AscitesNCT00591968
Telesonography Adaptation and Use to Improve the Standard of Patient Care Within a Dominican Community
A study testing SonoSite Titan portable ultrasound coupled with email telediagnosis in people with Ascites and Blunt Abdominal Trauma, run by Edward Via Virginia College of Osteopathic Medicine at 1 site in Dominican Republic.
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. Read more about this study
- Who is it for?
- Ages 13 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ascites, Blunt Abdominal Trauma, Cholelithiasis
- What is being tested?
- SonoSite Titan portable ultrasound coupled with email telediagnosis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteDominican Republic
- Study dates
- Jan 2008to Mar 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Urgent condition that requires immediate surgical intervention / transfer to tertiary medical center
Trial locations and contacts
1 site in 1 country.
Dominican Republic1 site
Primary Clinic of Veron
Punta Cana, La Altagracia Province, 23000
About this study
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.
Read the detailed 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.
- Conditions
- Ascites, Blunt Abdominal Trauma, Cholelithiasis, Cholecystitis, Cholangitis, Pancreatitis
- Being tested
- SonoSite Titan portable ultrasound coupled with email telediagnosis
- Keywords
- ultrasound, telediagnosis, teleultrasound, telesonography, teleultrasonography, teleradiology, telemedicine, dominican republic, puntacana, veron, store-and-forward, asynchronous
- Medical subject headings
- Ascites, Cholelithiasis, Cholecystitis, Cholangitis, Pancreatitis, Hydronephrosis, Aortic Aneurysm, Abdominal, Hepatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SonoSite Titan portable ultrasound coupled with email telediagnosisDevice
Also called SonoSite Titan, teleradiology, telesonography, ultrasound 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: SonoSite Titan portable ultrasound coupled with email telediagnosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 60 days
Measures of variability for interval data (time) will be obtained using standard deviation.
Measured: 60 days
Measures of variability for ordinal data (Likert-scale) will be obtained using a semi-interquartile range and standard deviation.
Measured: 60 days
The measure of central tendency will be assessed using the mean.
Measured: 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
Measured: 60 days
Correlational analysis of the interval data (time) will be obtained between groups using Spearman's rho (r2) and Pearson's r.
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2008 (estimated)
- Study startJan 2008
- Primary completionMar 2008
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AscitesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Edward Via Virginia College of Osteopathic Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Virginia Polytechnic Institute and State University
- Responsible party
- Sponsor
- Investigators
- James E Sutherland, D.O., Principal investigator, Edward Via Virginia College of Osteopathic MedicineDean Sutphin, Ph.D., Study chair, Edward Via Virginia College of Osteopathic Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00591968
- Sponsor's protocol ID
- 2007/039
- Status last verified
- Jul 2019
- First submitted
- 31 Dec 2007
- Last updated
- 22 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telesonography Adaptation and Use to Improve the Standard of Patient Care Within a Dominican Community
- ClinicalTrials.gov ID
- NCT00591968
- Acronym / sponsor ID
- 2007/039
- Conditions
- Ascites, Blunt Abdominal Trauma, Cholelithiasis, Cholecystitis, Cholangitis, Pancreatitis
- Keywords
- ultrasound, telediagnosis, teleultrasound, telesonography, teleultrasonography, teleradiology, telemedicine, dominican republic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Edward Via Virginia College of Osteopathic MedicineUniversity, hospital or other
- Collaborators
- Virginia Polytechnic Institute and State University
- Study start
- Jan 2008
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 11 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Device: SonoSite Titan portable ultrasound coupled with email telediagnosisThe 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. |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Urgent condition that requires immediate surgical intervention / transfer to tertiary medical center
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SonoSite Titan portable ultrasound coupled with email telediagnosisAlso: SonoSite Titan, teleradiology, telesonography, ultrasound telediagnosisSonographic 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. | Device | 2 |
Primary outcome
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.
Time frame: 60 days
6 secondary outcomes
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).
Time frame: 60 days
Measures of variability for interval data (time) will be obtained using standard deviation.
Time frame: 60 days
Measures of variability for ordinal data (Likert-scale) will be obtained using a semi-interquartile range and standard deviation.
Time frame: 60 days
The measure of central tendency will be assessed using the mean.
Time frame: 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
Time frame: 60 days
Correlational analysis of the interval data (time) will be obtained between groups using Spearman's rho (r2) and Pearson's r.
Time frame: 60 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James E Sutherland, D.O. principal investigator
Edward Via Virginia College of Osteopathic Medicine
Dean Sutphin, Ph.D. study chair
Edward Via Virginia College of Osteopathic Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SonoSite Titan portable ultrasound coupled with email telediagnosis in people with Ascites and Blunt Abdominal Trauma, run by Edward Via Virginia College of Osteopathic Medicine at 1 site in Dominican Republic.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Dominican Republic. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2019.