NonSubstantive Change Request Justification

BAA Explanation of Changes

This package is related to GAOS - Get Ahead of Sepsis Pilot Assessment for Consumers and Healthcare Professionals (OMB Control # 0920-1384) and can be reviewed as a set. Overall, the changes described below are very minor and do not constitute more than 10% change to the original package.

BAA Consumer Pre-Campaign web survey and BAA Consumer Post-Campaign web survey:

• Screener section was merged – resulting in one consumer screener for pre and post campaign. This change was made because there were no differences between the pre and post screener language.

• Online programming of the BAA survey was separated by audience and by pre and post survey. There were no changes to survey questions as a result or audiences as a result of this separation, only the execution of how they are being programmed. All surveys use the same set of questions as noted in the originally approved survey questions for a specific audience group.

• Vendor information was added and replaced the “XXX” location holder.

• Updated to include the informed consent document that was once standalone as Attachment I_BAA Informed consent form this was done to allow screening of participants to determine if they were part of the intended audience.

• Language in the first paragraph of the informed consent was updated to let participants know that they were currently in the screener and not the survey.

• OMB number added

• The question about Zip Code and State was separated to allow for programming to list zip code that are on the approved list, therefore disqualifying participants who did not reside in those zip codes.

• In the Behavior section – Posttest survey timeframes for Q26, 28, 30 and 32 have been changed from 12 months to 2-3 months to align with the timeframe of the intervention.

• Incentive page added (Originally referenced in OMB Statement A)

BAA HCP Pre-Campaign web survey and BAA HCP Post-Campaign web survey

• Screener section was merged – resulting in one HCP screener for pre and post campaign. This change was made because there were no differences between the pre and post screener language.

• Online programming of the BAA survey was separated by audience and by pre and post survey. There were no changes to survey questions as a result or audiences as a result of this separation, only the execution of how they are being programmed. All surveys use the same set of questions as noted in the originally approved survey questions for a specific audience group.

• Vendor information was added and replaced the “XXX” location holder.

• Updated to include the informed consent document that was once standalone as Attachment I_BAA Informed consent form this was done to allow screening of participants to determine if they were part of the intended audience.

• Language in the first paragraph of the informed consent was updated to let participants know that they were currently in the screener and not the survey.

• OMB number added

• The question about Zip Code and State was separated to allow for programming to list zip code that are on the approved list, therefore disqualifying participants who did not perform the majority of their work in those zip codes.

• In the Use of Campaign Materials section - The images in use of campaign materials were moved to one question where the participant then chooses what campaign material they had been exposed to.

• Incentive page added (Originally referenced in OMB Statement A)

Supporting Statement A_BAA

• This statement was added “...but participants will be sent the online screener survey link first, followed by the online cross-sectional survey link for those found eligible to participate.” This was the result of testing the surveys and determining it prematurely disqualified participants if they selected the first audience listed. They would not see the additional audiences, therefore eliminating participants who qualified for multiple audiences. This resulted in the separating of the screener and survey.

Support Statement B_BAA

• This statement was added “Participants who meet the inclusion criteria after responding to all the screening questions will receive a follow-up email with the online cross-sectional survey link to take the survey. Those who are deemed ineligible will be thanked for their time and provided with exit instructions.”  This was the result of testing the surveys and determining it prematurely disqualified participants if they selected the first audience listed. They would not see the additional audiences, therefore eliminating participants who qualified for multiple audiences. This resulted in the separating of the screener and survey.