[Federal Register Volume 85, Number 135 (Tuesday, July 14, 2020)]
[Notices]
[Pages 42404-42406]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-15147]


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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.''

DATES: Comments on this notice must be received by 60 days after date 
of publication of this notice.

ADDRESSES: Written comments should be submitted to: Doris Lefkowitz, 
Reports Clearance Officer, AHRQ, by email at 
[email protected].
    Copies of the proposed collection plans, data collection 
instruments, and specific details on the estimated burden can be 
obtained from the AHRQ Reports Clearance Officer.

FOR FURTHER INFORMATION CONTACT: Doris Lefkowitz, AHRQ Reports 
Clearance Officer, (301) 427-1477, or by emails 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 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

[[Page 42405]]

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.
    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 Primary Care Providers ``Evaluation 
Provider Survey'': This evaluation includes the collection of 
qualitative data through a short survey with primary care providers who 
used the clinician-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 clinician-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 Primary Care Providers ``Evaluation 
Provider Interview'': This evaluation component includes the collection 
of qualitative data through an in-depth thirty-minute interview with 
primary care providers who used the clinician-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 clinician-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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                                                                                      Average
                    Form name                        Number of     Total burden    hourly  wage     Total cost
                                                    respondents        hours          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
                                                 ---------------------------------------------------------------
    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).


[[Page 42406]]

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: July 8, 2020.
Virginia L. Mackay-Smith,
Associate Director.
[FR Doc. 2020-15147 Filed 7-13-20; 8:45 am]
BILLING CODE 4160-90-P