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Spirometry expert support in family practice: a cluster-randomised trial.

ABSTRACT: AIM:To assess the impact of two modes of spirometry expert support on Family physicians' (FPs') diagnoses and planned management in patients with apparent respiratory disease. METHOD:A cluster-randomised trial was performed with family practices as the unit of randomisation. FPs from 44 family practices recorded their diagnosis and planned management before and after spirometry for 868 patients. Intervention consisted of spirometry interpretation support by either a chest physician or expert software. Both interventions were compared with usual care (i.e. no additional interpretation support). Change in FPs' diagnoses after spirometry served as the primary outcome. Secondary outcomes were referral rate, additional diagnostic tests, and disease management changes. Effects were expressed as percentages and Odds Ratios (OR) with 95% confidence intervals. RESULTS:Diagnoses changed after intervention in all groups: 47.8% (95% CI 41.8 to 53.9) for chest physician support; 45.0% (95% CI 39.5 to 50.6) for software support; and 53.3% (95% CI 47.2 to 59.4) for usual care. Differences in the proportions of changed diagnosis were not statistically significant: chest physician support versus usual care OR 0.79 (95%CI 0.49 to 1.30); software support versus usual care OR 0.72 (95% CI 0.45 - 1.15). There were no differences in secondary outcomes. CONCLUSION:Neither chest physician spirometry support nor expert software spirometry support had a significant impact on FPs' diagnosis of respiratory conditions or management decisions. TRIAL NUMBER:http://www.clinicaltrials.gov/ct/show/NCT00131157?order=1.

SUBMITTER: Poels PJ

PROVIDER: S-EPMC6619272 | biostudies-literature | 2009 Sep

REPOSITORIES: biostudies-literature

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Spirometry expert support in family practice: a cluster-randomised trial.

Poels Patrick J P PJ Schermer Tjard R J TR Thoonen Bart P A BP Jacobs Johanna E JE Akkermans Reinier P RP de Vries Robbé Pieter F PF Quanjer Philip H PH Bottema Ben J A M BJ van Weel Chris C

Primary care respiratory journal : journal of the General Practice Airways Group 20090901 3

<h4>Aim</h4>To assess the impact of two modes of spirometry expert support on Family physicians' (FPs') diagnoses and planned management in patients with apparent respiratory disease.<h4>Method</h4>A cluster-randomised trial was performed with family practices as the unit of randomisation. FPs from 44 family practices recorded their diagnosis and planned management before and after spirometry for 868 patients. Intervention consisted of spirometry interpretation support by either a chest physicia ...[more]

PMID: 19649513

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Project description:BackgroundPatients continue to suffer from medically unexplained symptoms otherwise referred to as persistent physical symptoms (PPS). General practitioners (GPs) play a key role in the management of PPS and require further training. Patients are often frustrated with the care they receive. This study aims to assess the acceptability of an 'integrated GP care' approach which consists of offering self-help materials to patients with PPS and offering their GPs training on how to utilise cognitive behavioural skills within their consultations, as well as assessing the feasibility of conducting a future trial in primary care to evaluate its benefit.MethodsA feasibility cluster randomised controlled trial was conducted in primary care, South London, UK. GP practices (clusters) were randomly allocated to 'integrated GP care plus treatment as usual' or 'treatment as usual'. Patients with PPS were recruited from participating GP practices before randomisation. Feasibility parameters, process variables and potential outcome measures were collected at pre-randomisation and at 12- and 24-weeks post-randomisation at cluster and individual participant level.ResultsTwo thousand nine hundred seventy-eight patients were identified from 18 GP practices. Out of the 424 patients who responded with interest in the study, 164 fully met the eligibility criteria. One hundred sixty-one patients provided baseline data before cluster randomisation and therefore were able to participate in the study. Most feasibility parameters indicated that the intervention was acceptable and a future trial feasible. 50 GPs from 8 GP practices (randomised to intervention) attended the offer of training and provided positive feedback. Scores in GP knowledge and confidence increased post-training. Follow-up rate of patients at 24 weeks was 87%. However estimated effect sizes on potential clinical outcomes were small.ConclusionsIt was feasible to identify and recruit patients with PPS. Retention rates of participants up to 24 weeks were high. A wide range of health services were used. The intervention was relatively low cost and low risk. This complex intervention should be further developed to improve patients'/GPs' utilisation of audio/visual and training resources before proceeding to a full trial evaluation.Trial registrationNCT02444520 (ClinicalTrials.gov).

