GenIC Request Template (Project Description and Justification) for ORR Interviews

Request for Approval under the “Generic Clearance for the Collection of Routine Customer Feedback” (OMB Control Number: 0920-1050)

Instruction: This form should be completed by the primary contact person from the Program sponsoring the collection.

DETERMINE IF YOUR COLLECTION IS APPROPRIATE FOR THIS GENERIC CLEARANCE MECHANISM:

Instruction: Before completing and submitting this form, determine first if the proposed collection is consistent with the scope of the Collection of Routine Customer Feedback generic clearance mechanism. To determine the appropriateness of using the Collection of Routine Customer Feedback generic clearance mechanism, complete the checklist below.

If you select “yes” to all criteria in Column A, the Collection of Routine Customer Feedback generic clearance mechanism can be used. If you select “yes” to any criterion in Column B, the Collection of Routine Customer Feedback generic clearance mechanism cannot be used.

Column A	Column B
The information gathered will only be used internally to CDC. [X ] Yes [ ] No	Information gathered will be publicly released or published. [ ] Yes [ X ] No
Data is qualitative in nature and not generalizable to people from whom data was not collected. [X ] Yes [ ] No	Employs quantitative study design (e.g. those that rely on probability design or experimental methods) [ ] Yes [X ] No
There are no sensitive questions within this collection (e.g. sexual orientation, gender identity). [X ] Yes [ ] No	Sensitive questions will be asked (e.g. sexual orientation, gender identity). [ ] Yes [ X ] No
Collection does not raise issues of concern to any other Federal agencies. [X ] Yes [ ] No	Other Federal agencies may have equities or concerns regarding this collection. [ ] Yes [X ] No
Data collection is focused on determining ways to improve delivery of services to customers of a current CDC program. [X ] Yes [ ] No	Data will be used to inform programmatic or budgetary decisions, for the purpose of program evaluation, for surveillance, for program needs assessment, or for research. [ ] Yes [X ] No
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. [X ] Yes [ ] No

Did you select “Yes” to all criteria in Column A?

If yes, the Collection of Routine Customer Feedback generic clearance mechanism may be appropriate for your investigation. You may proceed with this form.

Did you select “Yes” to any criterion in Column B?

If yes, the Collection of Routine Customer Feedback generic clearance mechanism is NOT appropriate for your investigation. Stop completing this form now.

Note: Use OMB format when asking race/ethnicity as well as gender questions.

TITLE OF INFORMATION COLLECTION:

Opioid Rapid Response Patient Absorption Interviews

PURPOSE:

The federal Opioid Rapid Response Program is a cross-cutting program overseen by the Office of the Assistant Secretary for Health (OASH) and led by CDC in coordination with the HHS Office of Inspector General (OIG). The program aims to mitigate risks to patients impacted by disrupted access to prescription opioid therapy which can occur as the result of a law enforcement or regulatory action taken against a prescriber. Each action can impact hundreds of patients. CDC’s Opioid Rapid Response Program (ORRP) operates as an emergency response coordinating team, collaborating with federal partners and state/local health officials and providing technical support to build capacity to mitigate risks for patients displaced by these actions. Often a layered approach is needed, including the provision of risk communication and harm reduction, coordination with local area hospitals and health systems, and provision of direct patient and clinician outreach to facilitate care continuity for patients affected by these actions. In some cases, patients may need referral to treatment and recovery services for substance use disorder. More commonly, patients need connection with a qualified clinician who can provide immediate medication maintenance and ongoing medical care.

A challenge the ORRP team has observed when working with state health officials is the difficulty in identifying clinicians willing and able to absorb displaced patients, particularly those patients who have been receiving high dosage long-term opioid therapy or combinations of medications that are may raise the risk for overdose (e.g., benzodiazepines and opioids). Recent studies indicate that 40% of primary care clinics and up to 55% of pain clinics may not accept new patients who are already taking opioids for chronic pain. Displaced patients often are at risk of experiencing withdrawal symptoms, requiring more frequent emergency medical care, and turning to the illicit drug market where they are at risk of overdose, particularly if they encounter more potent substances, such as illicitly manufactured fentanyl. Displaced patients are also at increased risk of suicide.

Because a primary goal of the ORRP program is to facilitate care continuity for patients impacted by disrupted access to opioid prescriptions to mitigate these risks, the program needs to better understand the most salient barriers to connecting these patients with care. Barriers may be related to individual-level factors (e.g., clinicians’ beliefs and attitudes) as well as policy or systems-level factors. For example, possible reasons clinicians are not willing or able to accept these patients could include stigma, liability concerns, health system rules or prescribing limits, lack of training, or schedule/time constraints. This project aims to elucidate the most important factors affecting willingness and/or ability to accept displaced patients on long-term opioid therapy by conducting interviews with key stakeholders, including clinicians, health care administrators, public health practitioners, and federal partners. These interview responses will help ORRP delineate specific reasons clinicians are hesitant to accept new patients who have been taking long term opioid therapy AND possible approaches to address these barriers to facilitate the acceptance of these patients by clinicians and health systems. Information gathered will be used internally to inform effective intervention design with an ultimate goal of general service improvement. Without these types of feedback, ORRP will not be able to improve current and future resources to meet patient, clinician and health system needs.

DESCRIPTION OF RESPONDENTS:

TYPE OF COLLECTION: (Check one)

Instruction: Please sparingly use the Other category

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

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

[ ] Focus Group [X ] Other: __Stakeholder Interviews____

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.

Name:__________Karen Angel______________________________________7

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 [X ] No

3. If Applicable, has a System or Records Notice been published? [ ] Yes [ X ] No

Gifts or Payments:

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

If Yes: Please describe the incentive. If amounts are outside of customary incentives, please also provide a justification.

BURDEN HOURS

Category of Respondent	Form Name	No. of Respondents	Participation Time	Burden
State public health, justice and key organization leads/ Health system leaders/ Clinicians, Frontline Professionals or Clinical Experts / Other Stakeholders	Opioid Rapid Response Program Care Continuity Project Stakeholder Interview (Att. 1)	32	1	32
Totals		32		32

FEDERAL COST: The estimated annual cost to the Federal government is $ $117,655.60

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 Yes: Please provide a description of both below (or attach the sampling plan)

If No: Please provide a description of how you plan to identify your potential group of respondents and how you will select them or ask them to self-select/volunteer

Key organizations and/or informants will be identified from:

• Environmental scan and literature review findings for

  • Potential organizations from which to identify or nominate an interviewee

  • Specific individuals who authored, led or contributed to relevant resources

• CDC COR, ORRP team, or Abt Team recommended organizations or individuals based on past experiences or familiarity with the individuals’ expertise and experiences

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

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

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

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