Health and Medical Research Family Survey of the Greater Plains Collaborative (GPC)

1. Health and Medical Research Family Survey of the Greater Plains Collaborative (GPC) “The Obesity Project” “The GPC Obesity Project” “The Family Survey”

2. Purpose • Estimate the willingness of individuals to be contacted about research activities (Survey 1, Invitation). • Obtain information on the attitudes of parents of children and adults of child-bearing age about research, including participation by their child (Survey 2, Questionnaire). • Gain insight into participant attitudes about data usage for both local and national research (Survey 2). • Explore the impact of various demographic factors on the above outcomes (Survey 1 and 2). • Examine if there are differences between individuals across various weight classes (Survey 1 and 2). • Determine if there are regional variations in all of the above (Survey 1 and 2 by comparing across the 10 GPC sites).

3. Team/Teams (but may be unique to your local situation) • Informatics Team • Pull addresses and bin, provide information to clinical team in usable form for mailouts and tracking • Assign study numbers • Assist with uploads or downloads • Assist with local glitches • Clinical Team • Clerical • Assist with mailing, tracking, data entry • Research associates (IRB qualified) • Direct participant interaction • Assist with all other study operations

4. “Mail” • Regular mail • E-mail • Both • Used interchangeably in the protocol

5. Goals Survey 1 (Invitation) • GPC - 10,000 responses • Each site - 1,000 responses Survey 2 (Questionnaire) • GPC - 1,000 responses • Each site - 100 responses

6. Assumptions • 20% response rate to mail out (Survey 1, Invitation), therefore, estimate that 5000 individuals need to be contacted to get 1000 responses. • but you may want to pull more than 5000 addresses – (explained later) • Response rate will be enhanced by multiple contacts • up to 3 are permitted but are not required • If contact is done using local institutional stationery, response rate will be enhanced. • Sites will use email, snail mail or combination • Track means of contact and response

7. Participants Adults* • Parents of children, ages 2-20 years • Preferred, but may not be feasible at every site • Adults of child-bearing age, ages 21-49 years • Permitted • Combination of above • Permitted, but would try to get as many “known parents of children” as possible. * At most sites the index case is a child, but the contact is made with the adult (caretaker on record, COR)

8. Binning Process by Informatics Team • Pulling addresses and removing duplicates • explained later • “Binning” • Assigning study number • Provide the clinical team with Excel (or comparable) data base to permit address generation, mailings and tracking • more about that later

9. “Gender Bins” Gender • Male • Female If no gender or uncertain, excluded (the numbers of individuals without gender designation is likely to be very small and would not be possible to use for any analysis)

10. “Weight Bins” Weight (CDC Standards) • Normal Pediatric - 5% to <85% inclusive Adult - 18.25 to <25 inclusive • Overweight Pediatric - 85% to <95% inclusive Adult - 25 to <30 inclusive • Obese Pediatric - ≥95% inclusive Adult - ≥30 inclusive If inadequate patients to fill all bins, you are permitted to meet “Quota” for 1000 responses from other bins (discussed later). We have excluded underweight individuals since these are most likely to be individuals who are not otherwise healthy/well

11. “Age Bins” Age • 2 – 5 years inclusive (preschool) • 6-11 years inclusive (children) • 12-17 years inclusive (adolescents) • 18-20 years inclusive (young adults) • 21-49 years inclusive (for those using adults) Age is based on the date of data dump into i2b2 We are aware of concerns about “slippage in categories”

12. Total Number of Bins = 24 for those only doing children - (2 sexes, 3 weight classes, 4 age categories) = 30 for those doing adults and children - (2 sexes, 3 weight classes, 5 age categories) = 6 for those doing only adults - (2 sexes, 3 weight classes, 1 age category)

