Colorectal CancerNCT04389502
Efficacy of a Mobile Clinical Decision Support System (CaPtyVa CCR App) to Improve Performance of Gastroenterology and Coloproctology Specialists in Colorectal Cancer Screening and Surveillance According to Guideline Recommendations: A Randomized Clinical Trial.
A study testing CaPtyVa app in people with Colorectal Cancer, run by Hospital Aleman at 1 site in Argentina.
Trial summary
This prospective study evaluates the use of a (Mobile Decision Support Systems), MDSS (CaPtyVa CCR app) in order to improves gastroenterology and coloproctology specialist's performance in CRC screening and surveillance according to local current guidelines. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- CaPtyVa app
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteArgentina
- Study dates
- 15 May 2020to 1 Jun 2020
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Gastroenterologists and coloproctologists members of four medical societies from Argentina and Uruguay: Endoscopistas de Buenos Aires(ENDIBA), Federación Argentina de Endoscopía Digestiva(FAED), Sociedad Argentina de Coloproctología(SACP) and Sociedad Uruguaya de Endoscopía Digestiva(SUED)
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Argentina1 site, 1 recruiting
- Recruiting
Hospital Aleman
CABA, C1118AAT
Christian Ahumada, MD, 54 11 4827 7000 ext. 2861, cahumada@hospitalaleman.com
About this study
This prospective study evaluates the use of a (Mobile Decision Support Systems), MDSS (CaPtyVa CCR app) in order to improves gastroenterology and coloproctology specialist's performance in CRC screening and surveillance according to local current guidelines.
Read the detailed description
The proper implementation of clinical practice guidelines (CPGs) has the potential to improve health care quality and reduce costs by promoting the use of evidence-based interventions. However, these benefits vary largely according to the way CPGs are put into effect. The behavior of physicians towards CPGs is a determining factor in their successful implementation. It has been suggested that physicians have difficulties in memorizing and processing the complex information contained in CPGs.
Computer-Based Clinical Decision Support Systems (CDSSs) are defined as "any software designed to aid in clinical decision making in which characteristics of individual patients are matched to a computerized knowledge. These systems have shown to: improve prescribing practices, reduce serious medication errors, enhance the delivery of preventive care services, and improve adherence to recommended care standards.
Recent evidence had also suggests that mobile technologies could provide an effective approach in order to allow these Decision Support Systems to be implemented (Mobile Decision Support Systems, MDSS) without requiring personal computers or its integration into other clinical information systems.
Colorectal cancer (CRC) is a global major medical and public health challenge, accounting for 881.000 deaths annually. Evidence-based CRC screening strategies have shown to be effective in reducing CRC mortality. Hence, the majority of CRC deaths are believed to be the result of CRC screening process breakdowns. Multiple studies report overuse and underuse of colonoscopy, as well as poor physician's knowledge about CRC screening CPG's and their inability to apply them in daily clinical practice. All these factors may threaten the effectiveness of CRC screening programs.
The above mentioned problematic added to recent evidence showing a strong willingness of the physicians to use mobile-based apps in order to assist them in making guideline-concordant recommendations, motivated us to satisfy this need and we developed the first MDSS(CaPtyVa CCR app), to assist physicians in the CRC screening and surveillance task process.
The aim of this prospective study is to evaluate whether a MDSS (CaPtyVa CCR app) improves gastroenterology and coloproctology specialist's performance in CRC screening and surveillance according to local current guidelines
A prospective, nationwide, single blinded, randomized study will be conducted. A 10-question anonymous survey was created with CRC screening and surveillance clinical vignettes reflecting real life daily practice scenarios. After the question were developed, they were pre-tested and discussed for content and clarity by three experienced gastroenterologists. Gastroenterologists and coloproctologists; randomly selected will be invited by e-mail to participate in this study between May 2020 and June 2020.
- Conditions
- Colorectal Cancer
- Being tested
- CaPtyVa app, Control group
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CaPtyVa appDevice
The apps stores all the current local Clinical practice guidelines information related to CRC screening and surveillance and through its decision algorithms assist physicians in the screening process. In the screening function, CaPtyVa helps the physicians to classify patient´s according to their individual CRC risk and to determine how and when to start with screening tests. In the surveillance, function the app assist the physician in determining when to repeat the next colonoscopy according to guideline recommendation
Control groupOther
current physician knowledge on local current CRC screening and surveillance guidelines
| Study group | Role | What they receive |
|---|---|---|
| CaPtyVa app group | Experimental | Those assigned to the CaPtyVa app group will receive a tutorial video describing its operation and will have to complete 10-item clinical vignette quiz according to the app recommendations based on local current CRC screening and surveillance guidelines on every question. Physicians in this group will download a free of charge application (CaPtyVa CCR APP, Digital Means, Argentina) on their iOs or Android device. Receives: Device: CaPtyVa app |
| Control group | Active comparator | The ones assigned to the control group will be asked to complete the 10-item clinical vignette quiz according to their current knowledge on local current CRC screening and surveillance guidelines Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correct Answers (60% group)
Proportion of physicians correctly answering at least 60% of the clinical vignettes according to local current guidelines. Responses consistent with the current CRC screening and surveillance guidelines of the Instituto Nacional del Cancer (INC) of Argentina are considered accurate
Measured: 1 month
Secondary outcomes (1)
Correct Answers (80% group)
Proportion of physicians correctly answering at least 80% of the clinical vignettes according to the guidelines
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2020
- Study start15 May 2020 (estimated)
- Primary completion1 Jun 2020 (estimated)
- Study completion1 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Aleman
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lisandro Pereyra, Hospital Aleman
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04389502
- Sponsor's protocol ID
- CaPtyVa CCR app
- Status last verified
- May 2020
- First submitted
- 12 May 2020
- Last updated
- 15 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Mobile Clinical Decision Support System (CaPtyVa CCR App) to Improve Performance of Gastroenterology and Coloproctology Specialists in Colorectal Cancer Screening and Surveillance According to Guideline Recommendations: A Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT04389502
- Acronym / sponsor ID
- CaPtyVa CCR app
- Conditions
- Colorectal Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Hospital AlemanUniversity, hospital or other
- Study start
- 15 May 2020 (estimated)
- Primary completion
- 1 Jun 2020 (estimated)
- Study completion
- 1 Jun 2020 (estimated)
- First posted
- 15 May 2020 (actual)
- 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.
