[Federal Register Volume 87, Number 240 (Thursday, December 15, 2022)]
[Notices]
[Pages 76621-76624]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-27175]


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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.

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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

[[Page 76622]]

information collection project ``The AHRQ Safety Program for 
Telemedicine: Improving the Diagnostic Process and Improving Antibiotic 
Use.''

DATES: Comments on this notice must be received by February 13, 2023.

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 email at 
[email protected].

SUPPLEMENTARY INFORMATION:

Proposed Project

The AHRQ Safety Program for Telemedicine: Improving the Diagnostic 
Process and Improving Antibiotic Use

    Telemedicine visits increased dramatically in response to the 
COVID-19 pandemic and resulting changes in third-party payer 
reimbursement policies. Telemedicine visits increased from 0.3 percent 
of all ambulatory visits in 2019 to 23.6 percent by Spring 2020. Given 
this rapid growth, the need to ensure safe and appropriate patient care 
in this setting is urgent. Telemedicine has many benefits, such as 
facilitating continuity of care; improving access beyond normal hours; 
reducing patients' travel burden; overcoming health care provider (HCP) 
shortages; and providing support for patients managing chronic health 
conditions. However, transferring clinical practices from an in-person 
to a virtual environment poses potential risks. Many HCPs have never 
received formal training in using telemedicine effectively to diagnose 
and treat patients virtually. Additionally, inadequate internet access, 
which disproportionately impacts rural and minority populations, and 
struggles accessing telemedicine platforms may force video-based 
telemedicine visits to transition to audio-only or be skipped.
    This program aims to improve two at-risk areas among telemedicine 
practices by implementing the AHRQ- and Johns Hopkins Armstrong 
Institute for Patient Safety and Quality (JHAI)-developed Comprehensive 
Unit-based Safety Program (CUSP) approach: (1) the diagnostic process 
for breast, colorectal, and lung cancer; and (2) antibiotic stewardship 
(AS). The CUSP approach improves safety culture at the practice level, 
enables harm prevention, and engages providers who are on the front 
lines while integrating technical and adaptive/cultural approaches to 
making sustainable changes.
    This program constitutes the first large-scale implementation of a 
quality improvement effort for the cancer diagnostic process and AS in 
telemedicine. These areas were chosen given the need for clearer 
guidance and evidence-based telemedicine practices for clinicians and 
potential for positive impact on outcomes. This program will 
incorporate CUSP strategies to improve the diagnostic process for 
breast, colorectal, and lung cancer and to improve antibiotic 
prescribing in telemedicine. The program goals are to:
     Identify best practices in implementing interventions to 
improve the cancer diagnostic process and AS in telemedicine.
     Determine how best to adapt CUSP to enhance the cancer 
diagnostic process and AS in telemedicine.
    This study is being conducted by AHRQ through its contractor, NORC 
at the University of Chicago (NORC) and NORC's subcontractors, the 
Johns Hopkins Armstrong Institute of Patient Safety and Quality (JHAI) 
and Baylor College of Medicine (Baylor), 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 
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 the AHRQ Safety Program for Telemedicine 
(``Safety Program''), primary and secondary data collection activities 
will include:
    (1) Structural Assessment: A brief online assessment will be 
completed by a leader/champion from each practice to understand 
practices' infrastructure and capacity to implement the Safety Program.
    (2) AHRQ Office Readiness Survey: A brief online Office Readiness 
Survey will be completed by all participating staff from each practice 
in the cancer diagnostic process cohort to understand practices' 
readiness for implementation of the Safety Program.
    (3) The AHRQ Surveys on Patient Safety Culture: The Medical Office 
Survey on Patient Safety Culture (MOSOPS) (both cohorts) and a 
Diagnostic Safety Supplement (cancer diagnostic process cohort only) 
will be completed by all participating staff to assess patient safety 
issues, medical errors, and event reporting practices.
    (4) Participant Experience Survey: A brief online assessment will 
be completed by a leader/champion from each practice to assess how 
practices approached implementation of the Safety Program.
    (5) Semi-Structured Qualitative Interviews: A proportion of 
practices from both cohorts will be selected to participate in 
telephone/virtual discussions to understand the facilitators and 
barriers to implementing the Safety Program.
    (6) Clinical Data Collection Form: Practices in the cancer 
diagnostic process cohort will complete a Clinical Data Collection Form 
for patients suspected of having breast, colorectal, or lung cancer.
    (7) Electronic Health Record (EHR) Data: Practice-level antibiotic 
usage and clinical outcomes data will be extracted from the EHRs of 
practices in the AS cohort.
    This data collection effort will be part of a comprehensive 
evaluation strategy to assess the adoption of the Safety Program among 
telemedicine practices comprising the cancer diagnostic process and AS 
cohorts; measure the effectiveness of the Safety Program among the 
participating practices and evaluate how providers experienced the 
program as well as the perceived usefulness of the Safety Program's 
education materials and metrics; and understand drivers of antibiotic 
prescribing among practices in the AS cohort and drivers of timely 
diagnosis for patients suspected of having breast, colorectal, or lung 
cancer among practices in the cancer diagnostic process cohort.
    The evaluation is largely formative in nature as AHRQ seeks 
information on the implementation and effectiveness of CUSP in a novel 
setting--telemedicine. The evaluation will utilize a pre-post design, 
comparing data collected at baseline and at the end of the Safety 
Program within each cohort.

