Agency Information Collection Activities: Proposed Collection; Comment Request

 
CONTENT
Federal Register, Volume 84 Issue 145 (Monday, July 29, 2019)
[Federal Register Volume 84, Number 145 (Monday, July 29, 2019)]
[Notices]
[Pages 36603-36606]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-15986]
=======================================================================
-----------------------------------------------------------------------
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.'' In accordance
with the Paperwork Reduction Act, AHRQ invites the public to comment on
this proposed information collection. This proposed information
collection was previously published in the Federal Register on April
12, 2019, and allowed 60 days for public comment. AHRQ did not receive
any 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 by 30 days after date
of publication.
ADDRESSES: Written comments should be submitted to: AHRQ's OMB Desk
Officer by fax at (202) 395-6974 (attention: AHRQ's desk officer) or by
email at [email protected] (attention: AHRQ's desk officer).
FOR FURTHER INFORMATION CONTACT: Doris Lefkowitz, AHRQ Reports
Clearance Officer, (301) 427-1477, or by email at
[email protected].
SUPPLEMENTARY INFORMATION:
[[Page 36604]]
Proposed Project
Evaluating and Implementing the Six Building Blocks Team Approach To
Improve Opioid Management in Primary Care
    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
    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 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) 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 15 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 from
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
[[Page 36605]]
practices and relevant outcomes. Since this is only a study conducted
in 15 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 50 clinical sites
overall (with a range from 1 clinic to 17 per organization), for a
total of 1,000 staff across all 15 organizations. We assumed 750
clinical 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 75 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 15
individuals across all 15 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 15
individuals across all 15 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 *......................             750               2           15/60             375
2a. Staff Interview--QI Lead....................              15               2               1              30
2b. Staff Interview--Additional Staff...........              60               2               1             120
3. Virtual Launch Meeting.......................              15               1               2              30
4. Quarterly Check-In Calls.....................              75               5               1             375
5. QI Measures..................................              15               4              10             600
6. Secondary data...............................              15              12               4             720
                                                 -----------------
----------------------------------------------------------------------------------------------------------------
*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 $91,623.
                                   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........................             750             375          $48.45         $18,169
2a. Staff Interview--QI Lead....................              15              30           53.69           1,611
2b. Staff Interview--Additional Staff...........              60             120           38.83           4,660
3. Virtual Launch Meeting.......................              15              30           53.69           1,611
4. Quarterly Check-In Calls.....................              75             375           38.83          14,561
[[Page 36606]]

5. QI Measures..................................              15             600           20.59          12,354
6. Secondary data...............................              15             720           53.69          38,657
                                                 ---------------------------------------------------------------
    Total.......................................  ..............  ..............  ..............          91,623
----------------------------------------------------------------------------------------------------------------
    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 healthcare 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 healthcare
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 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.
    Dated: July 23, 2019.
Virginia L. Mackay-Smith,
Associate Director.
[FR Doc. 2019-15986 Filed 7-26-19; 8:45 am]
 BILLING CODE 4160-90-P