Navigation From Community to Clinic to Promote CRC Screening in Underserved Populations
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      The purpose of this study is to test the effectiveness of a two-phase intervention using
      "community-to-clinic navigators" to guide individuals from an especially hard-to-reach,
      multicultural, and underinsured population into primary care clinics and, subsequently, to
      track effects of the intervention on completion of colorectal cancer (CRC) screening in
      clinics. A cost-effectiveness analysis will lay the foundation for further implementation and
      dissemination research.

      Aim 1: Test effectiveness of community group education + tailored navigation versus community
      group education only in increasing clinic attendance among low-income, multicultural Arizona
      residents, aged 50 to 75 yrs.

      Hypothesis 1: Individuals receiving group education classes + tailored navigation will show
      higher rates of clinic attendance than those receiving only group education.

      * As a separate critical step for those who make clinic appointments, the investigators will
      examine the effect on follow through to screening, using initial group assignment as a
      control variable in analysis. Patients making clinic appointments will receive referral for
      screening and tailored navigation as usual care.

      Aim 2: Track outcomes of the Phase I intervention on CRC screening test completion among
      low-income, multicultural Arizona residents aged 50 to 75 years who attend clinic.

      Hypothesis 2: Individuals receiving group classes and tailored navigation during Phase I will
      have higher rates of CRC screening test completion than those receiving classes only,
      (however this outcome will be primarily due to clinic attendance).

      Aim 3: Determine the cost-effectiveness of each phase of the interventions on increasing CRC
      screening completion among low-income, multicultural Arizona residents aged 50 to 75 years.

      Exploratory Aim 4: Examine the levels of program dissemination from community to clinic to
      final screenings using the RE-AIM model.

      Research Question 2: What is the degree of Reach, Efficacy, Adoption, Implementation, and
      Maintenance of the community-to-clinic navigation, and clinic-to-screening outcomes?
    

Detailed description: 
      Design overview:

      This study will employ a 2-phase experimental, randomized design to test a community to
      clinic navigation intervention: (1) to increase attendance at primary care clinics (Phase I),
      and (2) to track CRC screening among those who visit clinics (Phase II). The investigators
      will recruit non-adherent individuals from multicultural community sites in low-income zip
      codes in the Phoenix Arizona metropolitan area.

      In Phase I, community sites will be randomized to either group education (GE) or group
      education plus tailored navigation (GE +TN) to increase attendance at the primary care
      clinics. In Phase II, individuals who complete a clinic appointment (from Phase I) will then
      receive the standard of care (provider prompts, navigation calls to patients) in the clinic.
      Phase I brings individuals into the primary care system (clinic attendance), and Phase II
      follows them through to CRC screening completion (either stool-based or colonoscopy). An
      accelerated plan will be initiated for individuals identified as at high risk for CRC,
      referring them for colonoscopy, to realistically evaluate effects of the interventions in
      real-world conditions, including the range of patient risk profiles in this setting.
      Recruitment, intervention, and data collection materials have been developed in English and
      Spanish and reviewed by a Cultural Community Advisory Board (CCAB) for cultural fit across
      our multicultural population of low-income participants.

      Intervention details:

      Group education (Phase I): Groups will be assembled for an educational class after all
      baseline surveys are completed for a community site. The curriculum for the 60 minute class
      will include:

        -  general information on cancer risk,

        -  specific risk factors for CRC,

        -  brief review of dietary and physical activity guidelines,

        -  stool blood test: purpose, preparation, and procedures(emphasis on the fecal occult
           blood test-- FOBT-- and FIT test),

        -  requirements and reasons for annual testing,

        -  meaning of results, and importance of follow-up for positive tests,

        -  instructions and sample kit discussion

        -  colonoscopy discussion,

        -  preventative potential when polyps are removed,

        -  colonoscopy preparation,

        -  anesthesia,

        -  guidelines regarding use of colonoscopy as the primary screening tool for individuals at
           higher risk, and for those who test positive on stool-based screening will be discussed

      Tailored navigation (TN) Phase I: Participants randomized to the groups receiving GE + TN
      intervention will be called within 5 days of the completion of the class and will be
      encouraged to schedule an appointment at the nearby identified clinic. Trained, culturally
      sensitive navigators will navigate participants through their individual barriers and
      concerns, using the tailored set of responses from the message library (with a
      multi-theoretical basis) developed in the co-PI's previous research (R21CA100566;PI:Menon &
      R01NR8425; PI: Menon). Calls will continue, for a total of 5 within an 8-week period (or
      less, if attendance to clinic and/or adherence to screening are obtained). In whichever call
      becomes the final, Tracking Questions will be administered to assess the status of clinic
      attendance or reasons for not scheduling or keeping a clinic appointment (with the same data
      collected at the end of 8 weeks for non-navigated control group participants).

