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Screening of Colorectal Cancer in the Public Healthcare Sector in Argentina

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04293315
Enrollment
1520
Registered
2020-03-03
Start date
2018-06-09
Completion date
2020-03-15
Last updated
2020-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Neoplasms

Keywords

screening, Fecal Occult Blood Test (FOBT), prevention, quality improvement cycles, health promotion

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.

Interventions

BEHAVIORALImprovement 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.

Sponsors

Inter-American Development Bank
CollaboratorOTHER
Institute for Clinical Effectiveness and Health Policy
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

Pragmatic Cluster Randomized Controlled Trial. Implementation Hybrid Type 2 Study. It will be used: Process Model: CFIR Theory of Change: COM-B Evaluation Framework: RE-AIM

Eligibility

Sex/Gender
ALL
Age
50 Years to 75 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Effective Screening3 monthsProportion 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.

Secondary

MeasureTime frameDescription
Proportion of participants with inadequate FOBT3 monthsThe 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.
Proportion of positive FOBT referred for colonoscopy3 monthsThe investigators will calculate the proportion of participants with a positive result in the FOBT that were referred to receive colonoscopy.
Implementation outcomes according to the RE-AIM framework3 monthsImplementation outcomes are: Reach, Effective implementation, adoption, implementation fidelity and maintenance

Countries

Argentina

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026