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Supporting care for suboptimally controlled type 2 diabetes mellitus in general practice with a clinical decision support system: a mixed methods pilot cluster randomised trial.

ABSTRACT: OBJECTIVES:We developed a complex intervention called DECIDE (ComputeriseD dECisIonal support for suboptimally controlleD typE 2 Diabetes mellitus in Irish General Practice) which used a clinical decision support system to address clinical inertia and support general practitioner (GP) intensification of treatment for adults with suboptimally controlled type2 diabetes mellitus (T2DM). The current study explored the feasibility and potential impact of DECIDE. DESIGN:A pilot cluster randomised controlled trial. SETTING:Conducted in 14 practices in Irish General Practice. PARTICIPANTS:The DECIDE intervention was targeted at GPs. They applied DECIDE to patients with suboptimally controlled T2DM, defined as a glycated haemoglobin (HbA1c) ?70?mmol/mol and/or blood pressure ?150/95?mmHg. INTERVENTION:The intervention incorporated training and a web-based clinical decision support system which supported; (i) medication intensification actions; and (ii) non-pharmacological actions to support care. Control practices delivered usual care. PRIMARY AND SECONDARY OUTCOME MEASURES:Feasibility and acceptability was determined using thematic analysis of semi-structured interviews with GPs, combined with data from the DECIDE website. Clinical outcomes included HbA1c, medication intensification, blood pressure and lipids. RESULTS:We recruited 14 practices and 134 patients. At 4-month follow-up, all practices and 114 patients were followed up. GPs reported finding decision support helpful navigating increasingly complex medication algorithms. However, the majority of GPs believed that the target patient group had poor engagement with GP and hospital services for a range of reasons. At follow-up, there was no difference in glycaemic control (-3.6?mmol/mol (95%?CI -11.2 to 4.0)) between intervention and control groups or in secondary outcomes including, blood pressure, total cholesterol, medication intensification or utilisation of services. Continuation criteria supported proceeding to a definitive randomised trial with some modifications. CONCLUSION:The DECIDE study was feasible and acceptable to GPs but wider impacts on glycaemic and blood pressure control need to be considered for this patient population going forward. TRIAL REGISTRATION NUMBER:ISRCTN69498919.

SUBMITTER: Murphy ME

PROVIDER: S-EPMC7045235 | biostudies-literature | 2020 Feb

REPOSITORIES: biostudies-literature

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Supporting care for suboptimally controlled type 2 diabetes mellitus in general practice with a clinical decision support system: a mixed methods pilot cluster randomised trial.

Murphy Mark E ME McSharry Jenny J Byrne Molly M Boland Fiona F Corrigan Derek D Gillespie Paddy P Fahey Tom T Smith Susan M SM

BMJ open 20200212 2

<h4>Objectives</h4>We developed a complex intervention called DECIDE (ComputeriseD dECisIonal support for suboptimally controlleD typE 2 Diabetes mellitus in Irish General Practice) which used a clinical decision support system to address clinical inertia and support general practitioner (GP) intensification of treatment for adults with suboptimally controlled type2 diabetes mellitus (T2DM). The current study explored the feasibility and potential impact ...[more]

PMID: 32051304

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Project description:Discontinuing antidepressant medication (ADM) can be challenging for patients and clinicians. In the current study we investigated if Mindfulness-Based Cognitive Therapy (MBCT) added to supported protocolized discontinuation (SPD) is more effective than SPD alone to help patients discontinue ADM. This study describes a prospective, cluster-randomized controlled trial (completed). From 151 invited primary care practices in the Netherlands, 36 (24%) were willing to participate and randomly allocated to SPD+MBCT (k = 20) or SPD (k = 16). Adults using ADM > 9 months were invited by GPs to discuss tapering, followed by either MBCT+SPD, or SPD alone. Exclusion criteria included current psychiatric treatment; substance use disorder; non-psychiatric indication for ADM; attended MBCT within past 5 years; cognitive barriers. From the approximately 3000 invited patients, 276 responded, 119 participated in the interventions and 92 completed all assessments. All patients were offered a decision aid and a personalized tapering schedule (with GP). MBCT consisted of eight group sessions of 2.5 hours and one full day of practice. SPD was optional and consisted of consultations with a mental health assistant. Patients were assessed at baseline and 6, 9 and 12 months follow-up, non-blinded. In line with our protocol, primary outcome was full discontinuation of ADM within 6 months. Secondary outcomes were depression, anxiety, withdrawal symptoms, rumination, well-being, mindfulness skills, and self-compassion. Patients allocated to SPD + MBCT (n = 73) were not significantly more successful in discontinuing (44%) than those allocated to SPD (n = 46; 33%), OR 1.60, 95% CI 0.73 to 3.49, p = .24, number needed to treat = 9. Only 20/73 allocated to MBCT (27%) completed MBCT. No serious adverse events were reported. In conclusion, we were unable to demonstrate a significant benefit of adding MBCT to SPD to support discontinuation in general practice. Actual participation in patient-tailored interventions was low, both for practices and for patients. (Trial registration: ClinicalTrials.gov PRS ID: NCT03361514 registered December 2017).

