Request for Approval

GenIC Request_Clinical Guidelines_Finalv2.docx

CDC/ATSDR Formative Research and Tool Development

Request for Approval

OMB: 0920-1154

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Request for genIC Approval

CDC/ATSDR Formative Research and Tool Development


0920-1154


Shape1

CIO: National Center for Emerging and Zoonotic Infectious Diseases


PROJECT TITLE: Clinician Preferences for CDC Clinical Guideline


PURPOSE AND USE OF COLLECTION: The purpose of this project is to understand the preferences of clinicians for CDC clinical guidance on infectious diseases, including its location and format, as well as their preferences for how they are alerted to the publication or updating of guidance. The project also seeks to understand any differences in preferences for guidance for routine care and guidance for use during public health emergencies. Information collected will be used to guide the future development, dissemination, and communication about clinical guidance.


DESCRIPTION OF RESPONDENTS: Respondents will be a random sampling of 25 physicians made up of family and general practitioners (9), OB/GYNs (8), and pediatricians (8) of varying years of practice and geographic location in the United States.


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. Information gathered will not be used to substantially inform influential policy decisions.

  5. The study is not intended to produce results that can be generalized beyond its scope.


Name: _Victoria Carter, PhD, MPH_____________________


To assist review, please answer the following questions:


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


Gifts or Payments:

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


For this research effort, approval is requested for a monetary token of appreciation valued at $75 for all participating physicians. This will likely be delivered as a gift card provided through the recruitment sub-contractor. The $75 amount was determined on three factors: (1) limited incentives represent a significant challenge to the timeline because of the challenge it creates to recruit physician participants which in turn affects our timeline; (2) the research focus on clinical guidelines requires research with specific healthcare provider respondents – specifically with practicing physicians; and (3) difficulties experienced in recruiting with low incentives.


Factor 1: Lower incentives represent a significant challenge to the overall timeline of the clinical guidelines research effort. The project team has limited time to conduct these in-depth interviews in order to obtain results before the expiration of the contract with Deloitte who will be facilitating the interviews.


  • Based on prior experience, (and per discussion with multiple recruitment firms) approximately $200 is needed for physicians to incentivize their participation in research efforts. This number is based on average billable rates that physicians charge for their consulting services. Given budget restraints, we ask for $75 in hopes that providing a percentage of their typical billable rate will incentivize them more than no incentive at all. From experience, lower incentives make recruiting these specialized audiences exceptionally difficult and increase the amount of time needed for recruitment and data collection. Increasing the time for the research will jeopardize the ability to conduct the research and place the project in its entirety at risk.


Factor 2: The focus on clinical guidelines for the research project requires recruit of very specific types of healthcare providers. It is critical that these specific types of physicians are recruited to participate as they are most likely to receive and implement clinical guidelines for diagnosis and treatment of patients in both regular and public health emergency settings. The specific healthcare provider types are those who CDC feels are critical to reach in order to educate and share the latest clinical guidelines and have them implemented in practice.


  • Specific types of healthcare providers are required for this research, including pediatricians, OBGYNs, general and family practitioners. These types of providers are notably difficult to recruit due to overwhelming requests for their participation in research and their busy schedules, and because they often serve in primary care roles caring for patients in busy practices. From experience, higher incentives are needed to recruit these audiences to participate in research.

  • The project’s screening criteria intentionally narrow the participant pool to ensure that we recruit physicians most likely to use CDC clinical guidance.

  • Because clinical guidelines will vary based on the infectious disease or the public health emergency, the project requires a sample of physicians from across the United States. These must be working physicians and as such they will lose billable patient time by participating in our research study. Providing the request monetary token of appreciation will help lessen the financial burden for the participants.


Factor 3: In previous unrelated research efforts with a similar target audience, Deloitte experienced many difficulties recruiting the target physicians. This indicates the need for a higher amount as a token of appreciation for participation in this research.


  • From past experiences, these groups of physician types are frequently inundated with requests to participate in interviews or surveys. As a result, they often decline to participate or they cancel at the last minute due to patient load or work obligations. Based on research and experience, a low token of appreciation amount hampers recruiting to this type of research because it fails to motivate these groups to participate due to the demands of their work schedules, professional commitments, and patient loads. From conversations with market recruiting firms, typical incentives range from $150 - $300 for 60 minutes of time depending on the physician type.

  • Because this interview will be conducted via phone, there is no travel required, but it may last up to one hour, costing the participant billable patient time, a $75 token of appreciation is requested.


BURDEN HOURS

Category of Respondent

Form Name

No. of Respondents

Participation Time (minutes)

Burden in Hours

General Practice/Family Physicians (Individual)


9

60

9

OB/GYN Physicians (Individual)


8

60

8

Pediatricians (Individual)


8

60

8

Totals




25


FEDERAL COST: The estimated annual cost to the Federal government is ___$1,207.50______


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? [X ] Yes [ ] 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?


The recruitment vendor, which will be subcontracted by Deloitte Consulting, will screen their participant database to identify, recruit, and schedule interviews with respondents that meet eligibility requirements for one-on-one interviews.


Administration of the Instrument

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

[ ] Web-based or other forms of Social Media

[X ] Telephone

[ ] In-person

[ ] Mail

[ ] Other, Explain

  1. Will interviewers or facilitators be used? [X ] Yes [ ] No

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


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File Typeapplication/vnd.openxmlformats-officedocument.wordprocessingml.document
File TitleDOCUMENTATION FOR THE GENERIC CLEARANCE
Author558022
File Modified0000-00-00
File Created2021-01-20

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