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Randomized Controlled Trial on Colorectal Cancer Screening Among Quality Circles of Primary Care Physicians

Primary Purpose

Colorectal Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Multilevel training intervention (intervention group)
Multilevel training intervention (control group with crossover)
Sponsored by
University of Bern
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Colorectal Cancer

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Physician-level: PCPs of different regions in Switzerland participating in Quality Circles comprising 4 to 19 PCPs and willing to participate in the study
  • Patient-level: Three Repeated measures over three years on 40 consecutive patients aged 50 to 75 years old seen in PCP offices over a 2 weeks to 2 months period. Patients will be included if there is a face-to-face consultation billed for at least 5 minutes at the practice.

Exclusion Criteria:

  • None except criteria which do not respect inclusion criteria.

Sites / Locations

  • Institute of Primary Health Care (BIHAM), University of Bern

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Intervention group

Control group with crossover

Arm Description

Participants in the control group will receive the intervention after 12 months, cross-over design

Outcomes

Primary Outcome Measures

Proportion of patients which have been tested for CRC
PCPs will systematically collect data from 40 consecutive patients, aged 50 to 75 years

Secondary Outcome Measures

Rate at which PCPs discuss CRC screening with eligible patients (patients not tested in recommended intervals, with no contra-indication for screening)
PCPs will systematically collect data from 40 consecutive patients, aged 50 to 75 years
Proportion of patients who were previously tested, plan to be tested or refuse tests
PCPs will systematically collect data from 40 consecutive patients, aged 50 to 75 years
Compare proportion of patients who were screened or plan to be screened with colonoscopy vs. FIT
PCPs will systematically collect data from 40 consecutive patients, aged 50 to 75 years
Intentions to prescribe tests to screen for CRC
A questionnaire filled by each participating PCP
Intention to prescribe colonoscopy vs. FIT within the next 6 months
Through a questionnaire filled by each participating PCP

