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OMB Control No: 0935-0257	ICR Reference No: 202010-0935-001
Status: Historical 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

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.

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

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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

ICR Summary of Burden

	Total Approved	Change Due to Agency Discretion
Annual Number of Responses	255	255
Annual Time Burden (Hours)	76	76
Annual Cost Burden (Dollars)	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.

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

Agency Contact: Erwin Brown 301 427-1652 erwin.brown@ahrq.hhs.gov

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