Agency Information Collection Activities: Proposed Collection; Comment Request, 14946-14949 [2019-07303]
Download as PDF
<![CDATA[
14946
Federal Register / Vol. 84, No. 71 / Friday, April 12, 2019 / Notices
jbell on DSK30RV082PROD with NOTICES
The systematic review will answer the
following questions. This information is
provided as background. AHRQ is not
requesting that the public provide
answers to these questions.
The Key Questions
1. What skin substitutes currently
used to treat chronic wounds are being
regulated by the U.S. Food and Drug
Administration (FDA) under the
following pathways: Premarket
Approval (PMA), Premarket Notification
(510[k]), Section 361 of the Public
Health Service Act (21 CFR 1270 and
1271)?
2. What classification systems have
been developed to categorize skin
substitutes?
a. What are important skin substitute
parameters and active components
currently being used when classifying
skin substitutes?
3. What are the study design
characteristics (such as those listed
below) in each included investigation
for each chronic wound type?
a. Comparator to skin substitute
b. Inclusion/exclusion criteria of
patients including at least age, gender,
and general health requirements (e.g.,
status of HbA1c, diabetes, peripheral
vascular disease, obesity, smoking,
renal)
c. Inclusion/exclusion criteria of
wounds including at least wound
type, wound size/depth/duration/
severity, vascular status, infection
status, and prior treatment
requirements (e.g., no treatment with
growth factors or negative pressure
wound therapy)
d. Patient characteristics of enrollees
including at least age, gender, general
health (e.g., status of HbA1c, diabetes,
peripheral vascular disease, obesity,
smoking, renal), and prior and
concurrent wound treatments
e. Wound characteristics of enrollees
including at least wound type, wound
size/depth/duration/severity, vascular
status, and infection status
f. Basic study design and conduct
information including at least method
of patient enrollment, care setting,
and use of run-in period
g. Definition of wound characteristics:
definition of ‘‘failure to heal’’, and
definition of a successfully healed
wound
h. Method of applying skin substitutes
including provider, frequency of
application, definition of standard of
care, and handling of infections
i. Measurement and assessment
methods including method of
assessment(s); frequency and time
points for assessment(s); and blinding
of assessors
VerDate Sep<11>2014
18:18 Apr 11, 2019
Jkt 247001
j. Statistical methods including power
calculations, intent-to-treat analysis
for studies designed to test
superiority, and handling of drop-outs
4. What are the outcomes of treatment
strategies including skin substitutes
alone and/or in addition to other wound
care modalities compared to other
wound care modalities in patients with
different types of chronic wounds, for
patient oriented outcomes such as the
following? Consider at least:
a. Number/percentage of completely
closed/healed wounds (skin closure
with complete re-epithelialization
without drainage or dressing
requirements versus failure to heal)
b. Time to complete wound closure
c. Wound reoccurrence (include time
when initial wound healing was
measured, and follow-up to assess
durability of healed wounds)
d. Wound infection
e. Need for amputation
f. Need for hospitalization (frequency
and duration)
g. Return to baseline activities of daily
living and function
h. Pain reduction
i. Exudate and odor reduction
j. Adverse effects (besides those above)
5. What skin substitutes are currently
being investigated in ongoing trials?
6. What best practices in study design
could be used to produce high quality
evidence on skin substitutes?
Gopal Khanna,
Director.
[FR Doc. 2019–07302 Filed 4–11–19; 8:45 am]
BILLING CODE 4160–90–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Agency for Healthcare Research
and Quality, HHS.
ACTION: Notice.
AGENCY:
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.
SUMMARY:
PO 00000
Frm 00036
Fmt 4703
Sfmt 4703
Written comments should
be submitted to: Doris Lefkowitz,
Reports Clearance Officer, AHRQ, by
email at doris.lefkowitz@AHRQ.hhs.gov.
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 doris.lefkowitz@
AHRQ.hhs.gov.
SUPPLEMENTARY INFORMATION:
ADDRESSES:
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 longterm 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
E:\FR\FM\12APN1.SGM
12APN1
Federal Register / Vol. 84, No. 71 / Friday, April 12, 2019 / Notices
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).
jbell on DSK30RV082PROD with NOTICES
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; selfreported 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
VerDate Sep<11>2014
18:18 Apr 11, 2019
Jkt 247001
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 webconference, 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. Checkin 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
PO 00000
Frm 00037
Fmt 4703
Sfmt 4703
14947
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
E:\FR\FM\12APN1.SGM
12APN1
14948
Federal Register / Vol. 84, No. 71 / Friday, April 12, 2019 / Notices
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 webconference, 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
Data collection method or project activity
Number of
respondents
Number of
responses per
respondent
Hours per
response
Total burden
hours
A.
B.
C.
D.
1. Clinical Staff Survey * ..................................................................................
2a. Staff Interview—QI Lead ...........................................................................
2b. Staff Interview—Additional Staff ................................................................
3. Virtual Launch Meeting ................................................................................
4. Quarterly Check-In Calls .............................................................................
5. QI Measures ................................................................................................
6. Secondary data ...........................................................................................
495
12
48
12
60
12
12
2
2
2
1
5
4
12
15/60
1
1
2
1
10
4
248
24
96
24
300
480
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
respondents
jbell on DSK30RV082PROD with NOTICES
Data collection method or project activity
Total burden
hours
Average
hourly wage
rate *
Total cost
burden
1. Clinical Staff Survey ....................................................................................
2a. Staff Interview—QI Lead ...........................................................................
