Addressing Prostate Cancer Information Disparities With eHealth Technology

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.

Inclusion Criteria:

- African american men,

- ages 45-70 who are able to provide informed consent to participate in the educational
intervention and associated data collection activities.

- English speaking

Exclusion Criteria:

- no prior personal history of prostate cancer

- no prior prostate cancer screening with the prostate specific antigen test within
preceding three years

- inability to speak English