The CTPQ Theory
A Subject’s* Willingness to Participate in a
Clinical Trial is a Function of:
Awareness
Appreciation
Education
Expectations
Environment
Credibility
Peril (risk)
Relationship
Responsiveness
Resources
Communicatio
n
Inconveniences
Impact of
“Influencers”
*subject, patient, volunteer, participant and/or their family member / care giver
CRC 3.0:Successful Recruitment and Retention Strategies Brainstorming Ideas –Summarized from Beth Harper’s Session
Notes:
 For
all ideas, ensure that you plan in advance to
secure all necessary approvals and that you
include ideas in budget proactively!
CRC 3.0:Successful Recruitment and Retention Strategies Brainstorming Ideas –Summarized from Beth Harper’s Session
CTPQ Factor
Solutions, Ideas, Best Practices
Building awareness of
the study – within your
institution
• Grand rounds, disease committees, e-mail colleagues, team meetings; flyers,
announcements; leverage patient navigators
• Interactive websites, CT booklets or lists summarizing active trials, tumor boards, study
is active emails, send out slot availability notices letting other staff know slots still open;
bulletin boards
• Flyers, posters, resource binders
• E-mail reminders of ongoing studies still needing patients – monthly reminder
messages to physicians, nurses, residents, fellows
• Lunch and learns, grand round presentations
• Faculty meetings, outreach with other departments
Building awareness of
the study – within the
public at large
• Websites (public – CT.gov, patient association, cancer center), cancer information
service, advertisements, presence at patient-focused events / fairs (e.g., healthfairs,
cultural fairs, expos), letters to local MDs; ads In public transportation, social media;
community outreach, traditional media ads (radio, TV, print)
• Reach out to local physicians with educational events, inperson visits to keep top of
mind
• Think about high touch interactions with referring physicians and public vs. just high
tech communications
• Ensure awareness materials are available in multiple languages
• Penny saver magazines
• Survivor workshops
• Community presentations
Recognizing or
appreciation the
subject’s contribution
• Provide thank you cards, birthday cards, sympathy cards provide reimbursement; bank
or debit cards for travel (pre-paid), good, gas, provide parking and lunch vouchers
• Build rapport – friendly staff; personal thanks from PI
• Small tokens of appreciation (as approved by IRB – such as med center note pad)
• Provide VIP –” Very important participant” buttons to patients and provide perks like
valet or free parking, no waiting time, etc.
• Periodic calls or notes from the PI and staff thanking the patient and famiy
CRC 3.0:Successful Recruitment and Retention Strategies Brainstorming Ideas –Summarized from Beth Harper’s Session
CTPQ Factor
Solutions, Ideas, Best Practices
Enhancing the
subject’s
understanding
about clinical
research in
general
• Provide literature / patient education materials; walk them through the information; educational
videos displayed in waiting rooms
• Patient education workshops / seminars (e.g., at patient advocacy groups, survivorship events)
• Provide education for staff on how to talk to patients about research
• CISCRP.org – aware for all research events and Medical Heroes information
• Spend adequate time to educate all patients not just research patients
• Ask me about research buttons (and other ideas from 1001 ideas book)
• Give info sheets about the phases of clinical trials and basic overview of drug and device
development process
Enhancing the
subject’s
understanding
about clinical
research about a
particular trial
•
•
•
•
•
Ensuring a
comfortable and
patient-friendly
environment
• Smile! Provide mirrors for staff and remind them to smile before approaching patient
• Keep to appointment schedule (on time)
• Tidy and neat offices / rooms, calming color palette; take patients to discussion room vs. exam
room for certain visits
• Provide refreshments
• Escorts or navigator to get patient to and from various departments
• Provide child care
• Private rooms; ensure patients are comfortable and feel their privacy is maintained
• Check in with the patient as they are in the waiting room and keep them informed of when they
will be seen
• Provide water, snacks and other amenities
Provide study-specific information; cancer websites
Provide educational video prior to the formal consent process
Use powerpiont presentations to emphasize key points from the consent
Provide patient with higlighter and sticky notes to identify and flag areas they don’t understand
Ensure information is available in multiple languages and that bilingual staff are available (or
use medical translation services)
• Think of how you would react as a patient and speak from a point of view of being in their shoes
