2020-12266. 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 “Identifying and Testing Strategies for Management of Opioid Use and Misuse in Older Adults in Primary Care Practices.”

DATES:

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

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 email at [e-mail].

SUPPLEMENTARY INFORMATION:

Proposed Project

Identifying and Testing Strategies for Management of Opioid Use and Misuse in Older Adults in Primary Care Practices

The goals of this project are to assess and describe the current prevalence, awareness, and management of opioid use, misuse, and abuse in older adults, and identify gaps and areas of needed research. Additionally, this project will support primary care practices (PCP) in developing and testing innovative strategies, approaches, and/or tools for opioid management within the context of facilitated learning collaboratives, culminating in a Compendium of Strategies for opioid management in older adults in primary care settings. Through this project, AHRQ is addressing the gaps in knowledge around opioid use in older adults in primary care settings. To accomplish this we are synthesizing what is known about the development and testing of innovative strategies, approaches, and/or tools for opioid management of older adults with pain on opioid medication, and/or opioid use disorder.

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 healthcare and on systems for the delivery of such care, including activities with respect to the quality, effectiveness, efficiency, appropriateness and value of healthcare 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. We will conduct a web-based survey of primary care clinicians who care for older adults. The purpose of the survey is to assess primary care clinician experiences caring for older adult patients with chronic pain on opioids. The survey will be sent to 5,000 randomly selected primary care clinicians.

2. Participating learning collaborative practices will be asked to implement strategies related to each of the key areas on the continuum: Prevention, management and treatment of opioid use, misuse and OUD in older adults. We will collect primary data via observations, interviews, and a survey, and secondary data including practice and learning collaborative documents. The following primary data collection activities are proposed:

a. PCP Clinical Staff Survey. A brief web-based survey will be emailed to all clinical staff participating in the learning collaborative at baseline before starting implementation and approximately 15 months later. We assumed 20 clinical staff per clinic site, and 24 clinics for a total of 480 staff.

b. Interviews. In-depth interviews will occur with up to three staff at each health care organization participating in the learning collaborative, for a total of up to 72 individuals. The evaluation team will conduct these interviews with:

c. Quality Improvement (QI) champion for the initiative in the clinics at baseline, mid-point and post-implementation.

d. Two additional staff (e.g. clinician, information technology analyst, behavioral health specialist) per organization (mid-point and post-implementation).

3. Self-Assessment. The QI champion will complete a self-assessment tool at baseline. A similar tool is used in the Six Building Blocks program and the Centers for Disease Control (CDC) Opioid QI Collaborative. This tool is for clinics or health systems to assess the status of their QI efforts to improve opioid prescribing, and the extent to which care is consistent with the CDC Opioid Prescribing Guidelines.

4. Quality Improvement Measures. Each clinic will report quarterly on the QI measures. The QI measures include both process and outcome measures. Process measures are reflective of recommended clinical strategies or tools being implemented, and outcome measures examine intermediate outcomes. A data analyst at each organization will provide aggregate reports of the specified QI measures to the evaluation team on a quarterly basis over the course of a 15-month period. The QI measures are measures of opioid prescribing that are critical for understanding the potential improvements in opioid prescribing in implementing the strategies.

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 providers (survey) and PCPs. The number of respondents listed in column A, Exhibit 1 reflects a projected response rate for data collection efforts.

1. Provider web-based survey. A survey will be sent to 5,000 randomly selected primary care clinicians. The survey will include no more than 30 items and is expected to take approximately 15 minutes to complete. We anticipate a 30% response rate, resulting in 1,500 completed surveys.

2. PCP Learning Collaboratives Primary Data Collection.

a. PCP Learning Collaborative Clinical Staff Survey. A brief survey will be emailed to all clinicians at baseline before starting implementation and approximately 15 months later. We assume 20 clinical staff per clinic site, and 24 clinics for a total of 480 staff. We assume 360 clinical staff will complete the survey based on a 75% response rate. It is expected to take up to 20 minutes to complete.

b. Interviews. In-depth interviews will occur with up to 3 staff at each health care organization, for a total of up to 72 individuals. The evaluation team will conduct these interviews, each lasting up to 30 minutes with:

i. QI champion for the initiative in the clinics at baseline, mid-point and post-implementation.

ii. Two additional staff (e.g., clinician, information technology analyst, behavioral health specialist) per PCP at mid-point and post-implementation.

