Trial Information

Effectiveness of an Electronic Alert Into the Primary Care Medical Health Record to Increase Participation in a Population Colorectal Cancer Screening Program.

Background:

Colorectal cancer (CRC) is an important public health problem in our country. Over the last
decade, several autonomous regions in Spain have carried out screening programs, but
population participation rates remain below recommended European targets.

Reminders on electronic medical record (EMR) have been identified as a low-cost and
high-reach strategy to increase participation. The population-based colorectal cancer
screening program in the city of Barcelona is aimed at men and women between ages 50 and 69
involving immunochemical fecal occult blood test (iFOBT) every 2 years. Community pharmacies
participating in the program are in charge of delivery and collection of iFOBT.

Aims:

Main: To asses the effectiveness of an intervention in primary care, by using reminder
systems applied to the electronic medical records to promote the population's participation
in a Public CRC Screening Program.

Secondary:

- To know the population's reasons for refusing to take part in the screening program.

- To know the health professionals' opinion on the official program implementation.

- To know the health professionals' opinion on the implementation of the new computerized
tool.

Methods:

Design: Randomized controlled trial and a cross-sectional second phase. Setting: 11 primary
care centers

Subjects:

Inclusion criteria Patients

- Men and women, aged between 50-69, with an average risk of developing CRC, involved to
participate in the first round of a population-based CRC screening program (N 57.020).

- To be registered with a primary care physician (PCP) at one of the centers
participating.

Health care professionals:

- All the physicians and nurses working at every center voluntarily participating (N 280).

Exclusion criteria Patients: Refusal to participate. Health care professionals: Refusal to
participate by the center where they work.

Intervention It consists of entering a reminder in the EMR of patients (e-cap program), in
the form of a specific icon, in the medical scheduler, which identifies subjects who had
been invited to take part in the CRC screening program. The alert is addressed to physicians
and nurses, in order to promote CRC screening, through some brief advice and asking the
patient to fill in a data collection sheet specifically designed for this study and also
included in the EMR. Health care professionals in the intervention group will have had a
training session on the intervention's characteristics and development.

Sample size: The target population registered with the centers involved in the study is
about 60.000 people. It is estimated that 90% of them will be invited to participate in the
screening program. In case of low participation (30%), the resulting sample could identify a
difference of at least 10% between the control group and the intervention group, with an
alpha error of 5% and a statistical power of 95%, and an estimated loss to follow up rate at
20 %.

Randomization:The randomization unit is the PCP. The allocation of the participant PCPs to
the control or intervention groups is carried out through a stratified random sampling by
center, allocating 50% of the physicians to the control or intervention group, respectively.

The nurses are allocated to the intervention/control group according to the study group of
the PCP that they share patients care with. Patients are allocated to the
intervention/control group according to the study group of their PCP.

Masking: Given the nature of the intervention, there's no masking of the health
professionals or of the statistician responsible for the statistical analysis, but due to
the objectivity of the final outcome we don't think the result could be influenced by this
fact. Moreover the data manager for the CRC screening program, responsible for the data
management of the participation outcome, does not know what study group the invited
population was allocated to. Patients are also unaware of study group that they have been
assigned to, and they have no access to the EMR.

Outcomes:

Primary outcome: CRC screening status (Update, not update, exclusion)

Secondary outcomes:

- Patient's characteristics: age, gender, socioeconomic deprivation index, risk factor
for colorectal cancer, clinical risk group, number of visits.

- Health professionals characteristics: age, gender, knowledge about CRC screening.

- Reminder: date when the sheet was filled in, previous participation in the CRC
screening program (yes, no and barriers), exclusion criteria (normal colonoscopy within
the previous five years, high CRC risk for personal or family history, symptoms of
CRC), intention to participate (yes, no and barriers).

- Health Professionals Opinion questionnaire on:

Population-based CRC screening program: Information given, process operation, primary care
professionals implication.

Electronic reminder: usefulness, usage, operation.

Data collection: Data obtained from population based CRC screening program, the EMR and two
questionnaires for the cross-sectional second phase.

Statistical analysis: Data will be analyzed using Stata, version 12.1, statistical software
package and an intention-to-treat approach will be applied. Analyses will include standard
descriptive statistics, Student's t tests, correlation and regression, to examine
differences between groups. All tests will be two-tailed and an alpha level of 0.05 will be
applied as the criterion for statistical significance.

Limits:

Given the nature of the intervention and the great social, economic and demographical
differences of the population registered with the centers participating in this study, we
take the physicians as a unit of randomization, instead of the centers or the patients.

External validity: This is an urban population study, but as the EMR is universally used in
Catalonia's primary care centers, we don't expect differences due to the area of work.

Ethical aspects:

The investigators are committed to complying with the prevailing norms of Good Clinical
Practice, as well as with the requirements of the Declaration of Helsinki and the clauses of
general and particular ethical conditions related to the right to privacy, anonymity and
confidentiality. Neither the first name nor the surnames or any other type of data
indicating the identity of the subjects will be registered. Therefore, identification will
be made by numerical codes. Since this type of study is developed in the usual clinical
setting, authorization and support must be and has already been granted by the
representatives and authorities of the groups involved and thus, individual informed consent
is not necessary. However, the consent of target population attending a primary care
appointment will be registered in the EMR. The protocol has been approved by the Clinical
Investigation Ethics Committee of the Jordi Gol i Gurina Foundation (protocol number
P10/31).