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临床试验/NCT02266303
NCT02266303Unknown不适用

The Effect of a Checklist on the Education of Simulated Patients During Insulin Initiation: a Randomized Controlled Trial

The University of The West Indies1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2014年7月最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
试验地点
1
主要终点
The total number of educational points addressed for the safe and effective use of insulin (of the possible 21 identified).

研究概览

简要总结

The increasing prevalence of diabetes is associated with increased insulin use. In developing countries it is frequently necessary to use insulin, with the needle and syringe method of administration being the cheapest approach. Competence of health care professionals is required to safely initiate insulin. The investigators will evaluate whether using a checklist during insulin initiation with a needle and syringe, can improve the safety and efficacy of its use.

详细描述

Introduction The prevalence of type 2 diabetes mellitus is increasing worldwide with a disproportionate increase in developing countries [1]. The burden is tremendous in developing countries, where the greatest increases are expected over time. For example, the prevalence of diabetes in adults in the North American and the Caribbean region is expected to increase by 37% in 2035. However, the increase in Africa and South and Central America over the same time period is expected to be 109% and 60% respectively[1].

This crisis is further compounded by the demand on financial resources placed by the high cost of care. Estimated costs of diabetes care reached $239.2 billion United Sates Dollars (USD) in 2013 in The North American and Caribbean region[2]. Abdulkadri et al estimated the economic cost of both diabetes and hypertension in four Caribbean countries (Barbados, Jamaica, Trinidad and Tobago and The Bahamas) in 2001 to be 753 million USD per year[3].

The management of type 2 diabetes has evolved from an algorithmic approach[4], towards individualized care[5, 6], but affordability limits treatment options in many developing countries. The evolution was driven by the increased availability of drugs used in diabetes treatment. However, drug availability has not equally penetrated the developed and developing world due to cost. Insulin in its cheapest forms (animal or human administered by a syringe) therefore remains critical in the management of diabetes in the developing world given its lower cost and greater efficacy. For example, Dipeptidyl peptidase-4 inhibitors cost approximately twice that of a month's supply of syringe delivered, intermediate human insulin, at a dose of 40 units daily. However, the potential reduction of HbA1C is 0.5-0.8% with DPP-4 inhibitors but as much as 3.5% with insulin titration[7]. Even in the developed world, the global financial crisis may result in similar shifts in lower income groups.

It is therefore critical for healthcare professionals to know how to safely initiate insulin. For insulin to be safely used, particularly by the needle and syringe method, healthcare professionals must adequately educate patients in a number of areas. These areas include side effects, drawing up and administration of insulin, and the recognition and treatment of hypoglycaemia. Given the complexity of the task all areas may not be recalled by health care professionals during a patient encounter.

The task of insulin initiation can be simplified through the use of a checklist. Ely and colleagues believe that checklists are an alternative to reliance on memory and reduce diagnostic errors[8]. Depending solely on recall is likely to open the gateway for omissions, particularly given that there is poor representation of structured teaching on insulin initiation during undergraduate medical training. An insulin initiation checklist can also simultaneously provide education for the healthcare professionals using insulin.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Registered General Practitioners in 2014, by the Barbados Medical Council, including those just recently completing supervised internship in June 2014.

排除标准

  • Practitioners not registered with the Barbados Medical Council in 2014

结局指标

主要结局

The total number of educational points addressed for the safe and effective use of insulin (of the possible 21 identified).

时间窗: 5 months

次要结局

  • The number of educational points addressed under each of the four themes of insulin side effects, hypoglycemia, drawing up and administering insulin.(5 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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