Clinical trial NCT04293315: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Colorectal Neoplasms
Keywords: screening
Fecal Occult Blood Test (FOBT)
prevention
quality improvement cycles
health promotion
Lead sponsor: Institute for Clinical Effectiveness and Health Policy
Sponsor class: OTHER
Collaborators: name: Inter-American Development Bank
First posted: 2020-03-03
Enrollment: 1520
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


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.

Primary outcomes:
measure: Effective Screening
timeFrame: 3 months
Secondary outcomes:
measure: Proportion of participants with inadequate FOBT
timeFrame: 3 months
measure: Proportion of positive FOBT referred for colonoscopy
timeFrame: 3 months
measure: Implementation outcomes according to the RE-AIM framework
timeFrame: 3 months
Other outcomes:
Locations:
city: Mendoza
country: Argentina
facility: Ministry of Health
Study officials:
affiliation: Institute for Clinical Effectiveness and Health Policy
name: Vilma Irazola
role: PRINCIPAL_INVESTIGATOR
References: