Abdominal Aortic Aneurysm Clinical Trial
Official title:
Telesonography Adaptation and Use to Improve the Standard of Patient Care Within a Dominican Community
NCT number | NCT00591968 |
Other study ID # | 2007/039 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | January 2008 |
Est. completion date | March 2008 |
Verified date | July 2019 |
Source | Edward Via Virginia College of Osteopathic Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The role of teleradiology has far reaching implications for the health of remote and
underserved populations. The ability to coordinate radiographic evaluation and diagnosis from
a distance has the potential to raise the standard of patient care throughout the world.
Perhaps the safest and most cost effective mode of teleradiology today is telesonography. The
current project attempts to determine the extent that telesonography improves the standard of
care within a rural government-run primary clinic within the Dominican Republic. The work
reported herein is intended to compare the use of telesonography to the current standard of
sonographic examination (referral to government hospital 60km from target clinic). The study
was conducted by randomly assigning 100 patients with clinical indications for sonographic
examination into experimental and control groups. Following a 60-day implementation period,
the following research questions will be addressed: 1) To what extent does the use of
asynchronous telesonography increase the percentage of definitive diagnoses based on the
total number of scans (definitive diagnoses / total number of scans)? 2) To what extent does
the use of asynchronous telesonography increase the continuity of care for patients? 3) To
what extent does the elapsed time between scanning and final radiological interpretation
decrease with the use of asynchronous telesonography? This study will also look at the
history of telemedicine / telesonography and its dissemination into the mainstream practice
of medicine, explore training protocols that may be used to assist others to establish new
telesonography programs in a developing nations, and discuss both advances and persistent
barriers to the implementation of telesonography programs.
Hypothesis:
The use of a store-and-forward telesonography system in this setting will increase the speed
and number of final diagnoses per scan received by the target clinic and will increase the
continuity of care by increasing the number and speed of follow-up appointments to the target
clinic.
Status | Completed |
Enrollment | 106 |
Est. completion date | March 2008 |
Est. primary completion date | March 2008 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 13 Years and older |
Eligibility |
Inclusion Criteria: - Clinical suspicion of one or more of the following: ascites, blunt abdominal trauma, cholelithiasis, cholecystitis, cholangitis, pancreatitis, hydronephrosis, abdominal aortic aneurysm, hepatitis, portal hypertension, urolithiasis, abnormal uterine bleeding, or ovarian mass or torsion Exclusion Criteria: - Urgent condition that requires immediate surgical intervention / transfer to tertiary medical center |
Country | Name | City | State |
---|---|---|---|
Dominican Republic | Primary Clinic of Veron | Punta Cana | La Altagracia |
Lead Sponsor | Collaborator |
---|---|
Edward Via Virginia College of Osteopathic Medicine | Virginia Polytechnic Institute and State University |
Dominican Republic,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Using frequency distribution graphs, the time to final diagnosis, time to follow-up appointments, and number of successful follow-ups will be compared between the experimental and control groups. | 60 days | ||
Secondary | A test for significant differences for ordinal data (Likert-scale) will be obtained using the Mann-Whitney test (if data is skewed) or the sign test (if data is non-skewed). | 60 days | ||
Secondary | Measures of variability for interval data (time) will be obtained using standard deviation. | 60 days | ||
Secondary | Measures of variability for ordinal data (Likert-scale) will be obtained using a semi-interquartile range and standard deviation. | 60 days | ||
Secondary | The measure of central tendency will be assessed using the mean. | 60 days | ||
Secondary | A number of ratios can be extracted from the data including time, number of scans, type of scan, number of reports, number of follow-ups, correct preliminary diagnoses, etc | 60 days | ||
Secondary | Correlational analysis of the interval data (time) will be obtained between groups using Spearman's rho (r2) and Pearson's r. | 60 days |
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