Johns Hopkins Institute for Clinical Translational Research OFFICE

Johns Hopkins Institute for Clinical & Translational Research OFFICE OF RECRUITMENT AND RETENTION Cheryl Dennison Key Features of a Recruitment Plan. Lessons from Marketing. October 16, 2009

“…the majority (nearly 80%) of clinical trials conducted in the US must extend enrollment by at least one month beyond the study completion period. ” Getz, K. “Meeting and Extending Enrollment Deadlines. ” PAREXEL Pharmaceutical R&D Statistical Sourcebook 2000. p. 104. The Office of Recruitment and Retention Lunch Lecture Series October 16, 2009

Key Features of Recruitment Process. Lessons from Marketing. Ensuring positive moments of truth Developing brand value Gaining legitimacy/ prestige Providing frequent positive reinforcement Facilitating standard operating procedures IV. Maintaining I. Building brand values engagement Engaging active sponsors, champions & change agents III. Making the sale II. Product and market planning Providing simple, complete processes Devising strategies for overcoming resistance Delivering a multiaudience, multilevel message Achieving buy-in Signaling worthiness Adopting an explicit marketing plan Campbell et al. Health Technology Assessment 2007; Vol. 11: No. 48. The Office of Recruitment and Retention Lunch Lecture Series October 16, 2009

5 Stages in “Marketing” a Trial • Set-up • Gaining prestige • Building robust systems • Market planning • Segmenting markets • Devising marketing story • Signaling • Conveying message • Enrolling patrons and sponsors • Learning • Developing market knowledge • Redirecting strategy Campbell et al. Health Technology Assessment 2007; Vol. 11: No. 48. • Reinforcing • Maintaining and renewing commitment The Office of Recruitment and Retention Lunch Lecture Series October 16, 2009

Where to Start? ? • Critically review protocol with emphasis on enrollment criteria / participant burden • Identify possible sources of participants and strategies to engage them • Develop marketing message(s) / plan • Develop outreach plan • Prepare materials • Recruit and train staff • Plan to evaluate plan The Office of Recruitment and Retention Lunch Lecture Series October 16, 2009

Reviewing the Study Design / Protocol • Length of Study ▫ What is the minimum duration necessary to see an effect? • Choice of Control Group ▫ Use of placebo typically increases difficulty • Number and Type of Tests Performed ▫ Blood draws ▫ Procedures [colonoscopy, pelvic exam, xray, biopsies, surgery] ▫ Medication withdrawal The Office of Recruitment and Retention Lunch Lecture Series October 16, 2009

Sampling Target Population Accessible Population Study Samples The Office of Recruitment and Retention Lunch Lecture Series October 16, 2009

Ideal Accessible Population • High risk for disease • Candidates for treatment • Representative of target population • Ethical considerations • Feasibility considerations ▫ recruitment ▫ follow-up ▫ high quality data The Office of Recruitment and Retention Lunch Lecture Series October 16, 2009

Enrollment Criteria • Inclusion Criteria ▫ Characteristics of accessible population • Exclusion Criteria ▫ Considerations related to: adherence follow-up safety ethics The Office of Recruitment and Retention Lunch Lecture Series October 16, 2009

Potential Nonadherence Indicators At Enrollment • • • Concerns about randomization Expectation for specific treatment Concerns about medication side effects Concerns about study task demands No-show or rescheduled assessment appointments Scored positive on blood alcohol concentration (BAC) on breath analyzer test at baseline interviews • Problems with detoxification • Unexpected social, occupational or health event The Office of Recruitment and Retention Lunch Lecture Series October 16, 2009

Developing a Recruitment Plan • Know your resources (human/financial) • Estimate # / month needed to achieve recruitment goal ▫ Information needed Start and stop dates, e. g. , 12 months Sample size, e. g. , 240 Yield from initial screening visit, e. g. , 10% Number of screening visits, 2, 400 = 240/. 1 Number of screening visits per month, 200=2, 400/12 The Office of Recruitment and Retention Lunch Lecture Series October 16, 2009

Developing a Recruitment Plan Establish “brand” for study Use multifaceted “marketing” approach Select acronym and logo for easy id q q Prepare key informational materials q Good Acronym (e. g. , HERS, COACH) Bad Acronym (e. g. , ORP, BIRP) Brochures, fact sheets, posters, pocket reference cards, video, podcast, stories, advertisements Prepare or purchase other promotional materials q Pens, bags, coffee mugs, memory sticks, …. The Office of Recruitment and Retention Lunch Lecture Series October 16, 2009

