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Clinical Trials/NCT02313805
NCT02313805UnknownNot Applicable

The Effect of a Checklist on the Quality of Education During Insulin Initiation by Trained Medical Students: a Randomized Controlled Trial

The University of The West Indies1 site in 1 country100 target enrollmentStarted: July 1, 2014Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
100
Locations
1
Primary Endpoint
The total number of educational points addressed for the safe and effective use of insulin (of the possible 21 specified)

Study Overview

Brief Summary

Diabetes prevalence continues to rise worldwide, leading to the increasing use of insulin. This especially applies to developing countries where the needle-and-syringe method of administration remains the most affordable and effective form of hyperglycemic treatment. Competent health care professionals are required to ensure safe insulin initiation. The investigators will evaluate a teaching intervention on insulin initiation for medical students, and whether after experiencing that intervention the use of a checklist, during simulate insulin initiation, improves the education they provide to patients.

Detailed Description

Introduction:

Diabetes is on the increase worldwide. The International Diabetes Federation estimates that there are currently 382 million persons diagnosed with diabetes. The prevalence is expected to increase to over 592 million in less than 25 years [1]. This increase is disproportional in the developing world, with 80% of those affected living in low- and middle-income countries. For example, in South and Central America, the prevalence of diabetes is estimated to increase by over 60% in the next two decades [2].

Insulin is one of the agents that can be used in the treatment of diabetes mellitus. Diabetes is characterized by a progressive decline in beta-cell function and insulin secretion. Over time, a significant number of persons with diabetes will require intensification of management, and possibly insulin treatment to achieve acceptable glycemic control [3]. Insulin remains the oldest and most effective treatment of hyperglycemia. It is also possibly the cheapest form of treatment relative to its potency, particularly when used in its animal or human forms.

Insulin is a particularly important treatment option in the developing world and in low-income groups in the developed world. In the developing world, drug affordability has limited the international evolution from an algorithmic to an individualized approach to glycemic management [4, 5]. In many countries, insulin remains the affordable second or third line choice for treatment, and will therefore be used with greater frequency.

Insulin initiation is, however, a complex task. To safely initiate insulin, many important aspects of patient education must be addressed. Patients must understand the technicalities of drawing insulin with a needle and syringe as well as administering insulin with a syringe, pen or pump. The side effects of weight gain and hypoglycemia must also be understood, including the recognition and treatment of the latter.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Single Group
Masking
None

Eligibility Criteria

Ages
17 Years to 40 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Undergraduate students in their final-year medicine clerkship at the University of the West Indies, who are within one year of starting supervised post-graduate employment (internship).
  • •Students who consent to participate in the study (voluntary participation only).

Exclusion Criteria

  • •Students who refuse consent to participate in the study.

Arms & Interventions

With checklist

Experimental

Students will simulate insulin initiation with the aid of a checklist

Intervention: Checklist (Other)

Without checklist

No Intervention

Students will simulate insulin initiation without the aid of a checklist

Outcomes

Primary Outcomes

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

Time Frame: 2 years

Secondary Outcomes

  • The number of educational points addressed under each of the four educational domains: insulin side effects, recognition and treatment of hypoglycemia, administration of insulin, and drawing up insulin using the syringe method.(2 years)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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