[Federal Register Volume 85, Number 71 (Monday, April 13, 2020)]
[Notices]
[Pages 20502-20505]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-07661]


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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 information collection 
project: ``Evaluating the Dissemination and Implementation of PCOR to 
Increase Referral, Enrollment, and Retention through Automatic Referral 
to Cardiac Rehabilitation (CR) with Care Coordination.'' This proposed 
information collection was previously published in the Federal Register 
on February 4th, 2020 and allowed 60 days for public comment. AHRQ did 
not receive comments from members of the public. The purpose of this 
notice is to allow an additional 30 days for public comment.

DATES: Comments on this notice must be received by 30 days after date 
of publication of this notice.

ADDRESSES: Written comments and recommendations for the proposed 
information collection should be sent within 30 days of publication of 
this notice to www.reginfo.gov/public/do/PRAMain. Find this particular 
information collection by selecting ``Currently under 30-day Review--
Open for Public Comments'' or by using the search function.

FOR FURTHER INFORMATION CONTACT: Doris Lefkowitz, AHRQ Reports 
Clearance Officer, (301) 427-1477, or by email at 
[email protected].

SUPPLEMENTARY INFORMATION: 

Proposed Project

Evaluating the Dissemination and Implementation of PCOR To Increase 
Referral, Enrollment, and Retention Through Automatic Referral to 
Cardiac Rehabilitation (CR) With Care Coordination

    The aim of AHRQ's TAKEheart project is to (a) raise awareness about 
the benefits of cardiac rehabilitation (CR) after myocardial infarction 
or coronary revascularization, then to (b) disseminate knowledge about 
the best practices to increase referrals to CR, and, finally, (c) to 
increase CR uptake. Currently over two-thirds of eligible cardiac 
patients are not referred to CR despite extensive evidence of its 
effectiveness in preventing subsequent morbidity; national estimates of 
referral range from 10-34%. To help improve CR rates, the Million 
Hearts[supreg] Cardiac Rehabilitation Collaborative--an initiative co-
led by the Centers for Disease Control and Prevention (CDC) and the 
Centers for Medicare & Medicaid Services (CMS)--developed a Cardiac 
Rehabilitation Change Package (CRCP) and established a national goal of 
70% participation in CR by 2022 for eligible patients. Recognizing that 
widespread adoption of the CRCP could help hospitals enhance CR rates, 
the CDC turned to AHRQ with a request that AHRQ consider disseminating 
and implementing evidence for CR and practices that promote CR. The 
CRCP is designed to facilitate this dissemination and implementation 
process. AHRQ reviewed this request in the context of its Patient 
Centered Outcomes Research Dissemination and Implementation initiative 
and judged the CDC nomination to have a high level of fit with AHRQ's 
criteria of having a substantial evidence base, high potential impact, 
and high feasibility for wide dissemination and implementation Outreach 
with stakeholders indicates that this initiative aligns well but does 
not duplicate work by NIH; PCORI; CMS and CDC.
    The core recommendations in the CDC package are, first to spread 
adoption of automatic referral system--where patients after 
cardiovascular events are referred by the Electronic Health Record to 
rehabilitation unless the cardiologist actively decides not to refer 
because of medical ineligibility. The second core recommendation is use 
of a care coordinator to guide patients through referral has resulted 
in the most significant increases in referral to CR.

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TAKEheart will facilitate dissemination and implementation of Automatic 
Referral with Care Coordination in selected, diverse hospitals 
nationwide which demonstrate their readiness.
    AHRQ will evaluate TAKEheart to assess:
     The extent and effectiveness of the dissemination and 
implementation efforts;
     the uptake and usage of Automatic Referral with Care 
Coordination; and
     levels of referral to CR at the end of the intervention.
    Evaluation results will be used to improve the intervention and to 
provide guidance for future AHRQ Dissemination and Implementation 
projects. Two cohorts of ``Partner Hospitals,'' up to 125 hospitals in 
total, will receive training that disseminates the importance of CR and 
ways to enhance CR referral and then engages them in efforts to 
implement Automatic Referral with Care Coordination over twelve month 
periods. The evaluation will ascertain the diversity of hospitals 
engaged, the activities that contributed to (or hindered) their 
efforts, and the types of support which they report having been most 
(and least) useful. This information will be used to improve 
recruitment, technical assistance, and tools for the second cohort.
    In addition, hospitals--including those involved in the 
dissemination and implementation support for Partner Hospitals--will be 
invited to attend Affinity Group virtual meetings organized around 
specific topics of interest which are not intrinsic to Automatic 
Referral with Care Coordination. Hospital staff engaged in Affinity 
Groups will create a vibrant Learning Community. The evaluation will 
determine which Affinity Groups engaged the most participants of the 
Learning Community, and which resources participants determined the 
most useful. This information will be used to develop resources which 
will be available on a new, permanent website dedicated to improving 
CR.
    This study is being conducted by AHRQ through its contractor, Abt 
Associates Inc., pursuant to AHRQ's statutory authority to disseminate 
government-funded research relevant to comparative clinical 
effectiveness research. 42 U.S.C. 299b-37(a).

