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Clinical Trials/NCT04293315
NCT04293315
Unknown
Not Applicable

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

Institute for Clinical Effectiveness and Health Policy1 site in 1 country1,520 target enrollmentJune 9, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Colorectal Neoplasms
Sponsor
Institute for Clinical Effectiveness and Health Policy
Enrollment
1520
Locations
1
Primary Endpoint
Effective Screening
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 9, 2018
End Date
March 15, 2020
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Institute for Clinical Effectiveness and Health Policy
Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Proportion of positive FOBT referred for colonoscopy(3 months)
  • Implementation outcomes according to the RE-AIM framework(3 months)
  • Proportion of participants with inadequate FOBT(3 months)

Study Sites (1)

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