c. Self-Assessment. A self-assessment tool used in the Six Building Blocks program, and CDC Opioid QI Collaborative for clinics or health systems will be provided to practices to assess where they are in their QI efforts to improve opioid prescribing, and the extent to which care is consistent with the CDC Opioid Prescribing Guideline. The QI champion or lead for the effort in each of the 24 participating PCPs will respond to the self-assessment which will take approximately 15 minutes to complete.

d. QI Measures. Aggregate reports of the specified quality measures will be provided on a quarterly basis over the course of a 15-month period by a data analyst at each PCP. This activity will involve 12 individuals at each learning collaborative for a total of 24. We assume 40 hours total for each data analyst to collect and provide these data: Twenty hours to develop a system for pulling these measures and five hours to pull and submit these reports each quarter. The QI measures are measures of opioid prescribing that are critical for understanding the potential improvements in opioid prescribing in implementing strategies and tools for management of opioid use, misuse, and abuse. Each health care organization is asked to report quarterly on the QI measures. Clinics may obtain these measures from electronic health record (EHR) data, or they may not have the sophistication or capacity to do that and may track these measures using Excel files or other methods.

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. Web-Based Provider Survey 1	1,500	1	15/60	375
2a. Learning Collaborative Clinical Staff Survey 2	360	2	20/60	240
2bi. Learning Collaborative QI Champion Interview	24	3	30/60	36
2bii. Learning Collaborative Staff Interview	48	2	30/60	48
2c. Learning Collaborative Self-Assessment	24	1	15/60	6
2di. Learning Collaborative QI Measures—develop system	24	1	20	480
2dii. Learning Collaborative QI Measures—pull and submit	24	4	5	480
Total	2,028	n/a	n/a	1,665
1 Number of respondents reflects a 30% response rate.
2 Number of respondents reflects a sample size assuming a 75% response rate.

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 $72,145.62.

Exhibit 2—Estimated Annualized Cost Burden

Data collection method or project activity	Number of respondents	Total burden hours	Average hourly wage rate *	Total cost burden
1. Web-Based Provider Survey 1	1,500	375	$101.82	$38,182.50
2a. Learning Collaborative Clinical Staff Survey 2	360	240	39.42	9,460.80
2bi. Learning Collaborative QI Champion Interview 3	24	36	54.68	1,968.48
2bii. Learning Collaborative Staff Interview 4	48	48	39.42	1,892.16
2c. Learning Collaborative Self-Assessment 5	24	6	54.68	328.08
2di. Learning Collaborative QI Measures—develop system 6	24	480	21.16	10,156.80
2dii. Learning Collaborative QI Measures—pull and submit 7	24	480	21.16	10,156.80
Total	2,028	1,917	n/a	72,145.62
1 The average hourly rate of $101.82 for the provider survey was calculated based on the 2018 mean hourly wage rate for family and general practitioners, (occupation code 29-1062).
2 The average hourly rate of $39.42 for the learning collaborative clinical staff survey was calculated based on the 2018 mean hourly wage rate for medical and health services managers (occupation code 29-0000).
3 The average hourly rate of $54.68 for QI champion interviews was calculated based on the 2018 mean hourly wage rate for medical and health services managers (occupation code 11-9111).
4 The average hourly rate of $39.42 for staff interviews was calculated based on the 2018 mean hourly wage rate for medical and health services managers (occupation code 29-0000).
5 The average hourly rate of 54.68 for the Learning Collaborative QI champion to complete the self-assessment was calculated based on the 2018 mean hourly wage rate for medical and health services managers (occupation code 11-9111).
6 The average hourly rate of $21.16 to develop the Learning Collaborative QI measures was calculated based on the 2018 mean hourly wage rate for medical records and health information technicians (occupation code 29-2071).
7 The average hourly rate of $21.16 to pull and submit the Learning Collaborative QI measures was calculated based on the 2018 mean hourly wage rate for medical records and health information technicians (occupation code 29-2071).

Mean hourly wage rates for these groups of occupations were obtained from the Bureau of Labor & Statistics on “Occupational Employment and Wages, May 2018” found at the following URL: http://www.bls.gov/​oes/​current/​oes_​nat.htm#b29-0000.htm.

Request for Comments

In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3520, 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: June 2, 2020.

Virginia L. Mackay-Smith,

Associate Director.