Agency Information Collection Activities: Proposed Collection; Comment Request, 53306-53310 [2010-21503]

Download as PDF 53306 Federal Register / Vol. 75, No. 168 / Tuesday, August 31, 2010 / Notices Estimated Annual Respondent Burden grants programs and other agency information exchange mechanisms. Method of Collection Grantees are required to enter data related to the progress of their grant funded research quarterly through a secure online interface which requires a user id and password. Exhibit 1 shows the estimated annualized burden hours for the respondents. It will take grantees an estimated 10 minutes to enter the necessary data into the Grant Reporting System (GRS) and reporting will occur four times annually. The total annualized burden hours are estimated to be 333 hours. Exhibit 2 shows the estimated annualized cost burden for the respondents. The total estimated cost burden for respondents is $11,159. EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS Number of responses per respondent Number of respondents Form name Hours per response Total burden hours Data entry into GRS ........................................................................ 500 4 .............................. 10/60 ..................... 333 Total ......................................................................................... 500 na ............................ na .......................... 333 EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN Number of respondents Form name Total burden hours Average hourly wage rate * Total cost burden Data entry into GRS ................................................................................. 500 333 $33.51 .................. $11,159 Total ................................................................................................... 500 333 na ......................... 11,159 * Based upon the average wages for Healthcare Practitioner and Technical Occupations (29–0000), ‘‘National Compensation Survey: Occupational Wages in the United States, May 2009,’’ U.S. Department of Labor, Bureau of Labor Statistics. Estimated Annual Costs to the Federal Government The annual cost to the government is $100,000 for licensing, support and maintenance. srobinson on DSKHWCL6B1PROD with NOTICES 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 healthcare 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 request for OMB approval of the proposed information collection. All comments will become a matter of public record. VerDate Mar<15>2010 16:33 Aug 30, 2010 Jkt 220001 Dated: August 16, 2010. Carolyn M. Clancy, Director. [FR Doc. 2010–21501 Filed 8–30–10; 8:45 am] BILLING CODE 4160–90–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Healthcare Research and Quality Agency Information Collection Activities: Proposed Collection; Comment Request Agency for Healthcare Research and Quality, HHS. AGENCY: ACTION: Notice. 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: ‘‘Avoiding Readmissions in Hospitals Serving Diverse Patients.’’ In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501–3520, AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the Federal Register on June 21st, 2010 and allowed 60 days for public comment. One comment was received. The purpose of SUMMARY: PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 this notice is to allow an additional 30 days for public comment. DATES: Comments on this notice must be received by September 30, 2010. ADDRESSES: Written comments should be submitted to: AHRQ’s OMB Desk Officer by fax at (202) 395–6974 (attention: AHRQ’s desk officer) or by email 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 the AHRQ Reports Clearance Officer. FOR FURTHER INFORMATION CONTACT: Doris Lefkowitz, AHRQ Reports Clearance Officer, (301) 427–1477, or by e-mail at doris.lefkowitz@AHRQ.hhs.gov. SUPPLEMENTARY INFORMATION: Proposed Project Avoiding Readmissions in Hospitals Serving Diverse Patients An important part of AHRQ’s mission is to disseminate information and tools that can support improvement in quality and safety in the U.S. health care community. The transition process from the hospital to the outpatient setting is nonstandardized and frequently inadequate in quality. One in five hospital discharges is complicated by an adverse event (AE) within 30 days, often leading to an emergency department visit and/or rehospitalization. Many E:\FR\FM\31AUN1.SGM 31AUN1 srobinson on DSKHWCL6B1PROD with NOTICES Federal Register / Vol. 75, No. 168 / Tuesday, August 31, 2010 / Notices readmissions stem from errors that can be directly attributed to the discontinuity and fragmentation of care at discharge. High rates of low health literacy, lack of coordination in the ‘‘hand-off’’ from the hospital to community care, gaps in social supports, and other limitations also contribute to the risk of rehospitalization. Boston University Medical Center (BUMC), through a grant from AHRQ, previously defined the discharge process and determined what improvements could be made to improve this care transition for patients. This new process was called the ‘‘reengineered discharge’’ (RED). The RED consists of 11 elements, including educating the patient throughout the hospital stay, making follow-up appointments, and giving the patient a written discharge plan. The RED was tested in a randomized controlled trial in an academic safety net hospital at BUMC with English speaking, general medical patients being discharged to home or community settings. Results of this trial of 749 patients showed a reduction in rehospitalizations within 30 days and emergency department visits following hospital discharge. Participants also followed up with primary care providers more often and reported higher patient satisfaction with the discharge process. Project RED researchers created several tools to help hospitals replicate RED. After AHRQ and Project RED researchers fielded many inquiries about how to implement Project RED at hospitals nationwide, AHRQ realized that the Project RED Toolkit did not provide sufficient guidance to potential replicators. Various components of the RED were not documented, and issues regarding implementing the RED at hospitals serving linguistically and culturally diverse patient populations had not been addressed. AHRQ has therefore contracted with the RED researchers to create a revised RED Toolkit that will address these issues. This proposed information collection supports AHRQ’s mission by improving upon the RED Toolkit. This project has the following 2 goals: (1) To pre-test the revised RED Toolkit in ten varied hospital settings, evaluating how the RED Toolkit is implemented in varied hospital settings by: (a) Documenting the implementation process; (b) assessing the fidelity of implementation; and (c) identifying the factors that affect redesign fidelity, including intensity of technical assistance (TA). VerDate Mar<15>2010 16:33 Aug 30, 2010 Jkt 220001 (2) To modify the revised RED Toolkit based on pre-testing and to disseminate it. BUMC will provide TA at two varying levels. Four selected hospitals will receive ‘‘train-the-trainer’’ TA, which includes: (1) Telephone assistance in conducting a baseline needs assessment; (2) Master trainer training; (3) Access to webinar trainings specifically designed for each user (nurse, IT professional, hospital leadership, and pharmacist); (4) An electronic template to print an After Hospital Care Plan (AHCP) booklet; and (5) E-mails regarding updates to the RED Web site and the opportunity to ask questions about the newly revised and enhanced RED tools and implementation via telephone and email. Six selected hospitals will receive intensive TA, which includes: (1) Telephone baseline needs assessment; (2) On-site training; (3) Monthly semi-structured interviews via phone calls with the implementation team to discuss implementation efforts and barriers; (4) Adaptation of the revised RED Toolkit to include specific details about the hospital (such as the hospital name on the cover of the AHCP booklet and hospital-specific services provided to patients included in the AHCP booklet); (5) An assessment and evaluation site visit by the organizational change evaluator (a member of the implementation team), at baseline and 12 months after the start of implementation efforts to interview select participating hospital staff; (6) IT support to install and support the RED Toolkit software to automatically generate the AHCP booklet; and (7) E-mails regarding updates to the RED Web site and the opportunity to ask questions about the newly revised and enhanced RED tools and implementation via telephone and email. A diverse group of hospitals will be selected to receive each level of TA, based upon hospital size, location, readmission rate and patient population. Implementing the revised RED Toolkit in diverse settings will provide a better understanding of whether and how RED can be best implemented in different hospital settings. The project will be framed within a model of organizational change and transformation called the Organizational Transformation Model (OTM), which is PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 53307 based on the evaluation of Robert Wood Johnson Foundation’s Pursuing Perfection initiative. OTM identifies key elements that drive dramatic system change and informs the implementation process and impact evaluation. Using a mixed-methods design, the evaluation tracks change over time and across the implementation period within each hospital. The evaluation therefore will encompass feedback on specific implementation processes and factors in microsystems where RED is adopted, in the larger organizational context, and interactions between the two. This research study is being conducted by AHRQ through its contractor, BUMC, pursuant to AHRQ’s statutory authority to conduct and support research on healthcare and disseminate information 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. 299(b) and 299a(a)(1) and (2). Method of Collection To achieve the projects’ goals, the following data collections and training will be implemented for the six hospitals that will receive intensive TA as well as the 4 hospitals receiving train-the trainer TA, unless otherwise noted: (1) Baseline needs assessment to help each hospital plan and prepare for implementation of the revised RED Toolkit and to evaluate it in varied settings (see Attachment C). This is not a data collection but will impose a time burden on the participating hospitals as they prepare to participate in this project. The purpose of the needs assessment is for the hospital to become familiar with their discharge process and what parts of the process are being done well and what parts of the process need improvement. In order to implement the new RED discharge process, it is important for a hospital to plan how they will do this. This information will be shared during the baseline key contact semi-structured interview. (2) Baseline key contact semistructured interviews will be administered by telephone, approximately two months prior to implementation, to the key contact at each of the ten study hospitals (see Attachment D). The purpose of the interview is to identify the implementation team, collect some basic information about the hospital, such as the number of beds and if electronic medical records are used, and E:\FR\FM\31AUN1.SGM 31AUN1 53308 Federal Register / Vol. 75, No. 168 / Tuesday, August 31, 2010 / Notices to establish the baseline readmission rate. (3) Monthly semi-structured interviews with the key contact or other implementation team member will be conducted monthly for 12 months after implementation (see Attachment E). These interviews will be conducted by phone with each of the six hospitals receiving intensive technical assistance (TA) (the two levels of TA are described above). The purpose of these interviews are to allow hospitals to share their experiences with implementing the revised RED Toolkit, their use of specific tools, changes resulting from using the tools and problems encountered implementing the revised RED Toolkit and how they are being addressed. (4) Baseline semi-structured interviews will be conducted prior to the implementation of the revised RED Toolkit with 15 hospital staff from each of the six study hospitals receiving intensive TA (see Attachment F). The purpose of this interview is to measure the staff’s opinion of the current discharge process, their perceived need for a redesigned process, and the perceived barriers and facilitators to redesigning the discharge process. (5) Post implementation semistructured interviews will be conducted 12 months after the implementation of the revised RED Toolkit with 15 hospital staff from each of the six study hospitals receiving intensive TA (see Attachment G). The purpose of this interview is to measure the staff’s opinion of the redesigned discharge process, which tools were used and their opinion of the tools, and the observed barriers and facilitators to redesigning the discharge process. (6) Patient surveys will be administered by telephone to a random sample of patients 30 days after being discharged from one of the six intensive TA study hospitals (see Attachment H). The purpose of this survey is to measure patient outcomes, including satisfaction with the care they received, 30-day hospital and emergency department visits, and physician appointments, to help determine the success of the RED Toolkit implementation in diverse patient populations. The survey will be administered by a hospital staff member to patients during the preimplementation period and again during the post-implementation period to compare patient outcomes. (7) Medical record review of patient outcomes at all ten study hospitals (see Attachment I). This data collection will be conducted both pre- and postimplementation of the revised RED Toolkit and will inform the success of the revised RED Toolkit implementation in diverse patient populations. Outcomes to be collected include process outcomes, such as primary care provider appointments scheduled prior to discharge, and patient outcomes, such as 30-day hospital and emergency department visits. (8) Master trainer training will be conducted with 3 staff members from each of