Neoplasms

Digestive System Diseases

All Conditions

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

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.

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.

Improvement Cycles

Vilma Irazola

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.

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

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

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.

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.

The investigators will calculate the proportion of participants with a positive result in the FOBT that were referred to receive colonoscopy.

Implementation outcomes are: Reach, Effective implementation, adoption, implementation fidelity and maintenance

Inter-American Development Bank

Institute for Clinical Effectiveness and Health Policy

Herbal and Botanical

All Drugs and Chemicals

Cola

Hal F Yee, MD, PhD

This study will compare patient adherence to different colorectal cancer (CRC) screening tests to identify the most cost-effective strategy to decrease mortality from CRC. We hypothesize that different types of tests will have different adherence rates, that these rates will alter the cost-effectiveness analysis, and that we can identify patient variables associated with non-adherence to specific CRC screening strategies.

Colorectal cancer (CRC) is a significant and preventable disease, yet CRC screening rates remain low. Previous investigators have identified barriers to adherence to CRC screening; however, the majority of data have been retrospectively derived, and the limited data produced from prospective assessment have been limited to fecal occult blood testing (FOBT). Constructs based on the Health Belief Model have been proposed to identify items associated with non-adherence to CRC screening, but prospective validation of this model is lacking. The U.S. Preventive Services Task Force report cites a major cause of uncertainty for calculation of the incremental cost-effectiveness of CRC screening is the deficit in primary data regarding adherence to CRC screening tests, specifically whether heterogeneity exists in screening rates of competing strategies. The Institute of Medicine confirmed the importance of detecting heterogeneity in adherence between strategies, understanding that some strategies currently recommended for CRC screening may be dominated by strategies that achieve greater levels of adherence.

This study aims to determine whether adherence rates to CRC screening are heterogeneous between competing strategies (FOBT and colonoscopy). This study will also prospectively examine domains of the Health Belief Model to identify associations with non-adherence to screening. Adherence rates specific to tested strategies will be incorporated in our existing economic models to compare the incremental cost-effectiveness of competing CRC screening strategies. These data will greatly impact policy decisions regarding resource allocation for CRC screening. It is also expected that future research based on data generated through this project will aim to develop and test interventions that optimize adherence to screening strategies to decrease mortality from CRC.

Procedures:

Patients who are due for CRC screening and meet eligibility requirements are identified through a query of the electronic medical record database at San Francisco General Hospital (SFGH). A research assistant (RA) obtains the PCP's approval to attempt recruitment at the patient's primary care appointment. The PCP discusses CRC screening with the participant during their regularly scheduled appointment.

Availability of CRC screening tests: Because of capacity constraints in the endoscopy unit at SFGH, the screening method for those at average risk of CRC had been limited to annual fecal occult blood testing (FOBT). However, the gastroenterology department initiated a pilot program which allows different primary care clinics to refer average-risk patients for colonoscopy screening in rotating 3-month time-blocks. To ensure the endoscopy unit has sufficient capacity to provide CRC screening via colonoscopy, providers in a given primary care clinic are able to refer their patients for (a) colonoscopy screening, (b) FOBT screening, or (c) a choice of either colonoscopy or FOBT screening, depending on the time block. This is not a study intervention; providers simply recommend that their patients complete a standard CRC screening test, and discuss the option or options available. Patients who decline to participate in the study undergo colorectal cancer screening under the guidance of their primary care provider; the same screening tests are available to those who participate and those who do not.

After giving written informed consent, participants complete an RA-administered 20-minute survey based on constructs of the Health Belief Model. Participants also grant us approval to review their medical records in one year to determine if they complete screening; those without a record of testing are contacted to determine if they completed testing outside of SFGH.

Adherence and the Economics of Colon Cancer Screening

Initial adherence measured at one year following enrollment. We have secured additional study funding that will allow us to extend the follow-up period for two more years, so we will measure programmatic adherence to CRC screening strategy over a 3-year period.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Screening of Colorectal Cancer in the Public Healthcare Sector in Argentina	NCT04293315	Colorectal Neop...	Improvement Cyc...	50 Years - 75 Years	Institute for Clinical Effectiveness and Health Policy
Adherence and the Economics of Colon Cancer Screening	NCT00705731	Colorectal Canc...		50 Years - 79 Years	University of California, San Francisco

Spots Global Cancer Trial Database for fecal occult blood test (fobt)