Awareness Appreciation Education Expectations Environment Credibility Relationship Responsiveness Resources Communicatio n Peril (risk) Inconveniences

AwarenessAppreciatio

n

Education Expectations Environment

CredibilityRelationship

Responsiveness Resources

Communication

Peril (risk)Inconveniences

Impact of “Influencers”

A Subject’s* Willingness to Participate in a Clinical Trial is a Function of:

The CTPQ Theory

*subject, patient, volunteer, participant and/or their family member / care giverCRC 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



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

• 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

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



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

• 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

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 trialsCRC 3.0:Successful Recruitment and Retention Strategies Brainstorming Ideas –Summarized from Beth Harper’s Session


Enhancing interim and ongoing communication with the patients by the PI

• 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

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

• 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



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

• 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

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


Documents

Awareness Appreciation Education Expectations Environment Credibility Relationship Responsiveness Resources Communicatio n Peril (risk) Inconveniences