SOW DRAFT_SOW_DoUDNH_12-17-2024.pdf

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Dissemination of Universal Decolonization in Nursing Homes

Statement of Work:

A. Purpose

The purpose of this project is to disseminate universal decolonization in nursing homes to a national cohort of nursing homes (NH), assess effectiveness of pragmatic implementation of the intervention, and develop an educational toolkit for posting on the AHRQ website to support ongoing dissemination and implementation after the project is completed.

B. Background

Healthcare-associated infections, or HAIs, contribute to morbidity, mortality and excess costs at all types of healthcare facilities. Many HAIs are caused by multi-drug resistant organisms (MDROs). MDRO-associated infections are difficult to treat, linked to higher mortality, and contribute to hospital readmissions (1). The US Centers for Disease Control (CDC)’s report in 2019 estimated more than 2.8 million antibiotic-resistant infections occur in the United States each year, and more than 35,000 people die as a result (2). The COVID-19 pandemic reversed much of the progress in HAI prevention that had been made recent years (3).

Nursing homes (NH) and long-term acute care facilities (LTACs) bear a substantial burden of HAIs and MDROs for several reasons. First, the prevalence of MDROs is higher than the typical hospital setting--reports have estimated MDRO prevalence reaches 40-65% in NHs and 80% in LTACs (4,5). Second, the population is particularly vulnerable to complications from infection and more likely to develop side effects from treatment (6). Next, NHs and LTACs have significantly fewer infection control resources compared to acute care hospitals (7). Finally, many interventions used to reduce MDRO transmission in hospitals, such as active surveillance testing and isolation, are not feasible in long-term care facilities and are associated with negative consequences. Active surveillance testing is expensive and resource intensive. Studies have shown contact precautions in non-acute care settings can result in social stigma, including feelings of isolation and constraint in what should be a home-like environment. Thus, most nursing homes do not use contact precautions for residents colonized with MDROs such as methicillin-resistant Staphylococcus aureus (MRSA) or vancomycin-resistant Enterococcus (VRE) (8,9).

Universal decolonization with chlorhexidine (CHG) bathing and nasal decolonization with mupirocin or iodophor has been proven effective in preventing bloodstream infections and MRSA-positive clinical cultures in the ICU inpatient setting and bloodstream infections and MRSA- and VRE-positive clinical cultures in among high-risk patients in the non-ICU setting (10, 11). The Agency for Healthcare Research and Quality has developed publicly available toolkits to help implement universal decolonization in acute care settings. Universal decolonization is preferred over targeted decolonization due to the resources required for targeted surveillance to identify those colonized with MDROs and the fact that routine clinical cultures do not identify most people with MDRO colonization (5).

In addition to proven benefit in acute care hospitals, newer data support the use of universal decolonization in long-term care facilities. The effectiveness of universal decolonization with topical chlorhexidine and nasal iodophor in lowering the risk of transfer from a nursing home to a hospital due to infection was demonstrated in the Decolonization in Nursing Homes to Prevent Infection and

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Hospitalization (PROTECT) trial (12). This AHRQ-funded study included 28 nursing homes (28,956 residents) in Los Angeles and Orange Counties in California. The 18-month cluster-randomized trial compared outcomes among residents of 14 control nursing homes (routine care) with those of residents at 14 intervention nursing homes who received decolonization with 10% povidone–iodine (nasal iodophor) and chlorhexidine for bathing. Nasal iodophor was administered to all residents twice daily for 5 days every other week. Chlorhexidine (4% chlorhexidine rinse-off antiseptic wash for showering and 2% chlorhexidine no-rinse cloths for bed bathing) was used for bathing on admission and then for all routine bathing or showering. Additionally, the nursing homes in the decolonization group were provided in-person training sessions, coaching calls, and a toolkit of protocols, training materials, and staff and resident handouts. The primary outcome was transfer to a hospital due to infection. Among the transfers to a hospital in the routine-care group, 62.2% (the mean across facilities) were due to infection during the baseline period and 62.6% were due to infection during the intervention period (risk ratio, 1.00; 95% confidence interval [CI], 0.96 to 1.04). The corresponding values in the decolonization group were 62.9% and 52.2% (risk ratio, 0.83; 95% CI, 0.79 to 0.88), for a difference in risk ratio, as compared with routine care, of 16.6% (95% CI, 11.0 to 21.8; P<0.001). Among the discharges from the nursing home in the routine-care group, transfer to a hospital for any reason accounted for 36.6% during the baseline period and for 39.2% during the intervention period (risk ratio, 1.08; 95% CI, 1.04 to 1.12). The corresponding values in the decolonization group were 35.5% and 32.4% (risk ratio, 0.92;

95% CI, 0.88 to 0.96), for a difference in risk ratio, as compared with routine care, of 14.6% (95% CI, 9.7 to 19.2). The number needed to treat was 9.7 to prevent one infection-related hospitalization and 8.9 to prevent one hospitalization for any reason (12).

