in the disease exacerbation, compared to standard clinical practice.Trial registrationClinical Trials.gov Identifier: NCT00922545;

Project description:Admissions for exacerbations of chronic obstructive pulmonary disease (COPD) present a significant proportion of patients in the acute medical take. The British Thoracic Society (BTS) provides guidelines for time specific interventions, that should be delivered to those with an acute exacerbation of COPD through the admission care bundle. These include correct diagnosis, correct assessment of oxygenation, early administration of treatment, recognition of respiratory failure, and specialist review. Gloucestershire Hospitals NHS Foundation Trust (GHNHSFT) chose improvement in acute COPD care to be a local Commissioning for Quality and Innovation (CQUIN) scheme, which enables commissioners to reward excellence by linking a proportion of English healthcare providers' income to the achievement of local quality improvement goals. The effects of initiatives put in place by senior clinicians had waned, and further improvements were required to meet the CQUIN target. The aim of the scheme was to improve compliance with the BTS guidelines and CQUIN scheme for patients admitted with an exacerbation of COPD. Specific bundle paperwork to be used for all patients admitted to the Trust with an exacerbation of COPD was introduced to the Trust in June 2014, with training and education of medical staff at that time. This had improved compliance rates from 10% to 63% by September 2014. Compliance with each intervention was audited through the examination of notes of patients admitted with an exacerbation of COPD. Compliance rates had plateaued over the last three months, and so a focus group involving junior medical staff met in September 2014 to try to increase awareness further, in order to drive greater improvements in care, and meet the CQUIN requirements. Their strategies were implemented, and then compliance with the CQUIN requirements was reaudited as described above. The December 2014 audit results showed a further improvement in overall COPD care, with 73% of patients receiving all elements of the COPD admission care bundle, versus 63% in September 2014. Appropriate blood gas analysis, nebuliser administration, and respiratory review also improved. Prescription of steroids and antibiotics remained static, with 96% of patients receiving these treatments within four hours in the emergency department (ED). The only criteria which showed a decline was appropriate oxygen prescription, which dipped from 97% to 87%. After the effect of initial strategies plateaued, this quality improvement project facilitated a further increase in compliance with the CQUIN targets, both improving patient care, and safeguarding continued CQUIN funding. There is further work to be done to maintain and support further improvement in standards, and to encourage use of the COPD admission bundle paperwork for documentation purposes.

Project description:BACKGROUND:Cancer patients experience psychological and social distress due to their medical treatment and social issues. However, continuous and specialized social support is still lacking. In Germany, a group of company health insurance funds has developed an approach to support cancer patients with monthly structured interviews conducted by specially trained Social Care Nurses. The nurses will identify patient needs in order to provide help with medical, personal, and social matters. One aim of the scientific evaluation is to analyze the effect of the consultations on various patient-reported outcomes, especially quality of life. The evaluation concept will be described in this study protocol. METHODS/DESIGN:The evaluation is a non-randomized, controlled, multi-center intervention study with a mixed-method design. It consists of three research modules which include primary data from questionnaires, and claims data from the health insurance funds. In Module 1, cancer patients will be recruited to form an intervention group (OSCAR, n?=?150) and a control group (n?=?200) in four study centers for a period of 1 year. One baseline and three follow-up questionnaires will be conducted to survey the patient-reported outcomes. Relevant secondary outcomes are health literacy, participation, and physician-patient communication. In Module 2, claims data will be used to analyze cost effects and thereby assess effectivity and hospitalization. Module 3 will involve a qualitative analysis of project diaries kept by the Social Care Nurses. The diaries will record the nurses' practical experiences and the benefits of deploying OSCAR across the German healthcare system. DISCUSSION:OSCAR is an innovative way of providing cancer patients with continuous support to improve their quality of life. The evaluation concept aims to assess the effects of the monthly consultations by the Social Care Nurses on the patients, and will use a mixed-method design. The results are important for assessing the transferability of OSCAR to the healthcare system as a whole. TRIAL REGISTRATION:German Clinical Trials Register (DRKS-ID: DRKS00013640 ). Registered 29 December 2017.

Project description:Chronic obstructive pulmonary disease (COPD) often remains undiagnosed and untreated. To date, COPD screening/case finding has not been designed to identify clinically significant COPD, disease ready for therapies beyond smoking cessation. Herein, we describe the ongoing prospective, pragmatic cluster-randomized controlled trial to assess specificity and sensitivity of the COPD Assessment in Primary Care To Identify Undiagnosed Respiratory Disease and Exacerbation Risk (CAPTURE) tool consisting of 5 questions and peak expiratory flow. The tool is designed to identify clinically significant COPD (forced expiratory volume in 1 second [FEV1] to forced vital capacity [FVC] ratio <.70 plus FEV1% predicted <60% or increased risk for exacerbation) and the trial will explore the impact of CAPTURE-based screening on COPD diagnosis and treatment rates in primary care patients. Of a total planned enrollment of 5000 English- or Spanish-speaking patients 45 to 80 years of age without a prior COPD diagnosis from 100 primary care practices, a total of 68 practices and 3064 patients have been enrolled in the study. Practices are centrally randomized to either usual care or clinician receipt of patient-level CAPTURE results. All clinicians receive basic COPD education with those in intervention practices also receiving CAPTURE interpretation education. In a single visit, patient participants complete a CAPTURE screening, pre- and post-bronchodilator spirometry and baseline demographic and health questionnaires to validate CAPTURE sensitivity, specificity, and predictive value of identifying undiagnosed, clinically significant COPD. One-year follow-up chart reviews and participant surveys assess the impact of sharing versus not sharing CAPTURE results with clinicians on clinical outcomes including level of respiratory symptoms and events and clinicians' initiation of recommendation-concordant COPD care. This is one of the first U.S. studies to validate and assess impact of a simple COPD screening tool in primary care.

Dataset Information

The improving care in chronic obstructive lung disease study: CAROL improving processes of care and quality of life of COPD patients in primary care: study protocol for a randomized controlled trial.

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The improving care in chronic obstructive lung disease study: CAROL improving processes of care and quality of life of COPD patients in primary care: study protocol for a randomized controlled trial.

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