Estimated Annual Respondent Burden

    Exhibit A.1 shows the estimated annualized burden hours for the 
respondents' time to complete the structural assessments, AHRQ office 
readiness and patient safety culture surveys, participant experience 
surveys, semi-structured qualitative interviews, clinical data 
collection instrument (collected for 3 patients monthly and submitted 
quarterly), and EHR data extractions (collected monthly and submitted 
quarterly). Data will be collected from up to 300 practices providing 
telemedicine for the cancer diagnostic process cohort and from up to 
500 practices providing telemedicine

[[Page 76623]]

for the AS cohort. For the three-year clearance period, the estimated 
annualized burden hours for the data collection activities are 5,570.

                                 Exhibit A.1--Estimated Annualized Burden Hours
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                                                                     Number of
                    Form name                        Number of     responses per     Hours per     Total  burden
                                                   respondents *    respondent       response          hours
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1. Structural Assessments (both cohorts)........             200               2             0.2              80
2. AHRQ Office Readiness Survey (cancer                      350               1             0.1              35
 diagnostic process cohort only)................
3. AHRQ Patient Safety Culture Surveys:
    a. MOSOPS (both cohorts)....................             933               2             0.5             933
    b. Diagnostic Safety Supplement (cancer                  350               2             0.2             140
     diagnostic process cohort only)............
4. Participant Experience Survey (both cohorts):
    a. Cancer diagnostic process cohort survey..              75               1            0.17              13
    b. AS cohort survey.........................             125               1            0.33              41
5. Semi-structured qualitative interviews (both               24               1               1              24
 cohorts).......................................
6. Clinical Data Collection Form (cancer                      90              54            0.33           1,604
 diagnostic process cohort).....................
7. HER data (AS cohort).........................             150              18               1           2,700
                                                 ---------------------------------------------------------------
    Total.......................................  ..............  ..............  ..............           5,570
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* Annualized number of respondents is based on maximum practices recruited and 75% response rate for forms 1 and
  4a and 4b, 50% response rate for forms 2, 3a and 3b, and 90% response rate for forms 5-7.

    Exhibit A.2 shows the estimated annualized cost burden based on the 
respondents' time to complete the data collection forms. The total cost 
burden is estimated to be $576,922.

                                  Exhibit A.2--Estimated Annualized Cost Burden
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                                                                                      Average
                    Form name                        Number of     Total  burden    hourly wage    Total  burden
                                                   respondents *       hours          rate **          cost
----------------------------------------------------------------------------------------------------------------
1. Structural Assessments (both cohorts)........             200              80     \a\ $111.30          $8,904
2. AHRQ Office Readiness Survey (cancer                      350              35      \a\ 111.30           3,896
 diagnostic process cohort only)................
3. AHRQ Patient Safety Culture Surveys:
    a. MOSOPS (both cohorts):
        i. Physicians...........................             466             466      \a\ 111.30          51,866
        ii. Other Health Practitioners..........             467             467       \b\ 31.19          14,566
    b. Diagnostic Safety Supplement (cancer
     diagnostic process cohort only):
        i. Physicians...........................             175              70      \a\ 111.30           7,791
        ii. Other Health Practitioners..........             175              70       \b\ 31.19           2,183
4. Participant Experience Survey (both cohorts).             200              54      \a\ 111.30           6,010
5. Semi-structured qualitative interviews (both               24              24      \a\ 111.30           2,671
 cohorts).......................................
6. Clinical Data Collection Form (cancer                      90           1,604      \a\ 111.30         178,525
 diagnostic process cohort only)................
7. EHR data (AS cohort only)....................             150           2,700      \a\ 111.30         300,510
                                                 ---------------------------------------------------------------
    Total.......................................           3,497           5,582  ..............         576,922
----------------------------------------------------------------------------------------------------------------
* Annualized number of respondents is based on maximum practices recruited and 75% response rate for forms 1 and
  4, 50% response rate for forms 2, 3a and 3b, and 90% response rate for forms 5-7.
** National Compensation Survey: Occupational wages in the United States May 2021 ``U.S. Department of Labor,
  Bureau of Labor Statistics:'' https://www.bls.gov/oes/current/oes_stru.htm#29-0000.
\a\ Based on the mean wages for 29-1069 Physicians and Surgeons, All Other.
\b\ Based on the mean wages for 29-9099 Miscellaneous Health Practitioners and Technical Workers: Healthcare
  Practitioners and Technical Workers, All Other.

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.


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    Dated: December 9, 2022.
Marquita Cullom,
Associate Director.
[FR Doc. 2022-27175 Filed 12-14-22; 8:45 am]
BILLING CODE 4160-90-P