Project description:BackgroundType 2 diabetes is a common metabolic disease with the potential for prevention of complications. The prevention requires a high level of lasting actions from the patients, which may be burdensome. The aim of this trial was to evaluate the effectiveness of a training course for general practice nurses in motivation support at 18 months follow-up in the affiliated type 2 diabetes population.MethodsForty general practices with nurse-led diabetes consultations from the area of Aarhus, Denmark were randomised 1∶1 to either intervention or usual practice. Intervention practices were offered a 16-hour Self-determination theory-based course including communication training for general practice nurses delivered over 10 months. The affiliated diabetes populations (aged 40-74 years) were identified from registers (intervention n = 2,005; usual n = 2,029). Primary outcomes were register-based glycated haemoglobin (HbA1c) -, total cholesterol levels, and well-being measured by the Problem Areas In Diabetes scale (PAID) and the mental component summary score, SF12 (SF12, mcs). Intention-to-treat analyses were performed. Predefined subgroups analyses were performed.ResultsThe differences between the intervention- and the control practices' mean HbA1c and total cholesterol at follow-up adjusted for baseline values and clustering were respectively: -0.02%-points (95% CI: -0.11 to 0.07; p: 0.67); 0.08 mmol/l (95% CI: 0.01 to 0.15; p: 0.02). Differences in median scores adjusted for clustering were for PAID: 1.25; p = 0.31 and SF12, mcs: 0.99; p = 0.15. Women in intervention practices differed from women in usual practices on mean HbA1c: -0.12%-points (-0.23 to -0.02; p = 0.02) and SF12, mcs: 2.6; p = 0.01.ConclusionsOffering a training course for general practice nurses in applying the Self-determination theory in current type 2 diabetes care had no effect compared with usual practice measured by HbA1c and total cholesterol levels and the well-being at 18 months of follow-up in a comprehensive register-based diabetes population. Subgroup analyses suggested a possible effect in women, which deserves further attention.Trial registrationClinicalTrials.gov (Identifier NCT01187069).

Project description:ObjectiveTo test the effectiveness of peer support for patients with type 2 diabetes.DesignCluster randomised controlled.Setting20 general practices in the east of the Republic of Ireland.Participants395 patients (192 in intervention group, 203 in control group) and 29 peer supporters with type 2 diabetes.InterventionAll practices introduced a standardised diabetes care system. The peer support intervention ran over a two year period and contained four elements: the recruitment and training of peer supporters, nine group meetings led by peer supporters in participant's own general practice, and a retention plan for the peer supporters.Main outcome measuresHbA(1c); cholesterol concentration; systolic blood pressure; and wellbeing score.ResultsThere was no difference between intervention and control patients at baseline. All practices and 85% (337) of patients were followed up. At two year follow-up, there were no significant differences in HbA(1c) (mean difference -0.08%, 95% confidence interval -0.35% to 0.18%), systolic blood pressure (-3.9 mm Hg, -8.9 to 1.1 mm Hg), total cholesterol concentration (-0.03 mmol/L, -0.28 to 0.22 mmol/L), or wellbeing scores (-0.7, -2.3 to 0.8). While there was a trend towards decreases in the proportion of patients with poorly controlled risk factors at follow-up, particularly for systolic blood pressure (52% (87/166) >130 mm Hg in intervention v 61% (103/169) >130 mm Hg in control), these changes were not significant. The process evaluation indicated that the intervention was generally delivered as intended, though 18% (35) of patients in the intervention group never attended any group meetings.ConclusionsA group based peer support intervention is feasible in general practice settings, but the intervention was not effective when targeted at all patients with type 2 diabetes. While there was a trend towards improvements of clinical outcomes, the results do not support the widespread adoption of peer support. Trial registration Current Controlled Trials ISRCTN42541690.

Project description:IntroductionManaging patients with multiple conditions (multimorbidity) is a major challenge for healthcare systems internationally, particularly in older patients. Multimorbidity and subsequent polypharmacy increase treatment burden and the risk of potentially inappropriate prescribing, and both are complex to manage in primary care. Limited evidence suggests integration of pharmacists into general practice teams could improve medication management for patients with multimorbidity and polypharmacy. Building on findings from a non-randomised, uncontrolled General Practice Pharmacist (GPP) feasibility study conducted in Irish primary care, the aim of this study is to conduct a pilot cluster randomised controlled trial (cRCT) of the GPP study, to assess feasibility, intervention impact, costs and appropriateness of continuing to a definitive cRCT.Methods and analysisThis pilot cRCT will involve 8 general practitioner (GP) practices and 120 patients. Practices will identify and recruit patients aged ≥65 years, who are taking ≥10 regular medications. Practices will be allocated to intervention or control after baseline data collection. Intervention practices will have a pharmacist integrated within their service, working with GPs, patients and practice staff to optimise prescribing and other medication-related activities. Control practices will provide standard GP care. The primary feasibility outcomes will include recruitment rate, uptake of medication reviews and study retention. For the primary clinical outcome, the number of potentially inappropriate prescribing incidences per patient will be collected. Secondary outcomes will include medication-related outcomes, patient-reported outcome measures, and data pertaining to the role and impact of the pharmacist on prescribing. In addition, economic and process evaluations will be conducted.Ethics and disseminationThis trial has been approved by the Irish College of General Practitioners Research Ethics Committee and will be performed in accordance with the Declaration of Helsinki. The results will be reported in peer-reviewed journals and be presented at national and international conferences.Trial registration numberISRCTN Registry (https://doi.org/10.1186/ISRCTN18752158).

