Screening of Colorectal Cancer in the Public Healthcare Sector in Argentina

NCT ID: NCT04293315

Last Updated: 2020-03-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 1520 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-09
• Study Completion Date: 2020-03-15

Brief 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.

Conditions

Colorectal Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention

The same as the Control Arm plus the primary care team of the PCCs will be trained and participate in 8 improvement cycles.

Group Type: EXPERIMENTAL

Improvement Cycles

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

quality improvement cycle

Eligibility Criteria

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Inter-American Development Bank

OTHER

Sponsor Role: collaborator

Institute for Clinical Effectiveness and Health Policy

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vilma Irazola

Role: PRINCIPAL_INVESTIGATOR

Institute for Clinical Effectiveness and Health Policy

Locations

Ministry of Health

Mendoza, , Argentina

Countries

Argentina

References

Irazola V, Santero M, Sanchez M, Tristao I, Ruiz JI, Spira C, Ismael J, Cavallo AS, Gutierrez L, Mazzaresi Y, Nadal AM, Garcia Elorrio E; CCR Trial development group. Quality improvement intervention to increase colorectal cancer screening at the primary care setting: a cluster-randomised controlled trial. BMJ Open Qual. 2023 Jun;12(2):e002158. doi: 10.1136/bmjoq-2022-002158.

Reference Type: DERIVED

PMID: 37339820 (View on PubMed)

Other Identifiers

BID CCR

Identifier Type: -

Identifier Source: org_study_id