13. “Bin” Comments • Keep the eye on the prize – 1000 responses • If inadequate number of patients in a particular bin (e.g., only 50 addresses of overweight girls ages 2-5 years) may use addresses from other bins to try to meet the 1000. • These will be tracked, so we will be aware • Example on next slide • Considerable flexibility is permitted, • Across the GPC we should get reasonably good representation • We elected to not have bins for race/ethnicity because • Doubled or tripled or … the number of bins • categories in the EHR are not necessarily correct or accurate • We will have information from the EHR on the index individual • We will have some information in Survey 2 on race/ethnicity, as well

14. “Bin Balance” Example • Site goal = 40-45 responses per bin • (40 X 24 = 960, 45 X 24 = 1,080). • We anticipate a 20% response rate, so ideally: • each bin should potentially have ~ 200 individuals • Example (balancing) • You have >200 in 20 bins. • In the remaining 4 bins you only have a total of 560 (Should have ~800) so a deficit of ~240. • Suggest (not mandated) that you send out about an additional 12 invitations in each of the other 20 categories (12 X 20 = 240) • Keep your eye on the prize

15. Exclusions • Age <2 and >20 • unless adults included, then age <2 to <50 • Weight (<5%) • Duplicate address and caretaker on record • No exclusions of pregnant women, mentally impaired, or other protected classes, since we have no way of knowing this from the EHR and their selection is not based on any of these categories (“don’t ask, don’t tell”)

16. Recommendations • Local discussion between informatics and clinical team. • If large patient pool, may want to randomly select a smaller subset or use a short time window or …… • Pull 10,000-25,000 potential participant addresses. • Eliminating duplicate individuals /addresses will lower the total number of available participants • Some bins will be larger than others . We would like to have >200-250 per bin to start with,in order to get back 40-45 responses into each bin (assuming 20% return rate) • Use relatively recent data/visit if possible for address • Up to a 3 year time window is permitted but not required. • More recent addresses are likely to get a higher response rate and less “loss”

17. Overview of Participant Contact • Survey 1 (Invitation Letter) • Up to 3 contacts per individual/dyad • 3 permitted (remember the goal is 1000 responses per site) • May use email, regular mail or combination • Possible outcomes • Nothing (no return mail, no response of any sort) • Wrong address • no further contact possible, unless you choose to use another means, i.e., email and then regular mail; change of address provided by USPS • Do not contact • remove from list, no further contact by any means • On-line completion of Survey 2 (will be able to track from REDCap) • Check REDCap before any subsequent effort at contact • Possible participant contacts staff • by any method – returned mail, phone, email, in person

18. Overview of Participant Contact • Survey 2 (Questionnaire) • Up to 3 efforts per individual/dyad • May contact by any means indicated by potential participant • Survey 2 can be provided to individual by any means that are acceptable to the participant and your institution (mail, email, verbally, in person) • Possible outcomes • Unable to contact • stop after 3 attempts and send thank you note #3* • Survey 2 provided and no response received • stop after 3 attempts and send thank you note #3* • Incomplete Survey 2 • <80% of the questions answered = “incomplete” • Use common sense • Complete • Thank you note #2* * Thank you notes are not mandated in the protocol but are recommended

19. Survey 1 - Comments • Easier to track using Excel spreadsheet (discussed later) • Institutional staff (e.g., secretarial staff) who are NOT credentialed/certified may help with mailing and tracking as long as that is acceptable to your institution • Decisions about study logistics are up to the local site (e.g., waves, method of contact, etc.) • It is suggested that 2nd contact (mailing ) be done within 7-14 days after the first contact and the same for 3rd contact if planned. • There is NO prohibition about contacting by email and mailing a letter at about the same time (but this would count as 2 contacts)

20. Goals for Survey 2 • 100 respondents per site or a total of 1,000 across the GPC • More is fine (if you get more than a 100, that is wonderful) • All by Direct Link to Survey 2 is fine • All by paper is fine • Any combination is fine • Getting equal representation from each “bin” would be ideal but may not be feasible at all sites or possible given the time frame; • i.e, if there are a large number of “Direct links” for the young adult group, and none from the preschool group, then study team might make an effort to pull more of those for direct contact (if permitted by the participant) • REDCap will allow you to see totals in “close to real time”

