[Federal Register Volume 84, Number 71 (Friday, April 12, 2019)]
[Notices]
[Pages 14946-14949]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-07303]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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 ``Evaluating and Implementing the Six Building Blocks Team 
Approach to Improve Opioid Management in Primary Care.''

DATES: Comments on this notice must be received by June 11, 2019.

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

Evaluating and Implementing the Six Building Blocks Team Approach To 
Improve Opioid Management in Primary Care

    In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-
3521, AHRQ invites the public to comment on this proposed information 
collection. The project ``Evaluating and Implementing the Six Building 
Blocks Team Approach to Improve Opioid Management in Primary Care'' 
fully supports AHRQ's mission. The ultimate aim of this project is to 
further validate and expand the Six Building Blocks to Safer Opioid 
Management (6BBs) intervention and its associated resources and 
guidance to support primary care providers in safer opioid prescribing.
    Opioid overdose deaths have increased dramatically since 1999, and 
despite recent decreases in the national opioid prescribing rate, 
prescribing rates remain high in many U.S. counties. Primary care 
providers (PCPs) are responsible for about half of all dispensed opioid 
pain relievers. To address the emerging opioid epidemic, the Six 
Building Blocks to Safer Opioid Management (6BBs) Toolkit has been 
developed to support primary care providers in safer opioid 
prescribing, largely concordant with the Centers for Disease Control 
and Prevention's Guideline for Prescribing Opioids for Chronic Pain. 
The 6BBs is a structured, systems-based approach for improving 
management of patients on long-term opioid therapy that targets six 
work areas a primary care practice needs to redesign in order to 
improve their clinic's management of patients on long-term opioid 
therapy.
    Building upon previous work supported by AHRQ to address the opioid 
epidemic, this research has the following goals:
    1. To improve the guidance for the 6BBs Toolkit,
    2. To further implement the 6BBs in primary care practices, and

[[Page 14947]]