the 4 hospitals receiving trainthe-trainer TA (see Attachment J). These people will be trained to administer the RED Toolkit and be able to use recorded webinar training sessions within their organization. They will be invited to travel to BUMC for a 2-day onsite orientation of the RED intervention. These people will meet with several members of the BUMC implementation team (physician leader, discharge advocate nurse) and will have the opportunity to shadow the nurse discharge advocates in conducting the RED intervention. (9) Intensive training will be conducted with about 28 staff from each of the 6 hospitals receiving intensive TA (see Attachment K). The training will consist of a two-day on-site orientation and training at each hospital conducted by the BUMC implementation team. The BUMC implementation team will consist of a physician researcher, a discharge advocate nurse, an organizational change champion/ evaluator and the information technology expert. The BUMC team will spend two days, 8 hours per day, to train the relevant hospital staff to perform the 11 components of the RED discharge. The training will include material for senior hospital management, hospital physicians, nurses, IT staff, and pharmacists. Estimated Annual Respondent Burden Exhibit 1 shows the estimated annualized burden hours associated with the respondent’s time to participate in this research. The baseline needs assessment will be conducted by staff at each of the 10 participating hospitals and takes about 8 hours to complete. Baseline key contact semistructured interviews will be conducted with the key contact at each hospital and requires 1 hour to complete. Monthly semi-structured interviews with the key contact or other implementation team member will be conducted monthly for 12 months after implementation. These interviews will be conducted by phone with each of the six hospitals receiving intensive TA and will require 1 hour to complete. Both the base-line and post-implementation semi-structured interviews will be conducted with 15 staff members from each of the 6 hospitals receiving intensive TA and will last about one hour. The patient survey will be administered twice, pre and post implementation, to 3,108 patients recently discharged from one of the 6 hospitals receiving intensive TA and requires 10 minutes to complete. The patient survey will be administered by the hospital staff and will require 10 minutes of their time to administer. Medical record review will be performed at all 10 participating hospitals both pre and post implementation and will take about 41.6 hours. Master trainer training will be conducted with 3 staff members from each of the 4 hospitals receiving train the trainer TA and will last 16 hours. Intensive training will be conducted with about 28 staff members from each of the 6 hospitals receiving intensive TA and will also last 16 hours. The total annualized burden is estimated to be 6,126 hours. Exhibit 2 shows the estimated annualized cost burden associated with the respondent’s time to participate in this research. The total annualized cost burden is estimated to be $194,163. srobinson on DSKHWCL6B1PROD with NOTICES EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS Number of respondents Form name Baseline needs assessment ............................................................................ Baseline key contact semi-structured interview .............................................. Monthly semi-structured interview ................................................................... Baseline semi-structured interview .................................................................. Post implementation semi-structured interview ............................................... Patient survey .................................................................................................. VerDate Mar<15>2010 16:33 Aug 30, 2010 Jkt 220001 PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 Number of responses per respondent 10 10 6 6 6 3,108 E:\FR\FM\31AUN1.SGM 1 1 12 15 15 2 31AUN1 Hours per response 8 1 1 1 1 10/60 Total burden hours 80 10 72 90 90 1,036 53309 Federal Register / Vol. 75, No. 168 / Tuesday, August 31, 2010 / Notices EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS—Continued Number of respondents Form name Number of responses per respondent Hours per response Total burden hours Administration of patient survey by hospital staff ............................................ Medical record review ...................................................................................... Master trainer training ...................................................................................... Intensive training .............................................................................................. 6 10 4 6 1,036 2 3 28 10/60 41.6 16 16 1,036 832 192 2,688 Total .......................................................................................................... 3,172 na na 6,126 EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN Number of respondents Form name Total burden hours Average hourly wage rate* Total cost burden Baseline needs assessment ............................................................................ Baseline key contact semi-structured interview .............................................. Monthly semi-structured interviews ................................................................. Baseline semi-structured interview .................................................................. Post implementation semi-structured interview ............................................... Patient survey .................................................................................................. Administration of patient survey by hospital staff ............................................ Medical record review ...................................................................................... Master trainer training ...................................................................................... Intensive training .............................................................................................. 10 10 6 6 6 3,108 6 10 4 6 80 10 72 90 90 1,036 1,036 832 192 2,688 a $41.94 i 40.91 $3,355 519 2,946 3,466 3,466 21,052 32,437 14,410 6,012 109,966 Total .......................................................................................................... 3,172 6,126 na 194,163 b 51.91 c 40.91 d 38.51 e 38.51 f 20.32 b31.31 g 17.32 h 31.31 * Based upon the mean of the average wages, National Compensation Survey: Occupational wages in the United States May 2008, ‘‘U.S. Department of Labor, Bureau of Labor Statistics.’’ (a) 75% Nurses (29–1111, $31.31/hr), 20% Physicians (29–1069, $79.33/hr) and 5% General and Operations Managers (29–1069, $51.91/hr). b 100% General and Operations Managers (29–1069, $51.91/hr). c 80% Nurses and 20% Physicians. d ande 85% Nurses and 15% Physicians. f 100% General public (00–0000, $20.32/hr). g 100% Statistical assistants (439111, $17.32/hr). h 100% Nurses. i 80% Nurses and 20% Physicians. Estimated Annual Costs to the Federal Government this clearance. The total cost is $449,976. Exhibit 3 shows the total and annualized cost over the 18 months of EXHIBIT 3—ESTIMATED TOTAL AND ANNUALIZED COST Cost component Total cost Annual cost Project RED Toolkit Development ........................................................................................................................... Dissemination Planning and Support ...................................................................................................................... Data Collection Activities ......................................................................................................................................... Data Processing and Analysis ................................................................................................................................. Publication of Results .............................................................................................................................................. Project Management ................................................................................................................................................ Overhead ................................................................................................................................................................. $97,413 98,080 84,563 52,215 3,184 28,892 85,629 $64,942 65,387 56,375 34,810 2,123 19,261 57,086 Total .................................................................................................................................................................. 449,976 299,984 srobinson on DSKHWCL6B1PROD with NOTICES 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 healthcare research and healthcare information dissemination VerDate Mar<15>2010 16:33 Aug 30, 2010 Jkt 220001 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 PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 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. E:\FR\FM\31AUN1.SGM 31AUN1 53310 Federal Register / Vol. 75, No. 168 / Tuesday, August 31, 2010 / Notices Dated: August 20, 2010. Carolyn M. Clancy, Director. use of information technology. Written comments should be received within 60 days of this notice. [FR Doc. 2010–21503 Filed 8–30–10; 8:45 am] Proposed Project Clostridium difficile Infection (CDI) Surveillance—New—National Center for Emerging and Zoonotic Infectious Diseases, (NCEZID), Centers for Disease Control and Prevention, (CDC). BILLING CODE 4160–90–M DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60 Day 10–10GP] Proposed Data Collections Submitted for Public Comment and Recommendations In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 for opportunity for public comment on proposed data collection projects, the Centers for Disease Control and Prevention (CDC) will publish periodic summaries of proposed projects. Alternatively, to obtain a copy of the data collection plans and instrument, call 404–639–5960 and send comments to Maryam I. Daneshvar, CDC Reports Clearance Officer, 1600 Clifton Road NE., MS–D74, Atlanta, Georgia 30333; comments may also be sent by e-mail to omb@cdc.gov. Comments are invited on (a) whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have a practical utility; (b) the accuracy of the agency’s estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarify of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the difficile toxin and abstract data on cases using a standardized case report form. For a subset of cases (e.g., communityassociated C. difficile cases) sites will administer a health interview. Remnant stool specimens from cases testing positive for C. difficile toxin will be submitted to reference laboratories for culturing, and isolates will be sent to CDC for confirmation and molecular typing. Outcomes of this surveillance project will include the populationbased incidence of community- and healthcare-associated CDI, and a description of the molecular characteristics of C. difficile strains and the epidemiology of this infection among the population under surveillance. For this proposed data collection, there is no cost to respondents other than their time. An estimated total of 8,750 CDI Surveillance Case Report Forms (CRFs) will be completed during a one-year study period. Approximately 4,370 cases will require a completed CRF taking one hour; the remaining 4,380 cases will only require a partially completed CRF taking 15 minutes. An estimated total of 500 CDI Surveillance Health Interviews (HI) will need to be completed for the same time period. The estimated time to complete the HI is 45 minutes. Therefore, the total estimated annualized burden for this data collection is 5,840 hours. The proposed surveillance for CDI through the Emerging Infections Program will expand CDC capacity to monitor incidence of C. difficile in community and healthcare settings as well as to monitor and detect antimicrobial resistance. This activity supports the HHS Action Plan for elimination of healthcare-associated infections. Background and Brief Description Steady increases in the rate and severity of Clostridium difficile infection (CDI) indicate a clear need to conduct longitudinal assessments of the impact of CDI in the United States. C. difficile is an anaerobic, spore-forming, gram positive bacillus that produces two pathogenic toxins: A and B. CDI ranges in severity from mild diarrhea to fulminant colitis and death. Transmission of C. difficile occurs primarily in healthcare facilities, where environmental contamination by C. difficile spores and exposure to antimicrobial drugs are common. No longer limited to healthcare environments, community-associated CDI is the focus of increasing attention. Recently, several cases of serious CDI have been reported in what have been considered low-risk populations, including healthy persons living in the community and peri-partum women. The surveillance population will consist of persons residing in the catchment area of the participating Emerging Infections Program (EIP) sites. This surveillance poses no more than minimal risk to the study participants as there will be no interventions or modifications to the care study participants receive. EIP surveillance personnel will perform active case finding from laboratory reports of stool specimens testing positive for C. ESTIMATE OF ANNUALIZED BURDEN HOURS Number of respondents Forms CDI Surveillance Case Report Form—Complete ............................................ CDI Surveillance Case Report Form—Partial ................................................. CDI Surveillance Health Interview ................................................................... Number of responses per respondent 10 10 10 437 438 50 srobinson on DSKHWCL6B1PROD with NOTICES Total .......................................................................................................... VerDate Mar<15>2010 16:33 Aug 30, 2010 Jkt 220001 PO 00000 Frm 00040 Fmt 4703 Sfmt 9990 Average burden per response (in hours) 1 15/60 45/60 Total burden (in hours) 4,370 1,095 375 5,840 E:\FR\FM\31AUN1.SGM 31AUN1

