Screening of Colorectal Cancer in the Public Healthcare Sector in Argentina
Primary Purpose
Colorectal Neoplasms
Status
Unknown status
Phase
Not Applicable
Locations
Argentina
Study Type
Interventional
Intervention
Improvement Cycles
Sponsored by
About this trial
This is an interventional health services research trial for Colorectal Neoplasms focused on measuring screening, Fecal Occult Blood Test (FOBT), prevention, quality improvement cycles, health promotion
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.
Sites / Locations
- Ministry of Health
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
Intervention
Arm Description
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.
The same as the Control Arm plus the primary care team of the PCCs will be trained and participate in 8 improvement cycles.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Implementation outcomes according to the RE-AIM framework
Implementation outcomes are: Reach, Effective implementation, adoption, implementation fidelity and maintenance
Full Information
NCT ID
NCT04293315
First Posted
January 31, 2020
Last Updated
March 1, 2020
Sponsor
Institute for Clinical Effectiveness and Health Policy
Collaborators
Inter-American Development Bank
1. Study Identification
Unique Protocol Identification Number
NCT04293315
Brief Title
Screening of Colorectal Cancer in the Public Healthcare Sector in Argentina
Official Title
Evaluation of the Effectiveness of a Collaborative Strategy to Increase the Screening of Colorectal Cancer in the Public Healthcare Sector in Argentina
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
June 9, 2018 (Actual)
Primary Completion Date
March 15, 2020 (Anticipated)
Study Completion Date
March 15, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institute for Clinical Effectiveness and Health Policy
Collaborators
Inter-American Development Bank
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Neoplasms
Keywords
screening, Fecal Occult Blood Test (FOBT), prevention, quality improvement cycles, health promotion
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1520 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Arm Title
Intervention
Arm Type
Experimental
Arm Description
The same as the Control Arm plus the primary care team of the PCCs will be trained and participate in 8 improvement cycles.
Intervention Type
Behavioral
Intervention Name(s)
Improvement Cycles
Other Intervention Name(s)
quality improvement cycle
Intervention Description
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.
Primary Outcome Measure Information:
Title
Effective Screening
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Proportion of participants with inadequate FOBT
Description
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.
Time Frame
3 months
Title
Proportion of positive FOBT referred for colonoscopy
Description
The investigators will calculate the proportion of participants with a positive result in the FOBT that were referred to receive colonoscopy.
Time Frame
3 months
Title
Implementation outcomes according to the RE-AIM framework
Description
Implementation outcomes are: Reach, Effective implementation, adoption, implementation fidelity and maintenance
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vilma Irazola
Organizational Affiliation
Institute for Clinical Effectiveness and Health Policy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ministry of Health
City
Mendoza
Country
Argentina
12. IPD Sharing Statement
Learn more about this trial
Screening of Colorectal Cancer in the Public Healthcare Sector in Argentina
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