The Shared Healthcare Intervention to Eliminate Life threatening Dissemination of MDROs in Orange County (SHIELD OC) was a Southern California regional public health collaborative funded and supported by the CDC and endorsed by the Orange County Health Care Agency and the California Department of Public Health. SHIELD OC involved 38 of 104 healthcare facilities in Orange County, California. The collaborative was designed to address the high rates of MDRO colonization in area NHs and LTACs. A previous study found the prevalence of MDROs in Orange County to be 65% in NHs and 80% in LTACs, but MDRO status was only known for 18% of NH residents and 49% of LTAC patients. The most common MDROs in NHs were MRSA (42%) and extended-spectrum beta-lactamase (ESBL)-producers (34%); in LTACs, the most common MDROs were VRE (55%) and ESBL-producers (38%) (13). SHIELD-OC investigators evaluated whether a coordinated decolonization intervention at facilities with a high degree of patient sharing would result in reductions in MDROs, infection-related hospitalizations, costs, and deaths. The interventions involved CHG bathing, nasal decolonization, training, educational materials, checklists, and assessment forms. Thirty-five facilities (16 hospitals, 16 NHs, 3 long-term acute care hospitals) adopted the intervention over a 25-month period. Comparing the intervention period with baseline periods, MDRO prevalence rates decreased across all types of facilities. Compared to hospitals, nursing homes and long-term acute care hospitals achieved greater reductions in MDRO (MRSA, VRE, ESBL producers, and carbapenem-resistant Enterobacterales (CRE)) prevalence and incident MDRO clinical cultures. For NHs, the rate of infection-related hospitalizations per 1000 resident-days changed from 2.31 during baseline to 1.94 during intervention among participating NHs, while the rate among nonparticipating NHs increased from 1.90 to 2.03 (group × period interaction reduction, 26.7%;

95%CI, 19.0%-34.5%). Associated hospitalization deaths per 1000 resident-days changed from 0.29 to

0.25 among participating NHs and from 0.23 to 0.24 among nonparticipating NHs (group × period interaction reduction, 23.7%; 95%CI, 4.5%-43.0%). Associated hospitalization costs per 1000 resident-days decreased from $64,651 to $55,149 among participating NHs and increased from $55,151 to $59,327 among nonparticipating NHs (group × period interaction reduction, 26.8%; 95%CI, 26.7%-

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26.9%). While there may be an initial financial investment involved, universal decolonization was determined to be a cost-saving strategy (14).

Universal decolonization is a feasible and impactful infection prevention practice in nursing homes and long-term care facilities. It can be implemented in these resource-limited settings because CHG bathing simply replaces routine bathing and does not add an entirely new task for residents, patients and healthcare personnel. The SHIELD project demonstrated that over time, the intervention is actually cost-saving. While the processes have great potential for sustainability over time given similarities in bathing processes and simplicity of the nasal iodophor application process, investment in up-front training will be required regarding the new bathing product, the importance of avoiding other skin care products that can inactivate the persistent antimicrobial activity of chlorhexidine, and the need for consistent and thorough bathing to maximize the effectiveness of the chlorhexidine. A high incidence of inadequate bathing has been reported at many nursing homes but can be addressed with training that is a part of an implementation project (15). In addition, acquisition of new bathing supplies including chlorhexidine and appropriate bathing cloths and addition of biweekly iodophor to a nursing home’s routine supply acquisition will take support and confirmation that the process is achievable and sustainable. Initial product supply will be necessary in order to overcome reluctance by nursing homes to invest effort and money into new processes.

This start up effort can be costly and will require significant investment in training and supplies in this under-resourced setting. This solicitation is intended to accelerate uptake of this innovative strategy and demonstrate broader feasibility. Successful completion of this project is intended to seed downstream dissemination through establishment of broader feasibility and benefit under pragmatic conditions and outside the southern California region in which both the PROTECT trial and SHIELD Orange County took place, in the following ways: 1.) Development of a toolkit which will be made publicly available, 2.) Establishment of geographically spread regional training hubs with demonstrated expertise in training and implementation, and 3.) Establishment of nursing homes with established and sustained implementation who can assist other facilities with implementation and dissemination.

Successful completion of this project will therefore facilitate downstream national spread of this important and lifesaving intervention.

References:

1). Burnham JP, Kwon JH, Olsen MA, Babcock HM, Kollef MH. Readmissions with multidrug-resistant infection in patients with prior multidrug resistant Infection. Infect Control Hosp Epidemiol 2018;39(1):12-19.

2). Centers for Disease Control and Prevention-US Antibiotic resistant threats in the United States, 2019.

Available at: https://www.cdc.gov/antimicrobial-resistance/data-research/threats/index.html. Accessed 02 October 2024.

3). Lastinger LM, Alvarez CR, Kofman A, et al. Continued increases in the incidence of healthcare-associated infection (HAI) during the second year of the coronavirus disease 2019 (COVID-19) pandemic. Infect Control Hosp Epidemiol 2023;44(6):997-1001.

