Changes to information collection

Attachment 14 Changes to the Information Collection

The following changes have been made to the information collection (IC):

1. Addition of a Staff Communication Questionnaire for Medical Providers (Att 11b). This addition is needed in order to determine how and if the model program improves patient outcomes through improved communication and collaboration between patients’ clinical providers and pharmacists.

2. An explanation for the reduction in the number of project staff and type of project staff who will complete the previously approved Staff Communication Questionnaire (Att 11a) has been added under section 1: “Circumstances Making the Collection of Information Necessary.”

3. The summary text box has been revised to shorten the text to 2-4 sentences for each bullet.

4. An update as to the status of the data collection from the previously approved Pharmacy cost form, Clinic cost form, Interviewer data collection worksheet and Staff communication has been added under the section “Circumstances Making the Collection of Information Necessary.”

5. Addition of screenshots for the electronic data collection of the Quarterly Patient Information form (Att 7c). The electronic data collection was previously approved as a “change request” on 10/6/2015.

Why changes have been made to the information collection

The project aims to develop and implement a model of HIV care that integrates community pharmacists with primary medical providers for patient-centered HIV care. Data collection is necessary in order to determine if the model program improves patient outcomes through improved communication and collaboration between patients’ clinical providers and pharmacists. Adverse events, medication interactions, inappropriate regimens, suboptimal regimens, ineffective regimens, contradicted regimens and poor compliance are all therapy related problems that can be recognized by pharmacists. Increased communication and collaboration between project clinic providers and pharmacists may decrease these therapy related issues potentially leading to improved health outcomes. As such, data on communication between the project clinic providers’ and project pharmacists’ will be collected to determine if active communication improves patients’ health outcomes. The previously approved Staff communication questionnaire (OMB approval 8/19/2015) focused on project pharmacists’ communication with the project clinic providers. In order to understand project clinicians’ communication with the project pharmacists, the Staff Communication Questionnaire for Medical Providers is being requested for approval. In addition, the number of project staff to complete the Staff Communication Questionnaire has been reduced from 70 to 30. This is because only the project pharmacists will now complete the Staff Communication Questionnaire since the Staff Communication Questionnaire focuses on the communication between the project pharmacists and clinic staff from the pharmacists’ perspective. Project physicians and nurses will no longer complete the Staff Communication Questionnaire, but rather will complete the Staff Communication Questionnaire for Medical Providers which focuses on the communication between project clinicians and pharmacists from the perspective of the clinic staff.

How changes will affect the information collection

Project clinic staff will be asked to complete the Staff Communication Questionnaire for Medical Providers, twice within the project period. The total burden hours will not change. In the previously approved OMB package the Staff Communication Questionnaire (Att 11a) was to be administered to both project staff pharmacists (total of three pharmacists at each of the 10 project sites for a total of 30 pharmacists)and clinic staff (total of four clinic staff at each of the 10 project sites for a total of 40 clinic staff). In this revision, the Staff Communication Questionnaire (Att 11a) will be administered only to the project staff pharmacists (three per each of the 10 project sites) and the Staff Communication Questionnaire for Medical Providers (Att 11b) will be administered to project clinic staff (four per each of the 10 project). The Staff Communication Questionnaire for Medical Providers (Att 11b) is estimated to take 30 minutes to complete which is the same time burden as the Staff Communication Questionnaire (Att 11a). The net number of burden hours and the annualized burden costs, therefore, does not change.