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:BACKGROUND:Inpatients are often prescribed cardiopulmonary resuscitation (CPR) without a shared decision-making process. Since implementation of decision aids into practice is highly sensitive to the clinical milieu, we performed a pilot study to refine our study procedures and to evaluate the acceptability and potential effectiveness of a shared decision-making intervention when implemented in a Canadian hospital setting. METHODS:In this before-after pilot study, we recruited patients and family members on the medical wards of 2 Canadian teaching hospitals between September 2015 and March 2017. The intervention consisted of viewing a CPR decision video and completing a values-clarification worksheet; follow-up discussion with the physician was encouraged. The primary feasibility outcome was acceptability of the video, and the primary effectiveness outcome was change in the Decisional Conflict Scale score (lower scores being more desirable) after the intervention. Participants rated the extent of shared decision-making using the CollaboRATE instrument. RESULTS:Of the 71 participants (43 patients with a mean age of 79.0 [standard deviation (SD) 11.4] yr and 28 family members with a mean age of 61.0 [SD 10.0] yr), 65 (92%) rated the CPR decision video as good to excellent. The intervention was associated with an improvement in knowledge about CPR (+2.7 points, 95% confidence interval [CI] 2.2 to 3.3, effect size 1.5) and a reduction in the Decisional Conflict Scale score (-18.1 points, 95% CI -21.8 to -14.3, effect size 1.4). The 36 participants who had a discussion with a physician about CPR after watching the video rated the extent of shared decision-making as 6.3 (SD 1.7) (possible maximum score 9). There was a nonsignificant decrease in the proportion of patients with a medical order for CPR after the intervention (71% before v. 63% after, p = 0.06). INTERPRETATION:The CPR decision video was acceptable to patients and family members. Our decision-support intervention may improve knowledge, reduce decisional conflict and reduce the prevalence of medical orders for CPR in the Canadian hospital setting.

Project description:AimsHeart failure (HF) is an important health problem for which multidisciplinary care is recommended, yet few studies involve primary care practitioners in the multidisciplinary management of HF. We set up a multifaceted prospective observational trial, OSCAR-HF, piloting audit and feedback, natriuretic peptide testing at the point of care, and the assistance of a specialist HF nurse in primary care. The aim was to optimize HF care in general practice.Methods and resultsThis is an analysis at 6 month follow-up of the study interventions of the OSCAR-HF pilot study, a nonrandomized, noncontrolled prospective observational trial conducted in eight Belgian general practices [51 general practitioners (GPs)]. Patients who were assessed by their GP to have HF constituted the OSCAR-HF study population. We used descriptive statistics and mixed-effects modelling for the quantitative analysis and thematic analysis of the focus group interviews. There was a 10.2% increase in the registered HF population after 6 months of follow-up (n = 593) compared with baseline (n = 538) and a 27% increase in objectified HF diagnoses (baseline n = 359 to 456 at T6 M). Natriuretic peptide testing (with or without referral) accounted for 54% (n = 60/111) of the newly registered HF diagnoses. There was no difference in the proportion of patients with HF with reduced ejection fraction who received their target dosage of renin-angiotensin-aldosterone system inhibitors or beta-blockers at 6 months compared with baseline (P = 0.9). Patients who received an HF nurse intervention (n = 53) had significantly worse quality of life at baseline [difference in Minnesota Living with Heart Failure Questionnaire (MLHFQ) score 9.2 points; 95% confidence interval (CI) 4.0, 14] and had a significantly greater improvement in quality-of-life scores at the 6 month follow-up [change in MLHFQ score -9.8 points; 95% CI -15, -4.5] than patients without an HF nurse intervention. GPs found audit and feedback valuable but time intensive. Natriuretic peptides were useful, but the point-of-care test was impractical, and the assistance of an HF nurse was a useful addition to routine HF care.ConclusionsThe use of audit and feedback combined with natriuretic peptide testing was a successful strategy to increase the number of registered and objectified HF diagnoses at 6 months. GPs and HF nurses selected patients with worse quality-of-life scores at baseline for the HF nurse intervention, which led to a significantly greater improvement in quality-of-life scores at the 6 month follow-up compared with patients without an HF nurse intervention. The interventions were deemed feasible and useful by the participating GPs with some specific remarks that can be used for optimization.Trial registrationClinicalTrials.gov (NCT02905786), registered on 14 September 2016 at https://clinicaltrials.gov/.

