Screening of Colorectal Cancer in the Public Healthcare Sector in Argentina

March 1, 2020 updated by: Institute for Clinical Effectiveness and Health Policy

Evaluation of the Effectiveness of a Collaborative Strategy to Increase the Screening of Colorectal Cancer in the Public Healthcare Sector in Argentina

Introduction: Early detection of certain types of cancer significantly increases the likelihood of successful treatment and reduces mortality from these causes. However, the use of screening and the early detection of selected tumors such as colorectal cancer (CRC) are lower than those expected in our country. The objective of this project is to evaluate the effectiveness of a multicomponent strategy that improves the screening and early detection of CRC in the population at risk of Primary Health Care Clinics (PCCs) of the public health system.

Population: people leaving in the catchment area of 10 selected primary care clinics from the public health system in the province of Mendoza, Argentina.

Design and methods: a Randomized clinical study by clusters. 10 PCCs will be included: 5 will be randomly assigned to receive an intervention to increase the CRC screening rates (improvement cycles) and 5 to the control arm (usual care). 150 participants will be included in each PCCs, in total, 1500 participants.

Intervention: An innovative vision is proposed, which combines a participatory and dynamic methodology based on improvement cycles. This approach includes the implementation of participatory learning sessions for health providers, involving the effectors of the design of the intervention. In the intervention branch at least 3 workshops (sessions) will be held with the members of the care system, in order to identify opportunities for improvement oriented to the design and application of an innovative intervention based on best practices. Each one of the sessions will constitute an analysis of the improvement cycle, following the following steps: 1) Selection of participants of the initial workshop; 2) Development of work model based on bibliographic review and initial qualitative phase; 3) Initial workshop with effectors for training in continuous improvement, objectives, interventions and data collection; 4) Learning workshops to discuss results, applicability of interventions and modifications to the work plan; 5) Closing session to evaluate preliminary results and discuss continuity of interventions beyond the project.

Outcomes: 1) Percentage of the population at risk that completes the screening; 2) Percentage of the population classified as at habitual risk or increased by risk factors.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1520

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Mendoza, Argentina
        • Ministry of Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects who have public health coverage
  • Age between 50 and 75 years old
  • Residence in the catchment area of the PCCs
  • With an indication to perform screening for CRC with FOBT
  • People who consent to participate

Exclusion Criteria:

  • People who are bedridden.
  • People who plan to move in the next 3 months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
This is the usual care arm. Healthcare workers will provide people with the Fecal Occult Blood Test (FOBT) and information about risk to develop CRC and the importance of early detection.
Experimental: Intervention
The same as the Control Arm plus the primary care team of the PCCs will be trained and participate in 8 improvement cycles.
Behavioral: Improvement Cycles
This is a multi-component intervention following the Institute for Healthcare Improvement (IHI)'s Collaborative Model for Achieving Breakthrough Improvement by implementing "plan-do-study-act" (PDSA) improvement cycles. The investigators will conduct 8 participative learning sessions for the primary care team. These sessions will be aimed at identifying opportunities for improvement oriented to the design and application of innovative approaches based on best practices.
Other Names:
  • quality improvement cycle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effective Screening
Time Frame: 3 months
Proportion of participants who with known result of the FOBT within 90 days from recruitment. The investigators will review National Information System Registry to count the number of participants in each arm with a known result for their FOBT. The investigators will calculate the proportion of participants with known result (Effective Screening) in each arm of the study.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of participants with inadequate FOBT
Time Frame: 3 months
The investigators will register the number of cases in each arm where the result of the FOBT is unknown because the test was inadequate, that is, the test could not be read.
3 months
Proportion of positive FOBT referred for colonoscopy
Time Frame: 3 months
The investigators will calculate the proportion of participants with a positive result in the FOBT that were referred to receive colonoscopy.
3 months
Implementation outcomes according to the RE-AIM framework
Time Frame: 3 months
Implementation outcomes are: Reach, Effective implementation, adoption, implementation fidelity and maintenance
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute for Clinical Effectiveness and Health Policy

Collaborators

Inter-American Development Bank

Investigators

  • Principal Investigator: Vilma Irazola, Institute for Clinical Effectiveness and Health Policy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 9, 2018

Primary Completion (Anticipated)

March 15, 2020

Study Completion (Anticipated)

March 15, 2020

Study Registration Dates

First Submitted

January 31, 2020

First Submitted That Met QC Criteria

March 1, 2020

First Posted (Actual)

March 3, 2020

Study Record Updates

Last Update Posted (Actual)

March 3, 2020

Last Update Submitted That Met QC Criteria

March 1, 2020

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BID CCR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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