NCT02313805

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 8, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 10, 2014

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Last Updated

December 10, 2014

Status Verified

November 1, 2014

Enrollment Period

2 years

First QC Date

December 8, 2014

Last Update Submit

December 9, 2014

Conditions

Keywords

Insulin initiationInsulin checklist

Outcome Measures

Primary Outcomes (1)

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

    2 years

Secondary Outcomes (1)

  • 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

Study Arms (2)

With checklist

EXPERIMENTAL

Students will simulate insulin initiation with the aid of a checklist

Other: Checklist

Without checklist

NO INTERVENTION

Students will simulate insulin initiation without the aid of a checklist

Interventions

The checklist is a simple A4 size, two sided, document. Eleven checklist items covering twenty-one key educational points are on the front. 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) are on the back.

Also known as: Insulin initiation checklist
With checklist

Eligibility Criteria

Age17 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • Students who refuse consent to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of the West Indies, Cave Hill Campus

Bridgetown, Saint Michael, Barbados

RECRUITING

Related Publications (10)

  • 1. International Diabetes Federation. IDF Diabetes Atlas 6th Edition <http://www.idf.org/diabetesatlas>. Accessed May. 2013.

    BACKGROUND
  • 2. [Anonymous]IDF Diabetes Atlas. Fifth Edition ed. 2011.

    BACKGROUND
  • Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). UK Prospective Diabetes Study (UKPDS) Group. Lancet. 1998 Sep 12;352(9131):837-53.

    PMID: 9742976BACKGROUND
  • Qaseem A, Humphrey LL, Sweet DE, Starkey M, Shekelle P; Clinical Guidelines Committee of the American College of Physicians. Oral pharmacologic treatment of type 2 diabetes mellitus: a clinical practice guideline from the American College of Physicians. Ann Intern Med. 2012 Feb 7;156(3):218-31. doi: 10.7326/0003-4819-156-3-201202070-00011.

    PMID: 22312141BACKGROUND
  • American Diabetes Association. Standards of medical care in diabetes--2014. Diabetes Care. 2014 Jan;37 Suppl 1:S14-80. doi: 10.2337/dc14-S014. No abstract available.

    PMID: 24357209BACKGROUND
  • 6. Gawande A. The Checklist Manifesto: How to Get Things Right. NY: Metropolitan Books, 2009.

    BACKGROUND
  • Ely JW, Graber ML, Croskerry P. Checklists to reduce diagnostic errors. Acad Med. 2011 Mar;86(3):307-13. doi: 10.1097/ACM.0b013e31820824cd.

    PMID: 21248608BACKGROUND
  • 8. Harden, J.,P.Collins, R.M. AMEE medical education guide no. 13: Real patients, simulated patients and simulators in clinical examinations. Med Teach. 1998; 20:508-521.

    BACKGROUND
  • Cleland JA, Abe K, Rethans JJ. The use of simulated patients in medical education: AMEE Guide No 42. Med Teach. 2009 Jun;31(6):477-86. doi: 10.1080/01421590903002821.

    PMID: 19811162BACKGROUND
  • 10. Kirkpatrick DL, Kirkpatrick JD. Implementing the Four Levels: A Practical Guide for Effective Evaluation of Training Programs. 235 Montgomery Street, Suite 650, San Francisco, CA 94104-2916: Berrett-Koehler Publishers, Inc., 2007.

    BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Checklist

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Data CollectionHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and Evaluation

Study Officials

  • Charles G Taylor Jr, MBBS MA MRCP

    University of the West Indies, Cave Hill

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Amanda M Worme, MBBS

CONTACT

Charles G Taylor Jr., MBBS MA MRCP

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 8, 2014

First Posted

December 10, 2014

Study Start

July 1, 2014

Primary Completion

July 1, 2016

Last Updated

December 10, 2014

Record last verified: 2014-11

Locations