    3. To understand the facilitators and barriers to implementing the 
Six Building Blocks to Safer Opioid Management.
    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 health care and on systems for the delivery of such 
care, including activities with respect to the quality, effectiveness, 
efficiency, appropriateness and value of health care 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) Clinical Staff Survey. A brief survey will be administered 
electronically to all clinical staff, including primary care 
physicians, nurse practitioners, physician assistants, social workers, 
medical assistants, registered nurses, pharmacists and behavioral 
health workers, toward the beginning of 6BBs Toolkit implementation and 
approximately 12 months later. A quality improvement (QI) point person 
will provide email addresses for the staff who will be invited to 
complete the survey from each participating organization. These email 
addresses will be used to send clinical staff the surveys at both time 
points. The survey will collect information about staff's self-reported 
use of evidence-based opioid prescribing practices; procedures in place 
around opioid prescribing management; self efficacy regarding safe 
opioid prescribing; knowledge, beliefs and attitudes regarding opioid 
prescribing; adaptive reserve; self-reported burnout; and reported 
implementation experiences. The survey will also collect information 
about staffs' background (e.g., clinic role and tenure). The survey 
will consist largely of closed-ended questions (e.g., scale or Likert 
response options) with several open-ended questions.
    (2) Staff Interviews. Interviews will be conducted with 5 staff at 
each of the 12 participating health care organizations. AHRQ will 
conduct 2 rounds of interviews, with the first round occurring within 
several months after the How-To-Guide is distributed to the 
organization and the second round occurring 12 months later. The 
evaluation team will conduct in-depth interviews with:
    a. The quality improvement (QI) lead and
    b. Four additional staff who are involved in 6BBs implementation at 
each organization, that might include a clinician, information 
technology analyst, social worker, behavioral health specialist, and/or 
care coordinator.
    Staff interviewees will be selected by the QI lead at each 
organization, who will be asked to nominate a range of staff from those 
who embraced changes to those who were less willing to implement 
changes. Interviews will capture qualitative data regarding the 
organization's history with efforts to curb opioid prescribing, 
experiences using the How-To-Guide, implementation of the 6BB 
intervention and associated opioid management interventions, and 
lessons learned that can be shared with other health care 
organizations.
    (3) Virtual Launch Meeting. A virtual launch meeting will be held 
for organization liaisons and quality improvement leaders participating 
health care organizations to launch 6BBs Toolkit implementation. The 
meeting will be conducted by web-conference, and will last up to 2 
hours.
    (4) Quarterly Check-In Calls. A project team member will hold a 
quarterly check-in call with organization liaisons and quality 
improvement leaders to assess the progress of implementation of the 
6BBs intervention and improvement initiatives at each organization. 
Check-in calls will occur quarterly for up to 12 months. Each call will 
be up to 60 minutes in duration, and notes will be taken by an 
evaluation team member during each call.
    (5) QI Measures. Each health care organization will be asked to 
report quarterly on the number of patients on long-term opioid therapy 
and the proportion of those who are on greater than 90 morphine 
milligram equivalents, co-prescribed a benzodiazepine, and had the 
prescription drug monitoring program checked and a urine drug screen. 
Organizations may also select other outcome measures aligned to their 
own goals.
    (6) Other outcome and output data from administrative records, 
electronic medical records, and organizational documents (Secondary 
Data). Health care organizations may also report their progress on 
implementing the 6BB intervention and associated changes in care 
processes through completion of worksheets contained in or associated 
with the How-To-Guide. Since these data collections involve simply 
submitting worksheets they complete for their own benefit while working 
through the How-To-Guide, they pose only minimal data collection burden 
to the health care organization, specifically the person who completes 
the worksheets (i.e., QI lead). The project team will also obtain 
relevant organizational documents (e.g., opioid prescribing policies, 
quality improvement plans, sample patient agreements, relevant practice 
workflows, screen shots of data dashboards).
    The purpose of the proposed data collection effort is to obtain 
information needed to modify and enhance the 6BB How-To-Guide and to 
provide information to health care organizations considering using the 
How-To-Guide to improve their opioid prescribing practices and relevant 
outcomes. Since this is only a study conducted in 12 organizations, 
outcomes or impacts will not be generalizable.
    The data collected will help the project team: (1) Understand the 
facilitators and barriers of using the 6BB Toolkit and recommended 
improvements to processes of care and opioid prescribing practices, and 
(2) assess the effectiveness of using the 6BB Toolkit to improve 
processes of care and opioid prescribing practices. The data collection 
effort may also provide insights that could guide dissemination of the 
Toolkit. For example, if it was found that a specific type of 
organization included in this pilot study (e.g., small, stand-alone 
clinic in a rural area) particularly benefitted from using the Toolkit, 
then AHRQ could tailor and target its dissemination of the Toolkit to 
similar organizations. Once revisions are made based on results of this 
evaluation, the How-To-Guide corresponding to the Toolkit will be 
published on AHRQ's website. A manuscript describing the pilot study 
and its results will also be produced for publication in a peer-
reviewed journal.

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 health care 
organizations. The number of respondents listed in column A, Exhibit 1 
reflects a projected 75% response rate for data collection efforts 2a 
and 2b below.
    1. Clinical Staff Survey. A brief survey will be emailed to all 
clinicians both toward the beginning of 6BBs Toolkit implementation and 
approximately 12 months later. We assumed 20 clinical staff per 
clinical site, and approximately 33 clinical sites overall (with a 
range from 1 clinic to 17 per organization), for a total of 660 staff 
across all 12 organizations. We assumed 495 clinical

[[Page 14948]]

