[Federal Register Volume 85, Number 135 (Tuesday, July 14, 2020)] [Notices] [Pages 42404-42406] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 2020-15147] ----------------------------------------------------------------------- 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 ``Clinical Decision Support (CDS) for Chronic Pain Management.'' 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 [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 Clinical Decision Support (CDS) for Chronic Pain Management Prescription opioid pain medication overuse, misuse, and abuse have been a significant contributing factor in the opioid epidemic. The goal of this project is to develop, implement, disseminate, and evaluate clinical decision support (CDS) tools for both patients and clinicians in the management of chronic pain. The CDS tools are intended to be interoperable and publicly-shareable, and will be designed to meet the needs of patients and clinicians through both patient-facing and clinician-facing channels and formats. The development and deployment of CDS tools designed to optimize opioid dose reduction is intended to support primary care physicians who are not pain-management specialists as they care for patients who are at high risk of harm from opioids. This goal will be achieved through the design, development, implementation, and evaluation of a clinician-facing CDS tool for chronic pain management that optimize presentation of patient data and evidence-based guidelines to support opioid tapering. The clinician-facing CDS tool will help non-pain specialists detect patients at high risk of harm from opioids, provide personalized evidence-based guidelines to support opioid tapering, optimize the presentation of patient data, and reduce unnecessary variation in clinical practice. The clinician-facing CDS tool will also assist non-pain specialists in determining if an opioid taper is necessary for a specific patient, aid in [[Page 42405]] performing the taper, and aid in providing follow-up and support during the taper. The clinician-facing CDS tools are meant to accomplish three goals: (1) Better monitor the patient's functional pain and opioid use, (2) visualize patient data, and (3) incorporate guidelines for prescribing and tapering opioids for chronic pain. The patient-facing CDS tool will be used to help patients at high-risk of harm from opioids track and manage chronic pain and daily function to support reduced opioid use. This goal will be achieved through the design, development, implementation, and evaluation of a CDS tool that facilitates continued patient provider engagement. This patient-facing CDS tool will deliver support in ways that enhance patient activation, education and engagement, and collaborative decisions and actions between patients and their care teams. The patient-facing CDS tool should enhance the quality of clinical discussion between healthcare providers and patients by allowing for continued patient engagement outside of the clinical setting. This study is being conducted by AHRQ through its contractor, MedStar Health, pursuant to AHRQ's statutory authority to assist users of health information technology focused on CDS to promote the timely incorporation of comparative clinical effectiveness research into clinical practices. 42 U.S.C 299b-37(c). Method of Collection To achieve the goals of this project the following data collections will be implemented. (1) Post-Use Survey with Primary Care Providers ``Evaluation Provider Survey'': This evaluation includes the collection of qualitative data through a short survey with primary care providers who used the clinician-facing CDS tool for chronic pain management (up to a maximum of 60). The research team will collect insights from providers on their experience of implementing and using the clinician-facing CDS tool for chronic pain management. The survey will be accessible in both online and paper formats. (2) Post-Use Survey with Patients ``Evaluation Patient Survey'': This evaluation includes the collection of qualitative data through a short survey with patients who used the patient-facing CDS tool for pain management (up to a maximum of 150). The research team will collect insights from patients on their experience of implementing and using patient-facing CDS. The survey will be accessible in both online and paper formats. (3) Post-Use Interview with Primary Care Providers ``Evaluation Provider Interview'': This evaluation component includes the collection of qualitative data through an in-depth thirty-minute interview with primary care providers who used the clinician-facing CDS tool for chronic pain management (up to a maximum of 10). The research team will collect insights from providers on their experience of implementing and using this clinician-facing CDS tool. (4) Post-Use Interviews with Patients ``Evaluation Patient Interview'': This evaluation component includes the collection of qualitative data through an in-depth thirty-minute interview with patients who used the patient-facing CDS tool for pain management (up to a maximum of 20). The research team will collect insights from patients on their experience of implementing and using the patient- facing CDS tool. (5) Post-Use Interviews with Site Champions ``Evaluation Site Champion Interview'': This evaluation component includes the collection of qualitative data through thirty-minute interviews with site leads (up to a maximum of 15) and site visits during which the research team will collect insights from providers and patients on their experience of implementing and using the clinical-facing and patient-facing CDS tools from the perspective of the site champions. Estimated Annual Respondent Burden Exhibit 1--Estimated Annualized Burden Hours ---------------------------------------------------------------------------------------------------------------- Number of Form name Number of responses per Hours per Total burden respondents respondent response hours ---------------------------------------------------------------------------------------------------------------- Post-Use Survey with Providers.................. 60 1 0.25 15 Post-Use Survey with Patients................... 150 1 0.25 37.5 Post-Use Interview with Providers............... 10 1 0.5 5 Post-Use Interview with Patients................ 20 1 0.5 10 Post-Use Interview with Site Champions.......... 15 1 0.5 7.5 --------------------------------------------------------------- Total....................................... 255 5 2 75 ---------------------------------------------------------------------------------------------------------------- Exhibit 2--Estimated Annualized Cost Burden ---------------------------------------------------------------------------------------------------------------- Average Form name Number of Total burden hourly wage Total cost respondents hours rate * burden ---------------------------------------------------------------------------------------------------------------- Post-Use Survey with Providers.................. 60 15 \b\ $102.73 $1,540.95 Post-Use Survey with Patients................... 150 37.5 \a\ 25.72 964.50 Post-Use Interview with Providers............... 10 5 \b\ 102.73 513.65 Post-Use Interview with Patients................ 20 10 \a\ 25.72 257.20 Post-Use Interview with Site Champions.......... 15 7.5 \b\ 102.73 770.48 --------------------------------------------------------------- Total....................................... 255 75 53.95 4,046.78 ---------------------------------------------------------------------------------------------------------------- * National Compensation Survey: Occupational wages in the United States May 2019, ``U.S. Department of Labor, Bureau of Labor Statistics'', https://www.bls.gov/oes/current/oes_nat.htm#b29-0000.htm. \a\ Based on the mean wages for all occupations (00-0000). \b\ Based on the mean wages for Family Medicine Physicians (29-1215). [[Page 42406]] 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: July 8, 2020. Virginia L. Mackay-Smith, Associate Director. [FR Doc. 2020-15147 Filed 7-13-20; 8:45 am] BILLING CODE 4160-90-P