Table 4 Rapid Cycle Evaluation of Study Implementation

Recruitment

1. Slow response time from recruitment materials

2. Labor intensive

3. Underwhelming graphic design in recruitment materials

4. Recruitment limited to Geisinger patient population

1. Patients aged out of eligibility 

1. Unused consenting visit slots

2. Less staff availability for visits

3. Recipients doubted authenticity of materials

3. Recruitment materials easy to overlook

4. Depleted pool of potentially eligible participants

1. Started making recruitment calls before postcards were returned

1. Removed return postcard from mailings

2. Outsourced printing and mailing

2. Outsourced non-responder recruitment calls

3. Utilized Geisinger’s Marketing & Communications department for ads

4. Placed flyers in the community

4. Added advertisements (social media, news media, newsletters)

4. Added referrals from participants

4. Added community outreach events

Enrollment

1. Staff time was divided between recruitment and enrollment and other study activities

2. Inefficient informed consenting process

3. Interested participants unwilling/unable to travel to available locations

1. Fluctuating monthly enrollment totals

2. Individual sessions limited number of participants enrolled per day

2. No-shows and cancellations impacted the number of participants enrolled per day

2. Consenter fatigue

3. Interested participants could not be scheduled for enrollment visit

1. Hired, cross-trained, and utilized staff from other departments

2. Group consenting sessions

2. Accounted for no-shows and cancellations by opening additional appointment slots

3. Secured additional enrollment locations for participant convenience and contacted particpants again

Protocol and Procedure Adherence

1. A staff member formatted an appointment sheet incorrectly

2. Photocopier not available at most visit sites required participants to sign two copies of the ICF

3. Paperwork (inclusion form, ICF, gift card confirmation, phlebotomy form, and baseline survey) was challenging to keep organized at visits

Protocol deviations:

1. Printed appointment information was inaccurate, and participants completed wrong visit types (one paricipant was consented twice and one participant had a blood draw before signing consent)

2. Participants only signed onecopy of ICF and took it home, which resulted in missing paperwork

PHI breach:

3. In two instances, participants took other participants paperwork home requiring reports to IRB and Privacy Office

1. Staff was trained on how to correctly format appointment sheets

1. Assigned appointment sheet formatting to a specific staff member

2. Implemented audits checking for unsigned or missing ICFs during visits

3. Utilized folders for each participant to organize paperwork at visits

Participant Experience

1. Inconsistent turnaround time for returning PET-CT scan results

2. Utilized 22 different enrollment sites, each with unique challenges

1. Five participants complained

1. Participants reported stress or anxiety when calling to inquire about PET-CT scan results

2. Site limitations included:

a. Poor parking

b. Lack of privacy

c. Lack of signage to visit area

d. Lack of operational management at non-clinic sites

1. Added primary care investigators to the study to return non-cancerous PET-CT results, requiring study oncologists to only return suspicious findings

2. Problem locations were no longer used, or processes were modified

a. Detailed parking instructions were provided during scheduling and reminder calls

b. Altered visit setup to accommodate for more privacy and safety for participants

c. Designed portable study signage for use at all sites

d. Assumed more responsibility at sites that lacked operational management