Telesonography Adaptation and Use to Improve the Standard of Patient Care Within a Dominican Community

Abdominal Aortic Aneurysm Clinical Trial

Official title:

Telesonography Adaptation and Use to Improve the Standard of Patient Care Within a Dominican Community

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00591968
• Other study ID #: 2007/039
• Status: Completed
• Phase: N/A
• Start date: January 2008
• Est. completion date: March 2008

Study information

• Verified date: July 2019
• Source: Edward Via Virginia College of Osteopathic Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

The aim of this project is comparable to the diagnostic imaging goals of the WHO including 1) make safe and reliable diagnostic imaging services available to as many as possible; 2) advise, guide and support those working in the field developing and maintaining diagnostic imaging services; 3) promote the importance of safe and appropriate diagnostic imaging services (WHO, 2007).

This project will use teleultrasound to rapidly diagnose and rule-out abdominal, retroperitoneal, and pelvic pathologies within the sole government-run ambulatory clinic of Veron, Dominican Republic. The clinic's patient records as well as the expert opinion of the clinic's physicians indicate a need for this diagnostic modality. These sources indicate a number of individuals with symptomologies suggestive of abdominal, retroperitoneal, and pelvic pathology including fever, abdominal pain, abdominal tenderness, abnormal menses, etc. (see appendix D). Given the large number of construction projects and transportation accidents within this area, it is not uncommon for individuals to present with blunt abdominal trauma. Combine these reasons and other patient indications with the clinic's remote location and the difficulty and/or resistance of members within this community to undergo timely radiological evaluation, and the utility of telesonography becomes immediately recognizable.

If the use of telesonography within this setting is shown to be feasible through this work, future projects will center on the education of native Dominican health care providers regarding the use and long-term operation of telesonography. This study could serve as a gateway to the permanent establishment of high-quality telesonography within this region of the DR. This project could also serve to augment the medical and technological knowledge of both the native health care workers and visiting U.S. medical students.

This study will contribute to the body of knowledge on telesonography by determining to what extent this technology can improve the standard of patient care within this setting. The results of this study will have implications to the practice of medicine within Veron and similar settings within the developing world. The further development of telesonography within this setting is important because it may improve the efficiency of health care through increased diagnoses, decreased time to diagnoses, and increased continuity of care.

While this pilot study focuses mainly on transabdominal evaluation of abdominal, retroperitoneal, and pelvic structures, long-term use of telesonography at the clinic could expand to include regular fetal monitoring, vascular studies, and perhaps interventional procedures granted the clinic physicians are provided with the appropriate training. Given the majority of health disparities within the DR are related to maternal, pre/perinatal, and circulatory pathologies, using telesonography to target these specific abnormalities will be the ultimate goal of a continuing telemedical presence.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Abdominal Aortic Aneurysm
• Abdominal Injuries
• Abnormal Uterine Bleeding
• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal
• Ascites
• Blunt Abdominal Trauma
• Cholangitis
• Cholecystitis
• Cholecystolithiasis
• Cholelithiasis
• Gallstones
• Hepatitis
• Hydronephrosis
• Hypertension, Portal
• Ovarian Mass
• Ovarian Torsion
• Pancreatitis
• Portal Hypertension
• Urolithiasis
• Uterine Hemorrhage

Intervention

Device:
• SonoSite Titan portable ultrasound coupled with email telediagnosis
Sonographic exam will be performed by principal investigator. A "first-look" diagnosis, correlated with patient symptomology and laboratory analysis, will be made at the point of care. Using a store-and-forward framework, properly formatted non-compressed sonographic images and "Request for Interpretation" (RFI) forms will be transmitted to participating radiologists. RFI forms will be used to record diagnostic findings and rate the quality of the images and/or diagnostic value using a five-point Likert scale. RFI forms will also include a five-digit patient number, age, sex, and symptomology / reason for sonographic exam. Completed RFI forms will be transmitted back to the clinic at the radiologist's earliest convenience.

Locations

Country	Name	City	State
Dominican Republic	Primary Clinic of Veron	Punta Cana	La Altagracia

Sponsors (2)

Lead Sponsor	Collaborator
Edward Via Virginia College of Osteopathic Medicine	Virginia Polytechnic Institute and State University

Country where clinical trial is conducted

Dominican Republic, 

Outcome

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