[Federal Register Volume 85, Number 77 (Tuesday, April 21, 2020)]
[Notices]
[Pages 22170-22172]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-08364]
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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 ``Evaluation of the SHARE Approach Model.''
This proposed information collection was previously published in
the Federal Register on February 4, 2020, and allowed 60 days for
public comment. AHRQ did not receive comments from members of the
public. 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 of this notice.
ADDRESSES: Written comments and recommendations for the proposed
information collection should be sent within 30 days of publication of
this notice to www.reginfo.gov/public/do/PRAMain. Find this particular
information collection by selecting ``Currently under 30-day Review--
Open for Public Comments'' or by using the search function.
FOR FURTHER INFORMATION CONTACT: Doris Lefkowitz, AHRQ Reports
Clearance Officer, (301) 427-1477, or by email at
[email protected]
SUPPLEMENTARY INFORMATION:
Proposed Project
Evaluation of the SHARE Approach Model
Shared decision making (SDM) occurs when a health care provider and
a patient work together to make a health care decision that is best for
the patient. Implementing SDM involves effective communication between
providers and patients to take into account evidence-based information
about available options, the provider's knowledge and experience, and
the patient's values and preferences in reaching the best health care
decision for a patient. To facilitate SDM in all care delivery
settings, AHRQ developed the five-step SHARE Approach, which includes
exploring and comparing the benefits, harms, and risks of each option
through meaningful dialogue about what matters most to the patient.
Using the SHARE Approach also builds a trusting and lasting
relationship between health care professionals and patients.
SDM is increasingly included in clinical care guidelines, and in
some cases is even mandated. While there is considerable interest in
improving SDM across broad health care settings, less is known about
how to effectively implement SDM. There is evidence that SDM is often
not conducted effectively in practice, and identifying ways to improve
SDM has therefore become an imperative. Lack of clinician support and
education have been identified as important barriers to SDM.
The SHARE Approach was released in 2015 by AHRQ as a clinician-
facing toolkit that teaches clinicians skills to facilitate SDM across
a broad range of clinical contexts. While several implementation
success stories have been shared with AHRQ, to date there has been no
formal evaluation of the effectiveness of the SHARE Approach materials
for improving SDM in primary and specialty care settings for which it
was designed. As a result, challenges that may be faced by practices
who wish to implement the SHARE Approach are currently unknown. Without
research to identify and address these issues, practices and
organization may be unable to effectively implement the SHARE Approach
and may be unwilling to do so absent evidence of its effectiveness at
improving SDM outcomes.
The Evaluation of the SHARE Approach Model project aims to revise
the SHARE Approach toolkit to remove outdated references and increase
applicability for SDM in contexts involving problem solving, evaluate
the implementation of the SHARE Approach model in eight primary care
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and four cardiology clinics, and evaluate the effectiveness of the
SHARE Approach model at improving SDM.
Method of Collection
The purpose of this clearance request is to collect the information
needed to evaluate the implementation and effectiveness of the modified
SHARE Approach materials. Specifically, the data collection activities
requested in this clearance are:
1. Brief surveys of physicians, advanced practice providers, other
clinicians, nurses and other staff in 12 clinics immediately following
the SHARE Approach training in each clinic.
2. A brief survey of physicians, advanced practice providers, other
clinicians, nurses and other staff in 12 clinics one month following
the SHARE Approach training in each clinic.
3. A short card survey completed by patients in the 12 clinics
immediately following a clinic visit with a physician or advanced
practice provider.
4. A short card survey completed by physicians or advanced practice
providers in the 12 clinics immediately following a clinic visit with a
patient.
5. Audio recordings of patient-provider (physician or advanced
practice provider) encounters in clinic examination rooms in the 12
clinics.
This study is being conducted by AHRQ through its contractor, the
University of Colorado, 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 clinical
practice, including primary care and practice-oriented research. 42
U.S.C 299a(a)(4).
Estimated Annual Respondent Burden
Exhibit 1 shows the estimated burden hours for the respondents'
time to participate in the research activities that will be conducted
under this clearance. Data collection will occur between September 2020
and October 2021. Surveys of physicians, advanced practice providers,
other clinicians, nurses and other staff in each of the 12 practices
will be conducted at the time of SHARE training and again approximately
1 to 2 months following training. These will be conducted with no more
than 100 physicians, advanced practice providers, other clinicians,
nurses and other staff for each survey and will require no more than 10
minutes to complete.
Brief card surveys will be completed by both patients and
clinicians. We estimate the maximum number of patients participating in
the card survey as follows: A maximum of 100 clinicians will see a
maximum of 20 patients per day, of which half (n = 10) will agree to
complete the card survey, over 6 days of data collection, totaling N =
6,000 patient respondents (100 x 10 x 6). The patient card survey will
take a maximum of 2 minutes per completed survey. Clinicians will
complete a card survey for every patient they see during the 6 days of
data collection, or a total of N = 12,000 card surveys (100 clinicians
x 20 patients per day x 6 days). The clinician card survey will require
a maximum of 1 minute per completed survey.
Audio recordings of up to 260 clinical encounters will be obtained
with burden not to exceed 10 minutes to obtain patient informed
consent.
Exhibit 1--Estimated Respondent Burden Hours
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Number of
Type of information collection Number of responses per Hours per Total burden
respondents respondent response hours
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Card survey (patient)........................... 6,000 1 2/60 200
Card survey (clinician)......................... 100 120 1/60 200
Audio recorded encounters....................... 260 1 10/60 44
Clinician survey *.............................. 100 2 10/60 34
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Totals...................................... 6,460 na na 478
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* May include telephone non-response follow-up in which case the burden will not change.
Exhibit 2 shows the estimated cost burden of respondents for these
data collection activities, based on the respondent's time to
participate in these data collection activities. The total cost burden
is estimated to be $29,831.
Exhibit 2--Estimated Cost Burden
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Number of Total burden Average hourly Total cost
Type of Information collection respondents hours wage rate * burden
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Card survey (patient)........................... 6,000 200 $24.98 $4,996
Card survey (clinician)......................... 100 200 101.43 20,286
Audio recorded encounters....................... 260 44 24.98 1,100
Clinician survey................................ 100 34 101.43 3,449
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Totals...................................... 6,460 478 na 29,831
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* Based upon the average wages for 29-1060 Physicians and Surgeons (broad) and 00-0000 All Occupations,
``National Compensation Survey: Occupational Wages in the United States, May 2018,'' U.S. Department of Labor,
Bureau of Labor Statistics https://www.bls.gov/oes/current/oes_nat.htm#29-0000.
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
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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: April 15, 2020.
Virginia L. Mackay-Smith,
Associate Director.
[FR Doc. 2020-08364 Filed 4-20-20; 8:45 am]
BILLING CODE 4160-90-P