Method of Data Collection

    To collect data on the many facets of the intervention, we will use 
multiple data collection tools, each of which has a specific purpose 
and set of respondents.
    1. Partner Hospital Champion Survey. Each Partner Hospital will 
designate a ``Champion,'' who will coordinate activities associated 
with implementing Automatic Referral with Care Coordination at the 
hospital, and provide the Champion's name and email address. The 
Champion may have any role in the hospital, although they are expected 
in relevant positions, such as cardiologists or quality improvement 
managers. We will conduct online surveys of 125 Champions (one Champion 
per hospital). We will use the email addresses to send the Champion a 
survey at two points: Seven months after the start of dissemination and 
implementation to the Partner Hospitals and at the end of the 12-month 
dissemination and implementation period. The first survey will focus on 
four constructs. First, it will capture data about the hospital 
context, such as whether it had prior experience customizing an 
electronic medical record (EMR) or is a safety net hospital. Second, it 
will address the hospital's decision to participate in TAKEheart. 
Third, it will capture data on the CR programs the hospital refers to, 
whether the number or type has changed, and why. Fourth, it will 
collect feedback on the training and technical assistance received. The 
second survey will focus on three constructs. First, it will collect 
feedback on the TAKEheart components, including training, technical 
assistance, and use of the website. Second, we will ask about the 
hospitals' response to participating in TAKEheart, such as changes to 
referral workflow or CR programs. Third, we will ask those Partner 
Hospitals which have not completed the process of implementing 
Automatic Referral with Care Coordination whether they anticipate 
continuing to work towards that goal and their confidence in 
succeeding.
    2. Partner Hospital Interviews.
    a. Interviews with Partner Hospital Champions. We will select, from 
each cohort, eight Partner Hospitals that demonstrated a strong 
interest in addressing underserved populations or reducing disparities 
in participation in cardiac rehabilitation. We will conduct a key 
informant interview with the Champion of each selected Partner Hospital 
to delve into their response to the information and guidance that was 
disseminated to them and to describe how they are addressing the needs 
of underserved populations by implementing Automatic Referral with Care 
Coordination.
    b. Interviews with Partner Hospital cardiologists. We will select, 
from each cohort, eight hospitals based on criteria such as hospitals 
which serve specific populations, or have the same EMRs, which will 
inform their experience customizing the EMR. We will conduct semi-
structured interviews with one cardiologist at each of the selected 
hospitals twice. In the second month of the cohort for dissemination 
and implementation, we will ask about their needs, concerns, and 
expectations of the program. In the 11th month of the cohort 
implementation, we will determine whether their concerns were addressed 
appropriately and adequately.
    c. Interviews with Partner Hospitals that withdraw. We expect that 
a small number of Partner Hospitals may withdraw from the cohort. We 
will identify these hospitals by their lack of participation in 
training and technical assistance events; technical assistance 
providers will confirm their withdrawal. We will interview up to nine 
withdrawing hospitals to better understand the reason for withdrawal 
(e.g., a merger resulted in a loss of support for the intervention, 
Champion left), as well as facilitators of, and barriers to, each 
hospital's approach to implementing Automatic Referral with Care 
Coordination. If more than nine hospitals withdraw, we will cease 
interviewing.
    3. Learning Community Participant Survey. We will conduct online 
surveys of 250 currently active Learning Community participants at two 
points in time, in months 18 and 31 of the project. We will administer 
the survey by sending a link to an online survey to email addresses 
entered by virtual meeting participants during registration. The email 
will describe the purpose of the survey.
    4. Learning Community Follow-up Survey. We will conduct a brief 
online survey with up to 15 Learning Community participants following 
the final virtual meeting for each of 10 Affinity Groups, to ascertain 
whether the hospitals were able to act on what they learned during the 
session. The total sample will be 150 Learning Community participants.

