[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

[[Page 22171]]

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

[[Page 22172]]

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