Agencies

[Federal Register Volume 75, Number 168 (Tuesday, August 31, 2010)]
[Notices]
[Pages 53306-53310]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-21503]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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: ``Avoiding Readmissions in Hospitals Serving Diverse 
Patients.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 
3501-3520, AHRQ invites the public to comment on this proposed 
information collection.
    This proposed information collection was previously published in 
the Federal Register on June 21st, 2010 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 September 30, 2010.

ADDRESSES: Written comments should be submitted to: AHRQ's OMB Desk 
Officer by fax at (202) 395-6974 (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 the AHRQ Reports Clearance Officer.

FOR FURTHER INFORMATION CONTACT: Doris Lefkowitz, AHRQ Reports 
Clearance Officer, (301) 427-1477, or by e-mail at 
doris.lefkowitz@AHRQ.hhs.gov.

SUPPLEMENTARY INFORMATION: 

Proposed Project

Avoiding Readmissions in Hospitals Serving Diverse Patients

    An important part of AHRQ's mission is to disseminate information 
and tools that can support improvement in quality and safety in the 
U.S. health care community. The transition process from the hospital to 
the outpatient setting is nonstandardized and frequently inadequate in 
quality. One in five hospital discharges is complicated by an adverse 
event (AE) within 30 days, often leading to an emergency department 
visit and/or rehospitalization. Many

