Collection of Information for: Agency for Healthcare Research and Quality’s (AHRQ) Guide to Improving Patient Safety in Primary Care Settings by Engaging Patients and Families – Evaluation

Forms and Documents

Document Name	Status
Form 6 Appendix F: Topic guide for Telephone Protocol- Guide Practice Champions Form and Instruction	New
Form 4 Appendix D: Post-Implementation Interview Protocol- Providers Form and Instruction	New
Form 3 Appendix C: Interview Guide- Baseline Practice Readiness Form and Instruction	New
Form 1 Attachment A: Baseline Practice Assessment Form and Instruction	New
Supporting Statement Part A final PASSBACK Clean.docx Supporting Statement A	2017-02-06
Supporting Statement Part B 20160605.doc Supporting Statement B	2016-11-02

IC Document Collections

IC ID	Document Title	Status
224301	Appendix F: Topic guide for Telephone Protocol- Guide Practice Champions Form and Instruction	New
224300	Appendix E: Post-Implementation Focus Group Protocol- Practice Staff Instruction	New
224299	Appendix D: Post-Implementation Interview Protocol- Providers Form and Instruction	New
224298	Appendix C: Interview Guide- Baseline Practice Readiness Form and Instruction	New
224296	Post-Implementation Focus Group for Patients and Family Members Instruction	New
224203	Attachment A: Baseline Practice Assessment Form and Instruction	New

ICR Details

OMB Control No: 0935-0235	ICR Reference No: 201610-0935-001
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/AHRQ	Agency Tracking No:
Title: Collection of Information for: Agency for Healthcare Research and Quality’s (AHRQ) Guide to Improving Patient Safety in Primary Care Settings by Engaging Patients and Families – Evaluation
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 with change	Conclusion Date: 02/06/2017
	Date Received in OIRA: 11/08/2016
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2018	18 Months From Approved
Responses	432	0	0
Time Burden (Hours)	525	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: There is a substantial evidence base showing that engaging patients and families in their care can lead to improvements in patient safety. Since the 2001 release of To Err is Human, there has been an undeniable focus on improving patient safety and eliminating patient harm within acute care. What is not as well documented is how to achieve these improvements in primary care settings. Patient and Family Engagement (PFE) strategies for acute care settings include, among others: patient and family advisory committees; membership on patient safety oversight bodies at both operations and governance levels; consultation in the development of patient information material; engaging patients in process improvement or redesign projects; rounding with patients and families; patient and family participation in clinical education programs, and welcoming patients and families to work alongside providers and health systems employees on transparency, culture change and high reliability organization initiatives. Although the field of PFE in patient safety for hospitals and health systems is maturing, leveraging PFE to improve patient safety in non-acute settings is in its infancy. Building sustainable processes and practice-based infrastructure are crucial to improving patient safety through patient and family engagement in primary care. In response to the limited guidance available for primary care practices to improve safety through patient and family engagement, the Agency for Healthcare Research and Quality (AHRQ) has sponsored the development of a Guide to Improving Safety in Primary Care Settings by Engaging Patients and Families (hereafter referred to as the Guide). The comprehensive guide will provide primary care practices with interventions that they can use to engage patients and families in ways that lead to improved patient safety. It will include explicit instructions to help primary care practices, providers, and patients and families adopt new behaviors. Existing evidence-based interventions are being refined to reduce complexity and enhance the opportunity for implementation. Implementation development activities including guidance for each intervention and the Guide as a whole are currently underway. Guide field testing will evaluate the implementation challenges faced by primary care practices whereby offering an opportunity to revise the Guide materials for optimal implementation success prior to widespread dissemination. The Guide will be made publicly-accessible through the AHRQ Web site for easy referral, access, and use by other healthcare professionals and primary care practices. AHRQ recognizes the importance of ensuring that the Guide will be useful, well implemented and effective in achieving the stated goals of improving patient safety by engaging patients and families. Thus, the purpose of the Field Testing evaluation is to gain insight on the implementation challenges identified by the twelve primary care practices field testing the Guide. The Guide materials will be revised in an effort to overcome these implementation challenges prior to broad dissemination.

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Authorizing Statute(s): US Code: 42 USC Sec.299 Name of Law: 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:
	81 FR 52864	08/10/2016
30-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 75402	10/31/2016
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 6

IC Title	Form No.	Form Name
Appendix F: Topic guide for Telephone Protocol- Guide Practice Champions	6	Appendix F: Topic guide for Telephone Protocol- Guide Practice Champions
Post-Implementation Focus Group for Patients and Family Members
Attachment A: Baseline Practice Assessment	1	Appendix A: Baseline Practice Assessment
Appendix C: Interview Guide- Baseline Practice Readiness	3	Appendix C: Interview Guide- Baseline Practice Readiness
Appendix D: Post-Implementation Interview Protocol- Providers	4	Appendix D: Post-Implementation Interview Protocol- Providers
Appendix E: Post-Implementation Focus Group Protocol- Practice Staff

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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	432	0	0	432	0	0
Annual Time Burden (Hours)	525	0	0	525	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 information collection request.

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Annual Cost to Federal Government: $388,316

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

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? 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: 11/08/2016

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