4). Mody L, Foxman B, Bradley S, et al. Longitudinal assessment of multidrug-resistant organisms in newly admitted nursing facility patients: implications for an evolving population. Clin Infect Dis 2018;67(6):837-844.

5). McKinnell JA, Miller LG, Singh RD, et al. High prevalence of multidrug-resistant organism colonization in 28 nursing homes: an “iceberg effect”. JAMA 2020;21(12):1937- 1943.e2.

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6). Strausbaugh LJ, Joseph CL. The burden of infection in long-term care. Infect Control Hosp Epidemiol 2000;21:674–9.

7). Roup BJ, Roche JC, Pass M. Infection control program disparities between acute and long-term care facilities in Maryland. Am J Infect Control 2006;34:122–7.

8). Furuno JP, Krein S, Lansing B, et al. Health care worker opinions on use of isolation precautions in long-term care facilities. Am J Infect Control 2012;40:263–266.

9). Mody L, Roghmann MC. Infrequent Use of Isolation Precautions in Nursing Homes: Implications for an Evolving Population. J Am Geriatr Soc 2017;65(3):472-473.

10). Huang SS, Septimus E, Kleinman K, et al. Targeted versus universal decolonization to prevent ICU infection.

NEJM 2013;368(24):2255-65.

11). Huang SS, Septimus E, Kleinman K, et al. Chlorhexidine versus routine bathing to prevent multidrug-resistant organisms and all-cause bloodstream infections in general medical and surgical units (ABATE Infection trial): a cluster-randomised trial. Lancet 2019;393(10177):1205-1215.

12). Miller LG, McKinnell JA, Singh RD, et al. Decolonization in nursing homes to prevent infection and hospitalization. NEJM 2023;389(19):1766-1777.

13) McKinnell JA, Singh RD, Miller LG, et al. The SHIELD Orange County project: Multidrug-resistant organism prevalence in 21 nursing homes and long-term acute care facilities in Southern California. Clin Infect Dis 2019;69(9):1566-1573.

14). Gussin GM, McKinnell JA, Singh RD, et al. Reducing hospitalizations and multidrug-Resistant organisms via regional decolonization in hospitals and nursing homes. JAMA. 2024;331(18):1544-1557.

15). Nguyen KP, Singh RD, Saavedra R, Billimek JT, et al. Not as simple as it seems: extensive facility and training gaps in nursing home bathing. Infect Control Hosp Epidemiol 2023; 44(9):1490-1493.

C. Objectives

Independently and not as an agent of the Government, the contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform the specific requirements below.

Under this task order the contractor shall:

1. Design and develop a toolkit containing written / electronic education and training materials by adapting and augmenting materials from Project PROTECT: Protecting Nursing Homes From Infections and Hospitalization and SHIELD (Shared Healthcare Intervention to Eliminate Life-threatening Dissemination of Multi-drug Resistant Organisms [MDROs])--Orange County.

2. Establish centers of excellence learning/training hubs in at least 3 HHS regions https://www.hhs.gov/about/agencies/iea/regional-offices/index.html to disseminate the decolonization intervention, including: oversight of product acquisition and use, training of nursing home staff in use of decolonization materials and bathing techniques, and assessment of effectiveness of the intervention.

https://www.hhs.gov/about/agencies/iea/regional-offices/index.html https://www.hhs.gov/about/agencies/iea/regional-offices/index.html

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3. Recruit and retain a minimum of 25 nursing homes in a hub-and-spoke model organized around the local learning/training hubs to participate in a dissemination project to implement universal decolonization in order to reduce transfers to the hospital for infection.

4. Propose and implement a strategy to support acquisition of chlorhexidine and iodophor by participating nursing homes in a partially subsidized fashion in order to support implementation.

5. Assess the adoption of universal decolonization and evaluate the effectiveness of the intervention in the participating nursing homes.

Statement of Work/Tasks

Base Period (45 Months)

Task 1: Establish Technical Expert Panel (TEP)

The contractor shall establish a Technical Expert Panel to advise the project team on all aspects of the project including but not limited to conceptual development of educational materials, educational approach, acquisition of chlorhexidine and nasal iodophor, supporting subsequent transition of acquisition of these products by nursing homes themselves, implementation of decolonization, and assessment of the effectiveness of the intervention. The TEP shall consist of no more than ten (10) non- Federal members with expertise in long-term care, preferably also with expertise in decolonization, MDRO transmission prevention, and/or Quality Assurance and Process Improvement (QAPI) implementation. The TEP shall also include additional Federal ex-officio members as appropriate (including at minimum AHRQ and CDC). The TEP may include master trainers as attendees (see Task 6).

Proposed TEP members shall be reviewed and agreed upon by AHRQ COR. If Optional Task 1 is awarded, this task will be extended as needed to correspond to the extended period of performance.