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 90% response rate for data collection effort 1, 
and an 80% response rate for efforts 3 and 4 below.
    1. Partner Hospital Champion Survey. We assumed 113 hospital 
champions

[[Page 20504]]

will complete the survey based on a 90% response rate. It is expected 
to take up to 45 minutes to complete for a total of 169.5 hours to 
complete.
    2. Partner Hospital Interviews. In-depth interviews will occur with 
select Partner Hospital staff.
    a. Interviews with Partner Hospital Champions. We will have a 
single, 90 minute interview with eight Partner Hospital Champions, in 
each cohort, from Partner Hospitals that have a common characteristic 
of particular interest, for a total of 24 hours.
    b. Interviews with Partner Hospital cardiologists. We will hold 
individual, up-to-30 minute interviews with eight cardiologists, twice 
in each cohort, for a total of 16 hours.
    c. Interviews with Partner Hospitals that withdraw. We will 
interview up to nine withdrawing hospitals for no more than 20 minutes 
to better understand the reason for withdrawal as well as facilitators 
and barriers, for a total of 2.7 hours.
    3. Learning Community Participant Survey. We assumed 200 Learning 
Community participants will complete the survey based on an 80% 
response rate. It is expected to take up to 15 minutes to complete each 
survey for a total of 100 hours.
    4. Learning Community Follow-up Survey. We will conduct a brief, up 
to 10 minute, online survey of participants of each of just ten 
selected Affinity Groups at two months after the virtual meeting. We 
assumed 120 Learning Community participants will complete the survey 
based on an 80% response rate. It is expected to take up to 15 minutes 
to complete each survey for a total of 20.4 hours.

                                  Exhibit 1--Estimated Annualized Burden Hours
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                                                                   B. Number of
   Data collection method or project activity      A. Number of    responses per   C. Hours per      D. Total
                                                    respondents     respondent       response      burden hours
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1. Partner Hospital Champion Survey *...........             113               2            0.75           169.5
2a. Interviews with Partner Hospital Champions..              16               1             1.5            24.0
2b. Interviews with Partner Hospital                          16               2             0.5            16.0
 Cardiologists..................................
2c. Interviews with Partner Hospitals that                     9               1             0.3             2.7
 withdraw.......................................
3. Learning Community Survey **.................             200               2            0.25           100.0
4. Learning Community Follow-up Survey **.......             120               1            0.17            20.4
                                                 ---------------------------------------------------------------
    Total.......................................             474  ..............  ..............           332.6
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* Number of respondents (Column A) reflects a sample size assuming a 90% response rate for this data collection
  effort.
** Number of respondents (Column A) reflects a sample size assuming an 80% 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. 
We obtained median hourly wage rates for relevant occupations from the 
Bureau of Labor & Statistics on ``Occupational Employment Statistics, 
May 2018 Occupation Profiles'' found at the following URL on October 1, 
2019: https://www.bls.gov/oes/current/oes_stru.htm#15-0000. We assumed 
that half the Partner Hospital Champions will be cardiologists and half 
will be Quality Improvement managers. We calculated the hourly rate of 
$72.27 by averaging the median hourly wage rate for cardiologists 
($96.58, occupation code 29-1069) and medical and health services 
managers ($47.95, occupation code 11-1141). The occupation of medical 
and health services managers has been used for quality improvement 
staff in other AHRQ projects. The total cost burden is estimated to be 
about $21,497.

                                   Exhibit 2--Estimated Annualized Cost Burden
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                                                   A. Number of      B. Total     Average hourly    Total cost
   Data collection method or project activity       respondents    burden hours      wage rate        burden
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1. Partner Hospital Champion Survey *...........             113           169.5          $72.27         $12,250
2a. Interviews with Partner Hospital Champions..              16            24.0           72.27           1,734
2b. Interviews with Partner Hospital                          16            16.0           96.58           1,545
 Cardiologists..................................
2c. Interviews with Partner Hospitals that                     9             2.7           72.27             195
 withdraw.......................................
3. Learning Community Survey **.................             200           100.0           47.95           4,795
4. Learning Community Follow-up Survey **.......             120            20.4           47.95             978
                                                 ---------------------------------------------------------------
    Total.......................................             474           332.6  ..............          21,497
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* Number of respondents (Column A) reflects a sample size assuming a 90% response rate for this data collection
  effort.
** Number of respondents (Column A) reflects a sample size assuming an 80% response rate for this data
  collection effort.

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 health care research and 
healthcare 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

[[Page 20505]]

request for OMB approval of the proposed information collection. All 
comments will become a matter of public record.

    Dated: April 7, 2020.
Virginia L. Mackay-Smith,
Associate Director.
[FR Doc. 2020-07661 Filed 4-10-20; 8:45 am]
 BILLING CODE 4160-90-P