Clinical Decision Support (CDS) for Chronic Pain Management

Forms and Documents

Document Name	Status
Form 5 Attachment 5 -- Evaluation Site Champion Interview Form and Instruction	New
Form 4 Attachment 4 -- Evaluation Patient Interview Form and Instruction	New
Form 3 Attachment 3 -- Evaluation Provider Interview Form and Instruction	New
Form 2 Attachment 2 -- Evaluation Patient Survey Form and Instruction	New
Form 1 Attachment 1 -- Evaluation Provider Survey Form and Instruction	New
Supporting Statement Part A_CDS for Chronic Pain_Draft_2020 06 09.docx Supporting Statement A	2020-10-15

IC Document Collections

IC ID	Document Title	Status
244081	Attachment 5 -- Evaluation Site Champion Interview Form and Instruction	New
244080	Attachment 4 -- Evaluation Patient Interview Form and Instruction	New
244078	Attachment 3 -- Evaluation Provider Interview Form and Instruction	New
244076	Attachment 2 -- Evaluation Patient Survey Form and Instruction	New
244072	Attachment 1 -- Evaluation Provider Survey Form and Instruction	New

ICR Details

OMB Control No: 0935-0257	ICR Reference No: 202010-0935-001
Status: Active	Previous ICR Reference No:
Agency/Subagency: HHS/AHRQ	Agency Tracking No:
Title: Clinical Decision Support (CDS) for Chronic Pain Management
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: 12/10/2020
	Date Received in OIRA: 10/15/2020
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2023	36 Months From Approved
Responses	255	0	0
Time Burden (Hours)	76	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: Prescription opioid pain medication overuse, misuse, and abuse have been a significant contributing factor in the opioid epidemic. The goal of this project is to develop, implement, disseminate, and evaluate clinical decision support (CDS) tools for both patients and clinicians in the management of chronic pain. The CDS tools are intended to be interoperable and publicly-shareable, and will be designed to meet the needs of patients and clinicians through both patient-facing and clinician-facing channels and formats. The development and deployment of CDS tools designed to optimize opioid dose reduction is intended to support primary care physicians who are not pain-management specialists as they care for patients who are at high risk of harm from opioids. This goal will be achieved through the design, development, implementation, and evaluation of a clinician-facing CDS tool for chronic pain management that optimize presentation of patient data and evidence-based guidelines to support opioid tapering. The clinician-facing CDS tool will help non-pain specialists detect patients at high risk of harm from opioids, provide personalized evidence-based guidelines to support opioid tapering, optimize the presentation of patient data, and reduce unnecessary variation in clinical practice. The clinician-facing CDS tool will also assist non-pain specialists in determining if an opioid taper is necessary for a specific patient, aid in performing the taper, and aid in providing follow-up and support during the taper. The clinician-facing CDS tools are meant to accomplish three goals: (1) better monitor the patient’s functional pain and opioid use, (2) visualize patient data, and (3) incorporate guidelines for prescribing and tapering opioids for chronic pain. The patient-facing CDS tool will be used to help patients at high-risk of harm from opioids track and manage chronic pain and daily function to support reduced opioid use. This goal will be achieved through the design, development, implementation, and evaluation of a CDS tool that facilitates continued patient provider engagement. This patient-facing CDS tool will deliver support in ways that enhance patient activation, education and engagement, and collaborative decisions and actions between patients and their care teams. The patient-facing CDS tool should enhance the quality of clinical discussion between healthcare providers and patients by allowing for continued patient engagement outside of the clinical setting.

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Authorizing Statute(s): US Code: 42 USC 299 Name of Law: Agency for Healthcare Research 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 42404	07/14/2020
30-day Notice:	Federal Register Citation:	Citation Date:
	85 FR 65404	10/15/2020
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 5

IC Title	Form No.	Form Name
Attachment 1 -- Evaluation Provider Survey	1	Attachment 1 -- Evaluation Provider Survey
Attachment 2 -- Evaluation Patient Survey	2	Attachment 2 -- Evaluation Patient Survey
Attachment 3 -- Evaluation Provider Interview	3	Attachment 3 -- Evaluation Provider Interview
Attachment 4 -- Evaluation Patient Interview	4	Attachment 4 -- Evaluation Patient Interview
Attachment 5 -- Evaluation Site Champion Interview	5	Attachment 5 -- Evaluation Site Champion Interview

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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	255	0	0	255	0	0
Annual Time Burden (Hours)	76	0	0	76	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 ICR.

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Annual Cost to Federal Government: $1,888,124

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? 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: 10/15/2020

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