The first meeting shall be held virtually six (6) months after the effective date of the contract (EDOC) and shall include discussion of the implementation plan (Task 7), educational approach (Task 2), data collection and analysis (Task 3), and recruitment plans (Task 5). Subsequent meetings shall be held virtually every six (6) months thereafter at minimum. A written draft/final TEP Report detailing the discussions of the TEP meetings and be a written summary of the TEP meeting with a dedicated section containing major recommendations by the TEP members shall be sent to the AHRQ COR thirty (30) days following the TEP meetings (Deliverable 1).

Task 2: Educational Approach and Toolkit Development

In order to support dissemination of the decolonization intervention in nursing homes, the contractor shall develop an educational toolkit based on the trial protocol of the Project PROTECT trial (https://clinicaltrials.gov/study/NCT03118232) and SHIELD Orange County (https://www.ucihealth.org/shield).The educational approach shall be based on the science of learning and training literature as well as that of adoption and the diffusion of innovation, and tailored to the broader nursing home setting.

https://clinicaltrials.gov/study/NCT03118232 https://www.ucihealth.org/shield

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The toolkit shall be designed to meet the following specifications:

• Materials shall provide educational support for staff training in decolonization for nursing home residents, as was performed in the intervention arm of the PROTECT trial and the SHIELD Orange County initiative and shall also assist nursing homes in implementing these interventions. A web layout for the toolkit shall be included. Please see the section in AHRQ’s Publishing and Communication Guidelines (https://www.ahrq.gov/research/publications/pubcomguide/index.html) about presenting toolkits to end users on the Web.

• In addition:

Development of the toolkit materials shall be based on the PROTECT trial intervention arm protocol and the SHIELD Orange County initiative but may include additional materials as deemed necessary through the implementation phase of the project. Contents of the toolkit shall be based on tools and educational materials that were utilized during the PROTECT trial and the SHIELD Orange County initiative, but the toolkit shall be designed for use in standard nursing home environments, eventually without project oversight. Additional materials should be developed where needed to promote implementation and sustainability and to provide adequate training.

Training materials shall include but not be limited to content on:

o Bathing with chlorhexidine (including bed bath, self bathing and showering) o Iodophor application o Integration of decolonization procedures into routine practice o Appropriate quality improvement processes o Resident and family education and engagement o Safety considerations

The Contractor shall ensure that any toolkit materials developed retain the look and feel of other AHRQ resources, such as the Toolkit for Decolonization of non-ICU Patients with Devices. All toolkit materials shall be free of copyright restrictions and shall be in the public domain. All materials shall follow requirements found in AHRQ's Publishing and Communication Guidelines.

In addition to content to support training staff on performing decolonization with chlorhexidine and iodophor in nursing homes, the toolkit shall also include content to support training nursing home staff on point prevalence testing, regardless of whether optional task 2 is exercised.

Regarding point prevalence testing, content shall include, but not be limited to:

o Instruction on discussion with residents and families, o body site selection and justification, o goals of point prevalence testing for internal nursing home use, o specimen collection o specimen handling o lab testing o interpretation of results https://www.ahrq.gov/research/publications/pubcomguide/index.html https://www.ahrq.gov/research/publications/pubcomguide/index.html

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Subtask 2A: Draft Toolkit Design and Development Plan

The Contractor shall submit to AHRQ a Toolkit Design and Development Plan that shall include:

• A discussion of the training goals that the toolkit shall be designed to achieve.

• An outline of proposed toolkit materials, with a description of changes to any existing materials, and organizational structure of the toolkit

• A description of intended target audiences and proposed materials (e.g., some materials would be for nursing staff including nursing assistants, etc., while some would be for residents)

• A timeline for complete toolkit creation, submission and review.

o The Contractor shall submit to AHRQ for review draft preliminary toolkit materials in a distributed pattern beginning six (6) months EDOC and completed by nine (9) months EDOC in order to allow adequate time for review and feedback to be made by the AHRQ COR, AHRQ Office of Communications (OC) staff and other Federal staff as necessary, and for the Contractor to incorporate this feedback into toolkit revisions. The Contractor should be aware that multiple rounds of review may be necessary.

o In a similar fashion, the Contractor shall submit to AHRQ for review draft revised toolkit materials after completion of the implementation cohorts (with revisions based on the experiences of the cohorts) in a distributed pattern beginning thirty-seven (37) months EDOC and completed by forty-one (41) months EDOC in order to allow adequate time for review and feedback by all relevant parties as described above.

The contractor shall submit the draft toolkit development plan to AHRQ for approval by three (3) months after EDOC. (Deliverable 2A)

Subtask 2B Final Toolkit Development Plan

The contractor shall submit the final toolkit development plan to AHRQ two (2) weeks after receiving comments from the COR. (Deliverable 2B)

Subtask 2C Draft Preliminary Educational Toolkit

The Contractor shall submit to AHRQ the written/electronic toolkit materials produced in accordance with the Toolkit Design and Development Plan.