      Tailored navigation (TN) Phase II will utilize the full message library to assist patients to
      overcome barriers to care, negotiate healthcare systems, and access quality care. Within each
      clinic, an existing trained, staff member(or study navigator) will follow up on the patients
      who attend a clinic appointment.

      Although patient navigators vary by site, the primary role of the clinic-based navigator
      includes connecting patients to resources and support systems; assisting in communication
      with clinic providers and staff; streamlining appointments and paperwork; helping patients
      identify and access financial services, basic counseling on psychosocial issues such as fear,
      anxiety, appropriate social services; and tracking all interactions and outcomes. Our TN will
      cover all these components in the proposed study. Calls will continue for a total of 5 within
      an 8-week period.

      Control conditions clarification. In Phase I, participants in the control arm of the study
      will receive 3 calls designed to support data collection and tracking, but will not receive
      navigation messages. Call 1: 1-2 weeks after the initial clinic visit to verify contact
      information; Call 2: during weeks 5-6 to inquire if a clinic appointment was made and kept
      and to schedule data collection call for week 8 (Call 3). Call 3 (or earlier, if clinic was
      attended) will utilize the Tracking survey to document clinic attendance or reasons for
      non-attendance. During any call if an appointment was made and kept, the clinic name and
      provider visited will be documented, and the patient will be followed through Phase II.

      Data Collection:

      Eligibility status will be determined using initial screening questions. Participants who we
      determine to be ineligible will be thanked for their time, encouraged to continue with CRC
      screening annually (or on whatever schedule appropriate based on risk status, age and type of
      screening obtained). Those who are eligible will be administered the study consent. Consent
      procedures will inform participants the purpose and details of the study.

      Once participants are consented, they will be interviewed for baseline data collection. The
      demographic data to be collected at baseline and confirmed (repeated) if participants appear
      in clinics for Phase II include age, date of birth, gender, race, ethnicity, education,
      income and insurance, marital status, and number of adults and children in household.
      Screening history and risk status will be obtained to determine eligibility and serve as
      baseline CRC screening data.

      Questionnaires will be administered face to face by a Survey Interviewers who will ask
      questions and record the answers. Questionnaire administration will be distributed across
      three different points: 1) at baseline, 2) post-intervention, and 3) 6 month
      post-intervention.

      Data collection materials have been developed in English and Spanish and reviewed by a
      Cultural Community Advisory Board for cultural fit across our multicultural population of
      low-income participants.

      Data collection for cost-effectiveness analysis:

      Data for the cost analyses will be drawn from study and clinic records and tracked separately
      for each phase of the study. Navigators will keep logs of time spent to recruit sites, run
      the group classes and implement TN to account for salary spent for Phase I intervention and
      control. Phase II navigation calls will be tracked by clinic staff in contracting clinics. We
      will also capture the number of clinic appointments made, kept, and missed without timely
      cancellation and the number of each of the different types of screenings received.

      Sample Size:

      We expect to recruit and randomize 1,840 participants total, allowing 15% attrition (that is,
      85% retention) for a final sample size of 1,600 participants. Approximately 266 groups of 5-7
      participants will be formed, resulting in approximately 133 each in the control condition and
      intervention condition. Education groups will begin in staggered sessions over 46 months.
      Approximately 450 participants will be recruited each year to achieve total recruitment
      goals.

      Recruitment:

      We will recruit older adult, low-income participants in community settings in Phase I by (a)
      identifying previously engaged and new formal sites (churches, senior citizen centers,
      employers) for recruitment, (b) continuing to canvass nontraditional options (apartment
      complexes, neighborhood associations, barber shops/salons, areas of commerce), and (c)
      investigating new types of sites to reach a broader range of multicultural populations in
      low-income areas.

      Members of our Cultural Community Advisory Board (CCAB) include both lay advisors and strong
      community leaders and directors representing key institutions with community links.
      Eligibility screening will be done in a face-to-face interview and if the criteria are met
      the informed consent will be administered.
    

Intervention name(s): Tailored navigation
Intervention type(s): Behavioral
Other intervention name(s): Tailored messages
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Tailored navigation; Tailored messages