[Federal Register Volume 72, Number 78 (Tuesday, April 24, 2007)]
[Notices]
[Pages 20341-20343]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 07-2012]


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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, Department of 
Health and Human Services.

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) allow the proposed information collection 
project: ``Improving Quality of Care in Long Term Care.'' In accordance 
with the Paperwork Reduction Act of 1995, Public Law 104-13 (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 January 16, 2007 and allowed 60 days for public 
comment. No public comments were 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 May 24, 2007.

ADDRESSES: Written comments should be submitted to: Karen Matsuoka by 
fax at (202) 395-6794 (attention: AHRQ's desk officer) or by e-mail at 
[email protected] (attention: AHRQ's desk officer). Copies 
of the proposed collection plans, data collection instruments, and 
specific details on the estimated burden can be obtained from AHRQ's 
Reports Clearance Officer.

FOR FURTHER INFORMATION CONTACT: Doris Lefkowitz, AHRQ, Reports 
Clearance Officer, (301) 427-1477.

SUPPLEMENTARY INFORMATION:

Proposed Project

``Improving Quality of Care in Long Term Care''

    The proposed project will design, implement, and evaluate an 
intervention program to prevent injurious falls in assisted living 
facilities. The project involves four major activities: (1) Adapting a 
multifaceted, evidence-based falls prevention program to a protocol 
tailored to the assisted living environment; (2) implementing the pilot 
protocol and collecting clinical and process data pre- and post-
intervention; (3) evaluating the results of the intervention; and (4) 
widely disseminating the protocol (revised as needed based on the 
evaluation), training materials, and research findings.
    The project design is a multi-component falls intervention program 
that will include medication review, resident assessment, environmental 
modification, and exercise. Its goal will be to reduce risk factors for 
falls, as well as fall and fracture rates, among

[[Page 20342]]

residents of assisted living facilities. The project will adapt 
existing evidence-based falls prevention interventions to the assisted 
living setting, and collect data to track the progress and impact of 
the intervention program. Data collection for the falls intervention 
project will be approved by the University of North Carolina-Chapel 
Hill and Research Triangle Institute (RTI) International Institutional 
Review Boards. It will be conducted in accordance with the Health 
Insurance Portability and Accountability Act (HIPAA) Privacy Rule and 
with the Protection of Human Research Subjects regulations, 45 CFR part 
46. In addition, the identifiable data collected in this study about 
provider organizations and individuals will only be used for the above-
statted purposes and will be kept confidential.

Methods of Collection

    The evaluation will use several methods to examine the efficacy of 
the intervention, including record review, in-person surveys, and in-
depth interviews. Data for this process evaluation of the 
implementation of the intervention will be collected at baseline, 6 and 
12 months at the facility-level (e.g., fall and fracture rates, 
intervention adoption) and the resident-level (e.g., risk factors for 
falls, adherence to intervention regimens). Data will be collected from 
4 facilities; two intervention sites and two control sites.
    The quantitative data will be collected using a series of 
questionnaires to collect information about the facility, its staff, 
and the participating residents. The information about residents' 
cognitive, medical, and functional status, and risk for falls will be 
collected using resident medication records and charts, performance 
based physical assessments, and standard measures of activities of 
daily living and cognition. Data collected from residents will take 
approximately 35 minutes per resident (approximately 270 residents will 
be interviewed); data obtained from direct caregiver staff related to 
resident falls risk will take approximately 6 minutes per resident 
(caregiver staff person will be interviewed about approximately 9 
residents each). Also, administrators will be asked to provide 
information about the facility at baseline only, which will take 
approximately 15 minutes.
    Physicians who care for residents who reside in the four 
participating facilities will also be interviewed before the quality 
improvement program is implemented, and twelve months later. They will 
be asked about their knowledge of falls prevention, the importance of 
falls prevention, self-efficacy with regard to ability to prevent 
falls, perspectives on the efficacy of others to prevent falls, outcome 
expectations, and the need for more information to prevent falls. The 
12 month follow-up will also ask their perspective about quality 
improvement programs for falls prevention in assisted living. These 
interviews will average 20 minutes.
    The in-depth interviews of residents and staff will use both open-
ended questions and items with categorical response options to 
facilitate analysis. Items will include the degree to which the 
facility has changed its practices; the degree to which residents 
accept and adhere to the intervention; facilitators for and obstacles 
to implementation; report of staff and resident satisfaction; reactions 
and experiences related to the use of volunteers; and lessons learned. 
These data will be gathered through 60-minute interviews with facility 
administrators. Medication staff will be interviewed about the process 
of identifying medications that put residents at risk for falls and 
communicating this information to the residents' physicians. These 
interviews will last approximately 60 minutes. Staff who run the 
exercise program will be asked about the exercise program in general 
and residents' involvement and participation. These interviews will 
last approximately 45 minutes. Interviews with residents will consist 
of questions to inform the participation level of residents as well as 
benefits the residents might receive through participation. Resident 
interviews will take approximately 30 minutes to complete. The research 
staff will interview the administrator at each intervention site, up to 
two medication staff at each intervention site, up to two exercise 
staff at each intevention site, and up to six residents at each 
intervention site.

