[Federal Register Volume 79, Number 19 (Wednesday, January 29, 2014)]
[Notices]
[Pages 4718-4721]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-01709]


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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: ``Pilot Test of an Emergency Department Discharge Tool.'' In 
accordance with the Paperwork Reduction Act of 1995, 44 U.S.C. 
3506(c)(2)(A), AHRQ invites the public to comment on this proposed 
information collection.
    This proposed information collection was previously published in 
the Federal Register on August 27th, 2013 and allowed 60 days for 
public comment. One comment was received. The purpose of this notice is 
to allow an additional 30 days for public comment.

DATES: Comments on this notice must be received by February 28, 2014.

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

Pilot Test of an Emergency Department Discharge Tool

    The research study ``Pilot Test of an Emergency Discharge Tool'' 
fully supports AHRQ's mission. The ultimate aim of this study is to 
pilot test a discharge tool which has the potential to reduce 
unnecessary visits to the Emergency Department (ED), reduce healthcare 
expenditure in the ED, as well as streamline and enhance the quality of 
care delivered to ED patients.
    The ED is an important and frequently used setting of care for a 
large part of the U.S. population. In 2006, there were nearly 120 
million ED visits in the U.S., of which only 15.5 million (14.7%) 
resulted in admission to the hospital or transfer to another hospital. 
Thus the majority ED visits result in discharge to home. Patients 
discharged from the ED face significant risk for adverse outcomes, with 
between 3-5 patients per 100,000 visits experiencing an unexpected 
death following discharge from the ED. Additionally, a sizable minority 
of patients return to the ED frequently. Published studies estimate 
that 4.5% to 8% of patients revisit the ED 4 or more times per year, 
accounting for 21% to 28% of all ED visits. Internal data from John 
Hopkins Hospital, AHRQ's contractor for this pilot test, supports these 
findings with 7% of their patients accounting for 26% of visits to the 
Johns Hopkins Hospital ED in 2011.
    Patients who revisit the ED contribute to overcrowding, unnecessary 
delays in care, dissatisfaction, and avoidable patient harm. ED 
revisits are also an important contributor to rising health care costs, 
as ED care is estimated to cost two to five times as much as the same 
treatment delivered by a primary care physician. Thus it is estimated 
that eliminating revisits and inappropriate use of EDs could reduce 
health care spending as much as $32 billion each year. Overall, an 
effective and efficient ED discharge process would improve the quality 
of patient care in the ED as well as reduce healthcare costs.
    To respond to the challenges faced by our nation's EDs and the 
patients they serve, AHRQ will develop and pilot test a tool to improve 
the ED discharge process. More specifically, this project has the 
following goals:
    (1) Develop and Pilot Test a Prototype ED Discharge Tool in a 
limited number of settings to assess:
    (a) The feasibility for use with patients;
    (b) The methodological and resource requirements associated with 
tool use;
    (c) The feasibility of measuring outcomes;
    (d) The costs of implementation and;
    (e) Preliminary outcomes or impacts of tool use.
    (2) Revise the Tool based on the results from the Pilot Test.
    This study is being conducted by AHRQ through its contractor, John 
Hopkins Hospital, 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

[[Page 4719]]

