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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: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).

Project description:BackgroundDespite growing evidence that deprescribing can improve clinical outcomes, quality of life and reduce the likelihood of adverse drug events, the practice is not widespread, particularly in hospital settings. Clinical risk assessment tools, like the Drug Burden Index (DBI), can help prioritise patients for medication review and prioritise medications to deprescribe, but are not integrated within routine care. The aim of this study was to conduct formative usability testing of a computerised decision support (CDS) tool, based on DBI, to identify modifications required to the tool prior to trialling in practice.MethodsOur CDS tool comprised a DBI MPage in the electronic medical record (clinical workspace) that facilitated review of a patient's DBI and medication list, access to deprescribing resources, and the ability to deprescribe. Two rounds of scenario-based formative usability testing with think-aloud protocol were used. Seventeen end-users participated in the testing, including junior and senior doctors, and pharmacists.ResultsParticipants expressed positive views about the DBI CDS tool but testing revealed a number of clear areas for improvement. These primarily related to terminology used (i.e. what is a DBI and how is it calculated?), and consistency of functionality and display. A key finding was that users wanted the CDS tool to look and function in a similar way to other decision support tools in the electronic medical record. Modifications were made to the CDS tool in response to user feedback.ConclusionUsability testing proved extremely useful for identifying components of our CDS tool that were confusing, difficult to locate or to understand. We recommend usability testing be adopted prior to implementation of any digital health intervention. We hope our revised CDS tool equips clinicians with the knowledge and confidence to consider discontinuation of inappropriate medications in routine care of hospitalised patients. In the next phase of our project, we plan to pilot test the tool in practice to evaluate its uptake and effectiveness in supporting deprescribing in routine hospital care.

Project description:BackgroundIncreasing numbers of family carers are providing informal care in community settings. This creates a number of challenges because family carers are at risk of poor physical and psychological health outcomes, with consequences both for themselves and those for whom they provide care. General Practitioners (GPs), who play a central role in community-based care, are ideally positioned to identify, assess, and signpost carers to supports. However, there is a significant gap in the literature in respect of appropriate guidance and resources to support them in this role.MethodsA scoping review was undertaken to examine clinical guidelines and recommendations for GPs to support them in their role with family carers. This involved a multidisciplinary team, in line with Arksey & O'Malley's framework, and entailed searches of ten peer-reviewed databases and grey literature between September-November 2020.ResultsThe searches yielded a total of 4,651 English language papers, 35 of which met the criteria for inclusion after removing duplicates, screening titles and abstracts, and performing full-text readings. Ten papers focused on resources/guidelines for GPs, twenty were research papers, three were review papers, one was a framework of quality markers for carer support, and one was an editorial. Data synthesis indicated that nine (90%) of the guidelines included some elements relating to the identification, assessment, and/or signposting of carers. Key strategies for identifying carers suggest that a whole practice approach is optimal, incorporating a role for the GP, practice staff, and for the use of appropriate supporting documentation. Important knowledge gaps were highlighted in respect of appropriate clinical assessment and evidence-based signposting pathways.ConclusionOur review addresses a significant gap in the literature by providing an important synthesis of current available evidence on clinical guidelines for GPs in supporting family carers, including strategies for identification, options for assessment and potential referral/signposting routes. However, there is a need for greater transparency of the existing evidence base as well as much more research to evaluate the effectiveness and increase the routine utilisation, of clinical guidelines in primary care.

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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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