[[Page 53307]]

readmissions stem from errors that can be directly attributed to the 
discontinuity and fragmentation of care at discharge. High rates of low 
health literacy, lack of coordination in the ``hand-off'' from the 
hospital to community care, gaps in social supports, and other 
limitations also contribute to the risk of rehospitalization.
    Boston University Medical Center (BUMC), through a grant from AHRQ, 
previously defined the discharge process and determined what 
improvements could be made to improve this care transition for 
patients. This new process was called the ``re-engineered discharge'' 
(RED). The RED consists of 11 elements, including educating the patient 
throughout the hospital stay, making follow-up appointments, and giving 
the patient a written discharge plan. The RED was tested in a 
randomized controlled trial in an academic safety net hospital at BUMC 
with English speaking, general medical patients being discharged to 
home or community settings. Results of this trial of 749 patients 
showed a reduction in rehospitalizations within 30 days and emergency 
department visits following hospital discharge. Participants also 
followed up with primary care providers more often and reported higher 
patient satisfaction with the discharge process. Project RED 
researchers created several tools to help hospitals replicate RED. 
After AHRQ and Project RED researchers fielded many inquiries about how 
to implement Project RED at hospitals nationwide, AHRQ realized that 
the Project RED Toolkit did not provide sufficient guidance to 
potential replicators. Various components of the RED were not 
documented, and issues regarding implementing the RED at hospitals 
serving linguistically and culturally diverse patient populations had 
not been addressed. AHRQ has therefore contracted with the RED 
researchers to create a revised RED Toolkit that will address these 
issues.
    This proposed information collection supports AHRQ's mission by 
improving upon the RED Toolkit. This project has the following 2 goals:
    (1) To pre-test the revised RED Toolkit in ten varied hospital 
settings, evaluating how the RED Toolkit is implemented in varied 
hospital settings by: (a) Documenting the implementation process; (b) 
assessing the fidelity of implementation; and (c) identifying the 
factors that affect redesign fidelity, including intensity of technical 
assistance (TA).
    (2) To modify the revised RED Toolkit based on pre-testing and to 
disseminate it.
    BUMC will provide TA at two varying levels. Four selected hospitals 
will receive ``train-the-trainer'' TA, which includes:
    (1) Telephone assistance in conducting a baseline needs assessment;
    (2) Master trainer training;
    (3) Access to webinar trainings specifically designed for each user 
(nurse, IT professional, hospital leadership, and pharmacist);
    (4) An electronic template to print an After Hospital Care Plan 
(AHCP) booklet; and
    (5) E-mails regarding updates to the RED Web site and the 
opportunity to ask questions about the newly revised and enhanced RED 
tools and implementation via telephone and e-mail.
    Six selected hospitals will receive intensive TA, which includes:
    (1) Telephone baseline needs assessment;
    (2) On-site training;
    (3) Monthly semi-structured interviews via phone calls with the 
implementation team to discuss implementation efforts and barriers;
    (4) Adaptation of the revised RED Toolkit to include specific 
details about the hospital (such as the hospital name on the cover of 
the AHCP booklet and hospital-specific services provided to patients 
included in the AHCP booklet);
    (5) An assessment and evaluation site visit by the organizational 
change evaluator (a member of the implementation team), at baseline and 
12 months after the start of implementation efforts to interview select 
participating hospital staff;
    (6) IT support to install and support the RED Toolkit software to 
automatically generate the AHCP booklet; and
    (7) E-mails regarding updates to the RED Web site and the 
opportunity to ask questions about the newly revised and enhanced RED 
tools and implementation via telephone and e-mail.
    A diverse group of hospitals will be selected to receive each level 
of TA, based upon hospital size, location, readmission rate and patient 
population. Implementing the revised RED Toolkit in diverse settings 
will provide a better understanding of whether and how RED can be best 
implemented in different hospital settings.
    The project will be framed within a model of organizational change 
and transformation called the Organizational Transformation Model 
(OTM), which is based on the evaluation of Robert Wood Johnson 
Foundation's Pursuing Perfection initiative. OTM identifies key 
elements that drive dramatic system change and informs the 
implementation process and impact evaluation. Using a mixed-methods 
design, the evaluation tracks change over time and across the 
implementation period within each hospital. The evaluation therefore 
will encompass feedback on specific implementation processes and 
factors in microsystems where RED is adopted, in the larger 
organizational context, and interactions between the two.
    This research study is being conducted by AHRQ through its 
contractor, BUMC, pursuant to AHRQ's statutory authority to conduct and 
support research on healthcare and disseminate information 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. 299(b) and 299a(a)(1) and (2).

