[Federal Register Volume 85, Number 110 (Monday, June 8, 2020)]
[Notices]
[Pages 35090-35092]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-12266]


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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 ``Identifying and Testing Strategies for Management of Opioid 
Use and Misuse in Older Adults in Primary Care Practices.''

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

[[Page 35091]]

can be obtained from the AHRQ Reports Clearance Officer.

FOR FURTHER INFORMATION CONTACT: Doris Lefkowitz, AHRQ Reports 
Clearance Officer, (301) 427-1477, or by email at 
[email protected].

SUPPLEMENTARY INFORMATION: 

Proposed Project

Identifying and Testing Strategies for Management of Opioid Use and 
Misuse in Older Adults in Primary Care Practices

    The goals of this project are to assess and describe the current 
prevalence, awareness, and management of opioid use, misuse, and abuse 
in older adults, and identify gaps and areas of needed research. 
Additionally, this project will support primary care practices (PCP) in 
developing and testing innovative strategies, approaches, and/or tools 
for opioid management within the context of facilitated learning 
collaboratives, culminating in a Compendium of Strategies for opioid 
management in older adults in primary care settings. Through this 
project, AHRQ is addressing the gaps in knowledge around opioid use in 
older adults in primary care settings. To accomplish this we are 
synthesizing what is known about the development and testing of 
innovative strategies, approaches, and/or tools for opioid management 
of older adults with pain on opioid medication, and/or opioid use 
disorder.
    This study is being conducted by AHRQ through its contractor, Abt 
Associates Inc., pursuant to AHRQ's statutory authority to conduct and 
support research on healthcare and on systems for the delivery of such 
care, including activities with respect to the quality, effectiveness, 
efficiency, appropriateness and value of healthcare services and with 
respect to quality measurement and improvement. 42 U.S.C. 299a(a)(1) 
and (2).

Method of Collection

    To achieve the goals of this project the following data collections 
will be implemented:
    1. We will conduct a web-based survey of primary care clinicians 
who care for older adults. The purpose of the survey is to assess 
primary care clinician experiences caring for older adult patients with 
chronic pain on opioids. The survey will be sent to 5,000 randomly 
selected primary care clinicians.
    2. Participating learning collaborative practices will be asked to 
implement strategies related to each of the key areas on the continuum: 
Prevention, management and treatment of opioid use, misuse and OUD in 
older adults. We will collect primary data via observations, 
interviews, and a survey, and secondary data including practice and 
learning collaborative documents. The following primary data collection 
activities are proposed:
    a. PCP Clinical Staff Survey. A brief web-based survey will be 
emailed to all clinical staff participating in the learning 
collaborative at baseline before starting implementation and 
approximately 15 months later. We assumed 20 clinical staff per clinic 
site, and 24 clinics for a total of 480 staff.
    b. Interviews. In-depth interviews will occur with up to three 
staff at each health care organization participating in the learning 
collaborative, for a total of up to 72 individuals. The evaluation team 
will conduct these interviews with:
    c. Quality Improvement (QI) champion for the initiative in the 
clinics at baseline, mid-point and post-implementation.
    d. Two additional staff (e.g. clinician, information technology 
analyst, behavioral health specialist) per organization (mid-point and 
post-implementation).
    3. Self-Assessment. The QI champion will complete a self-assessment 
tool at baseline. A similar tool is used in the Six Building Blocks 
program and the Centers for Disease Control (CDC) Opioid QI 
Collaborative. This tool is for clinics or health systems to assess the 
status of their QI efforts to improve opioid prescribing, and the 
extent to which care is consistent with the CDC Opioid Prescribing 
Guidelines.
    4. Quality Improvement Measures. Each clinic will report quarterly 
on the QI measures. The QI measures include both process and outcome 
measures. Process measures are reflective of recommended clinical 
strategies or tools being implemented, and outcome measures examine 
intermediate outcomes. A data analyst at each organization will provide 
aggregate reports of the specified QI measures to the evaluation team 
on a quarterly basis over the course of a 15-month period. The QI 
measures are measures of opioid prescribing that are critical for 
understanding the potential improvements in opioid prescribing in 
implementing the strategies.

Estimated Annual Respondent Burden

    Exhibit 1 presents estimates of the reporting burden hours for the 
data collection efforts. Time estimates are based on prior experiences 
and what can reasonably be requested of participating providers 
(survey) and PCPs. The number of respondents listed in column A, 
Exhibit 1 reflects a projected response rate for data collection 
efforts.
    1. Provider web-based survey. A survey will be sent to 5,000 
randomly selected primary care clinicians. The survey will include no 
more than 30 items and is expected to take approximately 15 minutes to 
complete. We anticipate a 30% response rate, resulting in 1,500 
completed surveys.
    2. PCP Learning Collaboratives Primary Data Collection.
    a. PCP Learning Collaborative Clinical Staff Survey. A brief survey 
will be emailed to all clinicians at baseline before starting 
implementation and approximately 15 months later. We assume 20 clinical 
staff per clinic site, and 24 clinics for a total of 480 staff. We 
assume 360 clinical staff will complete the survey based on a 75% 
response rate. It is expected to take up to 20 minutes to complete.
    b. Interviews. In-depth interviews will occur with up to 3 staff at 
each health care organization, for a total of up to 72 individuals. The 
evaluation team will conduct these interviews, each lasting up to 30 
minutes with:
    i. QI champion for the initiative in the clinics at baseline, mid-
point and post-implementation.
    ii. Two additional staff (e.g., clinician, information technology 
analyst, behavioral health specialist) per PCP at mid-point and post-
implementation.
    c. Self-Assessment. A self-assessment tool used in the Six Building 
Blocks program, and CDC Opioid QI Collaborative for clinics or health 
systems will be provided to practices to assess where they are in their 
QI efforts to improve opioid prescribing, and the extent to which care 
is consistent with the CDC Opioid Prescribing Guideline. The QI 
champion or lead for the effort in each of the 24 participating PCPs 
will respond to the self-assessment which will take approximately 15 
minutes to complete.
    d. QI Measures. Aggregate reports of the specified quality measures 
will be provided on a quarterly basis over the course of a 15-month 
period by a data analyst at each PCP. This activity will involve 12 
individuals at each learning collaborative for a total of 24. We assume 
40 hours total for each data analyst to collect and provide these data: 
Twenty hours to develop a system for pulling these measures and five 
hours to pull and submit these reports each quarter. The QI measures 
are measures of opioid prescribing that are critical for understanding 
the potential improvements in opioid prescribing in implementing 
strategies and tools for management of opioid use, misuse, and

