Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT02266303 |
| Other study ID # |
UWestIndies |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
October 10, 2014 |
| Last updated |
October 16, 2014 |
| Start date |
July 2014 |
Study information
| Verified date |
October 2014 |
| Source |
The University of The West Indies |
| Contact |
Karen Bynoe, MBBS |
| Phone |
(246)2669779 |
| Email |
karenbynoe[@]yahoo.com |
| Is FDA regulated |
No |
| Health authority |
Barbados: Ministry of Health |
| Study type |
Interventional
|
Clinical Trial Summary
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.
Description:
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.
Using human patient simulation we will evaluate the potential safety benefit of using a
checklist for insulin initiation by the syringe method. Human patient simulation allows the
assessment of clinical knowledge and skills without exposing individuals to risk.
Research hypothesis (alternate) The use of a checklist during insulin initiation via needle
and syringe, can improve patient education on safe and effective insulin use.
Methods Trial design
We will conduct a randomized controlled study. Participants will complete the simulation on
insulin initiation twice. Participants will be randomly assigned to the following groups and
each simulation will be separated by a 5 to 10-minute period as outlined below:
Group 1 (intervention group) - Participants will complete the simulation without the
checklist. They will then be introduced to the checklist and allowed up to ten minutes to
review it. They will subsequently repeat the simulation while using the checklist.
Group 2 (control group) - Participants will complete the simulation initially without the
checklist, as in group 1. They will then be allowed up to ten minutes to reflect on the
exercise. They will subsequently repeat the simulation exercise, but again without the
availability of the checklist.
The study design will attempt to ensure any improvements identified in association with the
checklist can be attributed to its use and not to a learning effect or previous skills.
Performance during each simulation will be assessed with the aid of a check sheet.
Educational tasks will be listed on this sheet under the headings of 'Side Effects',
'Hypoglycemia', 'Drawing up insulin', 'Administration of insulin' and 'Other'. Tick boxes
will be used to check off whether tasks are performed adequately, inadequately or not at
all. Each task will have brief notes on what constitute adequate performance.
The Checklist The checklist was developed by a taskforce. The group consisted of 11
individuals; a layperson, a pharmacist, two dietitians, two diabetes educators, a
podiatrist, a diabetes specialist nurse, a pediatrician and two diabetologists. The process
was lead by the pharmacist, diabetes specialist nurse and one of the diabetologists. The
first version was created by the three healthcare professionals leading the process, however
the final version was achieved through four iterative cycles of feedback and re-design.
The aim was to develop a simple A4 size, two sided, document that could be easily copied.
Eleven checklist items were agreed upon which covered twenty-one key educational points for
safe and effective insulin initiation. These educational points fell under four themes —
insulin side effects, recognition and treatment of hypoglycemia, drawing up insulin with a
syringe, and administration of insulin.
Images illustrating the process of using a syringe to draw up insulin from a vial as well as
injection sites (for children, adults and pregnant women) were included at the back. There
was also space provided for documentation of the client's name and registration number,
insulin type and when it should be taken, medications to be stopped, and the date and
signature of the facilitator.
Setting and simulation The interns will be asked to complete the simulation in the Clinical
Skills Building of The University of the West Indies. Established practitioners will have
the simulation carried out at their offices. During the simulation an actor/actress will
require education on the use and administration of insulin via a needle and syringe. The
participant will be given the equipment (insulin syringes and needles, injection pad and
insulin) and instructions for the exercise, which will include the clinical scenario.
Analysis Chi-squared analyses will establish whether the intervention and control groups are
equivalent with respect to demographic variables (age, gender, etc). The paired t-test will
determine differences between pair measurements of performance within groups, and the
student t-test between groups. If the necessary assumptions do not apply, the Wilcoxon
ranked sum test and Wilcoxon signed- rank test will be used respectively. Associations
between demographic variables and outcome variables will be determined using Pearson's
correlation coefficients.
