Improving Hospital Informed Consent with Training on Effective Tools and Strategies

Forms and Documents

Document Name	Status
Form 6 ATTACHMENT I – Rapid Feedback Patient Survey Form and Instruction	New
Form 5b Attachment H - Interview and Site Visit Guide Form and Instruction	New
Form 5a ATTACHMENT H – Interview and Site Visit Guide Form and Instruction	New
Form 4 ATTACHMENT G – HEALTH CARE PROFESSIONAL SURVEY Form and Instruction	New
Form 3 ATTACHMENT F - Monthly Check-In Form and Instruction	New
Form 2b Attachment E - Leaders Pre-/Post-Training Quiz Form and Instruction	New
Form 2 Attachment D - Health Care Professionals Pre-/Post-Training Quiz Form and Instruction	New
Form 1 Attachment C - Hospital Informed Consent Baseline and Final Assessment Form and Instruction	New
Revised Attachment B - HCP module REVISED.docx Supplementary Document	2014-10-22
Attachment A - Leader module 10-6-14 .docx Supplementary Document	2014-10-22
Supporting Statement Part B _Informed Consent.doc Supporting Statement B	2014-10-21
Supporting Statement Part A _Informed Consent Revised FINAL.doc Supporting Statement A	2015-01-15

IC Document Collections

IC ID	Document Title	Status
213594	Attachment M - Secondary Data Other-Description of data extraction.	New
213592	ATTACHMENT I – Rapid Feedback Patient Survey Form and Instruction	New
213591	Attachment H - Interview and Site Visit Guide Form and Instruction	New
213590	ATTACHMENT H – Interview and Site Visit Guide Form and Instruction	New
213586	ATTACHMENT G – HEALTH CARE PROFESSIONAL SURVEY Form and Instruction	New
213580	ATTACHMENT F - Monthly Check-In Form and Instruction	New
213577	Attachment E - Leaders Pre-/Post-Training Quiz Form and Instruction	New
213540	Attachment D - Health Care Professionals Pre-/Post-Training Quiz Form and Instruction	New
213539	Attachment C - Hospital Informed Consent Baseline and Final Assessment Form and Instruction	New

ICR Details

OMB Control No: 0935-0228	ICR Reference No: 201410-0935-002
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/AHRQ	Agency Tracking No:
Title: Improving Hospital Informed Consent with Training on Effective Tools and Strategies
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: 01/16/2015
	Date Received in OIRA: 10/27/2014
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2018	36 Months From Approved
Responses	2,144	0	0
Time Burden (Hours)	705	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The ultimate aim of this project is to pilot test training modules to improve the informed consent process in U.S. hospitals. Clinical informed consent is the process by which a patient is told about the risks and benefits of proposed treatments or procedures, as well as alternatives, and makes a decision based on that information. Informed consent may be jeopardized by incorrect clinician assumptions about patient comprehension, the manner in which consent is sought, and poor readability of consent forms (Paasche-Orlow et al., 2013). All too frequently, patients do not understand the risks, benefits, and alternatives of their treatments even after signing a consent form (Braddock et al., 1999; Sudore et al., 2006). De-identified accreditation data analyzed as part of AHRQ's preliminary research for this data collection effort suggest that some hospitals are not following the basic ethical principles underlying informed consent. These data, as well as the guidance from the study's Expert and Stakeholder Panel, indicate that hospital administrators and clinicians could benefit from training on evidence-based practices to improve the informed consent process. These include, improving communication, using interpreters to meet the communication needs of patients with limited English proficiency, using high-quality decision aids to support the informed consent discussion, and using teach-back to verify patient understanding (Temple University Health System, 2009). Hospital system changes that can facilitate these practices include improving hospitals' informed consent policies and the infrastructure that supports the informed consent process (e.g., interpreter services, high-quality decision aids, easy-to-understand forms). Building upon a previously published guide, a review of the literature, and the aforementioned analysis of de-identified accreditation data, AHRQ has developed two new Informed Consent training modules of approximately 1 hour each (one for hospital leaders, the other for health care professionals), to be offered through a Learning Management System. Health care professionals taking the training will be eligible for continuing education (CE) credit. In the project's next phase, AHRQ will pilot test the training modules to assess: • Facilitators and barriers of implementing the tools and recommended improvements in the training modules • Effectiveness of the training modules in improving informed consent processes and relevant outputs and outcomes Pilot test results will be used to improve the training modules and provide information to hospitals considering using the training modules to improve their informed consent processes. The pilot test will take place in four hospitals. Each participating hospital will be asked to: • Deliver the leader training module to hospital leaders of their choosing • Champion improvements in their informed consent policies and processes based on the information and tools in the leader training • Deliver the health care professional training module to health care professionals in four units, including at least one surgical unit • Implement improvement initiatives over a period of two to six months in participating units based on materials presented in the health care professional training o In at least one unit: implementation will last at least three months and use at least one of the techniques presented in the training (e.g., use teach-back to confirm patient understanding, use high quality decision aids, overcome communication barriers) • Conduct and cooperate with assessment activities. o In at least one unit, use the Rapid Feedback Patient Survey. o In at least one surgical unit, collect surgical cancellation and delay rates. o Collect other metrics to assess the effectiveness of the informed consent training modules. o Cooperate with project team in the data collection efforts described below.

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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:
	79 FR 38898	07/09/2014
30-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 58349	09/29/2014
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 9

IC Title	Form No.	Form Name
ATTACHMENT G – HEALTH CARE PROFESSIONAL SURVEY	4	ATTACHMENT G – HEALTH CARE PROFESSIONAL SURVEY
Attachment C - Hospital Informed Consent Baseline and Final Assessment	1	Attachment C– Baseline and Final Assessment of Hospital Informed Consent Proces
Attachment D - Health Care Professionals Pre-/Post-Training Quiz	2	Attachment D - Health Care Professionals Pre-/Post-Training Quiz
Attachment M - Secondary Data
Attachment E - Leaders Pre-/Post-Training Quiz	2b	ATTACHMENT E – Hospital Leader Pre-Post Training Quiz
ATTACHMENT F - Monthly Check-In	3	ATTACHMENT F - Monthly Check-In
ATTACHMENT H – Interview and Site Visit Guide	5a	ATTACHMENT H – Interview and Site Visit Guide
Attachment H - Interview and Site Visit Guide	5b	Attachment H - Interview and Site Visit Guide
ATTACHMENT I – Rapid Feedback Patient Survey	6	ATTACHMENT I – Rapid Feedback Patient Survey

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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	2,144	0	0	2,144	0	0
Annual Time Burden (Hours)	705	0	0	705	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: $261,467

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: 10/27/2014

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