[Federal Register Volume 84, Number 71 (Friday, April 12, 2019)] [Notices] [Pages 14946-14949] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 2019-07303] ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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 ``Evaluating and Implementing the Six Building Blocks Team Approach to Improve Opioid Management in Primary Care.'' DATES: Comments on this notice must be received by June 11, 2019. ADDRESSES: Written comments should be submitted to: Doris Lefkowitz, Reports Clearance Officer, AHRQ, by email at [email protected]. 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, (301) 427-1477, or by emails at [email protected]. SUPPLEMENTARY INFORMATION: Proposed Project Evaluating and Implementing the Six Building Blocks Team Approach To Improve Opioid Management in Primary Care In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501- 3521, AHRQ invites the public to comment on this proposed information collection. The project ``Evaluating and Implementing the Six Building Blocks Team Approach to Improve Opioid Management in Primary Care'' fully supports AHRQ's mission. The ultimate aim of this project is to further validate and expand the Six Building Blocks to Safer Opioid Management (6BBs) intervention and its associated resources and guidance to support primary care providers in safer opioid prescribing. Opioid overdose deaths have increased dramatically since 1999, and despite recent decreases in the national opioid prescribing rate, prescribing rates remain high in many U.S. counties. Primary care providers (PCPs) are responsible for about half of all dispensed opioid pain relievers. To address the emerging opioid epidemic, the Six Building Blocks to Safer Opioid Management (6BBs) Toolkit has been developed to support primary care providers in safer opioid prescribing, largely concordant with the Centers for Disease Control and Prevention's Guideline for Prescribing Opioids for Chronic Pain. The 6BBs is a structured, systems-based approach for improving management of patients on long-term opioid therapy that targets six work areas a primary care practice needs to redesign in order to improve their clinic's management of patients on long-term opioid therapy. Building upon previous work supported by AHRQ to address the opioid epidemic, this research has the following goals: 1. To improve the guidance for the 6BBs Toolkit, 2. To further implement the 6BBs in primary care practices, and [[Page 14947]] 3. To understand the facilitators and barriers to implementing the Six Building Blocks to Safer Opioid Management. 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 health care and on systems for the delivery of such care, including activities with respect to the quality, effectiveness, efficiency, appropriateness and value of health care 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) Clinical Staff Survey. A brief survey will be administered electronically to all clinical staff, including primary care physicians, nurse practitioners, physician assistants, social workers, medical assistants, registered nurses, pharmacists and behavioral health workers, toward the beginning of 6BBs Toolkit implementation and approximately 12 months later. A quality improvement (QI) point person will provide email addresses for the staff who will be invited to complete the survey from each participating organization. These email addresses will be used to send clinical staff the surveys at both time points. The survey will collect information about staff's self-reported use of evidence-based opioid prescribing practices; procedures in place around opioid prescribing management; self efficacy regarding safe opioid prescribing; knowledge, beliefs and attitudes regarding opioid prescribing; adaptive reserve; self-reported burnout; and reported implementation experiences. The survey will also collect information about staffs' background (e.g., clinic role and tenure). The survey will consist largely of closed-ended questions (e.g., scale or Likert response options) with several open-ended questions. (2) Staff Interviews. Interviews will be conducted with 5 staff at each of the 12 participating health care organizations. AHRQ will conduct 2 rounds of interviews, with the first round occurring within several months after the How-To-Guide is distributed to the organization and the second round occurring 12 months later. The evaluation team will conduct in-depth interviews with: a. The quality improvement (QI) lead and b. Four additional staff who are involved in 6BBs implementation at each organization, that might include a clinician, information technology analyst, social worker, behavioral health specialist, and/or care coordinator. Staff interviewees will be selected by the QI lead at each organization, who will be asked to nominate a range of staff from those who embraced changes to those who were less willing to implement changes. Interviews will capture qualitative data regarding the organization's history with efforts to curb opioid prescribing, experiences using the How-To-Guide, implementation of the 6BB