Draft preliminary versions of the written/electronic toolkit materials shall be due 9 months after EDOC. (Deliverable 2C)

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Subtask 2D: Final Preliminary Educational Toolkit: Final preliminary versions of the written/electronic toolkit materials shall be after receipt of AHRQ final comments and by 12 months after EDOC. (Deliverable 2D)

Subtask 2E: Draft Revised Educational Toolkit: Draft revised versions of the written/electronic toolkit materials, incorporating feedback and revisions based on the experiences of the participating nursing homes, shall be submitted on a rolling basis beginning by thirty-seven (37) months EDOC and completed by forty-one (41) months EDOC. (Deliverable 2E). If Optional Task 1 is exercised, this deliverable date will be extended corresponding to the extended period of performance.

Subtask 2F: Final Educational Toolkit

Final revised and 508-A compliant versions of the written/electronic toolkit materials shall be due after receipt of AHRQ final comments and by forty-two (42) months EDOC. (Deliverable 2F) If Optional Task 1 is exercised, this deliverable date will be extended corresponding to the extended period of performance.

Task 3: Data Collection and Analysis

The contractor shall develop a systematic evaluation strategy and associated data collection plan. The strategy shall include the best design scenario possible to determine effectiveness of the educational approach/training and the decolonization intervention under dissemination conditions. The strategy shall include consideration of measures already collected by nursing homes, including transfers to the hospital for infection, all-cause transfers to the hospital, and measures submitted to CMS such as data from the Minimum Data Set (MDS) module. The strategy shall also include consideration of data not otherwise collected but necessary to evaluate effectiveness of implementation of the intervention such as appropriate process measures and feasible for the nursing homes to collect. The plan shall be inclusive of the optional tasks included in this SOW.

Subtask 3A: Draft Data Collection and Analysis Plan the plan shall be due to the AHRQ COR three (3) months EDOC. (Deliverable 3A)

Subtask 3B: Final Data Collection and Analysis Plan shall be due to the AHRQ COR two (2) weeks after receipt of AHRQ final comments on the draft plan. (Deliverable 3B)

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Subtask 3C: Institutional Review Board (IRB) Review

The contractor shall submit a package to an accredited Institutional Review Board (IRB) for review for Human Subjects Research concerns. Should the work be considered Human Subjects Research by the IRB, the contractor shall abide by IRB review determinations. IRB submission shall be due by three (3) months EDOC. (Deliverable 3C)

Task 3D: Carry out the AHRQ approved Data Collection and Analysis Plan in the Recruited Nursing Homes in concert with implementation in Task 7.

Task 4: OMB Clearance Package

The contractor shall submit the draft OMB clearance package necessary to obtain review and approval of OMB Clearance under the Paperwork Reduction Act (PRA), including Supporting Statements A & B, all data collection instruments intended for this project, and a draft 60-day Federal Register Notice. The contractor shall work with AHRQ to provide any revisions deemed necessary during the review process.

The contractor shall maintain compliance with OMB requirements throughout the project, including submission of renewals and revisions as necessary and appropriate to the project. The approach described in the OMB package shall be inclusive of the optional tasks for the purpose of burden calculation and Supporting Statement B’s analytic approach description.

Subtask 4A Draft OMB Clearance Package Draft OMB Clearance Package including Supporting Statements A & B and data collection instruments due 8 weeks EDOC (Deliverable 4A).

Subtask 4B Final OMB Clearance Package

The contractor shall submit the final OMB Clearance Package for this project. The Final OMB Clearance Package is due 1 week after receiving comments from AHRQ (Deliverable 4B).

Task 5: Recruit Nursing Homes to Implement Universal Decolonization

Subtask 5A: Draft Nursing Home Recruitment Plan

The contractor shall submit a Recruitment Plan to describe activities designed to recruit nursing homes with representation from at least three (3) HHS Regions to participate in dissemination of the universal decolonization intervention. Recruitment shall occur in a hub-and-spoke model consisting of local centers of learning/training excellence (“hubs”) that will be responsible for local site visits and in-person training in surrounding of recruited nursing homes (“spokes”) which will be the setting of the decolonization intervention. Examples of candidate centers of learning/training excellence include, but are not limited to, academic medical centers with close relationships with nursing homes and public health departments. The contractor should consider first recruiting the centers learning/training excellence with letters of commitment from surrounding nursing homes.

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For the purposes of review for content and accessibility requirements, the Recruitment Plan shall include as appendices any written and electronic materials intended for public distribution as part of the recruitment process for program and Office of Communications (OC) review. Any materials intended for public distribution shall meet 508-A compliance standards. The draft recruitment plan shall be submitted two (2) months EDOC. (Deliverable 5A)

Subtask 5B: Final Nursing Home Recruitment Plan shall be due two (2) weeks after receipt of feedback from AHRQ. (Deliverable 5B)

Subtask 5C: Recruit Nursing Homes

The contractor shall recruit nursing homes in a hub-and-spoke model around the centers for learning/training excellence to maintain an implementation cohort of at least 25 long-term care facilities, including representation from at least three (3) HHS Regions to implement universal decolonization. The high likelihood of withdrawals should be anticipated; the contractor shall enable ongoing recruitment to retain at least 25 active sites to complete the full implementation period (18 months including a minimum 3-month ramp up period, and a 15-month intervention period). Because replacement sites may have a compressed timeline, the absolute minimum implementation period shall be 15 months (3 months ramp up with 12 months intervention) with a goal of 18 months implementation for a majority of sites. The contractor should aim to have facilities that average 100 beds each.

