2020-22837. Agency Information Collection Activities: Proposed Collection; Comment Request

AGENCY:

Agency for Healthcare Research and Quality, HHS.

ACTION:

Notice.

SUMMARY:

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project “Clinical Decision Support (CDS) for Chronic Pain Management.”

This proposed information collection was previously published in the Federal Register on July 14, 2020 and allowed 60 days for public comment. AHRQ received no substantive comments. The purpose of this notice is to allow an additional 30 days for public comment.

DATES:

Comments on this notice must be received within 30 days of publication date.

ADDRESSES:

Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to www.reginfo.gov/​public/​do/​PRAMain. Find this particular information collection by selecting “Currently under 30-day Review—Open for Public Comments” or by using the search function.

FOR FURTHER INFORMATION CONTACT:

Doris Lefkowitz, AHRQ Reports Clearance Officer, [phone], or by email at [e-mail].

SUPPLEMENTARY INFORMATION:

Proposed Project

Clinical Decision Support (CDS) for Chronic Pain Management

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 providers 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 providers through both patient-facing and provider-facing channels and formats.

The development and deployment of CDS tools designed to optimize opioid dose reduction is intended to support primary care providers (including physicians and advanced practice providers) who are not pain-management specialists as well as pain 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 provider-facing CDS tool for chronic pain management that optimize presentation of patient data and evidence-based guidelines to support opioid tapering. The provider-facing CDS tool will help providers 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 provider-facing CDS tool will also assist providers 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 provider-facing CDS tool is 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.

This study is being conducted by AHRQ through its contractor, MedStar Health, pursuant to AHRQ's statutory authority to assist users of health information technology focused on CDS to promote the timely incorporation of comparative clinical effectiveness research into clinical practices. 42 U.S.C 299b-37(c).

Method of Collection

To achieve the goals of this project the following data collections will be implemented.

(1) Post-Use Survey with Providers “Evaluation Provider Survey:” This evaluation includes the collection of qualitative data through a short survey with providers who used the provider-facing CDS tool for chronic pain management (up to a maximum of 60). The research team will collect insights from providers on their experience of implementing and using the provider-facing CDS tool for chronic pain management. The survey will be accessible in both online and paper formats.

(2) Post-Use Survey with Patients “Evaluation Patient Survey:” This evaluation includes the collection of qualitative data through a short survey with patients who used the patient-facing CDS tool for pain management (up to a maximum of 150). The research team will collect insights from patients on their experience of implementing and using patient-facing CDS. The survey will be accessible in both online and paper formats.

(3) Post-Use Interview with Providers “Evaluation Provider Interview:” This evaluation component includes the collection of qualitative data through an in-depth thirty-minute interview with providers who used the provider-facing CDS tool for chronic pain management (up to a maximum of 10). The research team will collect insights from providers on their experience of implementing and using this provider-facing CDS tool.

(4) Post-Use Interviews with Patients “Evaluation Patient Interview:” This evaluation component includes the collection of qualitative data through an in-depth thirty-minute interview with patients who used the patient-facing CDS tool for pain management (up to a maximum of 20). The research team will collect insights from patients on their experience of implementing and using the patient-facing CDS tool.

(5) Post-Use Interviews with Site Champions “Evaluation Site Champion Interview:” This evaluation component includes the collection of qualitative data through thirty-minute interviews with site leads (up to a maximum of 15) and site visits during which the research team will collect insights from providers and patients on their experience of implementing and using the clinical-facing and patient-facing CDS tools from the perspective of the site champions.

Estimated Annual Respondent Burden

Exhibit 1—Estimated Annualized Burden Hours

Form name	Number of respondents	Number of responses per respondent	Hours per response	Total burden hours
Post-Use Survey with Providers	60	1	0.25	15
Post-Use Survey with Patients	150	1	0.25	37.5
Post-Use Interview with Providers	10	1	0.5	5
Post-Use Interview with Patients	20	1	0.5	10
Post-Use Interview with Site Champions	15	1	0.5	7.5
Total	255	5	2	75

Exhibit 2—Estimated Annualized Cost Burden

Form name	Number of respondents	Total burden hours	Average hourly wage rate *	Total cost burden
Post-Use Survey with Providers	60	15	b $102.73	$1,540.95
Post-Use Survey with Patients	150	37.5	a 25.72	964.50
Post-Use Interview with Providers	10	5	b 102.73	513.65
Post-Use Interview with Patients	20	10	a 25.72	257.20
Post-Use Interview with Site Champions	15	7.5	b 102.73	770.48
Total	255	75	53.95	4,046.78
* National Compensation Survey: Occupational wages in the United States May 2019, “U.S. Department of Labor, Bureau of Labor Statistics”, https://www.bls.gov/​oes/​current/​oes_​nat.htm#b29-0000.htm.
a Based on the mean wages for all occupations (00-0000).
b Based on the mean wages for Family Medicine Physicians (29-1215).

Request for Comments

In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3520, comments on AHRQ's information collection are requested with regard to any of the following: (a) Whether the proposed collection of information is necessary for the proper performance of AHRQ's health care research and health care information dissemination functions, including whether the information will have practical utility; (b) the accuracy of AHRQ's estimate of burden (including hours and costs) of the proposed collection(s) of information; (c) ways to enhance the quality, utility and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information upon the respondents, including the use of automated collection techniques or other forms of information technology.

Comments submitted in response to this notice will be summarized and included in the Agency's subsequent request for OMB approval of the proposed information collection. All comments will become a matter of public record.

Dated: October 8, 2020.

Marquita Cullom-Stott,

Associate Director.