CRC 3.0:Successful Recruitment and Retention Strategies Brainstorming Ideas –Summarized from Beth Harper’s Session
CTPQ Factor
Solutions, Ideas, Best Practices
Setting and
managing
expectations
with the subject
/ families
• Improve communication, ask them, continuously assess their experiences and ask for feedback
• Give the patient day-to-day obligations and responsibilities, schedule with details
• Ensure that you have explained the importance of the data that comes from their participation
and importance of complying with visits, dosing and all protocol requirements
• Manage expectations and route questions to the appropriate clinicians
Enhancing
credibility of the
staff interacting
with the subjects
•
•
•
•
•
•
Enhancing
interim and
ongoing
communication
with the patients
by the CRC
• Be aware; be available, be transparent; ensure patient has current contact information of site
staff and vice versa
• Check in with patients between visits; text check in; provide cell phone # of staff
• Appointment reminder cards
• Use” My chart” patient portal (or equivalent) to keep in touch with patient
• Follow-up email or call after appointments (especially initial) to see how patient is doing
• Respond to all calls and emails promptly
• Provide newsletters with progress of study
• Provide information about where the patient can learn about the results (ct.gov) at end of trial
and keep in touch with patient over the long run so they become research advocates or
participate in future trials
Edify each other, provide adequate training;
Professionalism of staff; introduce the staff and highlight experience / certifications; honesty
Train non-research staff in the basics
Wear employee name badges; ensure they are visible
Establish rapport - find something in common
CICARE (Connect, Introduce Self, Communicate, Ask and Anticipate patient Needs, Respond to
questions, Exit courteously)
• Educate your self in the disease state – make sure you are credible and confident and can speak
from a place of knowledge
• Prepare questions you anticipate from the patient, read the consent form, conduct dry-run
consent discussion so you are prepared to answer questions with confidence
CRC 3.0:Successful Recruitment and Retention Strategies Brainstorming Ideas –Summarized from Beth Harper’s Session
CTPQ Factor
Solutions, Ideas, Best Practices
Enhancing interim
and ongoing
communication with
the patients by the PI
•
•
•
•
•
Responding to patient
/ family concerns /
questions
• Be timely in responses; go through risks and fully inform them, be available and be
knowledgeable; provide FAQs on website for patients
• Provide 1-800 # for patients to call for information; provide contact information for PI and
CRC
• Schedule longer time during visits
• Provide on-call nurse
• Ensure patient thoroughly understands the informed consent information before they
leave
• Involve family members in the consenting process
Facilitating adequate
resources for the
subjects to
participate
•
•
•
•
•
Be involved, encourage patients to contact office with questions
Provide interim lab results and updates
Provide contact information so patient/family can always reach the doctor
Refresh the PI on the patient’s status, concerns, etc. before the PI sees the patient each visit
Ensure the PI is present and spends time with the patient/family during the consent
process
Refer to social work, psycho or other departments to identify other support and resources
Provide free parking
Provide visit calendars
Ensure stipends are reasonable and appropriate for the subject’s investment
Negotiate better patient reimbursement rates with sponsors / CROs
CRC 3.0:Successful Recruitment and Retention Strategies Brainstorming Ideas –Summarized from Beth Harper’s Session
CTPQ Factor
Solutions, Ideas, Best Practices
Reducing risk /
addressing safety
concerns
• Process amendments quickly, follow the protocol
• Ongoing education
• Provide post-visit transportation if patient is uncomfortable
Minimizing study
burdens and
inconveniences
•
•
•
•
•
Keeping important
influencers informed
and engaged
• Have a communication plan; emails / letters
• Spend time talking to them before the consenting visit; if possible and appropriate have
the family member influencers present during the consent discussions
• Have PI follow-up with GP / Family Physician / Referring Physician
Pay for hotels / gas, combine visits if needed, provide parking passes, valet parking
Home health nurse visits
Provide convenient locations for lab and radiology procedures
Combine standard of care and research procedures to minimize duplication of procedures
Provide patient “ambassadors” (e.g., student volunteers)to help patients navigate through
the facilities
CRC 3.0:Successful Recruitment and Retention Strategies Brainstorming Ideas –Summarized from Beth Harper’s Session