Task 6: Train-the-Trainer meetings

The contractor shall recruit master trainer/change agents to facilitate implementation in the nursing homes. These master trainer/change agents shall be located in close geographical proximity to the nursing homes and be sufficient in number to conduct in person support of the intervention in the nursing homes, and ideally should be associated with the centers of learning/training excellence. The Contractor shall conduct an initial Stakeholder/“train-the-trainer” session with Master Trainers/Change Agents for this project before implementation (Task 7) begins. The meeting content shall include but not be limited to: overview of the project and decolonization intervention, overview of the educational materials and approach, responsibilities regarding product acquisition and monitoring use, site visits, and analysis. These master trainers shall be expected to provide local training using the toolkit materials for staff participants in the recruited nursing homes. Train the trainer sessions shall be done in-person.

The contractor shall hold subsequent train-the-trainer meetings annually after the first meeting for participating master trainers while implementation is ongoing in order to facilitate ongoing teaching and sharing of best practices. If possible, these meetings should be scheduled in conjunction with a national professional organization meeting which the master trainers also intend to attend. A summary report of the train-the-trainer session(s) shall be submitted thirty (30) days after the completion of the meeting(s) and describe at minimum a summary of the meeting content and discussion and any recommendations to the project by the master trainers. (Deliverable 6)

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Task 7: Implement Universal Decolonization in Nursing Homes

The contractor shall implement universal decolonization in the recruited nursing homes, supported by the toolkit developed in Task 2. Implementation shall begin by 12 months EDOC and include the following considerations:

• Implementation approach shall align with the approach used in the Project PROTECT trial intervention arm and SHIELD Orange County as closely as feasible under pragmatic dissemination conditions.

• Implementation shall occur over a 24-month period, to allow for a staggered start (or late start sites/replacements) where each site has an 18-month implementation period (a minimum 3-month ramp up period, and a 15-month intervention period). Because replacement sites may have a compressed timeline, the absolute minimum implementation period shall be 15 months (3 months ramp up with 12 months intervention) with a goal of 18 months implementation for a majority of sites.

• The contractor shall provide up to 7.5 months of product (direct distribution and/or acquisition support --see examples below) equaling product support for 50% of the intervention period for each nursing home, for the required chlorhexidine and iodophor to the recruited nursing homes with the aim of intervention retention and responsible adoption that will last beyond the close of the program. At minimum, the contractor shall directly distribute the first month’s supplies to each nursing home in time for the beginning of the intervention period.

The contractor shall recommend an approach to the timing of the distribution and/or acquisition support of the rest of the supplies to maximize adoption and retention.

Examples of appropriate strategies may include but are not limited to:

o Upfront payment: no funding during phase in; full product funding for months 3-7 of intervention followed by 50% for the next 5 months of intervention = 7.5 months of product coverage o Distributed payments: 50% product funding during 3 months of phase in and 12 months of intervention = 7.5 months of product coverage

OR

o Early supply: No supply during phase in; full product supply for months 3-7 of the intervention followed by 50% for the next 5 months = 7.5 months of product supply o Distributed supply: 50% product supply during 3 months phase in and 12 months of intervention = 7.5 months of product supply

OR

o Early supply reimbursement: No supply during phase in; full product supply for months 3-7 of the intervention followed by 50% for the next 5 months = 7.5 months of product supply

DRAFT – SOW: Dissemination of Universal Decolonization in Nursing Homes Page 12 of 18 o Distributed supply reimbursement: 50% product supply during 3 months phase in and 12 months of intervention = 7.5 months of product supply

• Technical assistance shall be provided to the nursing homes via both virtual and in-person site visits. In-person site visits shall be used by both national project team staff and training staff from the location educational hubs.

In-person site visits from master trainers and/or contract personnel are necessary to support implementation at the nursing home level and ensure proper use of chlorhexidine and iodophor (and compatible laundry detergent) and shall occur at a frequency that will assure appropriate use of materials and support implementation.

Site visits from local hubs are at minimum required weekly during the product/distribution support phase to assure responsible use of government-supplied resources.

• The contractor may provide a nominal monetary incentive to each nursing home for staff time and training. The total incentive amount per nursing home shall not exceed $1,000.

