Embedded Research in Care Delivery Systems

Forms and Documents

Document Name	Status
Form 1 Interviews with researchers and other operations staff Form and Instruction	New
Form 1 Interviews with physicians Form and Instruction	New
Form 1 Interviews with executive-level subjects Form and Instruction	New
OMB supporting statement A 7-12-19- clean_abrevisions.docx Supporting Statement A	2019-10-01
Attachment F-References.docx Supplementary Document	2019-09-30
Attachment D - with OMB language (2).docx Supplementary Document	2019-09-30
Attachment C Advance letters-revised.docx Supplementary Document	2019-09-30
Attachment B-Selection of interview subjects.docx Supplementary Document	2019-09-30
Attachment A Selection of Sites.docx Supplementary Document	2019-09-30

IC Document Collections

IC ID	Document Title	Status
237943	Interviews with researchers and other operations staff Form and Instruction	New
237942	Interviews with physicians Form and Instruction	New
237941	Interviews with executive-level subjects Form and Instruction	New

ICR Details

OMB Control No: 0935-0247	ICR Reference No: 201909-0935-002
Status: Active	Previous ICR Reference No:
Agency/Subagency: HHS/AHRQ	Agency Tracking No:
Title: Embedded Research in Care Delivery Systems
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: 12/02/2019
	Date Received in OIRA: 10/02/2019
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2022	36 Months From Approved
Responses	74	0	0
Time Burden (Hours)	74	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: In support of its mission and the goal of the Department of Health and Human Services of promoting affordable health care, AHRQ’s strategic agenda includes “catalyzing the evolution of learning health systems” through research, training, tools, and data. The Learning Health System is a model in which internal data and experience are systematically integrated with external evidence, and that knowledge is put into practice. As a result, patients get higher quality, safer, more efficient care, and health care delivery organizations become better places to work. One way to foster this type of system learning is to embed researchers within care delivery systems. Embedded researchers are either employed by a delivery system or invited to work in them on a specified project. Embedded researchers contribute to health system learning by collaborating with delivery system stakeholders to identify and evaluate innovations and practice changes that can improve the outcomes of individual and populations and health system performance. AHRQ is developing tools and findings to support embedded research, and is funding training of researchers to conduct this embedded research. Evidence about strategies for deploying embedded researchers can contribute directly to AHRQ’s strategic initiatives in support of embedded research and the learning health system and to related programs conducted by the federally-funded Patient Centered Outcomes Research Institute (PCORI); the National Academy of Medicine; AcademyHealth and other non-governmental entities. Most available information on embedded research and learning systems comes from descriptions offered by the participants. There is little independent research on ways that delivery systems currently organize and use embedded research to promote improved care delivery. To provide research background on the current state of embedded research, the investigators for this project conducted an environmental scan. It included preliminary, key informant interviews with six nationally recognized experts on embedded research and consultations with several staff members at AHRQ and AcademyHealth, who contribute to programs supporting embedded research and learning health systems. Additionally, the researchers scanned published and grey literature on embedded research and reviewed summaries of discussions at the inaugural meeting of the Embedded Researcher’s Interest Group within AcademyHealth (June, 2019) and a national conference on Accelerating the Development of Learning Healthcare Systems through Embedded Research (February, 2019). This conference was jointly funded by AHRQ, PCORI and the Department of Veterans Affairs Health Services Research & Development Service (VA HSR&D).

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Authorizing Statute(s): US Code: 42 USC 299 Name of Law: Agency for Healthcare Research and 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 36606	07/29/2019
30-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 52108	10/01/2019
Did the Agency receive public comments on this ICR? Yes

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

IC Title	Form No.	Form Name
Interviews with physicians	1	Interview Protocol
Interviews with executive-level subjects	1	E. Interview Protocol
Interviews with researchers and other operations staff	1	Interview Protocol

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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	74	0	0	74	0	0
Annual Time Burden (Hours)	74	0	0	74	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: $16,379

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]? No

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: 10/02/2019

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