Developing Recruitment Materials Make materials appealing q Items to include q Major inclusion and exclusion criteria q Potential benefits and incentives q Large fonts, interesting graphics, eyecatching message Contact information Educate and engage potential referrers JHMIRB guidance The Office of Recruitment and Retention Lunch Lecture Series October 16, 2009

Five Levels Of Potential Participant’s Commitment 1. Uninformed (inform and persuade with targeted stories) 2. Unconvinced (address concerns point -by-point; get to yes) 3. Laggards (enroll, cajole, facilitate and target) 4. Steady performers (reward, renew, upgrade and recognize) 5. Stars (honor, learn from, exploit and nourish) Campbell et al. Health Technology Assessment 2007; Vol. 11: No. 48. The Office of Recruitment and Retention Lunch Lecture Series October 16, 2009

Ongoing Recruitment Activities • Track and evaluate progress • Drop and add new strategies based on performance • Maintain rapport with referring physicians ▫ Avoid perception that you are competing for patients ▫ Refer participants back for medical care ▫ Report abnormal findings and medical issues to primary care doctors The Office of Recruitment and Retention Lunch Lecture Series October 16, 2009

Tracking Recruitment • Record activity (contacts, visits) • Track the process in detail by ▫ recruitment source or strategy, if possible ▫ recruiter or staff person ▫ time to return calls • Use flexible database software (e. g. , Access) • Use reports routinely to guide decisions and allocate resources • Review progress frequently The Office of Recruitment and Retention Lunch Lecture Series October 16, 2009

Measuring Success • Recruiting method ▫ ▫ ▫ # calls in / out # appointments scheduled # eligible # enrolled # trial completers • If possible, estimate: ▫ Total costs of the method ▫ Cost per enrolled participant The Office of Recruitment and Retention Lunch Lecture Series October 16, 2009

Office of Recruitment & Retention, 10/16/2009

Staff Recruitment and Training • Planning ▫ Budget adequately for personnel and training • Hiring ▫ Focus on interpersonal skills (phone, in-person) Customer service ▫ Strive for diversity (race-ethnicity, gender) • Training ▫ Study disorder and its implications ▫ Trial marketing message(s) ▫ Recruiting goals, procedures, and regulations The Office of Recruitment and Retention Lunch Lecture Series October 16, 2009

Staff Retention • Motivate ▫ Set personal recruitment goals ▫ Acknowledge challenges and interim progress ▫ Check in formally (e. g. , staff meetings) as well as informally (e. g. , view from the trenches) • Celebrate ▫ Interim goals and end of recruitment The Office of Recruitment and Retention Lunch Lecture Series October 16, 2009

Advertising Your Study at Hopkins • Hopkins Ink ▫ Kara Yeager, editor, 5 -1396 ▫ hopkinsink@jhmi. edu ▫ Deadline is noon on Thursdays ▫ Like electronic submissions ▫ http: //www. insidehopkinsmedicine. org/hopkins_ink/ • The JHU Gazette ▫ 443 -287 -9900, gazette@jhu. edu ▫ Free listing in notices ▫ Deadline is noon on Mondays, 1 week prior to publication date ▫ www. jhu. edu/~gazette • Digital TV ads ▫ Melissa Schmelick, Content Manager, 4 -6610 ▫ Broadcasts your message on plasma TVs across the university ▫ $50/month ▫ Runs for 15 seconds each cycle The Office of Recruitment and Retention Lunch Lecture Series October 16, 2009

Office of Recruitment & Retention, 10/16/2009 Marketing Your Study Kathy Smith Director Market Development ksmith 19@jhmi. edu 5 -0088 (please state that you have been referred by the ORR) The Office of Recruitment and Retention Lunch Lecture Series October 16, 2009

Office of Recruitment & Retention (ORR) • ORR Consult Service (ORRCS): ▫ Expert guidance to assist PI’s and Study Coordinators with: Developing recruitment & retention plan Troubleshooting plan that is not working Boosting recruiting & retention rates ▫ Contact us through ICTR Connection Request system at: http: //ictr. johnshopkins. edu/connection ▫ Select ORRCS to complete the form, which will be forwarded to us immediately The Office of Recruitment and Retention Lunch Lecture Series October 16, 2009

Office of Recruitment & Retention (ORR) • Contact Us: ▫ http: //ictr. johnshopkins. edu/ORR ▫ 5 -9872