2b. Staff Interview—Additional Staff ................................................................
3. Virtual Launch Meeting ................................................................................
4. Quarterly Check-In Calls .............................................................................
5. QI Measures ................................................................................................
6. Secondary data ...........................................................................................
495
12
48
12
60
12
12
248
24
96
24
300
480
576
$48.45
53.69
38.83
53.69
38.83
20.59
53.69
$12,016
1,289
3,728
1,289
11,649
9,883
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).
VerDate Sep<11>2014
18:18 Apr 11, 2019
Jkt 247001
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
PO 00000
Frm 00038
Fmt 4703
Sfmt 4703
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
E:\FR\FM\12APN1.SGM
12APN1
Federal Register / Vol. 84, No. 71 / Friday, April 12, 2019 / Notices
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:
https://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.
grant applications and the discussions
could disclose confidential trade secrets
or commercial property such as
patentable material, and personal
information concerning individuals
associated with the grant applications,
the disclosure of which would
constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Disease,
Disability, and Injury Prevention and
Control Special Emphasis Panel (SEP)—
RFA–CE–19–006, Grants to Support
New Investigators in Addressing CrossCutting Violence Prevention and Opioid
Overdose Prevention.
Date: June 11, 2019.
Time: 11:00 a.m.–5:00 p.m., EDT.
Place: Teleconference.
Agenda: To review and evaluate grant
applications.
For Further Information Contact:
Kimberly Leeks, Ph.D., M.P.H.,
Scientific Review Official, NCIPC, CDC,
4770 Buford Highway NE, Mailstop F–
63, Atlanta, Georgia 30341, Telephone
(770)488–6562, KLeeks@cdc.gov.
The Chief Operating Officer, Centers
for Disease Control and Prevention, has
been delegated the authority to sign
Federal Register notices pertaining to
announcements of meetings and other
committee management activities, for
both the Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
Sherri Berger,
Chief Operating Officer, Centers for Disease
Control and Prevention.
[FR Doc. 2019–07266 Filed 4–11–19; 8:45 am]
Centers for Disease Control and
Prevention
jbell on DSK30RV082PROD with NOTICES
Notice of Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended, and the Determination of
the Chief Operating Officer, CDC,
pursuant to Public Law 92–463. The
VerDate Sep<11>2014
18:18 Apr 11, 2019
Jkt 247001
Sherri Berger,
Chief Operating Officer, Centers for Disease
Control and Prevention.
[FR Doc. 2019–07265 Filed 4–11–19; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
BILLING CODE 4160–90–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
healthcare Work Settings in the United
States; CK19–004, Study To Assess the
Risk of Blood Borne Transmission of
Classic Forms of Creutzfeldt-Jakob
Disease (CJD); and CK17–005SUPP,
Vector-Borne Disease Regional Centers
of Excellence; May 7, 2019; 10:00 a.m.—
5:00 p.m., (EDT) which was published
in the Federal Register on March 15,
2019, Volume 84, Number 51, pages
9523.
The meeting is being amended to
remove CK17–005SUPP, Vector-Borne
Disease Regional Centers of Excellence.
The meeting is closed to the public.
FOR FURTHER INFORMATION CONTACT:
Gregory Anderson, M.S., M.P.H.,
Scientific Review Officer, CDC, 1600
Clifton Road NE, Mailstop E60, Atlanta,
Georgia 30329, (404) 718–8833, gca5@
cdc.gov.
The Chief Operating Officer, Centers
for Disease Control and Prevention, has
been delegated the authority to sign
Federal Register notices pertaining to
announcements of meetings and other
committee management activities, for
both the Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
BILLING CODE 4163–18–P
Centers for Disease Control and
Prevention
[FR Doc. 2019–07303 Filed 4–11–19; 8:45 am]
14949
Disease, Disability, and Injury
Prevention and Control Special
Emphasis Panel (SEP)—CK19–002,
Quantifying Contact Rates and Mixing
Patterns in Workers in Non-healthcare
Work Settings in the United States;
CK19–004, Study To Assess the Risk
of Blood Borne Transmission of
Classic Forms of Creutzfeldt-Jakob
Disease (CJD); and CK17–005SUPP,
Vector-Borne Disease Regional
Centers of Excellence
Amended Notice of Meeting
Notice is hereby given of a change in
the meeting of the Disease, Disability,
and Injury Prevention and Control
Special Emphasis Panel (SEP); CK19–
002, Quantifying Contact Rates and
Mixing Patterns in Workers in Non-
PO 00000
Frm 00039
Fmt 4703
Sfmt 4703
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request; Information
Collection Request Title: Rural
Communities Opioid Response
Program Performance Measures, OMB
No. 0906–xxxx, New
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
In compliance with the
requirement for opportunity for public
comment on proposed data collection
projects of the Paperwork Reduction Act
of 1995, HRSA announces plans to
submit an Information Collection
Request (ICR), described below, to the
Office of Management and Budget
(OMB). Prior to submitting the ICR to
OMB, HRSA seeks comments from the
public regarding the burden estimate,
below, or any other aspect of the ICR.
SUMMARY:
E:\FR\FM\12APN1.SGM
12APN1
]]>Agencies
[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: https://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
