SPECIAL DIABETES PROGRAM FOR INDIANS Healthy Heart Project: Year 4 Meeting 1

SPECIAL DIABETES PROGRAM FOR INDIANS Healthy Heart Project: Year 4 Meeting 1

Healthy Heart Project: Year 4 Meeting 1


DATA UPDATE / REVIEW

Jeanne AmosCC HH Data Coordinator

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QUALITY ASSURANCE (QA)

Unless you try to do something beyond what you

have already mastered, you will never grow. Ralph Waldo Emerson

Everyone makes errorsExpect “good faith effort”CC doesn’t like to make assumptions

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TIMELINES

Baseline Annuals

Document activities and meeting regularly.

Don’t wait until the end of the year!

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BASELINE TIMELINES

Baseline (B1/B2/B3)Within 30 days PRIOR to the FIRST Case Management Visit

– Start with the hardest thing to schedule, e.g., physical exam and labs

– Hand out questionnaires (B2/B3) to be collected at first CMV

– Schedule the first CMV before the 30 days is up

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ANNUAL TIMELINES

Annual (A1/A2/A3)Within the 30 days following the 12 month anniversary of the FIRST Case Management Visit

– The Lab values and measurements are important to have done within the time frame…start here!

– Hand out questionnaires (A2/A3) to be collected at next CMV.

– Keep trying till you get it!

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Data “LINGO”Participant-Level

Forms (on website) or questionnaires (scannable) associated with a particular participant (B1-B3, A1-A3, I2, I3, SAE, IRF)

Grantee-LevelForms (on website) or questionnaires (scannable) specific to each site’s project staff meetings or activities (R3, I1, AD1, AD2, AD3, AD4, AD5)

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How To Avoid Using the Wrong Form

Download the most current forms off the CC website

http://www.uchsc.edu/ai/sdpi/hh/data/hh_data.htm

If the incorrect version of a form is submitted, the grantee may be asked to transcribe it to the correct form.

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Current Form Versions• Step 2 forms

– Baseline Assessment of Core Elements (B1)11-7-06

• Step 3 forms– Participant Attendance Form (I2) 4-27-07– Individual Retention Form (I3) 4-27-07

• Step 5 forms– Annual Assessment of Core Elements (A1) 5-25-07

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Training Resources

• The CC website– View previous meeting presentations

• Technical Assistance Training, Oct. 2006

• Technical Assistance Training DVD• Laminated Data Submission Reference Card• CC Data Coordinator• Other Grantees!!!

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Changes to the I2/I3 forms

I2: The first page has been modified so that it clearly states which dates need to be recorded. No changes to other pages.

6/13/08 – 7/13/08

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I3: The third page has been modified with a check box to indicate if the participant has dropped out. No changes to other pages. For participants who have not dropped out, the Retention Efforts (page 2) and the check box (page 3) will be the only required information.

In May, 2007, a notice was sent out by the CC requiring that these

forms be updated for all current participant files and that all new enrollees

from that date forward use the updated form.

9/27/2007

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Tips to Avoid Errors: I2/I3 forms

• TOTW August 17, 2007: When to submit I2/I3 Forms. Must be submitted together.

• TOTW Sept 14, 2007: Refresher on how to correctly fill out the I2 form.

• Make sure the 1st Case Management Visit date is consistent!

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Common Question: I2/I3What do you do if a participant has been

inactive (officially dropped) and wants to come back?

Note on their existing I3 form when they decided to come back and notify the CC via the tracking logsheet in the comments section that the individual is now active (list PID and date of return). Please also review the Retention and Drop-out Policy when in doubt.

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Common Errors: SAE/IRF formsSerious Adverse Event (SAE) Make sure to have a staff member sign the SAE form Review the materials carefully for PHI – Obliterate any PHI found &

re-copy

Incident Report Form (IRF) This form is used very rarely Check the Operations Manual if you’re unsure how to use this form DO NOT check the IRF box on the Tracking Logsheet if you are

submitting an I3 form…they are not the same form! The acroynms are listed at the bottom of the Tracking Logsheet as a reminder.

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Responding to an ENLAll initial ENL responses are to be submitted

via e-mail to the [email protected] address. Direct other concerns/questions to Jeanne.

On rare occasions you may need to re-submit a partial or full form in response to an ENL. Then and ONLY then should an ENL response be submitted along with a data submission package. The form also needs to be labeled clearly, separating it from NEW data!

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Reminder E-mailsNot the same as ENL’s

• Reminder e-mails list participants who are coming up on their one-year anniversary

• This list includes both ACTIVE and INACTIVE participants

• May also include 2006 I2 and or I3s not yet received

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Tips for Data Submission

Tracking Logsheet (TLS)Start with a clean TLS Include a copy of the TLS in the

submission packageUpdate the # Consented bi-weekly

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Tips for Data Submission (continued)

Only list the PID numbers of participants for whom you are sending new forms

List PID numbers in numeric order

Please staple all non-scannable forms (e.g., B1, A1, I2, I3)

DO NOT staple top or side of the scannable questionnaires

Separate new forms from requested “ENL responses”

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Tips on How to Avoid Sending Personal Health Information (PHI)

Violations as of 9-12-07

Make sure a second person reviews and certifies the bi-weekly electronic data submission (16/47)

Double-check each participant form/questionnaire for written names (14/47)

Double-check ENL responses (17/47)

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Confidentiality/Privacy in Everything

Paperwork/forms visible on screening table

Computer screen visible to people walking by

Staff discussions/consult on a participantConsenting processPHI on data submission

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Grantee-Level Forms

Thank you for submitting Annual December forms. Get ready for another round!

“Doing all this paper work has actually been good for me because it tells me what I didn’t do and should be doing. There is going to be a change

for the better in my project this year”

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Tips on Annual December (AD) forms

• Write clearly• Write legibly • Write clearly

• Make sure it’s decipherable• Write clearly

We’ll get back to you if we have questions or concerns

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UPDATE/REVIEW

Q & A

Jeanne M. AmosCC HH Data Coordinator

[email protected]

Documents

SPECIAL DIABETES PROGRAM FOR INDIANS Healthy Heart Project: Year 4 Meeting 1