2020-02116. 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 “Evaluation of the SHARE Approach Model.”

DATES:

Comments on this notice must be received by 60 days after date of publication.

ADDRESSES:

Written comments should be submitted to: Doris Lefkowitz, Reports Clearance Officer, AHRQ, by email at [e-mail].

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, [phone], or by emails at [e-mail].

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 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 over the full 3 years of this clearance for the respondents' time to participate in the research activities that will be conducted under this clearance. Brief card surveys will be completed by both patients and clinicians. The physician/advanced practice provider card survey will require a maximum of 60 seconds. The patient card survey will take a maximum of 2 minutes. Number of observations will include a maximum of 6,000 patient and 6,000 clinician surveys. Audio recordings of up to 260 clinical encounters will be obtained, with burden not to exceed 10 minutes to obtain patient informed consent. Two clinician surveys will be conducted, one immediately following SHARE training and one following the second observation period, one month following SHARE training. These will be conducted with no more than 100 clinicians and will require no more than 10 minutes to complete.

Exhibit 2 shows the estimated cost burden over 3 years, based on the respondents' time to participate in these research activities. The total cost burden is estimated to be $19,688.

Exhibit 1—Estimated Burden Hours Over 3 Years

Type of information collection	Number of respondents	Number of responses per respondent	Hours per response	Total burden hours
Card survey (patient)	6,000	1	2/60	200
Card survey (clinician)	6,000	1	1/60	100
Audio recorded encounters	260	1	10/60	44
Clinician survey immediately following training	100	1	10/60	17
Clinician survey one month following training	100	1	10/60	17
Totals	12,460	na	na	378
* May include telephone non-response follow-up in which case the burden will not change

Exhibit 2—Estimated Cost Burden Over 3 Years

Type of information collection	Number of respondents	Total burden hours	Average hourly wage rate *	Total cost burden
Card survey (patient)	6,000	200	$24.98	$4,996
Card survey (clinician)	6,000	100	101.43	10,143
Audio recorded encounters	260	44	24.98	1,100
Clinician survey immediately following training	100	17	101.43	1,725
Clinician survey one month following training	100	17	101.43	1,725
Totals	12,460	378	na	19,689
* 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 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: January 29, 2020.

Virginia L. Mackay-Smith,

Associate Director.