Participant Retention and Follow up

1. Participant Retention and Follow up Diane G. Ives MPH Senior Research Associate Center for Aging and Population Health Department of Epidemiology University of Pittsburgh

2. WHI CHS Diane Health ABC LIFE GEMS Look AHEAD

3. Something was wrong….. • CHS Year 20 of follow up • Losing contact with subjects • Missing data/missing visits • Losing quality proxies • Difficulty acquiring documentation • Talked with each site • Group conference call • Basis for discussion points

4. Participant and proxies Ascertainment of information Events/outcomes Investigation of information New Strategies & Techniques

5. Clinical measurements: Robotic, controlled, no variability, strict protocols Retention issues: Clinical judgment, every case is different, past experience with subject, flexibility, creativity Use your brain, use your instincts, use your knowledge….. THINK OUTSIDE THE BOX Protocol

6. Remember…… “Participants volunteered to be followed by the study, and signed informed consent. All you are doing is carrying out their wishes to help us by contacting the proxies when the participants cannot complete the information themselves.” Piera Kost Pittsburgh Clinic Coordinator Expert in all-things-participant

7. Proxies/Contacts/Informants/Designees • A person who can provide information about the participant if the participant is not able to answer for him/herself • You can never have too many • Not all in one household • Update at regular and frequent intervals • Consider ways to verify they know they have been identified by participant

8. Expanded Tracking Information • Address • Phone number • Cell phone • Email • Relationship to Participant • Identify DMPA • Identify NOK

9. Consenting of Proxies • Rules vary by site • Verbal agreement • ‘Implicit’ • Document ‘consent’

10. Reasons for Calling a Proxy • The participant cannot be reached after multiple attempts. • The participant’s telephone number is disconnected. • The participant has a catastrophic health event and can no longer provide information. • The participant specifically requests that his/her proxy be called to obtain the information. • The participant has significant hearing impairment. • The participant is in a nursing home and does not have the ability to complete his/her own calls.

11. Talking with the proxy • Determine the frequency and type of contact proxy has with the participant • Remind the proxy to answer for the participant. • ‘Don’t know’ is better than a guess • If the reason for calling the proxy is permanent, remind the proxy you will be calling back in 6 months

12. Talking with the proxy • Refer to something about the participant when speaking to the proxy to let the proxy know the participant is truly part of the study and know what has been going on in the participant’s life. Ex. recent health or life event • Be confident! • Maybe diffuse suspicion or concern of proxy • Lends credibility to call

13. Participants in Nursing Homes • Don’t assume participant cannot speak • May only be temporary • Proxies may not be able to assess function of participant, especially if out of the area • Consider nursing home staff possible proxies, especially for medications • Use HIPAA release

14. Cognitive Impairment • Most common reason for inability to answer questions • Cannot provide important study information (dates or reasons for hospitalizations, medications) • Unable to assess own physical function/ability

15. Signs of Cognitive Impairment • The participant does not seem ‘with it’ on the call. • The participant provides vague or inappropriate responses, responds to simple questions inappropriately angry, or answers ‘don’t know’ to simple questions. • The participant becomes disinterested quickly and forgets he/she is completing the surveillance call. • Documentation in the participant’s chart indicates previous proxy contact AND that proxy contact should be continued.

16. Documentation • Available to all staff with participant contact - centralized • Completed consistently in a standardized manner • Progress notes • Index cards • NOT on individual forms in chart • Communication!

17. What to Document • Changes in the participant’s living arrangements (ex. Moving to a nursing home). • Changes in the participant’s cognitive or health status affecting his/her ability to provide responses on the surveillance calls. • Changes in the status of the proxy or contacts such as death, lost to follow up, no longer willing to provide information. • Reasons for calling a proxy or contact that are temporary (ex. Participant is out of the country and unable to be reached but will be returning). • Reasons a proxy or contact is not able to provide information (ex. No longer has frequent contact with the participant).

18. What to Document • Recommendations from a proxy or contact for other potential proxies or contacts that may be able to provide the surveillance information (ex. name of nurse at a nursing home). • The relationship to the participant of the proxy/contact providing information. • The frequency the proxy/contact speaks to the participant. • The type of contact the proxy or contact has with the participant (in-person vs. telephone). • Any other information which may be useful in characterizing the status of the participant or situations with proxies and/or contacts.

19. Events

21. Challenges in Ascertainment • Subject Issues • Vague/inaccurate source information (dates, location, diagnosis) • Co-morbidity and dementia • Poor or missing proxies/contacts • Resistance by participants and gatekeepers • Relocating • Multiple Medical Records Departments • Copy services

22. Documentation-Strategies & Tools • Electronic medical records • Local obituaries • Minimum document sets • Good tracking systems • Clear, concise requests • Read the chart!

23. World Wide Web • www.ancestry.com/ • www.ancestry.com/search/rectype/vital/ssdi/main.htm • www.ahd.com/ • www.longlostpeople.com • http://www.hospitalsoup.com/hospitalsearch.asp

24. World Wide Web * • http://findadoc.upmc.com/ • www.wpahs.org/patients/physician/index.cfm • www.post-gazette.com/obituaries/ • www2.county.allegheny.pa.us/RealEstate/ * Local sources

26. HIPAA Impact on Research • Changes in new Informed Consent document • Standardized HIPAA compliant authorization to release medical records • Communication with Privacy Officer • Release of records on deceased subjects • Open-ended dates

27. The Privacy Rule has a general set of authorization requirements that apply to all uses and disclosures, including those for research purposes. However, several special provisions apply to research authorizations: Unlike other authorizations, an authorization for a research purpose may state that the authorization does not expire, that there is no expiration date or event, or that the authorization continues until the “end of the research study.” HIPAA

28. HIPAA regulations Section 164.532 Transition Provisions, paragraph (c)-Implementation specification: Effect of prior permission for research. A covered entity may, to the extent allowed by one of the following permissions, use or disclose, for research, Protected Health Information (PHI) that it created or received either before or after the applicable compliance date. Permissions include: 1) The authorization or other express legal permission from an individual to use or disclose PHI for the research; 2) The informed consent of the individual to participate in the research; or 3) A waiver by an IRB or informed consent for research.

29. Final Thoughts….. • Encourage staff to use their minds and instincts • Use knowledge of the individual participants • Use communication skills to inform people of what you need • Engage the investigators!

30. You can catch more flies with honey than with vinegar

31. Many thanks to the staff at the CHS field centers for sharing their experiences, successes and failures Special thanks to Piera Kost and Norma Dermond