intervention and associated opioid management interventions, and lessons learned that can be shared with other health care organizations. (3) Virtual Launch Meeting. A virtual launch meeting will be held for organization liaisons and quality improvement leaders participating health care organizations to launch 6BBs Toolkit implementation. The meeting will be conducted by web-conference, and will last up to 2 hours. (4) Quarterly Check-In Calls. A project team member will hold a quarterly check-in call with organization liaisons and quality improvement leaders to assess the progress of implementation of the 6BBs intervention and improvement initiatives at each organization. Check-in calls will occur quarterly for up to 12 months. Each call will be up to 60 minutes in duration, and notes will be taken by an evaluation team member during each call. (5) QI Measures. Each health care organization will be asked to report quarterly on the number of patients on long-term opioid therapy and the proportion of those who are on greater than 90 morphine milligram equivalents, co-prescribed a benzodiazepine, and had the prescription drug monitoring program checked and a urine drug screen. Organizations may also select other outcome measures aligned to their own goals. (6) Other outcome and output data from administrative records, electronic medical records, and organizational documents (Secondary Data). Health care organizations may also report their progress on implementing the 6BB intervention and associated changes in care processes through completion of worksheets contained in or associated with the How-To-Guide. Since these data collections involve simply submitting worksheets they complete for their own benefit while working through the How-To-Guide, they pose only minimal data collection burden to the health care organization, specifically the person who completes the worksheets (i.e., QI lead). The project team will also obtain relevant organizational documents (e.g., opioid prescribing policies, quality improvement plans, sample patient agreements, relevant practice workflows, screen shots of data dashboards). The purpose of the proposed data collection effort is to obtain information needed to modify and enhance the 6BB How-To-Guide and to provide information to health care organizations considering using the How-To-Guide to improve their opioid prescribing practices and relevant outcomes. Since this is only a study conducted in 12 organizations, outcomes or impacts will not be generalizable. The data collected will help the project team: (1) Understand the facilitators and barriers of using the 6BB Toolkit and recommended improvements to processes of care and opioid prescribing practices, and (2) assess the effectiveness of using the 6BB Toolkit to improve processes of care and opioid prescribing practices. The data collection effort may also provide insights that could guide dissemination of the Toolkit. For example, if it was found that a specific type of organization included in this pilot study (e.g., small, stand-alone clinic in a rural area) particularly benefitted from using the Toolkit, then AHRQ could tailor and target its dissemination of the Toolkit to similar organizations. Once revisions are made based on results of this evaluation, the How-To-Guide corresponding to the Toolkit will be published on AHRQ's website. A manuscript describing the pilot study and its results will also be produced for publication in a peer- reviewed journal. 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 health care organizations. The number of respondents listed in column A, Exhibit 1 reflects a projected 75% response rate for data collection efforts 2a and 2b below. 1. Clinical Staff Survey. A brief survey will be emailed to all clinicians both toward the beginning of 6BBs Toolkit implementation and approximately 12 months later. We assumed 20 clinical staff per clinical site, and approximately 33 clinical sites overall (with a range from 1 clinic to 17 per organization), for a total of 660 staff across all 12 organizations. We assumed 495 clinical [[Page 14948]] staff will complete the survey based on a 75% response rate. It is expected to take up to 15 minutes to complete. 2. Staff Interviews. In-depth interviews will occur with 5 staff at each health care organization, for a total of up to 60 individuals. The evaluation team will conduct these interviews, each lasting up to 1 hour, at 2 points in time with: a. One QI lead per organization (toward the start of and at the end of the project). b. Four additional staff (e.g., clinician, information technology analyst, social worker) per organization (midway through and at the end of the project). 3. Virtual Launch Meeting. The meeting will occur with the quality improvement (QI) leads at participating health care organizations to launch 6BBs Toolkit implementation. The meeting will be conducted by web-conference, and will last up to 2 hours. 