[Federal Register Volume 85, Number 200 (Thursday, October 15, 2020)]
[Notices]
[Pages 65404-65406]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-22837]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality


Agency Information Collection Activities: Proposed Collection; 
Comment Request

AGENCY: Agency for Healthcare Research and Quality, HHS.

ACTION: Notice.

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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, (301) 427-1477, or by email at 
[email protected].

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

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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
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                                                                     Number of
                    Form name                        Number of     responses per     Hours per     Total burden
                                                    respondents     respondent       response          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
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                                   Exhibit 2--Estimated Annualized Cost Burden
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                                                     Number of     Total burden   Average hourly    Total cost
                    Form name                       respondents        hours        wage rate *       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
                                                 ---------------------------------------------------------------

[[Page 65406]]

 
    Total.......................................             255              75           53.95        4,046.78
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* 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.
[FR Doc. 2020-22837 Filed 10-14-20; 8:45 am]
BILLING CODE 4160-90-P