This prospective study evaluates the use of a (Mobile Decision Support Systems), MDSS (CaPtyVa CCR app) in order to improves gastroenterology and coloproctology specialist's performance in CRC screening and surveillance according to local current guidelines.
Detailed description
The proper implementation of clinical practice guidelines (CPGs) has the potential to improve health care quality and reduce costs by promoting the use of evidence-based interventions. However, these benefits vary largely according to the way CPGs are put into effect. The behavior of physicians towards CPGs is a determining factor in their successful implementation. It has been suggested that physicians have difficulties in memorizing and processing the complex information contained in CPGs.
Computer-Based Clinical Decision Support Systems (CDSSs) are defined as "any software designed to aid in clinical decision making in which characteristics of individual patients are matched to a computerized knowledge. These systems have shown to: improve prescribing practices, reduce serious medication errors, enhance the delivery of preventive care services, and improve adherence to recommended care standards.
Recent evidence had also suggests that mobile technologies could provide an effective approach in order to allow these Decision Support Systems to be implemented (Mobile Decision Support Systems, MDSS) without requiring personal computers or its integration into other clinical information systems.
Colorectal cancer (CRC) is a global major medical and public health challenge, accounting for 881.000 deaths annually. Evidence-based CRC screening strategies have shown to be effective in reducing CRC mortality. Hence, the majority of CRC deaths are believed to be the result of CRC screening process breakdowns. Multiple studies report overuse and underuse of colonoscopy, as well as poor physician's knowledge about CRC screening CPG's and their inability to apply them in daily clinical practice. All these factors may threaten the effectiveness of CRC screening programs.
The above mentioned problematic added to recent evidence showing a strong willingness of the physicians to use mobile-based apps in order to assist them in making guideline-concordant recommendations, motivated us to satisfy this need and we developed the first MDSS(CaPtyVa CCR app), to assist physicians in the CRC screening and surveillance task process.
The aim of this prospective study is to evaluate whether a MDSS (CaPtyVa CCR app) improves gastroenterology and coloproctology specialist's performance in CRC screening and surveillance according to local current guidelines
A prospective, nationwide, single blinded, randomized study will be conducted. A 10-question anonymous survey was created with CRC screening and surveillance clinical vignettes reflecting real life daily practice scenarios. After the question were developed, they were pre-tested and discussed for content and clarity by three experienced gastroenterologists. Gastroenterologists and coloproctologists; randomly selected will be invited by e-mail to participate in this study between May 2020 and June 2020.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CaPtyVa app group | Experimental | Device: CaPtyVa appThose assigned to the CaPtyVa app group will receive a tutorial video describing its operation and will have to complete 10-item clinical vignette quiz according to the app recommendations based on local current CRC screening and surveillance guidelines on every question. Physicians in this group will download a free of charge application (CaPtyVa CCR APP, Digital Means, Argentina) on their iOs or Android device. |
| Control group | Active comparator | Other: Control groupThe ones assigned to the control group will be asked to complete the 10-item clinical vignette quiz according to their current knowledge on local current CRC screening and surveillance guidelines |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Gastroenterologists and coloproctologists members of four medical societies from Argentina and Uruguay: Endoscopistas de Buenos Aires(ENDIBA), Federación Argentina de Endoscopía Digestiva(FAED), Sociedad Argentina de Coloproctología(SACP) and Sociedad Uruguaya de Endoscopía Digestiva(SUED)
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| CaPtyVa appThe apps stores all the current local Clinical practice guidelines information related to CRC screening and surveillance and through its decision algorithms assist physicians in the screening process. In the screening function, CaPtyVa helps the physicians to classify patient´s according to their individual CRC risk and to determine how and when to start with screening tests. In the surveillance, function the app assist the physician in determining when to repeat the next colonoscopy according to guideline recommendation | Device | CaPtyVa app group |
| Control groupcurrent physician knowledge on local current CRC screening and surveillance guidelines | Other | Control group |
Primary outcome
Correct Answers (60% group)
Time frame: 1 month
Proportion of physicians correctly answering at least 60% of the clinical vignettes according to local current guidelines. Responses consistent with the current CRC screening and surveillance guidelines of the Instituto Nacional del Cancer (INC) of Argentina are considered accurate
1 secondary outcome
Correct Answers (80% group)
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2020.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CaPtyVa app in people with Colorectal Cancer, run by Hospital Aleman at 1 site in Argentina.
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: status not confirmed, as of the sponsor's last update on 15 May 2020. 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 Argentina. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correct Answers (60% group) (time frame: 1 month). 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 15 May 2020.