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PROTOCOL
CLASS OF 2016
SUPERVISOR:
Professor Pinto Pereira (Pharmacology Unit)
November 2012
Protocol Declaration
We hereby declare that this protocol is entirely the product of our own independent
investigation. The various sources are indicated in the bibliography/references.
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_________________ (Leader)
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Background:
Type 2 diabetes is a heterogeneous metabolic disorder associated with serious
complications including hypertension, stroke, kidney failure, heart disease and
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neuropathy. Type 2 Diabetes Mellitus results from insulin resistance combined with
relative insulin deficiency, as defined by the American Diabetic Association. It affects
between 102,000 145,000 person in Trinidad & Tobago and according to the
International Diabetes Federation, has the highest morbidity and mortality statistics in the
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Western Hemisphere . Type 2 diabetes poses many challenges for primary care staff in
preventing and managing complications. Effective management is important since the
disorder is associated with serious complications which may lead to a reduction in both
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longevity and quality of life . Most type 2 diabetes is managed in primary care settings.
Increasingly, this care is led by practice nurses and/or GPs with an interest in diabetes,
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although there are large variations in the quality and range of services provided .
1
Strutton, I. et al Association of glycaemia with macrovascular and microvascular
complication of type 2 diabetes (UKPDS 35): prospective observational study. British
Medical Journal 2000; 321: 405-412.
2
icholls, Kenwyn,M.D.,M.P.H. The Diabetes Epidemic in Trinidad and Tobago. 2010
N
August 3rd [cited on 4 November 2012]. Available from
https://docs.google.com/viewer?a=v&q=cache:trwvcyiZaegJ:www.rcsocialjusticett.org/d
ownloads/diabetic_epidemic.pdf+Diabetes+trends+trinidad&hl=en&gl=tt&pid=bl&srcid
=ADGEESj4UofTg2JPRBjyQ9LkjjNVPUxvdtvTOT4X2FqyduV692HwGOTuPtHzxXn
THKIBbXdp_5N2JNhma6HWNJWkBj0wHTOdcPNDxJxnvq3CjO6qFup0pwSboeD-eK
-jJQYzs10-IW3C&sig=AHIEtbTvmkCRPJZFxUfmNgEAW3TyTVHodw
3
Mold, F. et al , The challenges of managing type 2 diabetes in primary care Nursing
Times 2008; 104: 7, 32-33.
4
Farooqi, A. et al Diabetes service provision in primary care: a baseline survey in a city
primary care trust (PCT). Practical Diabetes International 2004; 21: 1, 13-17.
Justification
The data from this research project will be used to determine if the guidelines outlined
by the Caribbean Health Research Council have been followed by medical practitioners,
nurses and other health care professionals. A structured audit of patient medical records
(n=1000) will be undertaken in specific health care institutions. The audit aims to explore
the relationship between the care provided by health care professionals and the clinical
outcomes. Compliance with the guidelines will be determined based on analysis of data
collected from health institutions under the jurisdiction of the North Central Regional
Health Authority. The re-audit is deemed necessary to complete the audit cycle and
highlight the effect of the changes in practice made. The table below illustrates the
information that should be collected on each patient visit.
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Caribbean
Health Research Council. Managing Diabetes in Primary Care in the
Caribbean. CHRC; St. Augustine, Trinidad and Tobago, 2006.
Figure 2 - Criteria to be checked at least once a year from CHRC guidelines.
Research Question:
Are Type II Diabetes patients in public health care centres in North Central Trinidad
managed in accordance with Caribbean Health Research Council guidelines?
Aim:
To review the management of Type 2 Diabetes in the community.
Objectives:
Principle Objective:
Secondary Objective:
METHOD:
Study Design
In medical research, there are 2 classic types of study designs. The first is the Controlled
Design which classifies patients into two or more groups and each group is given a
different treatment (or no treatment at all). The other type is the Observational Design.
In this design, one would observe the effects of a drug, activity, lifestyle, etc in a general
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population without placing the patients into a controlled environment.
For this study, the Observational Design will be utilized. An audit of the management of
patients with Type II Diabetes Mellitus in the community will be carried out. This will be
done by extracting data specific to type 2 diabetes from patient records in health centers
of the NCRHA.
Patient registration #
- This is necessary to keep track of patients progress and to allow later retrieval of files
for verification purposes
Treatments used
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[1] George Mason University. Study Design [Internet]. STATS.
http://www.stats.org/faq_type.htm. Published Apr 11 2012. Accessed Nov 05 2012
to determine which treatments are more effective
to determine which patients respond better to each treatment
Study Setting
Patient records will be collected at public health care institutions throughout the North
Central region in Trinidad. Within this region there are 2 hospitals, 3 health facilities and
11 health centres. These include:
Caura Hospital
Mt. Hope Women's Hospital
Arima District Health Facility
Chaguanas District Health Facility
Tacarigua Extended Care Facility,
Arouca Health Centre
Blanchisseuse and Brasso Seco Health Centre
Cunupia Health Centre
Eric Williams Medical Sciences Complex,
La Horquetta Health Centre
Macoya Health Centre
Maloney Health Centre
San Rafael Health Centre
St. Helena Health Centre
St. Joseph Enhanced Health Centre
Talparo Health Centre
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Tunapuna Health Centre.
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Ministry of Health [Internet]. Trinidad and Tobago: Public Health Facilities. c2012 -
Study Population:
Study Sample:
Data will be collected from the files of Type 2 Diabetics who are over 18 years of age
and who have returned for follow up treatment/s. The ease of data collection will be
dependent on the completeness and the accuracy of records taken at the various health
care institutions included in this research. Informed consent from patients will not be
obtained before data collection due to the inherent difficulty involved in contacting
patients in a retrospective study like this.
Inclusion Criteria:
Patients diagnosed with type 2 diabetes after 2006
Sample Size:
A sample size of 1000 persons will be used for the purposes of this study. Purposive
sampling will be utilized, i.e, cases are selected for specific purpose because they have
particular characteristics for example, diagnosis, age etc.
Data Collection:
Data will be extracted on all patients with type 2 diabetes. Health institutions under the
NCRHA will be visited pending ethical approval. Records of patients with type 2
diabetes will be used. Specific criteria as seen in the table below will be recorded from
Wt BG BP Wt BG BP Wt BG BP
Data Analysis
Data Protection
Data will be stored on a spread sheet on a password protected computer. Patient name
will not be used but rather, file number attached to the patients file. This will allow for
easy referencing of the file.
Expected Outcomes
By using the data analysed, it can be determined which guidelines given by the CHRC
were implemented and followed by health care professionals. The audit will assist in
determining which guidelines have to be modified for increased compliance by health
care professionals and patients alike. It will also show which guidelines were most
successful in improving the outcome of patient care and aided in the management of type
2 diabetes.
Dissemination of Findings
Data collected will be presented to colleagues, lecturers and specially invited guests on
Research Day 2013. A chart will be published with a summarized version of the project
showing results of the groups findings. Pending approval, the results will also be
published.