Estimated Annual Respondent Burden

    The table below indicates the estimated time and cost burden to the 
respondents for obtaining all of the data needed to meet the study's 
objectives. There will be no cost burden to the respondent other than 
the cost burden associated with their time to provide the required 
data. There will be no additional costs for capital equipment, 
software, computer services, etc. Time required to analyze the data and 
prepare it for reporting and publication is not included in these 
estimates.

                                      Table 1.--Estimated Respondent Burden
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                                                    Number of
       Type of respondent           Number of     responses per     Estimated time per    Estimated total burden
                                   respondents     respondent      respondent  (hours)            (hours)
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                           Quantitative Interviews at Baseline, 6 Months and 12 Months
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Direct Caregiver Staff*........              30              27  0.10 hours.............  81 hours.
                                                                 (6 minutes)............
Facility Administrator.........               4               3  0.25 hours.............  3 hours.
                                                                 (15 minutes)...........
Facility Residents.............             270               3  0.583 hours............  472 hours.
                                                                 (35 minutes)...........
Physicians.....................              30               2  .333 hours.............  20 hours.
                                                                 (20 minutes)...........
ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½
                   Qualitative Implementation Evaluation Interviews at Intervention Facilities
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Residents......................              12               1  0.5 hours..............  6 hours.
                                                                 (30 minutes)...........
Exercise Staff.................               2               1  .75 hours..............  1.5 hours.
                                                                 (45 minutes)...........
Facility Administrator.........               2               1  1 hour.................  2 hours.
                                                                 (60 minutes)...........

[[Page 20343]]

 
Medication Staff...............               4               1  1 hour.................  4 hours.
                                                                 (60 minutes)...........
ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½
Total Burden...................  ..............  ..............  .......................  589.5 hours.
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*Each direct caregiver staff person will be interviewed about multiple residents (approximately 9 each). These
  interviews will occur three times--at baseline, at 6 months and at 12 months for a total of 27 interviews.
  Direct caregiver staff and other facility staff we interview will be similar to certified nurse assistants. We
  do not include professional level staff in this category.

Estimated Annual Costs to the Federal Government

    The total estimated one-time cost of this intervention 
implementation and related data collection to the federal government is 
$199,600. This funding will be used to support the cost of implementing 
the intervention, salary and fringe benefits for the research team to 
conduct the survey interview and in-depth interview, costs for members 
of the research team to travel to each site, and the incentives paid to 
facilities for participation in the intervention. The project proposes 
to work with assisted living facilities with which the research team 
already has established relationships and familiarity and will attempt 
to minimize burden to the assisted living facility staff by being 
flexible to schedules and requirements of care practices within the 
facilities.

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 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 for information technology.

    Dated: April 11, 2007.
Carolyn M. Clancy,
Director.
[FR Doc. 07-2012 Filed 4-23-07; 8:45 am]
BILLING CODE 4160-90-M