staff will complete the survey based on a 75% response rate. It is 
expected to take up to 15 minutes to complete.
    2. Staff Interviews. In-depth interviews will occur with 5 staff at 
each health care organization, for a total of up to 60 individuals. The 
evaluation team will conduct these interviews, each lasting up to 1 
hour, at 2 points in time with:
    a. One QI lead per organization (toward the start of and at the end 
of the project).
    b. Four additional staff (e.g., clinician, information technology 
analyst, social worker) per organization (midway through and at the end 
of the project).
    3. Virtual Launch Meeting. The meeting will occur with the quality 
improvement (QI) leads at participating health care organizations to 
launch 6BBs Toolkit implementation. The meeting will be conducted by 
web-conference, and will last up to 2 hours.
    4. Quarterly Check-In Calls. Calls will occur with QI leads, 
clinical champions, and other relevant staff the QI lead identifies, 
for a total of no more than 5 individuals per organization. These calls 
will assess progress with the organization's use of the Toolkit and 
implementation of associated practice changes, and will occur quarterly 
over 15 months, for a total of 5 quarterly check-in calls. Each call 
will take up to 60 minutes.
    5. QI Measures. Aggregate reports of the specified quality measures 
will be provided on a quarterly basis over the course of an 18-month 
period by a data analyst at each organization, for a total of 12 
individuals across all 12 organizations. We assume 40 hours total (10 
hours per quarter) for each data analyst to collect and provide these 
data.
    6. Other outcome and output data from administrative records and 
organizational documents (Secondary Data). These secondary data will be 
provided by the QI lead at each organization, for a total of 12 
individuals across all 12 organizations. We assume 4 hours per month 
for 12 months for a total of 48 hours for each QI lead to collect and 
provide these data.

                                  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. Clinical Staff Survey *......................             495               2           15/60             248
2a. Staff Interview--QI Lead....................              12               2               1              24
2b. Staff Interview--Additional Staff...........              48               2               1              96
3. Virtual Launch Meeting.......................              12               1               2              24
4. Quarterly Check-In Calls.....................              60               5               1             300
5. QI Measures..................................              12               4              10             480
6. Secondary data...............................              12              12               4             576
                                                 ---------------------------------------------------------------
    Total.......................................             651              na              Na           1,748
----------------------------------------------------------------------------------------------------------------
* Number of respondents (Column A) reflects a sample size assuming a 75% response rate for this data collection
  effort.

    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 about $70,779.

                                   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. Clinical Staff Survey........................             495             248          $48.45         $12,016
2a. Staff Interview--QI Lead....................              12              24           53.69           1,289
2b. Staff Interview--Additional Staff...........              48              96           38.83           3,728
3. Virtual Launch Meeting.......................              12              24           53.69           1,289
4. Quarterly Check-In Calls.....................              60             300           38.83          11,649
5. QI Measures..................................              12             480           20.59           9,883
6. Secondary data...............................              12             576           53.69          30,925
                                                 ---------------------------------------------------------------
    Total.......................................  ..............  ..............  ..............          70,779
----------------------------------------------------------------------------------------------------------------

    The average hourly rate of $48.45 for the clinical staff survey was 
calculated based on the 2017 mean hourly wage rate for health 
diagnosing and treating practitioners, $48.45 (occupation code 29-
1000).
    The average hourly rate of $53.69 for QI lead interviews was 
calculated based on the 2017 mean hourly wage rate for medical and 
health services managers, $53.69 (occupation code 11-9111).
    The average hourly rate of $38.83 for staff interviews was 
calculated based on the 2017 mean hourly wage rate for health care 
practitioners and technical occupations, $38.83 (occupation code 29-
0000).
    The average hourly rate of $53.69 for the virtual launch meeting 
was calculated based on the 2017 mean hourly wage rate for medical and 
health services managers, $53.69 (occupation code 11-9111).
    The average hourly wage rate of $38.83 for quarterly check-in calls 
was calculated based on the 2017 mean hourly wage rate for health care 
practitioners and technical occupations, $38.83 (occupation code 29-
0000).
    The average hourly rate of $20.59 for QI measures was calculated 
based on the 2017 mean hourly wage rate for medical records and health 
information

[[Page 14949]]

technicians, $20.59 (occupation code 29-2071).
    The average hourly rate of $53.69 for secondary data was calculated 
based on the 2017 mean hourly wage rate for medical and health services 
managers, $53.69 (occupation code 11-9111).
    Mean hourly wage rates for these groups of occupations were 
obtained from the Bureau of Labor & Statistics on ``Occupational 
Employment and Wages, May 2017'' 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, 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.

Gopal Khanna,
Director.
[FR Doc. 2019-07303 Filed 4-11-19; 8:45 am]
 BILLING CODE 4160-90-P