[[Page 35092]]

abuse. Each health care organization is asked to report quarterly on 
the QI measures. Clinics may obtain these measures from electronic 
health record (EHR) data, or they may not have the sophistication or 
capacity to do that and may track these measures using Excel files or 
other methods.

                                  Exhibit 1--Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                     Number of
   Data collection method or project activity        Number of     responses per     Hours per     Total burden
                                                    respondents     respondent       response          hours
                                                              A.              B.              C.              D.
----------------------------------------------------------------------------------------------------------------
1. Web-Based Provider Survey 1..................           1,500               1           15/60             375
2a. Learning Collaborative Clinical Staff Survey             360               2           20/60             240
 2..............................................
2bi. Learning Collaborative QI Champion                       24               3           30/60              36
 Interview......................................
2bii. Learning Collaborative Staff Interview....              48               2           30/60              48
2c. Learning Collaborative Self-Assessment......              24               1           15/60               6
2di. Learning Collaborative QI Measures--develop              24               1              20             480
 system.........................................
2dii. Learning Collaborative QI Measures--pull                24               4               5             480
 and submit.....................................
                                                 ---------------------------------------------------------------
    Total.......................................           2,028             n/a             n/a           1,665
----------------------------------------------------------------------------------------------------------------
1 Number of respondents reflects a 30% response rate.
2 Number of respondents reflects a sample size assuming a 75% response rate.

    Exhibit 2, below, presents the estimated annualized cost burden 
associated with the respondents' time to participate in this research. 
The total cost burden is estimated to be $72,145.62.

                                   Exhibit 2--Estimated Annualized Cost Burden
----------------------------------------------------------------------------------------------------------------
                                                     Number of     Total burden   Average hourly    Total cost
   Data collection method or project activity       respondents        hours        wage rate *       burden
----------------------------------------------------------------------------------------------------------------
1. Web-Based Provider Survey 1..................           1,500             375         $101.82      $38,182.50
2a. Learning Collaborative Clinical Staff Survey             360             240           39.42        9,460.80
 2..............................................
2bi. Learning Collaborative QI Champion                       24              36           54.68        1,968.48
 Interview 3....................................
2bii. Learning Collaborative Staff Interview 4..              48              48           39.42        1,892.16
2c. Learning Collaborative Self-Assessment 5....              24               6           54.68          328.08
2di. Learning Collaborative QI Measures--develop              24             480           21.16       10,156.80
 system 6.......................................
2dii. Learning Collaborative QI Measures--pull                24             480           21.16       10,156.80
 and submit 7...................................
                                                 ---------------------------------------------------------------
    Total.......................................           2,028           1,917             n/a       72,145.62
----------------------------------------------------------------------------------------------------------------
1 The average hourly rate of $101.82 for the provider survey was calculated based on the 2018 mean hourly wage
  rate for family and general practitioners, (occupation code 29-1062).
2 The average hourly rate of $39.42 for the learning collaborative clinical staff survey was calculated based on
  the 2018 mean hourly wage rate for medical and health services managers (occupation code 29-0000).
3 The average hourly rate of $54.68 for QI champion interviews was calculated based on the 2018 mean hourly wage
  rate for medical and health services managers (occupation code 11-9111).
4 The average hourly rate of $39.42 for staff interviews was calculated based on the 2018 mean hourly wage rate
  for medical and health services managers (occupation code 29-0000).
5 The average hourly rate of 54.68 for the Learning Collaborative QI champion to complete the self-assessment
  was calculated based on the 2018 mean hourly wage rate for medical and health services managers (occupation
  code 11-9111).
6 The average hourly rate of $21.16 to develop the Learning Collaborative QI measures was calculated based on
  the 2018 mean hourly wage rate for medical records and health information technicians (occupation code 29-
  2071).
7 The average hourly rate of $21.16 to pull and submit the Learning Collaborative QI measures was calculated
  based on the 2018 mean hourly wage rate for medical records and health information technicians (occupation
  code 29-2071).

    Mean hourly wage rates for these groups of occupations were 
obtained from the Bureau of Labor & Statistics on ``Occupational 
Employment and Wages, May 2018'' found at the following URL: http://www.bls.gov/oes/current/oes_nat.htm#b29-0000.htm.

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: June 2, 2020.
Virginia L. Mackay-Smith,
Associate Director.
[FR Doc. 2020-12266 Filed 6-5-20; 8:45 am]
BILLING CODE 4160-90-P