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临床试验/NCT04792268
NCT04792268已完成不适用

Implementation of an Electronic Clinical Decision Support System (eCDSS) for the Early Recognition and Management of Diabetes and Dysglycaemia in Secondary Mental Healthcare : Feasibility Study

King's College London1 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2022年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
4
试验地点
1
主要终点
Number of wards and clinician end-users recruited to the study

研究概览

简要总结

People with serious mental illness (SMI) such as schizophrenia, schizoaffective disorder and bipolar affective disorder have a significantly reduced life expectancy, caused in part by increased incidences of mortality from physical health conditions such as cardiovascular disease (CVD) and diabetes.

Electronic clinical decision support systems (eCDSS) offer clinicians patient-specific advice and recommendations based on clinical guidelines, theoretically overcoming obstacles in the use of existing paper-based guidelines. Adoption of eCDSS to address CVD risk in people with SMI presents a unique opportunity for research, but requires evidence of acceptability and feasibility before scaling up of research.

The key objective of this study is to establish the feasibility and acceptability of an eCDSS (CogStack @ Maudsley) compromising a real-time electronic health record powered alerting and clinical decision support system for diabetes management in secondary inpatient mental healthcare settings. End-users of the eCDSS will be clinicians only.

Firstly we will conduct initial surveys and interviews with clinicians on inpatient wards to scope experiences of managing diabetes in secondary mental healthcare settings and attitudes towards use of digital technologies to aid in clinical decision making.

A feasibility study will then be run to evaluate the acceptability and feasibility of implementing eCDSS on inpatient wards. This will involve a cluster RCT on inpatient general adult psychiatry wards, where 4 months of eCDSS use by clinicians on intervention wards will be compared to 4 months of treatment as usual on control wards. All clinicians on recruited wards will be eligible to participate.

At the end of the study, participating clinicians on intervention wards will be invited to take part in a survey and interview which will explore their experiences and attitudes towards using the eCDSS, and an implementation science framework will be applied to inform future implementation of eCDSS. Group level pseudonymised outcome data will be gathered through a separate study.

详细描述

People with serious mental illness (SMI) such as schizophrenia, schizoaffective disorder and bipolar affective disorder have a significantly reduced life expectancy in comparison to the general population. Improvements to the primary prevention of physical health illnesses like diabetes in the general population have not been mirrored to the same extent in people with SMI.

Diabetes is a group of metabolic disorders characterized by a high blood sugar level over a prolonged period of time. If left untreated or poorly managed, diabetes can lead to various long term health complications including cardiovascular disease, stroke, chronic kidney disease, foot ulcers, damage to the nerves and damage to the eyes. Diabetes accounts for approximately 10% of healthcare resources in the UK, and this is set to rise to 17% with an estimated cost of £39.8billion by 2035 when direct healthcare costs and indirect costs on productivity are taken into account.

People with SMI have higher rates of cardiovascular disease (CVD) risk factors such as central obesity, high blood pressure, raised cholesterol levels, and raised blood sugar levels compared to the general population. Local rates of diabetes in people with a diagnosis of established psychosis are 20% with a further 30% evidencing dysglycaemia (raised blood sugar levels). Again locally, rates of glucose dysregulation (indicator for high risk of developing diabetes) doubles in the first year after a first psychotic episode, creating a unique window for prevention strategies to address these risks as early as possible.

A key inequality in healthcare provision in people with SMI is the less than adequate assessment and treatment of physical health conditions such as diabetes in secondary mental healthcare settings. There is therefore a need for more targeted and clinically informed interventions, that improve the standard of physical healthcare screening and interventions offered to people with SMI across both primary and secondary care settings.

Globally, studies evaluating the provision of care by clinicians reveal that there is a sub-optimal uptake of guidelines into actual practice. The underlying factors for this are complex and occur at a combination of patient, clinician and system levels.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • General adult psychiatry inpatient wards at South London and Maudsley NHS Foundation Trust. Wards will be entered into the study if their respective management are agreeable to participate.
  • All clinical staff on recruited wards will be eligible to participate and will be invited to take part in a preliminary survey and individual interview with the research team at the start of the study.
  • Staff on intervention wards will also be asked to complete a survey and individual interview at the end of the study.

排除标准

  • Staff on recruited wards who are not of a clinical or healthcare professional background.
  • Staff who lack capacity to provide informed consent to participate.

结局指标

主要结局

Number of wards and clinician end-users recruited to the study

时间窗: 4 months

Ability to recruit wards and clinicians to the study. Retention and participation of clinicians on recruited wards through to end of study. Availability of data to fulfil outcome measures.

Extent to which eCDSS is perceived by clinician users to be acceptable

时间窗: 4 months

This outcome measure will explore clinician perceptions on how acceptable the eCDSS is in improving evidence-based dysglycaemia management, and where applicable, diabetes care. Data will be gathered through qualitative analysis of individual semi-structured interviews with clinician users.

次要结局

  • Rate of documentation of discussion with patient regarding exercise, diet and smoking cessation(4 months)
  • Rates of documentation of diabetes related screening interventions(4 months)
  • Rate of HbA1c testing(12 months)
  • Rate of delivery of evidence-based pharmacological interventions for diabetes or pre-diabetes where clinically indicated(4 months)
  • Rate of documentation of dysglycaemia/diabetes in clinical notes(4 months)
  • Rates of communication with GP/CMHT regarding diabetes or dysglycaemia follow up(4 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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