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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.

Primary Purpose

Colorectal Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Argentina
Study Type
Interventional
Intervention
CaPtyVa app
Control group
Sponsored by
Hospital Aleman
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Colorectal Cancer

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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:

-

Sites / Locations

  • Hospital AlemanRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CaPtyVa app group

Control group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Correct Answers (80% group)
Proportion of physicians correctly answering at least 80% of the clinical vignettes according to the guidelines

Full Information

First Posted
May 12, 2020
Last Updated
May 12, 2020
Sponsor
Hospital Aleman
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1. Study Identification

Unique Protocol Identification Number
NCT04389502
Brief 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.
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.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 15, 2020 (Anticipated)
Primary Completion Date
June 1, 2020 (Anticipated)
Study Completion Date
June 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Aleman

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CaPtyVa app group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Device
Intervention Name(s)
CaPtyVa app
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Control group
Intervention Description
current physician knowledge on local current CRC screening and surveillance guidelines
Primary Outcome Measure Information:
Title
Correct Answers (60% group)
Description
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
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Correct Answers (80% group)
Description
Proportion of physicians correctly answering at least 80% of the clinical vignettes according to the guidelines
Time Frame
1 month

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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: -
Facility Information:
Facility Name
Hospital Aleman
City
Caba
ZIP/Postal Code
C1118AAT
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christian Ahumada, MD
Phone
54 11 4827 7000
Ext
2861
Email
cahumada@hospitalaleman.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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.

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