Project description:BackgroundDiagnostic errors pose significant health risks and contribute to patient mortality. With the growing accessibility of electronic health records, machine learning models offer a promising avenue for enhancing diagnosis quality. Current research has primarily focused on a limited set of diseases with ample training data, neglecting diagnostic scenarios with limited data availability.ObjectiveThis study aims to develop an information retrieval (IR)-based framework that accommodates data sparsity to facilitate broader diagnostic decision support.MethodsWe introduced an IR-based diagnostic decision support framework called CliniqIR. It uses clinical text records, the Unified Medical Language System Metathesaurus, and 33 million PubMed abstracts to classify a broad spectrum of diagnoses independent of training data availability. CliniqIR is designed to be compatible with any IR framework. Therefore, we implemented it using both dense and sparse retrieval approaches. We compared CliniqIR's performance to that of pretrained clinical transformer models such as Clinical Bidirectional Encoder Representations from Transformers (ClinicalBERT) in supervised and zero-shot settings. Subsequently, we combined the strength of supervised fine-tuned ClinicalBERT and CliniqIR to build an ensemble framework that delivers state-of-the-art diagnostic predictions.ResultsOn a complex diagnosis data set (DC3) without any training data, CliniqIR models returned the correct diagnosis within their top 3 predictions. On the Medical Information Mart for Intensive Care III data set, CliniqIR models surpassed ClinicalBERT in predicting diagnoses with <5 training samples by an average difference in mean reciprocal rank of 0.10. In a zero-shot setting where models received no disease-specific training, CliniqIR still outperformed the pretrained transformer models with a greater mean reciprocal rank of at least 0.10. Furthermore, in most conditions, our ensemble framework surpassed the performance of its individual components, demonstrating its enhanced ability to make precise diagnostic predictions.ConclusionsOur experiments highlight the importance of IR in leveraging unstructured knowledge resources to identify infrequently encountered diagnoses. In addition, our ensemble framework benefits from combining the complementary strengths of the supervised and retrieval-based models to diagnose a broad spectrum of diseases.

Project description:PURPOSE Practice facilitation is an evidence-informed implementation strategy to support quality improvement (QI) and aid practices in aligning with best evidence. Few studies, particularly of this size and scope, identify strategies that contribute to facilitator effectiveness. METHODS We conducted a sequential mixed methods study, analyzing data from EvidenceNOW, a large-scale QI initiative. Seven regional cooperatives employed 162 facilitators to work with 1,630 small or medium-sized primary care practices. Main analyses were based on facilitators who worked with at least 4 practices. Facilitators were defined as more effective if at least 75% of their practices improved on at least 1 outcome measure—aspirin use, blood pressure control, smoking cessation counseling (ABS), or practice change capacity, measured using Change Process Capability Questionnaire—from baseline to follow-up. Facilitators were defined as less effective if less than 50% of their practices improved on these outcomes. Using an immersion crystallization and comparative approach, we analyzed observational and interview data to identify strategies associated with more effective facilitators. RESULTS Practices working with more effective facilitators had a 3.6% greater change in the mean percentage of patients meeting the composite ABS measure compared with practices working with less effective facilitators (P <.001). More effective facilitators cultivated motivation by tailoring QI work and addressing resistance, guided practices to think critically, and provided accountability to support change, using these strategies in combination. They were able to describe their work in detail. In contrast, less effective facilitators seldom used these strategies and described their work in general terms. Facilitator background, experience, and work on documentation did not differentiate between more and less effective facilitators. CONCLUSIONS Facilitation strategies that differentiate more and less effective facilitators have implications for enhancing facilitator development and training, and can assist all facilitators to more effectively support practice changes.

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).

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Supporting care for suboptimally controlled type 2 diabetes mellitus in general practice with a clinical decision support system: a mixed methods pilot cluster randomised trial.

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Supporting care for suboptimally controlled type 2 diabetes mellitus in general practice with a clinical decision support system: a mixed methods pilot cluster randomised trial.

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