Subtask 7A: Draft Implementation Plan

The contractor shall submit a Draft Implementation Plan by six (6) months EDOC (Deliverable 7A). The plan shall provide a description of all planned activities that will be employed to support implementation of the intervention in the nursing homes including but not limited to—

• Delivery of educational content to nursing home staff

• Distribution of supplies and support for product acquisition

• Assurance of responsible use of Government-supplied products

• Provision of technical assistance

• Plan for in-person and virtual site visits

• Assessment of implementation at the nursing home level

Subtask 7B: Final Implementation Plan (Deliverable 7B) shall be due 2 weeks after receipt of feedback from AHRQ.

Subtask 7C: The contractor shall implement the AHRQ approved plan (Subtask 7B) in the recruited nursing homes. Implementation shall begin by 12 months EDOC and be completed by 36 months EDOC.

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Task 8: Project Administration

The contractor shall manage all aspects of project administration and is responsible for reporting to AHRQ their progress or impediments to their progress in a timely manner, including solutions for any impediments that may arise.

Subtask 8A Contract Kickoff Meeting

The contractor shall develop the agenda and convene a contract kick off meeting between the contractor, the COR, and AHRQ Project Team members. The meeting shall take place within 2 weeks of EDOC. The purpose of this meeting is to discuss the scope of work by task and delivery schedule in detail, delineate roles and responsibilities, review the workplan and corresponding timeline and establish minimum communication protocols. This meeting shall take place virtually. A draft agenda shall be submitted 1-week EDOC (Deliverable 8A).

Subtask 8B Draft Work Plan

The contractor shall develop and submit a Draft Work Plan and project timeline that incorporates outcomes from the contract kick off meeting. The Work Plan should describe the work of the contract by task. The contractor shall submit the Draft Work Plan 2 weeks post kickoff meeting date (Deliverable 8B).

Subtask 8C Final Work Plan

The contractor shall submit and implement the Final Work Plan that incorporates COR comments. The contractor shall submit the Final Work Plan within 2 weeks of receiving comments, and no later than 8 weeks EDOC (Deliverable 8C).

Subtask 8D Progress Calls

The Contractor shall conduct phone calls with the COR to discuss progress and any outstanding issues.

These calls shall occur biweekly at minimum, or more often as determined appropriate by the COR.

Minutes of these meetings shall be submitted to the COR within 5 business days of the call (Deliverable 8D).

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Subtask 8E Monthly Progress Reports

The contractor shall develop and submit a monthly progress report in electronic format. The monthly progress report shall include:

• Progress by Task that covers accomplishments to date, remaining activities to be completed and the status of the project compared with its timeline. The report shall describe any significant problems encountered and plans for correction;

• Any findings to date;

• The progress report shall include a financial status report (Excel or equivalent), which has the monthly expenditures broken down by task. A statement on planned versus actual expenditure by major task area. Discrepancies greater than 10% percent shall be noted, and a plan to rectify the discrepancy shall be submitted. Monthly financial status reports may be submitted with the corresponding invoice.

• A summary of the activities (Tasks) planned for the upcoming 30 days.

The Monthly Progress Report shall be submitted on the 6th business day of the month following the month being reported on, beginning the 6th business day of the second month EDOC (Deliverable 8E) .

Subtask 8F: Presentation to AHRQ

The contractor shall present results of the project to AHRQ in a 45-minute presentation. Due approximately forty-two (42) months EDOC and no later than 5 business days prior to the end of the contract (Deliverable 8F). If Optional Task 1 is exercised, this date will be extended accordingly.

Subtask 8G: Draft Base Period Report: The draft final report shall describe the activities of the project team over the contract, emphasizing the experiences of recruitment and implementation, and evaluation of the effectiveness of the intervention as described in the Data Collection and Analysis Plan with any updates appropriate based on the experience of the implementation cohort with input from the TEP. The Draft Final Report shall be due two (2) months prior to the end of the period.

(Deliverable 8G)

Subtask 8H: Final Base Period Report: The final Report shall be due two (2) weeks after receipt of AHRQ COR comments and at least one (1) week prior to the end of the period to assure 508-A compliance. (Deliverable 8H)

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Option Task 1: Recruit and retain an additional 25 nursing homes minimum to implement universal decolonization. If exercised, the period of performance will be extended for an additional fifteen (15) months. This option task may be exercised any time between 6 months and 18 months EDOC (base period).

Subtask OT1A: Recruit Nursing Homes to Implement Universal Decolonization

The contractor shall recruit additional nursing homes in a hub-and-spoke model geographically near new/additional centers for learning/training excellence hubs to maintain an additional implementation cohort of at least 25 long-term care facilities, including representation from at least three (3) HHS Regions (of which at least one HHS region is new to the project) to implement universal decolonization.

The high likelihood of withdrawals should be anticipated; the contractor shall enable ongoing recruitment to retain at least 25 active sites to complete the full intervention (defined as at least 3 months ramp up and at least 12 months intervention). The contractor should aim to have facilities that average 100 beds each.

