Screening of Colorectal Cancer in the Public Healthcare Sector in Argentina

Colorectal Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04293315
• Other study ID #: BID CCR
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 9, 2018
• Est. completion date: March 15, 2020

Study information

• Verified date: April 2019
• Source: Institute for Clinical Effectiveness and Health Policy
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1520
• Est. completion date: March 15, 2020
• Est. primary completion date: March 15, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Argentina	Ministry of Health	Mendoza

Sponsors (2)

Lead Sponsor	Collaborator
Institute for Clinical Effectiveness and Health Policy	Inter-American Development Bank

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effective Screening	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	Proportion of participants with inadequate FOBT	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
Secondary	Proportion of positive FOBT referred for colonoscopy	The investigators will calculate the proportion of participants with a positive result in the FOBT that were referred to receive colonoscopy.	3 months
Secondary	Implementation outcomes according to the RE-AIM framework	Implementation outcomes are: Reach, Effective implementation, adoption, implementation fidelity and maintenance	3 months