Addressing Prostate Cancer Information Disparities With eHealth Technology
Condition: Prostate Neoplasm
MeSH terms: Prostatic Neoplasms
Study type: Interventional

Summary: 
      This is a multicenter study that involves research on screening for prostate cancer. This
      study pilot tests a culturally appropriate decision aid (DA) for African American (AA) men
      that will empower them to take part in decision-making regarding prostate cancer screening
      (PCS). The Prostate Cancer Screening Preparation (PCSPrep) tool was designed with intend to
      be delivered in primary care settings with attention to patient/provider interaction. Funding
      for this study comes from the National Institute of Health/National Cancer Institute
      (1R21CA178296).
    

Detailed description: 
      STUDY AIMS AIM 1: Among AA men ages 45-70, estimate the impact of PCSPrep on primary
      outcomes: (a) knowledge; (b) confidence in ability to make informed decisions and communicate
      with provider; (c) consistency between values & PCS preferences.

      AIM 2: Among primary care providers, to assess secondary outcomes: (a) perceptions regarding
      patient engagement in SDM; and (b) concordance with patient's ratings of SDM.

      AIM 3: Among patients, providers and clinic staff, document the feasibility and acceptability
      of integrating PCSPrep into primary care practices.

      RECRUITMENT & ENROLLMENT

      Primary Care Providers Recruitment:

      PCPs eligible to participate will be Emory Health Care practitioners who see at least 20
      potentially eligible patients. These PCPs will be sent information from the Investigator Team
      and Clinic Director explaining the study We will use effective clinician recruitment
      procedures established in our prior work, including presentations at standing clinician
      meetings, meeting individually with providers, and being on site to answer questions. Ten
      PCPs who consent to participate will complete a brief survey following the visit from each of
      their enrolled patients, and allow these clinical encounters to be audio-recorded. See
      appendix B for post encounter survey for providers. As is standard in studies involving
      physicians, a financial incentive will be provided following completion of post-visit data
      collection for each patient when allowable and not in conflict with federal regulations. In
      the case of the VA hospital system, providers are not allowed to take financial incentives
      for research, so they will not receive this. Following the visit from each of their enrolled
      patients, providers will respond to a brief, online survey about the extent to which they
      involved the patient in the SDM process, and their perceptions regarding the quality of the
      communication about PCS. Total provider time in the study is estimated at 120 minutes (up to
      15 enrolled patients x 10 minutes per post-encounter survey + 20 minutes of informed consent
      discussions).

      Patient Recruitment and Enrollment:

      The study will enroll AA men (age 45-70) who have not undergone prostate cancer screening
      (PCS) in the prior 3 years. Additional eligibility criteria will include: (1) self-reported
      AA race/ethnicity; (2) age 45-70; (3) English speaking. Exclusion criteria will include:
      personal history of prostate cancer (CaP), life expectancy of <10 years as determined by the
      primary care provider (PCP); or serious psychiatric conditions or cognitive impairment.
      Identification and recruitment of patients will be conducted by the Clinical Research
      Associate (CRA) under supervision of the investigators and in partnership with PCP's who opt
      to participate. Electronic medical records (EMR) and scheduling systems may be used to
      identify potentially eligible men who are scheduled for a non-acute, routine medical visit
      with a participating PCP during the enrollment period (i.e., Dr. Filson will access his EMR
      account and supervise all viewing by the CRA). See appendix D for Patient recruitment letter.
      Two weeks prior to a scheduled visit, eligible men will be mailed study information and an
      opt-out card informing them that they will be contacted by phone. Men who do not opt out will
      be called by the CRA, screened for eligibility, and provided with information about the study
      procedures. See appendix E for telephone recruitment script. Men interested in participating
      will be asked to arrive at the clinic 90 min prior to their scheduled visit to review study
      information with the CRA, provide informed consent, complete pre- and post-test and
      post-clinical encounter surveys, and the PSCPrep. The day prior to their scheduled visit, the
      CRA will call to remind them of their appointment and the opportunity to participate in this
      study.

      INTERVENTION ADMINISTRATION PCSPrep meets the International Patient Decision Aid Standards
      for high quality DAs, and adheres to best practices for culturally relevant
      interventions.Learning objectives for participants include to: (1) understand that there is a
      decision to be made; (2) identify their preferred role in decision-making; (3) obtain
      accurate, unbiased information about benefits, limitations and potential harms of screening;
      (4) understand personal risk of CaP; (5) clarify one's values as they relate to the potential
      screening outcomes; (6) seek input from significant others, if desired; (7) develop skills
      for communicating with provider; (8) elicit input from provider; and (9) develop a plan for
      action based on desired course of action.

      PCSPrep uses an audiovisual and touch-screen format on an iPad to simplify use for
      individuals with limited literacy and/or computer skills. It is comprised of a series of
      modules on the web in which professional actors describe the decision-making process,
      communication with a provider, and discussion of PCS. Content is delivered by actors
      presented as physicians who answer call-in questions in a format modeled on a health-focused
      television show, based on focus group feedback. Questions and discussion are presented to
      normalize the idea that decisions are based on individual values and preferences.
    

Intervention name(s): Prostate Cancer Screening Decision Aid
Intervention type(s): Other
Intervention description(s): All patients recruited to the study will receive the PCSPrep decision aid. There is only 'study arm.' The Clinical Research Coordinator (CRC) will provide the patient with an iPad to complete the pre-test, PCSPrep and post-test. Individuals will see the survey questions on screen and will hear accompanying audio through headsets. Participants will: (1) be introduced to PCSPrep and the menu of activities/topics; (2) enter information about themselves for personal tailoring (e.g., risk factors); (3) participate in a values-clarification exercise to rate the personal importance of varied courses of action (i.e., pros/cons of PCS); (4) receive a printout with an individualized plan for discussing PCS with their primary care provider.
Other intervention name(s): PCSPrep
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: African american men; prostate cancer screening; web-based decision aid; informed decision making; shared decision-making