2020-08364. Agency Information Collection Activities: Proposed Collection; Comment Request  

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    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 “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.

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    FOR FURTHER INFORMATION CONTACT:

    Doris Lefkowitz, AHRQ Reports Clearance Officer, (301) 427-1477, or by email at doris.lefkowitz@AHRQ.hhs.gov

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    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 Start Printed Page 22171and 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 × 10 × 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 × 20 patients per day × 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

    Type of information collectionNumber of respondentsNumber of responses per respondentHours per responseTotal burden hours
    Card survey (patient)6,00012/60200
    Card survey (clinician)1001201/60200
    Audio recorded encounters260110/6044
    Clinician survey *100210/6034
    Totals6,460nana478
    * 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

    Type of Information collectionNumber of respondentsTotal burden hoursAverage hourly wage rate *Total cost burden
    Card survey (patient)6,000200$24.98$4,996
    Card survey (clinician)100200101.4320,286
    Audio recorded encounters2604424.981,100
    Clinician survey10034101.433,449
    Totals6,460478na29,831
    * 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 Start Printed Page 22172collection(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.

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    Dated: April 15, 2020.

    Virginia L. Mackay-Smith,

    Associate Director.

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    [FR Doc. 2020-08364 Filed 4-20-20; 8:45 am]

    BILLING CODE 4160-90-P