Screening of Colorectal Cancer in the Public Healthcare Sector in Argentina

NCT04293315 | Unknown DMC

• 1 other identifier: BID CCR
• Study Type: interventional
• Target: 1,520
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months

Secondary Outcomes (3)

• Proportion of participants with inadequate FOBT

  3 months

• Proportion of positive FOBT referred for colonoscopy

  3 months

• Implementation outcomes according to the RE-AIM framework

  3 months

Study Arms (2)

Control

NO INTERVENTION

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.

Intervention

EXPERIMENTAL

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

Behavioral: Improvement Cycles

Interventions

Improvement Cycles 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.

Also known as: quality improvement cycle

Intervention

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• People who are bedridden.
• People who plan to move in the next 3 months.

Sponsors & Collaborators

• Institute for Clinical Effectiveness and Health Policy: lead
• Inter-American Development Bank: collaborator

Study Sites (1)

Ministry of Health

Mendoza, Argentina

Location

Related Publications (1)

• 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.

  PMID: 37339820 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Vilma Irazola

  Institute for Clinical Effectiveness and Health Policy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: January 31, 2020
• First Posted: March 3, 2020
• Study Start: June 9, 2018
• Primary Completion: March 15, 2020
• Study Completion: March 15, 2020
• Last Updated: March 3, 2020

Record last verified: 2019-04

Locations

AR (1)