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

NCT00591968 | Completed

• 1 other identifier: 2007/039
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ascites; Blunt Abdominal Trauma; Cholelithiasis; Cholecystitis; Cholangitis; Pancreatitis; Hydronephrosis; Abdominal Aortic Aneurysm; Hepatitis; Portal Hypertension; Urolithiasis; Abnormal Uterine Bleeding; Ovarian Mass; Ovarian Torsion

Keywords

ultrasound; telediagnosis; teleultrasound; telesonography; teleultrasonography; teleradiology; telemedicine; dominican republic; puntacana; veron; store-and-forward; asynchronous

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

• Measures of variability for interval data (time) will be obtained using standard deviation.

  60 days

• Measures of variability for ordinal data (Likert-scale) will be obtained using a semi-interquartile range and standard deviation.

  60 days

• The measure of central tendency will be assessed using the mean.

  60 days

• 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

Study Arms (2)

1

NO INTERVENTION

The control group will receive traditional ultrasound consults (i.e. travel to nearest tertiary center for intraabdominal sonographic evaluation and return with radiologist's report).

2

EXPERIMENTAL

The experimental group will receive the teleultrasound service. Participants are randomly assigned to this group. All patients will receive a traditional clinical work-up. An ultrasound examination will be offered if, based on initial clinical evaluation by an attending physician, the patient is found to have symptoms consistent with any the following abnormalities: ascites, blunt abdominal trauma, cholelithiasis, cholecystitis, cholangitis, pancreatitis, hydronephrosis, abdominal aortic aneurysm, hepatitis, portal hypertension, urolithiasis, abnormal uterine bleeding, ovarian mass or torsion.

Device: SonoSite Titan portable ultrasound coupled with email telediagnosis

Interventions

SonoSite Titan portable ultrasound coupled with email telediagnosis DEVICE

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.

Also known as: SonoSite Titan, teleradiology, telesonography, ultrasound telediagnosis

2

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Urgent condition that requires immediate surgical intervention / transfer to tertiary medical center

Sponsors & Collaborators

• Edward Via Virginia College of Osteopathic Medicine: lead
• Virginia Polytechnic Institute and State University: collaborator

Study Sites (1)

Primary Clinic of Veron

Punta Cana, La Altagracia Province, 23000, Dominican Republic

Location

MeSH Terms

Conditions

Ascites; Cholelithiasis; Cholecystitis; Cholangitis; Pancreatitis; Hydronephrosis; Aortic Aneurysm, Abdominal; Hepatitis; Hypertension, Portal; Urolithiasis; Metrorrhagia; Ovarian Torsion

Interventions

Teleradiology

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Biliary Tract Diseases; Digestive System Diseases; Gallbladder Diseases; Bile Duct Diseases; Pancreatic Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Liver Diseases; Uterine Hemorrhage; Uterine Diseases; Genital Diseases, Female; Genital Diseases; Hemorrhage; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Endocrine System Diseases; Torsion Abnormality; Pathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

Technology, Radiologic; Investigative Techniques; Radiology Information Systems; Management Information Systems; Organization and Administration; Health Services Administration; Telemedicine; Delivery of Health Care; Patient Care Management

Study Officials

• James E Sutherland, D.O.

  Edward Via Virginia College of Osteopathic Medicine

  PRINCIPAL INVESTIGATOR

• Dean Sutphin, Ph.D.

  Edward Via Virginia College of Osteopathic Medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 31, 2007
• First Posted: January 11, 2008
• Study Start: January 1, 2008
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: July 22, 2019

Record last verified: 2019-07

Locations

DO (1)