Subtask OT1A-1: Revised Draft Nursing Home Recruitment Plan

The contractor shall submit an updated Recruitment Plan to meet recruitment requirements and account for circumstances encountered during the base period. For the purposes of review for content and accessibility requirements, the Recruitment Plan shall include as appendices any new written and electronic materials intended for public distribution as part of the recruitment process for program and Office of Communications (OC) review and compliance with 508-A standards. The revised draft recruitment plan shall be submitted two (2) months EDOT1. (Deliverable OT1A-1)

Subtask OT1A-2: Final Nursing Home Recruitment Plan shall be due two (2) weeks after receipt of feedback from AHRQ. (Deliverable OT1A-2)

Subtask OT1B: Train-the-trainer meetings.

The contractor shall continue to use master trainer/change agents to facilitate implementation in the nursing homes. These master trainer/change agents shall be in close geographical proximity to the nursing homes and be sufficient in number to conduct in person support of the intervention in the nursing homes. The Contractor shall conduct an initial Stakeholder/“train-the-trainer” session with Master Trainers/Change Agents for this task as described in Task 6. Subsequent meetings shall occur on an annual basis while implementation continues, in conjunction with meetings in the base period.

A report of the initial train-the-trainer session shall be submitted thirty (30) days after the completion of the meeting. (Deliverable OT1B).

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Subtask OT1C-1: Revised Draft Implementation Plan

The contractor shall submit a Revised Draft Implementation Plan by four (4) months EDOO (Deliverable OT1C-1) to cover changes related to implementation during Optional Task 1. The plan shall provide a description of all planned activities that will be employed to support implementation of the intervention in the nursing homes including but not limited to:

• Delivery of educational content to nursing home staff

• Distribution of supplies

• Provision of technical assistance

• Plan for in-person and virtual site visits

• Assessment of implementation at the nursing home level

Subtask OT1C-2: Final Revised Implementation Plan (Deliverable OT1C-2) shall be due 2 weeks after receipt of feedback from AHRQ.

Subtask OT1D. Implement Universal Decolonization in Nursing Homes

The contractor shall implement universal decolonization in the recruited nursing homes as described in Task 7 (including the purchase of supplies) and Subtask OT1C-2, supported by the toolkit developed in Task 2.

Subtask OT1E: Data Collection and Analysis

Using the Data Collection and Analysis Plan developed in Task 3 of the base period, collect and analyze data regarding the effectiveness of the intervention in the recruited nursing homes.

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Option Task 2: Point Prevalence Testing

Period of Performance 39 months. May be exercised up to two times - first within 6 months EDOC for base period tasks and within 6 months of Option Task 1 exercise date).

In order to inform quality improvement processes at the nursing home level, the contractor shall support point prevalence testing for multi-drug resistant organisms (MDRO) at participating nursing homes. The contractor shall:

Subtask OT2A: Plan for Point Prevalence Testing

• Develop a plan for nursing home surveillance testing of 40% of residents selected at random from each of the participating nursing homes (at minimum 25 nursing homes) at baseline and after 12 months of intervention. This plan shall include how the contractor will:

o obtain and distribute testing supplies (e.g., swabs), or support nursing homes to obtain these supplies o educate residents and family members on testing o train and support nursing home staff to obtain swab testing of nares, axilla, and groin at minimum, and consider inclusion of hands (webspaces/nails) and the perirectal area o safely transport swabs for testing o complete testing of the swabs to detect the presence of MDRO. Testing shall include methicillin-resistant Staphylococcus aureus (MRSA), and may include vancomycin-resistant Enterococcus species (VRE), extended-spectrum beta-lactamase (ESBL)-producing organisms, carbapenem-resistant Enterobacterales (CRE), carbapenem-resistant Acinetobacter baumannii (CRAB), Candida auris and or other organisms as discussed with and agreed upon by AHRQ.

o collect deidentified results data from the nursing homes for analysis o analysis of surveillance data collected (e.g., prevalence of each MDRO, prevalence of any MDRO).

o train nursing home staff on sustaining testing after the project is over.

Deliverable OT2A-1: The draft point prevalence testing plan shall be submitted by 2 months after effective date of optional task (EDOOT).

Deliverable OT2A-2: The final point prevalence testing plan shall be submitted by 2 weeks after AHRQ comments.

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Subtask OT2B: Implement the AHRQ approved plan for point prevalence testing in participating nursing homes. Testing shall begin after the ramp-up period begins for participating nursing homes.

Subtask OT2C: Data Collection and Analysis

The contractor shall work with the nursing homes to obtain aggregate results of the point prevalence testing, conduct data analysis, and report results.

Deliverable OT2C-1: The draft report of aggregate data results and analysis of point prevalence testing shall be submitted by 37 months EDOOT.

Deliverable OT2C-2: The final report of aggregate data results and analysis shall be submitted 2 weeks after AHRQ comments.

If exercised, findings from Deliverable OT2C-1 and OT2C-2 shall be summarized and incorporated into the final project report. See Tasks 8G, 8H.

The toolkit shall be designed to meet the following specifications:

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