Governance of Diabetes Management in Non-specialistic Hospital Settings
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,449
- 试验地点
- 10
- 主要终点
- Composite performance score computed as the sum of the performance scores of all 5 domains of appropriateness and efficacy in both the intervention and the control wards
研究概览
简要总结
The prevalence of diabetes among inpatients in medical wards, surgery and intensive care units in Italy is approximatively 12-25%. The management of in hospital diabetes and hyperglycemia is complex and requires a specific training for physicians and nurses in non-specialist settings. The overall project aims at the implementation of a "best practice" model of care for hospitalized diabetic patients in non-specialist settings.
详细描述
The project aims at defining a model of care for hospitalized diabetic patients in non-specialist settings based on the national and international recommendations. This is a cluster randomized study to evaluate the efficacy of a structured education training program for physicians and nurses in improving an ad hoc composite performance score of diabetes management and some clinical outcomes. The study will be carried out in 6 hospitals of the Emilia-Romagna region in Italy and it will involve 3 different wards (internal medicine, intensive care unit, surgery). For each hospital one intervention and two controls wards will be randomly identified.
At baseline the clinical management of patients with stress hyperglycemia/diabetes will be assessed in all participating wards over a 3-month period. Then, a structured educational program regarding the management of stress hyperglycemia/diabetes in the inpatient setting will be carried out only in the intervention wards. This program will last 2 months. Health care professionals also will be trained in the regular use of appropriate management tools (hyperglycemia dedicated standard operation procedures, audits, etc.).
Three months after the end of the educational program, the 3-month assessment of clinical management of patients with stress hyperglycemia/diabetes will be repeated in all participating wards.
The assessment of clinical management of stress hyperglycemia/diabetes will be based on a set of clinical performance indicators concerning 5 major domains (admission assessment, glucose monitoring, medical therapy, management of consults, management of discharge). These indicators will be used to define a composite performance score of appropriateness and efficacy. The highest score (1) will be assigned when the indicator is monitored, the lowest (0) when the indicator will be not detected, according to the scoring method previously reported by Rossi et al. Therefore, the score of each domain will range between 0 and the number of indicators used to assess appropriateness and efficacy of that domain.
Domain 1 - Initial assessment: score 0-5
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with type 2 or type 1 diabetes or stress hyperglycemia
排除标准
- •age <18,
- •patients hospitalized for diabetic complications: ketoacidosis, hyperosmolar syndrome, hypoglycemic coma, pregnant diabetics or gestational diabetes
结局指标
主要结局
Composite performance score computed as the sum of the performance scores of all 5 domains of appropriateness and efficacy in both the intervention and the control wards
时间窗: 11 months
Efficacy of educational training will be evaluated as absolute change of the performance scores after the intervention compared to baseline in the two groups
次要结局
- hypoglycemic events in the intervention and control wards(11 months)
- severe hypoglycemic events in the intervention and control wards(11 months)
- difference between plasma glycemia at admission and mean plasma glucose during the last-48-hours before discharge(11 months)
- achievement of glycemic goals in the intervention and control wards(11 months)
- survival rate during hospitalization in the intervention and control wards(11 months)
- discharge condition in the intervention and control wards(11 months)
研究者
Ivana Zavaroni
Associate Professor
Azienda Ospedaliero-Universitaria di Parma