Research Subject Enrollment by Primary Care Pediatricians Using an Electronic Health Record

1. Research Subject Enrollment by Primary Care Pediatricians Using anElectronic Health Record Robert W. Grundmeier, MD1Marguerite Swietlik, CRNP1Louis M. Bell, MD2 1The Children’s Hospital of Philadelphia, Philadelphia, PA2University of Pennsylvania, Philadelphia, PA

2. Background • Clinical research relies on volunteer subjects • There are many barriers to participation • Fear, inconvenience, lack of interest, lack of awareness • Patients/families are more likely to participate if their clinician discusses research opportunities • In pediatric research the parent or guardian often consents on behalf of the child

3. Historical Approaches to Subject Enrollment • Mailing lists • Advertising in the media • Flyers in patient care areas • Direct enrollment on-site using research assistants

4. Electronic Health Record (EHR) May Help Research Subject Enrollment • Large number of potential subjects with unprecedented “richness” and “freshness” of data • Usually favorable experience at other organizations • One organization actually funded their EHR implementation with clinical research1 • Some organizations have published successful examples of subject enrollment in an EHR2 • Published results are limited 1 Miller JL. The EHR solution to clinical trial recruitment in physician groups. Health Management Technology. 2006;27(12):22-5 2 Embi PJ. Jain A. Clark J. Bizjack S. Hornung R. Harris CM. Effect of a clinical trial alert system on physician participation in trial recruitment. Arch Intern Med. 2005;165:2272-0

5. Success is Not Guaranteed • One organization’s early attempt at subject enrollment using an EHR failed1 • Study required primary care clinicians to obtain formal consent from patients at the point of care 1 Mosis G. Dieleman JP. Stricker BCh. van der Lei J. Sturkenboom MC. A randomized database study in general practice yielded quality data but patient recruitment in routine consultation was not practical. Journal of Clinical Epidemiology. 2006;59(5):497-502

6. Research Subject Enrollment Using an EHR at The Children’s Hospital of Philadelphia (CHOP) • Success at CHOP with EHR based research subject enrollment has been variable • CHOP’s Pediatric Research Consortium (PeRC) facilitated the EHR based subject enrollment efforts • 32 Practices • 185,000 Patients

7. Early experience with research subject enrollment:The Study of Estrogen Activity and Development-Judy Bernbaum, MD

8. Rapid Growth of New Research Projects using EHR

9. Evaluation The large number of PeRC studies using EHR for subject enrollment presented a natural opportunity for evaluation Specific Aims • Describe two methods for supporting research subject enrollment in primary care pediatrics using the EHR • Automated alerts delivered to clinicians • Patient lists delivered to research assistants • Describe experience to date with the research subject enrollment process in the EHR

10. Study Enrollment Option #1 Automated alerts delivered to clinicians • Actionable and informative enrollment alerts that favor specificity over sensitivity • Start date, end date • Age range, gender, race/ethnicity • Department • Visit type (office vs telephone) • Reason for visit • Diagnoses • Additional custom criteria for specific studies

12. Study EnrollmentOption #2Patient lists delivered to research assistants • Lists of appointments for potential subjects that favor sensitivity over specificity • Sent each Friday to research team • Study team can target specific dates/times to be on-site to maximize their recruitment potential

13. Results • Between 3/1/2005 and 3/1/2007 there were research subject enrollment efforts from 14 studies available for review • 11 utilized pop-up enrollment alerts delivered to clinicians at the point of care • 3 utilized patient lists delivered to on-site research assistants • Only 9 were aligned with PeRC interest areas

15. Results: Enrollment Alerts (N=11 Studies) • Qualitative feedback obtained from PeRC clinicians at advisory board meetings and EHR “super-user” workgroups • Overall satisfaction with the pop-up enrollment alerts • The prompts were too easily overlooked due to the number of other alerts that appeared • Recommended moving the prompt to the history of present illness (HPI) section at the top of the note HPI usually completed by clinicians in the exam room, whereas assessment and plan may be completed later

16. 10 months, 5 sites 6 months, 4 sites 19 months, 2 sites 22 months, 6 sites 21 months, 3 sites 19 months, 5 sites 9 months, 4 sites 8 months, 1 site   3 months, 4 sites 6 months, 2 sites 6 months, 1 site   * Studies marked with an asterisk were only seeking a control group

17. Number of Referred Subjects that Consented

18. Potential vs. Active Clinician Participants

19. Results: Patient Lists (N=3 Studies) • Clinician feedback • Well received, minimal clinician effort was required • Principal investigator feedback • Two of the three studies reached their enrollment goal • All principal investigators were satisfied, even for the one study that did not meet the enrollment goal

20. Subject Enrollment Using Patient Lists and On-site Research Assistants

21. Discussion • These observational results show that in the correct setting, an EHR can effectively facilitate research subject enrollment • Both clinician alerts and patient lists delivered to research assistants can succeed • Qualitative feedback was encouraging from both clinicians and researchers • Success is not guaranteed

22. Discussion: Clinician Alerts • Modest number of patient’s referred by clinicians through the “pop-up” alerts were ultimately enrolled (median 11%) • Documenting best phone number and time to call may help • Only a minority of clinicians receiving alerts actually referred potential subjects (median 30%) • Focusing prompts only on clinicians who express interest in each study may increase satisfaction

23. Discussion: Patient Lists • Both clinicians and principal investigators were satisfied with this approach • Requires an on-site research assistant • May not work for studies that require patients from a large geographic area, or have limited budget • By nature of the inclusion criteria, there is some disclosure of information to the research team for potential subjects that have not yet consented • IRB unlikely to approve this approach for studies investigating sensitive matters (e.g. HIV)

24. Acknowledgements • Dr. Trude Haecker, chief medical officer for the ambulatory care network • Pediatric Research Consortium (PeRC) • Agency for Healthcare Research and Quality (AHRQ)