Method of Collection

    To achieve the projects' goals, the following data collections and 
training will be implemented for the six hospitals that will receive 
intensive TA as well as the 4 hospitals receiving train-the trainer TA, 
unless otherwise noted:
    (1) Baseline needs assessment to help each hospital plan and 
prepare for implementation of the revised RED Toolkit and to evaluate 
it in varied settings (see Attachment C). This is not a data collection 
but will impose a time burden on the participating hospitals as they 
prepare to participate in this project. The purpose of the needs 
assessment is for the hospital to become familiar with their discharge 
process and what parts of the process are being done well and what 
parts of the process need improvement. In order to implement the new 
RED discharge process, it is important for a hospital to plan how they 
will do this. This information will be shared during the baseline key 
contact semi-structured interview.
    (2) Baseline key contact semi-structured interviews will be 
administered by telephone, approximately two months prior to 
implementation, to the key contact at each of the ten study hospitals 
(see Attachment D). The purpose of the interview is to identify the 
implementation team, collect some basic information about the hospital, 
such as the number of beds and if electronic medical records are used, 
and

[[Page 53308]]

to establish the baseline readmission rate.
    (3) Monthly semi-structured interviews with the key contact or 
other implementation team member will be conducted monthly for 12 
months after implementation (see Attachment E). These interviews will 
be conducted by phone with each of the six hospitals receiving 
intensive technical assistance (TA) (the two levels of TA are described 
above). The purpose of these interviews are to allow hospitals to share 
their experiences with implementing the revised RED Toolkit, their use 
of specific tools, changes resulting from using the tools and problems 
encountered implementing the revised RED Toolkit and how they are being 
addressed.
    (4) Baseline semi-structured interviews will be conducted prior to 
the implementation of the revised RED Toolkit with 15 hospital staff 
from each of the six study hospitals receiving intensive TA (see 
Attachment F). The purpose of this interview is to measure the staff's 
opinion of the current discharge process, their perceived need for a 
redesigned process, and the perceived barriers and facilitators to 
redesigning the discharge process.
    (5) Post implementation semi-structured interviews will be 
conducted 12 months after the implementation of the revised RED Toolkit 
with 15 hospital staff from each of the six study hospitals receiving 
intensive TA (see Attachment G). The purpose of this interview is to 
measure the staff's opinion of the redesigned discharge process, which 
tools were used and their opinion of the tools, and the observed 
barriers and facilitators to redesigning the discharge process.
    (6) Patient surveys will be administered by telephone to a random 
sample of patients 30 days after being discharged from one of the six 
intensive TA study hospitals (see Attachment H). The purpose of this 
survey is to measure patient outcomes, including satisfaction with the 
care they received, 30-day hospital and emergency department visits, 
and physician appointments, to help determine the success of the RED 
Toolkit implementation in diverse patient populations. The survey will 
be administered by a hospital staff member to patients during the pre-
implementation period and again during the post-implementation period 
to compare patient outcomes.
    (7) Medical record review of patient outcomes at all ten study 
hospitals (see Attachment I). This data collection will be conducted 
both pre- and post-implementation of the revised RED Toolkit and will 
inform the success of the revised RED Toolkit implementation in diverse 
patient populations. Outcomes to be collected include process outcomes, 
such as primary care provider appointments scheduled prior to 
discharge, and patient outcomes, such as 30-day hospital and emergency 
department visits.
    (8) Master trainer training will be conducted with 3 staff members 
from each of the 4 hospitals receiving train-the-trainer TA (see 
Attachment J). These people will be trained to administer the RED 
Toolkit and be able to use recorded webinar training sessions within 
their organization. They will be invited to travel to BUMC for a 2-day 
onsite orientation of the RED intervention. These people will meet with 
several members of the BUMC implementation team (physician leader, 
discharge advocate nurse) and will have the opportunity to shadow the 
nurse discharge advocates in conducting the RED intervention.
    (9) Intensive training will be conducted with about 28 staff from 
each of the 6 hospitals receiving intensive TA (see Attachment K). The 
training will consist of a two-day on-site orientation and training at 
each hospital conducted by the BUMC implementation team. The BUMC 
implementation team will consist of a physician researcher, a discharge 
advocate nurse, an organizational change champion/evaluator and the 
information technology expert. The BUMC team will spend two days, 8 
hours per day, to train the relevant hospital staff to perform the 11 
components of the RED discharge. The training will include material for 
senior hospital management, hospital physicians, nurses, IT staff, and 
pharmacists.

