Evaluation of Patient-Centered Outcomes Research Trust Fund—Training Program

Forms and Documents

Document Name	Status
Form 3 Key Informant Interview Guide for K12 Program Directors Form and Instruction	New
Form 2 Attachment B: K Awardee /K12 Scholar Primary Mentor Survey Form and Instruction	New
Form 1 Attachment A: K Awardee Survey/K12 Scholar Survey Form and Instruction	New
OMB_StatementA_PCORTFEval 01272020.docx Supporting Statement A	2020-01-29
Attachment G_Invitation message to be sent by AHRQ 11 07 19.docx Supplementary Document	2020-01-28
AttachmentF_Invitation message to be sent by AHRQ 11 07 19.docx Supplementary Document	2020-01-28
Attachement E_Invitation message to be sent by AHRQ 11 07 19.docx Supplementary Document	2020-01-28
OMB_StatementB_PCORTFEval 11 07 19.docx Supporting Statement B	2020-01-28

IC Document Collections

IC ID	Document Title	Status
239582	Key Informant Interview Guide for K12 Program Directors Form and Instruction	New
239581	Attachment B: K Awardee /K12 Scholar Primary Mentor Survey Form and Instruction	New
239575	Attachment A: K Awardee Survey/K12 Scholar Survey Form and Instruction	New

ICR Details

OMB Control No: 0935-0250	ICR Reference No: 202001-0935-001
Status: Active	Previous ICR Reference No:
Agency/Subagency: HHS/AHRQ	Agency Tracking No:
Title: Evaluation of Patient-Centered Outcomes Research Trust Fund—Training Program
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 03/05/2020
	Date Received in OIRA: 01/29/2020
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2023	36 Months From Approved
Responses	288	0	0
Time Burden (Hours)	151	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: AHRQ Authorization to Provide Researcher Training in Comparative Effectiveness Research/Patient-Centered Outcomes Research (CER/PCOR) Methods Section 6301(b) of the Patient Protection and Affordable Care Act, Public Law 111-148 (the “Affordable Care Act”), enacted Section 937(e) of the Public Health Service Act, authorizes AHRQ to build capacity for comparative effectiveness research (CER) by establishing grant programs that provide training for researchers in methods used to conduct research. It also notes that, “[at] a minimum, such training shall be in methods that meet the methodological standards adopted [by PCORI] under 1181(d)(9) of the Social Security Act.” In addition, AHRQ is charged with dissemination of patient-centered outcomes research (PCOR) and CER into practice, Section 937(a). To this end, AHRQ’s PCOR Trust Fund training program (PCORTF-TP) responds to Congress’ direction to AHRQ to invest in training grants that build researchers’ skills and enhance research capacity in these areas. PCOR is research that assesses the benefits and harms of preventive, diagnostic, therapeutic, palliative, or health delivery system interventions. This research helps clinicians, patients, and caregivers make decisions about health care choices by highlighting comparisons and outcomes that matter to people, such as survival, function, symptoms, and health related quality of life. The AHRQ PCORTF-TP supports individuals and academic institutions to train researchers and clinicians in CER methods applied within the context of PCOR (CER/PCOR) via mentored career development award mechanisms for emerging independent investigators as well as targeted skill development and applied experiences via research grant mechanisms for independent researchers. PCORTF-TP grants support training for recent graduates, mid-career professionals, and established professionals in research and clinical settings. The program prioritizes expanding capacity in underserved and predominantly minority communities. AHRQ recognizes the importance of ensuring that its training activities are useful, well implemented, and effective in achieving their intended goals. Therefore, the PCORTF-TP evaluation reflects AHRQ’s commitment to ensuring responsible stewardship. The PCORTF-TP evaluation comprises analysis of grantee progress reports, a bibliometric analysis of grantee publications, key informant interviews with AHRQ program staff responsible for managing PCORTF-TP grants, focused discussions with a PCORTF-TP evaluation Stakeholder Working Group, and surveys of grantees and mentors. The purpose of this evaluation is to assess the outputs, outcomes, and impact of AHRQ’s PCOR Career Development (K) Award training and infrastructure capacity-building programs. The evaluation will address the following questions: • What is the nature of PCORTF–TP activities for scholar/investigator development? • Which activities for PCORTF–TP scholars/investigators have the greatest influence on intended outcomes (e.g., PCOR careers)? • How have PCORTF–TP and partner institutions developed the capacity for PCOR training and mentoring, and in what ways is this sustainable? • What do mentors and mentees perceive to be the most important ways that the program has contributed to the field of CER//PCOR? To achieve the goals of this project, the evaluator will survey PCORTF–TP awardees, scholars, and mentors. Online surveys (Attachment A: K Awardee Survey/K12 Scholar Survey and Attachment B: K Awardee /K12 Scholar Primary Mentor Survey) will be used to: 1) collect non-identifying demographic information; and 2) ask respondents about their training activities and outcomes. Key informant interviews (Attachment C: Key Informant Interview Guide) will be used to collect qualitative data about program processes, outcomes, and lessons learned from K12 scholar program directors.

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Authorizing Statute(s): US Code: 42 USC USC 299b-2 Name of Law: Health Care Quality Act of 1999
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 68170	12/13/2019
30-day Notice:	Federal Register Citation:	Citation Date:
	85 FR 4666	01/27/2020
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 3

IC Title	Form No.	Form Name
Attachment A: K Awardee Survey/K12 Scholar Survey	1	Attachment A: K Awardee Survey/K12 Scholar Survey
Attachment B: K Awardee /K12 Scholar Primary Mentor Survey	2	Attachment B: K Awardee /K12 Scholar Primary Mentor Survey
Key Informant Interview Guide for K12 Program Directors	3	Key Informant Interview Guide for K12 Program Directors

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ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	288	0	0	288	0	0
Annual Time Burden (Hours)	151	0	0	151	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: This is a new data collection.

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Annual Cost to Federal Government: $198,721

Does this IC contain surveys, censuses, or employ statistical methods? No

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     Yes

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? Yes

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? Uncollected

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Common Form ICR:  No

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On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(i) Why the information is being collected;

(ii) Use of information;

(iii) Burden estimate;

(iv) Nature of response (voluntary, required for a benefit, or mandatory);

(v) Nature and extent of confidentiality; and

(vi) Need to display currently valid OMB control number;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

Certification Date: 01/29/2020

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