Colorectal Cancer Screening in Primary Care
Condition: Colorectal Neoplasms
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      The implementation of screening programs for colorectal cancer by screening for fecal occult
      blood has proven effective in reducing the incidence and mortality from this type of
      neoplasms. However, to ensure the efficiency of the programs require population participation
      rates of at least 50%. Experiences in our country show that the population participation is
      far from this recommended minimum number.

      Interventions to promote preventive activities in primary care are well received by the
      population; in the case of colorectal cancer, direct recommendation of primary care
      professionals to carry out the screening is one of the factors with greatest impact on
      increasing population participation in such programs. Care overload, circuit design for
      screening without the direct intervention of primary care professionals and the multiplicity
      of tasks that they must face, are elements that influence the low recommendation for
      screening in the target population who consults for any other reason.

      The introduction of specific reminders in electronic medical record (in widespread use in
      primary care), as a tool to facilitate and encourage direct referral by physicians and nurse
      practitioners to perform colorectal cancer screening will mean an increase of at least 10% in
      participation of the target population, increasing the efficiency of screening programs. The
      introduction of this new software tool will have good acceptance and increase compliance with
      recommendations from health professionals.
    

Detailed description: 
      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).
    

Intervention name(s): electronic reminder
Intervention type(s): Behavioral
Intervention description(s): Electronic reminder introduced into primary care medical health record, identifying invited people to the population-based colorectal cancer screening program, to promote their participation.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Screening
Keywords: Comparative Effectiveness Research; Reminder Systems; Patient Participation; Primary Health Care; Early Detection of Cancer; Colorectal Neoplasms