Development of the Guide to Patient and Family Engagement in Health Care Quality and Safety in the Hospital Setting

Forms and Documents

Document Name	Status
Form Form #11 Patient survey Form and Instruction	New
Form Form #10 Staff survey Form and Instruction	New
Form Form #9 Focus group with patients & family Form and Instruction	New
Form Form #8 Focus group with patients' family Form and Instruction	New
Form Form #7 Focus group with patients Form and Instruction	New
Form Form #6 Bi-weekly semi-structured interviews Form and Instruction	New
Form Form #5 Collection of documentation Form and Instruction	New
Form Form #4 Semi-structured staff interviews - post-implementation Form and Instruction	New
Form Form #3 Semi-structured staff interviews - pre-implementation Form and Instruction	New
Form Form #2 Semi-structured leader interviews - post-implementation Form and Instruction	New
Form Form #1 Semi-structured leader interviews - pre-implementation Form and Instruction	New
IRB DETERMINATION FORM_02434 007 (Task 7)_4 12 11.pdf Supplementary Document	2011-04-18
Attachment K -- Observation Protocol_040911.doc Supplementary Document	2011-04-18
Supporting Statement Part B -- Evaluation of the Guide to PFE 4-18-2011.doc Supporting Statement B	2011-04-18
Attachment D -- Component 3_materials.pdf Supplementary Document	2011-02-10
Attachment C -- Component 2_materials.pdf Supplementary Document	2011-02-10
Attachment B -- Component 1_Materials.pdf Supplementary Document	2011-02-10
Attachment A -- Healthcare Research and Quality Act of 1999.pdf Supplementary Document	2011-02-10
Attachment R -- Invitation to Participate in Patient Survey 020411.doc Supplementary Document	2011-02-10
Attachment P -- Invitation to Participate in Staff Survey 020411.doc Supplementary Document	2011-02-10
Supporting Statement Part A -- Evaluation of the Guide to PFE 4-18-2011.doc Supporting Statement A	2011-04-18

IC Document Collections

IC ID	Document Title	Status
196396	Patient survey Form and Instruction	New
196395	Staff survey Form and Instruction	New
196394	Focus group with patients & family Form and Instruction	New
196393	Focus group with patients' family Form and Instruction	New
196392	Focus group with patients Form and Instruction	New
196391	Bi-weekly semi-structured interviews Form and Instruction	New
196390	Collection of documentation Form and Instruction	New
196389	Semi-structured staff interviews - post-implementation Form and Instruction	New
196388	Semi-structured staff interviews - pre-implementation Form and Instruction	New
196387	Semi-structured leader interviews - post-implementation Form and Instruction	New
196386	Semi-structured leader interviews - pre-implementation Form and Instruction	New

ICR Details

OMB Control No: 0935-0176	ICR Reference No: 201102-0935-002
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/AHRQ	Agency Tracking No:
Title: Development of the Guide to Patient and Family Engagement in Health Care Quality and Safety in the Hospital Setting
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: 04/25/2011
	Date Received in OIRA: 02/25/2011
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	04/30/2013	24 Months From Approved
Responses	2,272	0	0
Time Burden (Hours)	1,190	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: This project will develop a program to help patients, families, and health professionals in the hospital support one another to improve quality and safety. To accomplish these goals, patients and families must be able to express what they want from their hospital care and how they want to be involved and then effectively communicate this information with health professionals. Conversely, health professionals must be able to understand what patients want to do and what is appropriate for them to do and feel that they have the system supports and tools to facilitate these actions. To address this issue and help fulfill AHRQ's mission of health care quality improvement, AHRQ will develop a set of interventions and materials, entitled the Guide to Patient and Family Engagement in Health Care Quality and Safety in the Hospital Setting ("the Guide"), for use by patients, their family members, health care professionals, and hospital leaders to foster patient and family engagement around the issues of hospital safety and quality.

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Authorizing Statute(s): US Code: 42 USC 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:
	75 FR 69674	11/15/2010
30-day Notice:	Federal Register Citation:	Citation Date:
	76 FR 4697	01/26/2011
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 11

IC Title	Form No.	Form Name
Semi-structured staff interviews - post-implementation	Form #4	Semi-Structured Staff Interview Post-Implementation Protocol
Semi-structured leader interviews - post-implementation	Form #2	Semi-Structured Leader Interview Post-Implementation Protocol
Collection of documentation	Form #5	Collection of Documentation Protocol
Bi-weekly semi-structured interviews	Form #6	Bi-Weekly Semi-Structured Interview Protocol
Focus group with patients	Form #7	Focus Group with Patients Protocol
Focus group with patients' family	Form #8	Focus Group with Patients' Family Protocol
Focus group with patients & family	Form #9	Focus Group with Patients & Family Protocol
Staff survey	Form #10	Staff Survey
Patient survey	Form #11	Patient Survey
Semi-structured leader interviews - pre-implementation	Form #1	Semi-Structured Leader Interview Pre-Implementation Protocol
Semi-structured staff interviews - pre-implementation	Form #3	Semi-Structured Staff Interview Pre-Implementation 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	2,272	0	0	2,272	0	0
Annual Time Burden (Hours)	1,190	0	0	1,190	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: $536,397

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

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: 02/25/2011

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