Evaluation of the SHARE Approach Model

Forms and Documents

Document Name	Status
Form 4 Audio recorded encounters Form and Instruction	New
Form 2 Card survey (clinician) Form and Instruction	New
Form 3 Clinician survey Form and Instruction	New
Form 1 Attachment B – SHARE Approach evaluation clinician and staff surveys Form and Instruction	New
Supporting Statement Part A (6).docx Supporting Statement A	2020-04-22
Supporting Statement Part B_LS.docx Supporting Statement B	2020-04-21

IC Document Collections

IC ID	Document Title	Status
241470	Audio recorded encounters Form and Instruction	New
241469	Card survey (clinician) Form and Instruction	New
241465	Clinician survey Form and Instruction	New
241462	Attachment B – SHARE Approach evaluation clinician and staff surveys Form and Instruction	New

ICR Details

OMB Control No: 0935-0253	ICR Reference No: 202004-0935-004
Status: Active	Previous ICR Reference No:
Agency/Subagency: HHS/AHRQ	Agency Tracking No:
Title: Evaluation of the SHARE Approach Model
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: 10/09/2020
	Date Received in OIRA: 04/22/2020
Terms of Clearance: Approval is granted with the following terms of clearance: 1. On the Pre-training clinician survey to assess prior experience with SDM instrument, AHRQ will refer to "MD" as "Doctor of Medicine" rather than "Medical Doctor" to avoid implying a hierarchy between physicians who hold the MD degree and those who hold the Doctor of Osteopathic Medicine degree 2. This collection will be conducted in compliance with Federal and local COVID-19 social distancing guidelines.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	10/31/2023	36 Months From Approved
Responses	18,460	0	0
Time Burden (Hours)	476	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: Shared decision making (SDM) occurs when a health care provider and a patient work together to make a health care decision that is best for the patient. Implementing SDM involves effective communication between providers and patients to take into account evidence-based information about available options, the provider's knowledge and experience, and the patient's values and preferences in reaching the best health care decision for a patient. To facilitate SDM in all care delivery settings AHRQ developed the five-step SHARE Approach that includes exploring and comparing the benefits, harms, and risks of each option through meaningful dialogue about what matters most to the patient. SDM is increasingly included in clinical care guidelines, and in some cases is even mandated. While there is considerable interest in improving SDM across broad health care settings, less is known about how to effectively implement SDM. There is evidence that SDM is often not conducted effectively in practice, and identifying ways to improve SDM has therefore become an imperative. Lack of clinician support and education have been identified as important barriers to SDM. The SHARE Approach was developed by AHRQ as a clinician-facing toolkit that teaches clinicians skills to facilitate shared decision-making (SDM) across a broad range of clinical contexts. While several implementation success stories have been shared with AHRQ, to date there has been no formal evaluation of the effectiveness of the SHARE Approach materials for improving SDM in primary and specialty care settings for which it was designed. As a result, challenges that may be faced by practices who wish to implement the SHARE Approach are currently unknown. Without research to identify and address these issues, practices and organization may be unable to effectively implement the SHARE Approach and may be unwilling to do so absent evidence of its effectiveness at improving SDM outcomes. The Evaluation of the SHARE Approach Model has the following goals: 1. Revise the SHARE Approach toolkit to remove outdated references and increase applicability for SDM in contexts involving problem solving 2. Evaluate the implementation of the SHARE Approach in eight primary care and four cardiology clinics 3. Evaluate the effectiveness of the SHARE Approach at improving SDM.

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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:
	85 FR 6193	02/04/2020
30-day Notice:	Federal Register Citation:	Citation Date:
	85 FR 22170	04/21/2020
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 4

IC Title	Form No.	Form Name
Attachment B – SHARE Approach evaluation clinician and staff surveys	1	Card survey (patient)
Clinician survey	3, 3, 3	Post-training survey to assess experiences with SHARE training: ,   Clinician survey to assess use of SHARE two months following training ,   Pre-training clinician survey to assess prior experience with SDM
Card survey (clinician)	2	Card survey (clinician)
Audio recorded encounters	4	Audio recorded encounters

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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	18,460	0	0	18,460	0	0
Annual Time Burden (Hours)	476	0	0	476	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: $399,982

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

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? No

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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: 04/22/2020

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