Request for Approval

Request for Approval under the “Generic Clearance for the Collection of Routine Customer Feedback” (OMB Control Number: 0920-0974)

TITLE OF INFORMATION COLLECTION:

Anticoagulation Manager Mobile App User Feedback Survey

PURPOSE:

The iOS-based Anticoagulation Manager app allows physicians to select the most appropriate laboratory test(s) that will point to the best anticoagulant drug, determine its proper dose and formulation adjusted for other existing conditions, and monitor the anticoagulation effect of the drug in patients. Patients with certain clotting disorders or conditions have a greater risk of developing arterial or venous clots and downstream embolisms, strokes, and arterial insufficiency. These patients need prescription anticoagulant drugs to reduce the possibility of clot formation. The clinical decision making workflow in determining the correct type and dosage of anticoagulant(s) can be challenging, based on the complicated coagulation pathways and individual clinician’s knowledge of the subject and prior experience. To address this challenge, the Anticoagulation Manager, an intelligent clinical decision workflow management system is developed by Centers for Disease Control and Prevention’s Division of Laboratory Systems to help clinicians effectively choose the appropriate coagulation tests to guide drug selection for patient management, by just a few clicks on a phone or tablet screen.

The Anticoagulation Manager user feedback voluntary survey will be accessible by clicking a link in the app and will be promoted through push notifications on the user’s iOS mobile device. The clickable link in the app interface links to a Survey Monkey webpage where users can choose to participate in the survey. The push notification will not interfere with the use of the mobile app. The information to be collected aims to understand users’ satisfaction with the mobile app (including satisfaction with content and ease of use). The survey questions will take approximately 5 minutes to complete. Responses will be anonymous and no unique identifying information will be sought or kept. The feedback we receive will be used by our program in aggregate only. The user feedback will help the continuous quality assurance of the app and inform the update process to align the app to user needs. User feedback will provide valuable insight on the benefits and limitations of the mobile app that would not be captured elsewhere.

DESCRIPTION OF RESPONDENTS:

This is a voluntary survey to collect information from users of the Anticoagulation Manager Mobile App, which may include laboratory professionals, practicing physicians, medical residents, nurse practitioners, and other healthcare professionals.

TYPE OF COLLECTION: (Check one)

[ ] Customer Comment Card/Complaint Form [ x ] Customer Satisfaction Survey

[ ] Usability Testing (e.g., Website or Software [ ] Small Discussion Group

[ ] Focus Group [ ] Other: ______________________

CERTIFICATION:

I certify the following to be true:

1. The collection is voluntary.

2. The collection is low-burden for respondents and low-cost for the Federal Government.

3. The collection is non-controversial and does not raise issues of concern to other federal agencies.

4. The results are not intended to be disseminated to the public.

5. Information gathered will not be used for the purpose of substantially informing influential policy decisions.

6. The collection is targeted to the solicitation of opinions from respondents who have experience with the program or may have experience with the program in the future.

Name:____Collette Leaumont Fitzgerald ____________________________________

To assist review, please provide answers to the following question:

Personally Identifiable Information:

1. Is personally identifiable information (PII) collected? [ ] Yes [ x] No

2. If Yes, is the information that will be collected included in records that are subject to the Privacy Act of 1974? [ ] Yes [ ] No

3. If Applicable, has a System or Records Notice been published? [ ] Yes [ ] No Not Applicable

Gifts or Payments:

Is an incentive (e.g., money or reimbursement of expenses, token of appreciation) provided to participants? [ ] Yes [ x] No

BURDEN HOURS

Category of Respondent	No. of Respondents	Participation Time	Burden
Individuals and households	0	0	0
Private sector	2000	5/60	167
State, local, tribal government	0	0	0
Federal government	0	0	0
Totals	2000	5/60	167

FEDERAL COST: The estimated annual cost to the Federal government is ______$3,610______

If you are conducting a focus group, survey, or plan to employ statistical methods, please provide answers to the following questions:

The selection of your targeted respondents

1. Do you have a customer list or something similar that defines the universe of potential respondents and do you have a sampling plan for selecting from this universe?

[ ] Yes [x ] No

If the answer is yes, please provide a description of both below (or attach the sampling plan)? If the answer is no, please provide a description of how you plan to identify your potential group of respondents and how you will select them?

• Because this is a voluntary user feedback survey we do not have a pre-defined list of respondents. We anticipate users of the Anticoagulation Manager Mobile App to include laboratory professionals, practicing physicians, medical residents, nurse practitioners, and other healthcare professionals. These app users will voluntarily participate in the survey administered through Survey Monkey.

Administration of the Instrument

1. How will you collect the information? (Check all that apply)

[ x] Web-based or other forms of Social Media

[ ] Telephone

[ ] In-person

[ ] Mail

[ ] Other, Explain

2. Will interviewers or facilitators be used? [ ] Yes [ x ] No

Please make sure that all instruments, instructions, and scripts are submitted with the request.

Instructions for completing Request for Approval under the “Generic Clearance for the Collection of Routine Customer Feedback”

TITLE OF INFORMATION COLLECTION: Provide the name of the collection that is the subject of the request. (e.g., Comment card for soliciting feedback on xxxx)

PURPOSE: Provide a brief description of the purpose of this collection and how it will be used. If this is part of a larger study or effort, please include this in your explanation.

DESCRIPTION OF RESPONDENTS: Provide a brief description of the targeted group or groups for this collection of information. These groups must have experience with the program.

TYPE OF COLLECTION: Check one box. If you are requesting approval of other instruments under the generic, you must complete a form for each instrument.

CERTIFICATION: Please read the certification carefully. If you incorrectly certify, the collection will be returned as improperly submitted or it will be disapproved.

Personally Identifiable Information: Provide answers to the questions.

Gifts or Payments: If you answer yes to the question, please describe the incentive and provide a justification for the amount.

BURDEN HOURS:

Category of Respondents: Identify who you expect the respondents to be in terms of the following categories: (1) Individuals or Households;(2) Private Sector; (3) State, local, or tribal governments; or (4) Federal Government. Only one type of respondent can be selected.

No. of Respondents: Provide an estimate of the Number of respondents.

Participation Time: Provide an estimate of the amount of time required for a respondent to participate (e.g. fill out a survey or participate in a focus group)

Burden: Provide the Annual burden hours: Multiply the Number of responses and the participation time and divide by 60.

FEDERAL COST: Provide an estimate of the annual cost to the Federal government.

If you are conducting a focus group, survey, or plan to employ statistical methods, please provide answers to the following questions:

The selection of your targeted respondents. Please provide a description of how you plan to identify your potential group of respondents and how you will select them. If the answer is yes, to the first question, you may provide the sampling plan in an attachment.

Administration of the Instrument: Identify how the information will be collected. More than one box may be checked. Indicate whether there will be interviewers (e.g. for surveys) or facilitators (e.g., for focus groups) used.

Please make sure that all instruments, instructions, and scripts are submitted with the request.

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