Colorectal Cancer Clinical Trial
Official title:
Colorectal Cancer Testing in Swiss Primary Care: A Cluster Randomized Controlled Trial Among Primary Care Physicians of the Swiss Sentinel Surveillance Network
Colorectal cancer (CRC) is the third leading cause of cancer mortality in Switzerland, and
kills 1600 people annually. Most deaths could be prevented by screening, but the 2012 Swiss
national health survey found that only 40% of 50-75-year-olds had been tested within
recommended intervals (26% with colonoscopy in the last 10 year, 7% with fecal occult blood
test [FOBT] in the last 2 years, and 7% with both). If screening starts at age 50, in the
average risk population absolute risk of dying from CRC at age 80 can be cut from 2% to 1%,
reducing relative risk by 50%. Since 2013, Switzerland has reimbursed screening by
colonoscopy every 10 years or FOBT every 2 years for adults 50-69 years old. Conforming to
current recommendations, the Federal Office of Public Health (FOPH) officially recognizes
both screening modalities.
When patients are offered a choice of screening test (colonoscopy vs. FOBT), they are as
likely to opt for one as the other. Patient preferences are unlikely to vary much between PCP
practices, so distribution of colonoscopy and FOBT within each practice should also be
roughly equal. Family physicians are recognized as the most trusted professional to discuss
CRC screening in Switzerland. However, many primary care physicians (PCPs) prefer prescribing
colonoscopy over FOBT, but physician preference for method seems to vary widely between
regions. If physician preferences and local medical culture currently influence choice of
method more strongly than patient preferences, encouraging PCPs to diagnose patient
preferences for screening method may reduce the number of PCPs who prescribe only one method.
An earlier study in Switzerland showed that training PCPs and giving them educational support
and decision aids raised the number who intend to prescribe colonoscopy and FOBT in equal
proportions. A randomized controlled trial in the US showed that when patients were offered
both FOBT and colonoscopy rather than only colonoscopy alone, more patients were screened for
CRC. Offering choice of method may thus increase overall screening rates.
The Swiss Sentinel Surveillance Network (Sentinella) is a cooperative surveillance project
including the Federal Office of Public Health (FOPH), PCPs representatives and the five Swiss
institutes of family medicine. A sample of 150 to 250 general practitioners, internists and
pediatricians in private practices from all regions of Switzerland report weekly morbidity
data to the network using irreversibly anonymized patient data collected during
consultations. In 2017, 91 out of 129 eligible PCPs of the Sentinella network participated in
a cross-sectional data collection on CRC screening. The Sentinella network appears ideally
suited to perform an intervention in order to modify screening practices and measure outcomes
using the same collection form as in 2017.
This study will test the benefits of a prepackaged training program in participatory medicine
sent by post to PCPs in Switzerland. The package is designed to improve their diagnoses of
patient preferences for screening and screening method (colonoscopy or FOBT). The study
begins with the hypothesis that giving PCPs evidence summaries on CRC screening, decision
aids for patients, and performance feedback on the 2017 data collection will increase the
number of PCPs whose patients include at least one screened with FOBT, and who will prescribe
at least one FOBT/FIT (Fecal Immunochemical Test) instead of prescribing only colonoscopy.
This might reduce variation in care between PCP practices by increasing variation in methods
of screening prescribed within each PCP practices. Analyses from the 2017 data collection
suggest that fewer patients refused CRC testing in practices that offered both methods than
in practices that offered only colonoscopy. This intervention might increase screening rates
overall, while respecting patient's autonomy to refuse the test and to be prescribed the test
they prefer.
The study will compare outcomes among PCPs allocated to the intervention group to those in
the control group, and will be measured by collecting anonymous structured patient data on 40
consecutive patients by PCPs and questionnaires filled by PCPs.
The study is designed to fit within the Reach, Effectiveness, Adoption, Implementation and
Maintenance (RE-AIM) framework for structuring data collection. RE-AIM ensures that a study's
outcomes for future implementation and dissemination works are collected. The RE-AIM criteria
will be used to identify the translatability and public health impact of this intervention,
and for making clear to future stakeholders the internal and external validity of study
results.
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