4. Quarterly Check-In Calls. Calls will occur with QI leads, clinical champions, and other relevant staff the QI lead identifies, for a total of no more than 5 individuals per organization. These calls will assess progress with the organization's use of the Toolkit and implementation of associated practice changes, and will occur quarterly over 15 months, for a total of 5 quarterly check-in calls. Each call will take up to 60 minutes. 5. QI Measures. Aggregate reports of the specified quality measures will be provided on a quarterly basis over the course of an 18-month period by a data analyst at each organization, for a total of 12 individuals across all 12 organizations. We assume 40 hours total (10 hours per quarter) for each data analyst to collect and provide these data. 6. Other outcome and output data from administrative records and organizational documents (Secondary Data). These secondary data will be provided by the QI lead at each organization, for a total of 12 individuals across all 12 organizations. We assume 4 hours per month for 12 months for a total of 48 hours for each QI lead to collect and provide these data. Exhibit 1--Estimated Annualized Burden Hours ---------------------------------------------------------------------------------------------------------------- Number of Data collection method or project activity Number of responses per Hours per Total burden respondents respondent response hours A. B. C. D. ---------------------------------------------------------------------------------------------------------------- 1. Clinical Staff Survey *...................... 495 2 15/60 248 2a. Staff Interview--QI Lead.................... 12 2 1 24 2b. Staff Interview--Additional Staff........... 48 2 1 96 3. Virtual Launch Meeting....................... 12 1 2 24 4. Quarterly Check-In Calls..................... 60 5 1 300 5. QI Measures.................................. 12 4 10 480 6. Secondary data............................... 12 12 4 576 --------------------------------------------------------------- Total....................................... 651 na Na 1,748 ---------------------------------------------------------------------------------------------------------------- * Number of respondents (Column A) reflects a sample size assuming a 75% response rate for this data collection effort. 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 about $70,779. Exhibit 2--Estimated Annualized Cost Burden ---------------------------------------------------------------------------------------------------------------- Number of Total burden Average hourly Total cost Data collection method or project activity respondents hours wage rate * burden ---------------------------------------------------------------------------------------------------------------- 1. Clinical Staff Survey........................ 495 248 $48.45 $12,016 2a. Staff Interview--QI Lead.................... 12 24 53.69 1,289 2b. Staff Interview--Additional Staff........... 48 96 38.83 3,728 3. Virtual Launch Meeting....................... 12 24 53.69 1,289 4. Quarterly Check-In Calls..................... 60 300 38.83 11,649 5. QI Measures.................................. 12 480 20.59 9,883 6. Secondary data............................... 12 576 53.69 30,925 --------------------------------------------------------------- Total....................................... .............. .............. .............. 70,779 ---------------------------------------------------------------------------------------------------------------- The average hourly rate of $48.45 for the clinical staff survey was calculated based on the 2017 mean hourly wage rate for health diagnosing and treating practitioners, $48.45 (occupation code 29- 1000). The average hourly rate of $53.69 for QI lead interviews was calculated based on the 2017 mean hourly wage rate for medical and health services managers, $53.69 (occupation code 11-9111). The average hourly rate of $38.83 for staff interviews was calculated based on the 2017 mean hourly wage rate for health care practitioners and technical occupations, $38.83 (occupation code 29- 0000). The average hourly rate of $53.69 for the virtual launch meeting was calculated based on the 2017 mean hourly wage rate for medical and health services managers, $53.69 (occupation code 11-9111). The average hourly wage rate of $38.83 for quarterly check-in calls was calculated based on the 2017 mean hourly wage rate for health care practitioners and technical occupations, $38.83 (occupation code 29- 0000). The average hourly rate of $20.59 for QI measures was calculated based on the 2017 mean hourly wage rate for medical records and health information [[Page 14949]] technicians, $20.59 (occupation code 29-2071). The average hourly rate of $53.69 for secondary data was calculated based on the 2017 mean hourly wage rate for medical and health services managers, $53.69 (occupation code 11-9111). Mean hourly wage rates for these groups of occupations were obtained from the Bureau of Labor & Statistics on ``Occupational Employment and Wages, May 2017'' 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, 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. Gopal Khanna, Director. [FR Doc. 2019-07303 Filed 4-11-19; 8:45 am] BILLING CODE 4160-90-P