Colorectal NeoplasmsNCT04293315
Screening of Colorectal Cancer in the Public Healthcare Sector in Argentina
A study testing Improvement Cycles in people with Colorectal Neoplasms, run by Institute for Clinical Effectiveness and Health Policy at 1 site in Argentina.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Neoplasms
- What is being tested?
- Improvement Cycles
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,520 participants
- Where
- 1 siteArgentina
- Study dates
- 9 Jun 2018to 15 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- People who are bedridden.
- People who plan to move in the next 3 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effectiveness of a Collaborative Strategy to Increase the Screening of Colorectal Cancer in the Public Healthcare Sector in Argentina
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.
Read more
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
- Being tested
- Improvement Cycles
- Keywords
- screening, Fecal Occult Blood Test (FOBT), prevention, quality improvement cycles, health promotion
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Improvement CyclesBehavioural
Also called quality improvement cycle
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Improvement Cycles |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (3)
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.
Measured: 3 months
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.
Measured: 3 months
Implementation outcomes according to the RE-AIM framework
Implementation outcomes are: Reach, Effective implementation, adoption, implementation fidelity and maintenance
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2020
- Study start9 Jun 2018
- Primary completion15 Mar 2020 (estimated)
- Study completion15 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 1,520 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute for Clinical Effectiveness and Health Policy
- Sponsor type
- University, hospital or other
- Collaborators
- Inter-American Development Bank
- Responsible party
- Sponsor
- Investigators
- Vilma Irazola, Principal investigator, Institute for Clinical Effectiveness and Health Policy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04293315
- Sponsor's protocol ID
- BID CCR
- Status last verified
- Apr 2019
- First submitted
- 31 Jan 2020
- Last updated
- 3 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37339820
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of a Collaborative Strategy to Increase the Screening of Colorectal Cancer in the Public Healthcare Sector in Argentina
- ClinicalTrials.gov ID
- NCT04293315
- Acronym / sponsor ID
- BID CCR
- Conditions
- Colorectal Neoplasms
- Keywords
- screening, Fecal Occult Blood Test (FOBT), prevention, quality improvement cycles, health promotion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,520 participants (actual)
- Lead sponsor
- Institute for Clinical Effectiveness and Health PolicyUniversity, hospital or other
- Collaborators
- Inter-American Development Bank
- Study start
- 9 Jun 2018 (actual)
- Primary completion
- 15 Mar 2020 (estimated)
- Study completion
- 15 Mar 2020 (estimated)
- First posted
- 3 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Improvement CyclesThe same as the Control Arm plus the primary care team of the PCCs will be trained and participate in 8 improvement cycles. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- People who are bedridden.
- People who plan to move in the next 3 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Improvement CyclesAlso: quality improvement cycleThis 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. | Behavioural | Intervention |
Primary outcome
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.
3 secondary outcomes
Proportion of participants with inadequate FOBT
Time frame: 3 months
Proportion of positive FOBT referred for colonoscopy
Time frame: 3 months
Implementation outcomes according to the RE-AIM framework
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2020.
- Derived from this study: PubMed 37339820Irazola 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vilma Irazola principal investigator
Institute for Clinical Effectiveness and Health Policy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Improvement Cycles in people with Colorectal Neoplasms, run by Institute for Clinical Effectiveness and Health Policy at 1 site in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effective Screening (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04293315, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2020.