Estimated Annual Respondent Burden

    Exhibit 1 shows the estimated annualized burden hours associated 
with the respondent's time to participate in this research. The 
baseline needs assessment will be conducted by staff at each of the 10 
participating hospitals and takes about 8 hours to complete. Baseline 
key contact semi-structured interviews will be conducted with the key 
contact at each hospital and requires 1 hour to complete. Monthly semi-
structured interviews with the key contact or other implementation team 
member will be conducted monthly for 12 months after implementation. 
These interviews will be conducted by phone with each of the six 
hospitals receiving intensive TA and will require 1 hour to complete. 
Both the base-line and post-implementation semi-structured interviews 
will be conducted with 15 staff members from each of the 6 hospitals 
receiving intensive TA and will last about one hour. The patient survey 
will be administered twice, pre and post implementation, to 3,108 
patients recently discharged from one of the 6 hospitals receiving 
intensive TA and requires 10 minutes to complete. The patient survey 
will be administered by the hospital staff and will require 10 minutes 
of their time to administer. Medical record review will be performed at 
all 10 participating hospitals both pre and post implementation and 
will take about 41.6 hours. Master trainer training will be conducted 
with 3 staff members from each of the 4 hospitals receiving train the 
trainer TA and will last 16 hours. Intensive training will be conducted 
with about 28 staff members from each of the 6 hospitals receiving 
intensive TA and will also last 16 hours. The total annualized burden 
is estimated to be 6,126 hours.
    Exhibit 2 shows the estimated annualized cost burden associated 
with the respondent's time to participate in this research. The total 
annualized cost burden is estimated to be $194,163.

                                  Exhibit 1--Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                     Number of
                    Form name                        Number of     responses per     Hours per     Total burden
                                                    respondents     respondent       response          hours
----------------------------------------------------------------------------------------------------------------
Baseline needs assessment.......................              10               1               8              80
Baseline key contact semi-structured interview..              10               1               1              10
Monthly semi-structured interview...............               6              12               1              72
Baseline semi-structured interview..............               6              15               1              90
Post implementation semi-structured interview...               6              15               1              90
Patient survey..................................           3,108               2           10/60           1,036

[[Page 53309]]

 
Administration of patient survey by hospital                   6           1,036           10/60           1,036
 staff..........................................
Medical record review...........................              10               2            41.6             832
Master trainer training.........................               4               3              16             192
Intensive training..............................               6              28              16           2,688
                                                 ---------------------------------------------------------------
    Total.......................................           3,172              na              na           6,126
----------------------------------------------------------------------------------------------------------------


                                   Exhibit 2--Estimated Annualized Cost Burden
----------------------------------------------------------------------------------------------------------------
                                                     Number of     Total burden   Average hourly    Total cost
                    Form name                       respondents        hours        wage rate*        burden
----------------------------------------------------------------------------------------------------------------
Baseline needs assessment.......................              10              80      \a\ $41.94          $3,355
Baseline key contact semi-structured interview..              10              10       \b\ 51.91             519
Monthly semi-structured interviews..............               6              72       \c\ 40.91           2,946
Baseline semi-structured interview..............               6              90       \d\ 38.51           3,466
Post implementation semi-structured interview...               6              90       \e\ 38.51           3,466
Patient survey..................................           3,108           1,036       \f\ 20.32          21,052
Administration of patient survey by hospital                   6           1,036        \b\31.31          32,437
 staff..........................................
Medical record review...........................              10             832       \g\ 17.32          14,410
Master trainer training.........................               4             192       \h\ 31.31           6,012
Intensive training..............................               6           2,688       \i\ 40.91         109,966
                                                 ---------------------------------------------------------------
    Total.......................................           3,172           6,126              na        194,163
----------------------------------------------------------------------------------------------------------------
* Based upon the mean of the average wages, National Compensation Survey: Occupational wages in the United
  States May 2008, ``U.S. Department of Labor, Bureau of Labor Statistics.''
(a) 75% Nurses (29-1111, $31.31/hr), 20% Physicians (29-1069, $79.33/hr) and 5% General and Operations Managers
  (29-1069, $51.91/hr).
\b\ 100% General and Operations Managers (29-1069, $51.91/hr).
\c\ 80% Nurses and 20% Physicians.
\d\ and\e\ 85% Nurses and 15% Physicians.
\f\ 100% General public (00-0000, $20.32/hr).
\g\ 100% Statistical assistants (439111, $17.32/hr).
\h\ 100% Nurses.
\i\ 80% Nurses and 20% Physicians.

Estimated Annual Costs to the Federal Government

    Exhibit 3 shows the total and annualized cost over the 18 months of 
this clearance. The total cost is $449,976.

             Exhibit 3--Estimated Total and Annualized Cost
------------------------------------------------------------------------
             Cost component                 Total cost      Annual cost
------------------------------------------------------------------------
Project RED Toolkit Development.........         $97,413         $64,942
Dissemination Planning and Support......          98,080          65,387
Data Collection Activities..............          84,563          56,375
Data Processing and Analysis............          52,215          34,810
Publication of Results..................           3,184           2,123
Project Management......................          28,892          19,261
Overhead................................          85,629          57,086
                                         -------------------------------
    Total...............................         449,976         299,984
------------------------------------------------------------------------

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


[[Page 53310]]


    Dated: August 20, 2010.
Carolyn M. Clancy,
Director.
[FR Doc. 2010-21503 Filed 8-30-10; 8:45 am]
BILLING CODE 4160-90-M