21. Clinical Team Activities • Mail out Survey 1 and track • Track Direct Link to REDCap activities • Make contacts for Survey 2 and track • Review data for completeness • Transmit to Informatics Team when data complete

22. Study Documents • Protocol • Survey 1 (Invitation Letter) • Survey 2 (Questionnaire) • Thank you note 1, 2 and 3 • template only, can be tweaked or use your own • Data management tool (Excel) • we will provide, but you may use your own IF data can be uploaded to REDCap so that data can be compiled across the GPC • REDCap compilation • Informatics teams will assist with collations and de-identification • Local information and personal identifiers do NOT leave local institution

23. Access to Study Documents • All official UTHSCSA IRB documents are approved and final. • Sarah has a full set and they can be provided to anyone in the study group if you request them (“ask and ye shall receive”) • A full set has been provided electronically to the listed IRB contact at your institution

24. Final Protocol 04.19.2015

25. NOTES Notes are “suggestions, ideas, responses to questions that have already come up, etc.)

26. Protocol • IRB approved • Substantial changes to protocol, survey or invitation letter cannot be made without going back to the UTHSCSA IRB • Considerable flexibility left in the protocol in recognition of the variability of the different centers. • If you have questions, please email me (hale@uthscsa.edu) and cc: David Rupert (rupertd@uthscsa.edu) and Sarah Schlachter (sschlachter@kumc.edu)

27. Survey 1: (Invitation)

28. Survey 1 (Invitation) • Comments (blue) • Needs to be put on your local stationery • Unique to your institution (yellow) • Institutional name, investigator name(s) and contact information • Unique to individual participant family (red) • Adult Name and Address

29. Survey 1 (Invitation) • Un-highlighted is IRB approved so cannot be tweaked • Decision about institutional name and affiliation is up to local precedent and preference • The person listed as point of contact, or who signs the letter, should be someone that was listed on the designation of authority form that was submitted (you can add people if needed)

30. Survey 1 (Invitation) • We are in the process of getting this translated into Spanish and will make the translated version available to everyone. • The decision as to how to word the first line is up to you/your institution, e.g. Dear Clark Family, Dear Mr. or Mrs. Clark; Dear Ms. Clark; Hello Mrs. Clark;

31. Survey 1 (Invitation) • Addresses will be provided at most sites as an Excel spreadsheet • discuss with local informatics team • other approaches are permissible, but we (UTHSCSA) cannot help you • Can mail merge for: • address labels • letters to families

32. Survey 1 (Invitation) Page 2

33. Survey 1 (Invitation) Page 2 • If the family sends an email, you may send them the survey via email, or send them the link via email or both. Note that the survey does not contain PHI • If the family prefers a phone call, they may be called. At the time of the phone call, the questionnaire can be completed over the phone, or send to the family by postal service or by email. • Family may also be met in a clinical setting

34. Survey 1 (Invitation) Page 2 • If participant completes Survey 1 and wants to complete Survey 2 but you are understaffed and only plan to survey a limited number of responses, you would send out a thank you note (Thank You Note 1) • It is recommended that this note be on your institutional stationery • It is just a thank you note. It does not require IRB approval. • It can be tweaked however you wish to tweak it.

35. Survey 2 • 20 questions • In REDCAP at EACH institution • Unique identifier for each participant • Unique identifier provided to the participant in Survey 1 letter • Unique identifier on all documents that go to or come from the participant. • Participant can log on to website, enter number and complete Survey 2 one time.

36. Survey 2 • Electronic format has drop down boxes for answers • Most have a “prefer not to answer” box • Except for the ID box, all answers are optional (no mandatory answers in order to move forward). • GO TO REDCaP Desktop view

37. Survey 2 Paper form available (approved by IRB) • May be mailed to participant • May be faxed to participant • May be e-mailed to participant • but if they have email, might suggest that they go on line and complete • May be read to participant and information recorded by qualified staff • Capture the data as soon as it is available • May be handed to participant in clinical setting