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 these goals the following data collections will be 
implemented:
    (1) Pilot Test of the Emergency Department Discharge Tool (EDT)--
The EDT will be pilot tested in the three John Hopkins EDs in 
Baltimore. The purpose of the EDT is to assist hospitals in identifying 
patients who excessively use the ED and can be categorized as 
``frequent ED users,'' as well as to target interventions to these 
patients to reduce the risk of further avoidable revisits. A research 
assistant will screen the medical record of all adult patients for the 
presence of frequent ED use, the key risk factor for ED discharge 
failure. Frequent ED use is defined as: (1) 1 or more previous ED visit 
within the last 72-hours, or (2) 3 or more previous ED visits within 
the last 3 months, or (3) 4 or more ED visits within the last 12 
months. This definition can be modified to align with the resources of 
the individual ED.
    This tool uses data collected from the record of patients that are 
flagged as frequent ED users. By asking patients a series of questions 
about their medical history, the tool also helps to identify 
individuals with risk factors that have been shown in the literature to 
predict sub-optimal ED discharges and resulting revisits. These risk 
factors include being uninsured, lack of a primary care physician, 
having psychiatric diseases, abusing substances, difficulty caring for 
oneself, or having trouble comprehending ED discharge instructions.
    A User's Guide (EDT User's Guide) is also provided to assist EDs in 
developing resources to provide interventions recommended by the EDT. 
No data collection activities will occur from this manual.
    (2) One Month Patient Follow-up Telephone Interview--After the ED 
visit, a project research assistant (RA) will have a follow-up 
telephone interview with all enrolled patients. During the interview, 
the RA will inquire about the success of the interventions that were 
given for the patient.
    (3) Three Month Patient Follow-up Telephone Interview--Patients who 
are uninsured will receive an additional phone call 3 months after the 
ED visit to assess whether or not they were able to acquire insurance.
    (4) Implementer Focus Groups--AHRQ will conduct four sets of focus 
groups to collect qualitative data about the usability and usefulness 
of the EDT from four stakeholder groups: Three groups of EDT 
implementers and one group of research assistants. Questions for each 
of the focus groups will vary based on their differing objectives:
    (a) EDT Implementers Focus Group (non-RA)--For non-RA implementers 
of the EDT (RNs, case managers, social workers,), the objectives will 
include exploring: (1) How well it does or does not meet implementer 
goals of discharge; (2) experiences with rollout and implementation, 
including resources required for implementation; (3) impressions of the 
value, strengths and weaknesses of the EDT; and (4) unintended 
consequences or impacts on other ED operations. The focus groups will 
consist of 8 implementers. Three focus groups will be conducted, one 
for each pilot site.
    (b) Research Assistant Focus Group--The three research assistants 
who will be implementing the EDT will participate in one focus group in 
which they discuss: (1) Experiences with implementation (including 
comparisons in their experiences across the three test sites; (2) 
possible areas for improvement; (3) unintended consequences or impacts 
on other ED operations.
    (5) Key Informant Interviews--AHRQ will conduct semi-structured 
interviews with no more than twenty-four individuals that can be 
classified as either ED Directors, patients, or community care 
providers. These individuals will provide feedback on issues surfaced 
during the focus groups. This will provide an opportunity to delve more 
deeply into specific topics of interest. The interview guides are 
included as for patients, for community care providers, and for ED 
Directors.
    (a) Patient Interviews--For the patients, the objective will be to 
explore: (1) The barriers they face in obtaining health care; (2) their 
experiences in the ED in visits prior to, and after, implementation of 
the EDT (3) their satisfaction with the care they received in the ED 
and their remaining unmet needs. Fifteen patients will be interviewed 
individually.
    (b) Community Care Providers Interviews--For the post-ED care 
providers, the objectives are to explore challenges in communication 
and coordination for patients referred to them by the ED and the degree 
to which the EDT can address those challenges. Post-ED care provider 
focus group members will be drawn from Johns Hopkins Community 
Physicians, East-Baltimore Medical Center (a primary referral site for 
patients without primary care), and Healthcare for the Homeless, a not-
for-profit organization in Baltimore, Maryland that provides health 
services, education and advocacy to people affected by homelessness. 
Six community care providers will be interviewed for this section.
    (c) ED Directors Interviews--Interviews from ED Directors will 
occur to get their opinions of the EDT from their perspectives as the 
ultimate orchestrators of processes in the emergency room and decision-
makers regarding operations (resources use, staffing). Three ED 
directors will be interviewed separately for this portion.
    (6) Administrative and Observational Data--Quantitative outcome 
measures will come from an extraction of medical record data and direct 
observations performed by project RAs. Data will be extracted from 
hospital billing records and Electronic Medical Records (EMRs) and will 
include frequency of revisits, cost of 72-hour returns, cost of ED 
visits per 3 months, and the cost of implementing the EDT. To calculate 
costs of program implementation, RAs will observe the time required by 
social work, case management, and nursing staff to implement the 
interventions prescribed in the tool. They will also keep a log of the 
materials given to the patients as part of the intervention. To 
evaluate the percentage of patients evaluated for assistance or 
placement, RAs will observe case managers/social workers during their 
interaction with the patients. To evaluate the percentage of follow-up 
phone calls, the RAs will keep a log of attempts and actual contacts. 
Since these data collections involve RA observations, or extractions 
from existing medical records, they pose no burden to the hospital or 
public and therefore are not included in the burden estimates in 
Exhibits 1 and 2 below.
    No pre-intervention measures will be collected because this is a 
feasibility study to evaluate the methodology and feasibility of 
collection of this data.