Project description:BackgroundAcute diarrhoeal disease management often requires rehydration alone without antibiotics. However, non-indicated antibiotics are frequently ordered and this is an important driver of antimicrobial resistance. The mHealth Diarrhoea Management (mHDM) trial aimed to establish whether electronic decision support improves rehydration and antibiotic guideline adherence in resource-limited settings.MethodsA cluster randomised controlled trial was done at ten district hospitals in Bangladesh. Inclusion criteria were patients aged 2 months or older with uncomplicated acute diarrhoea. Admission orders were observed without intervention in the pre-intervention period, followed by randomisation to electronic (rehydration calculator) or paper formatted WHO guidelines for the intervention period. The primary outcome was rate of intravenous fluid ordered as a binary variable. Generalised linear mixed-effect models, accounting for hospital clustering, served as the analytical framework; the analysis was intention to treat. The trial is registered with ClinicalTrials.gov (NCT03154229) and is completed.FindingsFrom March 11 to Sept 10, 2018, 4975 patients (75·6%) of 6577 screened patients were enrolled. The intervention effect for the primary outcome showed no significant differences in rates of intravenous fluids ordered as a function of decision-support type. Intravenous fluid orders decreased by 0·9 percentage points for paper electronic decision support and 4·2 percentage points for electronic decision support, with a 4·2-point difference between decision-support types in the intervention period (paper 98·7% [95% CI 91·8-99·8] vs electronic 94·5% [72·2-99·1]; pinteraction=0·31). Adverse events such as complications and mortality events were uncommon and could not be statistically estimated.InterpretationAlthough intravenous fluid orders did not change, electronic decision support was associated with increases in the volume of intravenous fluid ordered and decreases in antibiotics ordered, which are consistent with WHO guidelines.FundingUS National Institutes of Health.

Project description:BackgroundSocial, emotional and behavioural problems in early childhood are associated with increased risk for a wide range of poor outcomes associated with substantial cost and impact on society as a whole. Some of these problems are rooted in the early mother-infant relationship and might be prevented. In Denmark, primary health care has a central role in preventive care during pregnancy and the first years of the child's life and general practice provides opportunities to promote a healthy mother-infant relationship in early parenthood.ObjectiveIn the context of standardised antenatal and child development assessments focused on psychosocial wellbeing, we examine the impact of a complex intervention designed to improve maternal mentalisation skills, involving training of general practice clinicians and signposting towards a web-based resource. Joint main outcomes are child socio-emotional and language development at age 30 months measured by parentally reported questionnaires (Communicative Development Inventory and Strengths and Difficulties Questionnaire).MethodsThe study is a cluster-randomised controlled trial based in general practices in the Capital Region and the Zealand Region of Denmark. Seventy practices were included. Practices were randomised by a computer algorithm in a ratio of 1:1 to intervention or control groups. Each practice was asked to recruit up to 30 women consecutively at their first scheduled antenatal assessment. Clinicians in both groups received one day of training in preventive antenatal and child development consultations with added focus on parental psychosocial well-being, social support, and parent-child interaction. These preventive consultations delivered in both trial arms require enhanced data recording about psychosocial factors. In intervention clinics, clinicians were asked to signpost a web page at three scheduled antenatal consultations and at four scheduled consultations when the child is 5 weeks, 5 months, 1 and 2 years.DiscussionWe hypothesise that the intervention will increase mothers' ability to be sensitive to their child's mental state to an extent that improves the child's language and mental state at 30 months of age measured by parent-reported questionnaires.Trial registrationClinicalTrials.gov NCT04129359. Registered on Oct 16 2019.

Project description:To investigate staff and trainer perspectives on the barriers and facilitators to implementing a complex intervention to help staff support the recovery of service users with a primary diagnosis of psychosis in community mental health teams.Process evaluation nested within a cluster randomised controlled trial (RCT).28 interviews with mental health care staff, 3 interviews with trainers, 4 focus groups with intervention teams and 28 written trainer reports.14 community-based mental health teams in two UK sites (one urban, one semi-rural) who received the intervention.The factors influencing the implementation of the intervention can be organised under two over-arching themes: Organisational readiness for change and Training effectiveness. Organisational readiness for change comprised three sub-themes: NHS Trust readiness; Team readiness; and Practitioner readiness. Training effectiveness comprised three sub-themes: Engagement strategies; Delivery style and Modelling recovery principles.Three findings can inform future implementation and evaluation of complex interventions. First, the underlying intervention model predicted that three areas would be important for changing practice: staff skill development; intention to implement; and actual implementation behaviour. This study highlighted the importance of targeting the transition from practitioners' intent to implement to actual implementation behaviour, using experiential learning and target setting. Second, practitioners make inferences about organisational commitment by observing the allocation of resources, Knowledge Performance Indicators and service evaluation outcome measures. These need to be aligned with recovery values, principles and practice. Finally, we recommend the use of organisational readiness tools as an inclusion criteria for selecting both organisations and teams in cluster RCTs. We believe this would maximise the likelihood of adequate implementation and hence reduce waste in research expenditure.Controlled-Trials.com ISRCTN02507940.

Dataset Information

Spirometry expert support in family practice: a cluster-randomised trial.

Publications

Spirometry expert support in family practice: a cluster-randomised trial.

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