Full Information

First Posted
April 15, 2018
Last Updated
March 23, 2020
Sponsor
University of Bern
Collaborators
Swiss National Science Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT03510858
Brief Title
Randomized Controlled Trial on Colorectal Cancer Screening Among Quality Circles of Primary Care Physicians
Official Title
Colorectal Cancer Testing in Swiss Primary Care: A Pilot Pragmatic Cluster Randomized Controlled Trial in Quality Circles of Physicians
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 14, 2018 (Actual)
Primary Completion Date
October 30, 2020 (Anticipated)
Study Completion Date
October 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Bern
Collaborators
Swiss National Science Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
In Switzerland, colorectal cancer (CRC) is the third most common cause of death from cancer with 1600 persons dying from CRC each year. CRC screening can prevent most of these deaths. If screening begins at age 50, with either colonoscopy or faecal immunological test (FIT), the absolute risk of dying from CRC at age 80 can be cut in half. The choice between CRC screening methods can be seen as preference-sensitive condition. FIT can detect CRC at a similar rate as colonoscopy, but cannot detect as many polyps and advanced polyps as colonoscopies. Colonoscopy would seem the best choice for patients who want to reduce their risk of developing CRC or dying from CRC, but colonoscopy is an invasive procedure with rare but serious adverse effects. Patients who choose FIT do not need to prepare their bowels, or take a day off, but instead sample their own stool at home and mail the test to the laboratory. Offering the choice of test might also increase overall screening rates. Guidelines from the US Services Task Force (USPSTF) suggest shared decision making as a method for increasing adherence to screening and elicit patients' preferences for screening options. Family physicians are recognized as the most trusted professional to discuss CRC screening in Switzerland. However, many primary care physicians (PCPs) appear to prefer colonoscopy over FIT, and the preferred method seems to vary widely between regions. Physician preferences and local medical culture likely determine these choices more than patient preference. It may be possible to reduce the number of PCPs who prescribe only one screening method by encouraging them to diagnose their patient's preferences for screening method. In Switzerland, training PCPs with educational support and decision aids increased the number who intend to prescribe both screening modalities in equal proportions (prescription of both colonoscopy and FIT in equal proportions). To implement the intervention and determine how and if it changes PCP practice over time, the study will be conducted in quality circles (QCs) of PCPs. QCs are usually groups of 6 to 12 PCPs who meet regularly to reflect on their practice. QCs are a multifaceted, step-based intervention for quality improvement that has gained international traction because they can foster long-lasting behaviour change. In Switzerland, 80% of all PCPs attend QC regularly. Through QCs following the principles of Plan-Do-Check-Act (PDCA) quality improvement cycles, PCPs can find ways to lower structural barriers to screening, assess their screening practices, and give each other feedback. The study hypothesizes that providing PCPs with evidence summaries on CRC screening, decision aids for patients, and sample FIT tests will increase the number of patients screened for CRC, better balance the selection of screening methods (colonoscopy vs. FIT), increase the proportion of patients with whom PCPs discuss CRC testing, and increase the number of patients who make decision for or against CRC screening. The outcomes in PCPs of QCs allocated to the intervention group will be compared to those in the control group. The outcomes will be measured through anonymous structured patient data collected on 40 consecutive patients by PCPs and questionnaires filled by PCPs. To ensure that relevant outcomes important for future implementation and dissemination works are collected, the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) framework will be followed for structuring the data collection. The RE-AIM framework helps structure the collection of data on the characteristics of the participants invited who finally participate in the study (Reach), on the integration of the planned intervention in their work (Adoption), on the consistency of implementation of the planned intervention by study participants (Implementation), on the maintenance of the intervention effects over time (Maintenance), and finally, on the effectiveness of the intervention on the planned outcomes (Effectiveness). The RE-AIM criteria are useful for identifying the translatability and public health impact of this intervention, and for making clear to future stakeholders the internal and external validity of study results. This study will test the benefits of a multilevel training program in participatory medicine designed to help PCPs in Switzerland to better diagnose patient preferences for screening and method of screening method (colonoscopy or FIT) through. If the program is successful it will increase the proportion of patients who can decide to undergo testing or not and with which method. This should increase in number of patients who are screened or intend to be screened for CRC, and thus reduce CRC deaths in the longer term.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Title
Control group with crossover
Arm Type
Other
Arm Description
Participants in the control group will receive the intervention after 12 months, cross-over design
Intervention Type
Other
Intervention Name(s)
Multilevel training intervention (intervention group)
Intervention Description
QC meetings with PCPs in the intervention group to reflect on their CRC screening practices and implement changes in sequential Plan-Do-Check-Act (PDCA) quality improvement cycles. In the first meeting, they will be given evidence summaries on CRC screening, a decision support leaflet designed to help them discuss CRC screening with their patients and a patient decision aid in form of a brochure (Plan-Do). PCPs will receive sample FIT kits recommended for organized screening programs and will be encouraged to offer FIT tests if they have not done so before. In the second QC meeting, PCPs will be shown how to fill out the patient data collection form (Check). The third QC meeting will take place after data collection and analysis. Researchers will present their results to the QCs and PCPs will discuss subsequent steps to improve care (Act). The QC will then repeat one PDCA cycle. The control group will receive the same intervention one year later.
Intervention Type
Other
Intervention Name(s)
Multilevel training intervention (control group with crossover)
Intervention Description
The control group will undergo a crossover and receive the same intervention one year after the intervention group. QC meetings with PCPs in the intervention group to reflect on their CRC screening practices and implement changes in sequential Plan-Do-Check-Act (PDCA) quality improvement cycles. In the first meeting, they will be given evidence summaries on CRC screening, a decision support leaflet designed to help them discuss CRC screening with their patients and a patient decision aid in form of a brochure (Plan-Do). PCPs will receive sample FIT kits recommended for organized screening programs and will be encouraged to offer FIT tests if they have not done so before. In the second QC meeting, PCPs will be shown how to fill out the patient data collection form (Check). The third QC meeting will take place after data collection and analysis. Researchers will present their results to the QCs and PCPs will discuss subsequent steps to improve care (Act).
Primary Outcome Measure Information:
Title
Proportion of patients which have been tested for CRC
Description
PCPs will systematically collect data from 40 consecutive patients, aged 50 to 75 years
Time Frame
At 16 months after study begin
Secondary Outcome Measure Information:
Title
Rate at which PCPs discuss CRC screening with eligible patients (patients not tested in recommended intervals, with no contra-indication for screening)
Description
PCPs will systematically collect data from 40 consecutive patients, aged 50 to 75 years
Time Frame
At 16 months after study begin
Title
Proportion of patients who were previously tested, plan to be tested or refuse tests
Description
PCPs will systematically collect data from 40 consecutive patients, aged 50 to 75 years
Time Frame
At 16 months after study begin
Title
Compare proportion of patients who were screened or plan to be screened with colonoscopy vs. FIT
Description
PCPs will systematically collect data from 40 consecutive patients, aged 50 to 75 years
Time Frame
At 16 months after study begin
Title
Intentions to prescribe tests to screen for CRC
Description
A questionnaire filled by each participating PCP
Time Frame
At 16 months after study begin
Title
Intention to prescribe colonoscopy vs. FIT within the next 6 months
Description
Through a questionnaire filled by each participating PCP
Time Frame
At 16 months after study begin

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: Physician-level: PCPs of different regions in Switzerland participating in Quality Circles comprising 4 to 19 PCPs and willing to participate in the study Patient-level: Three Repeated measures over three years on 40 consecutive patients aged 50 to 75 years old seen in PCP offices over a 2 weeks to 2 months period. Patients will be included if there is a face-to-face consultation billed for at least 5 minutes at the practice. Exclusion Criteria: None except criteria which do not respect inclusion criteria.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Reto Auer, MD, MAS
Organizational Affiliation
Institute of Primary Health Care of Bern (BIHAM), University of Bern
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Primary Health Care (BIHAM), University of Bern
City
Bern
ZIP/Postal Code
3012
Country
Switzerland

12. IPD Sharing Statement

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Randomized Controlled Trial on Colorectal Cancer Screening Among Quality Circles of Primary Care Physicians

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