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.

Colorectal Cancer Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04389502
• Other study ID #: CaPtyVa CCR app
• Status: Recruiting
• Phase: N/A
• Start date: May 15, 2020
• Est. completion date: June 1, 2020

Study information

• Verified date: May 2020
• Source: Hospital Aleman
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 1, 2020
• Est. primary completion date: June 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Device:
• CaPtyVa app
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

Other:
• Control group
current physician knowledge on local current CRC screening and surveillance guidelines

Locations

Country	Name	City	State
Argentina	Hospital Aleman	Caba

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Aleman

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	1 month
Secondary	Correct Answers (80% group)	Proportion of physicians correctly answering at least 80% of the clinical vignettes according to the guidelines	1 month