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 Department of Health and Human Services Agency for Healthcare Research and Quality
 AGENCY: Agency for Healthcare Research and Quality, Department of Health and Human Services.
 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) 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 
                        *OIRA_submission@omb.eop.gov*
                         (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 
                    ( print 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
Type of respondent
Number of 
                             respondents
Number of 
                             responses per respondent
Estimated time per respondent 
                             (hours)
Estimated total burden 
                             (hours)**Quantitative Interviews at Baseline, 6 Months and 12 Months**Direct Caregiver Staff*
30
27
0.10 hours 
                             (6 minutes)
81 hours.Facility Administrator
4
3
0.25 hours 
                             (15 minutes)
3 hours.Facility Residents
270
3
0.583 hours
                             (35 minutes)
472 hours.Physicians
30
2
.333 hours
                             (20 minutes)
20 hours.**Qualitative Implementation Evaluation Interviews at Intervention Facilities**Residents
12
1
0.5 hours
                             (30 minutes)
6 hours.Exercise Staff
2
1
.75 hours
                             (45 minutes)
1.5 hours.Facility Administrator
2
1
1 hour
                             (60 minutes)
2 hours.( print page 20343)Medication Staff
4
1
1 hour
                             (60 minutes)
4 hours.Total Burden



589.5 hours.*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