Estimated Annual Respondent Burden

    Exhibit 1 shows the estimated annualized burden for the 
respondents' time to participate in this pilot test. A research 
assistant will use the EMR to screen patients for past frequent ED use. 
This step does not represent a participant burden. Based upon 
historical data at our three participating sites, we expect 
approximately 200 patients per week to qualify as ``frequent users'' at 
these sites. Based upon available resources and recruitment, we expect 
to enroll and use the EDT with approximately 50 of these patients per 
week at each site to identify their specific risk factors and tailor

[[Page 4720]]

interventions to their needs. Thus we will have a total of 900 patient 
participants (50 patients/per week * 6 weeks * 3 sites = 900 patients 
total). It will take about 20 minutes per patient to collect the data 
associated with the EDT. The one-month patient follow-up will be 
conducted with all 900 patients and will take 10 minutes to complete. 
The 3-month patient follow-up will be conducted with those patients 
identified as being uninsured and is estimated to take 5 minutes to 
complete.
    Four focus groups will take place among RAs and non-RA EDT 
implementers. The first focus group will consist of three RAs who 
implemented the discharge tool. The other three separate focus groups 
will exclude RAs and include eight other ED personnel that implemented 
the discharge tool. The total annualized burden for these focus groups 
is estimated to be 54 hours.
    As a follow-up to the focus groups, in-depth interviews will also 
be conducted with members from different stakeholder groups. Between 12 
and 16 patients will be interviewed as well as three ED directors and 
six community healthcare providers. The interviews will be conducted in 
person and require one hour to complete. The total annualized burden 
for these interviews is estimated to be 30 hours.
    Exhibit 2 shows the annualized cost burden associated with the 
respondents' time to participate in the pilot test. The total 
annualized cost burden is estimated to be $13,262.

                                  Exhibit 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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                           Pilot Test of the Emergency Department Discharge Tool (EDT)
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EDT.............................................             900               1           20/60             300
One Month Patient Follow-up.....................             900               1           10/60             150
Three Month Patient Follow-up...................             180               1            5/60              15
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                                            Implementer Focus Groups
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RA Focus Group..................................               3               1               2               6
EDT Implementer (non-RA) 1 Focus Group.               8               1               2              16
EDT Implementer (non-RA) 2 Focus Group.               8               1               2              16
EDT Implementer (non-RA) 3 Focus Group.               8               1               2              16
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                                            Key Informant Interviews
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Community Healthcare Provider Interview.........               6               1               2              12
Patient Interview...............................              15               1               1              15
ED Director Interview...........................               3               1               1               3
                                                 ---------------------------------------------------------------
    Total.......................................           2,031              NA              NA             549
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                                   Exhibit 2--Estimated Annualized Cost Burden
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                                                     Number of     Total burden   Average hourly    Total cost
                    Form name                       respondents        hours        wage rate*        burden
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                           Pilot Test of the Emergency Department Discharge Tool (EDT)
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EDT.............................................             900             300      \a\ $22.01          $6,603
One Month Patient Follow-up.....................             900             150       \a\ 22.01           3,302
Three Month Patient Follow-up...................             180              15       \a\ 22.01             330
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                                            Implementer Focus Groups
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RA Focus Group..................................               3               6       \d\ 17.86             107
EDT Implementer (non-RA) 1 Focus Group.               8              16       \b\ 27.42             439
EDT Implementer (non-RA) 2 Focus Group.               8              16        \b\ 27.4             439
EDT Implementer (non-RA) 3 Focus Group.               8              16       \b\ 27.42             439
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                                            Key Informant Interviews
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Community Healthcare Provider Focus Group.......               6              12       \c\ 45.36             544
Patient Interview...............................              15              15       \a\ 22.01             330
ED Director Interview...........................               3               3       \e\ 97.30             292
                                                 ---------------------------------------------------------------
    Total.......................................           2,031             549              NA          12,825
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* National Compensation Survey: Occupational wages in the United States May 2012, ``U.S. Department of Labor,
  Bureau of Labor Statistics.''
\a\ based on the mean wages for All Occupations (00-0000).
\b\ salary based upon average of: 2 nurses (29-1141), 2 case managers (29-1141), 2 social workers (21-1022), and
  2 research assistants (19-4061).
\c\ salary based upon average of: 2 physicians (29-1060), 2 nurses (29-1141), 2 case managers (29-1141), 2
  social workers (21-1022).
\d\ based on mean hourly wage of: Social Science Research Assistants (19-4061).
\e\ based on mean annual wage of: Physicians and Surgeons (29-1060).


[[Page 4721]]

Request for Comments

    In accordance with the above-cited Paperwork Reduction Act 
legislation, 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, quality improvement and 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: January 16, 2014.
Richard Kronick,
AHRQ Director.
[FR Doc. 2014-01709 Filed 1-28-14; 8:45 am]
BILLING CODE 4160-90-P