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.

NCT04389502 | Unknown

• 1 other identifier: CaPtyVa CCR app
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Correct Answers (80% group)

  1 month

Study Arms (2)

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.

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

Other: Control group

Interventions

CaPtyVa app DEVICE

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

CaPtyVa app group

Control group OTHER

current physician knowledge on local current CRC screening and surveillance guidelines

Control group

Eligibility Criteria

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

You may qualify if:

• 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)

Sponsors & Collaborators

• Hospital Aleman: lead

Study Sites (1)

Hospital Aleman

CABA, C1118AAT, Argentina

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 12, 2020
• First Posted: May 15, 2020
• Study Start: May 15, 2020
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: May 15, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

AR (1)