Validation and Pilot Testing of a Guide to Measure the Costs Associated with the Management of COVID-19 and of Healthcare Associated Infections in Residential and Long-Term Care Facilities in Quebec

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INTRODUCTION
As elsewhere in the world, Quebec is currently facing the COVID-19 pandemic.As of April 8, 2021, more than 321,411 infections and 10,718 deaths have been registered (Institut national de santé publique du Québec, 2021).What is most alarming is that many residents were infected in their longterm care (LTC) centers (in Quebec termed CHSLDs), nursing homes, or intermediate resources.Worse still, during the first wave of the pandemic (March to July 2020) about 92% of the deaths occurred among adults aged over 70, and 64.4% of these adults lived in one of the hundreds of infected CHSLDs (Bonjour Residences, 2020; Le Devoir, 2020; Ministère de la Santé et des Services sociaux, 2021).Unfortunately, this trend has continued during the second wave (September 2020 to February 2021) and must be seen as a sounding of the alarm to ensure adequate and consistent care for the elderly in CHSLDs (Fischer et al., 2020).
In light of the interventions implemented to address these issues in CHSLDs, public authorities, CHSLD board members and managers, healthcare providers and residents will be interested to know the real health and economic impacts of COVID-19.It is therefore timely to plan a socio-economic impact evaluation of COVID-19 in living environments of the elderly.Before conducting such an evaluation, and given the lack of a cost measurement guide, it would be important to measure the cost of management of COVID-19 in CHSLDs using a valid and reliable guide adapted to this context.
The costs of managing a disease or infection include the costs of investing in preventive measures, and the costs that occur as a result of that disease or infection (Finkler, 1996).According to Resar et al. (2012) and Tchouaket et al. (2020), four overlapping clinical best practices (CBPs) are considered essential infection prevention and control (IPC) measures: 1) hand hygiene; 2) hygiene and sanitation, including the cleaning and disinfecting of surfaces and equipment; 3) systematic screening; 4) basic precautions (wearing personal protective equipment) and additional precautions (isolation).Problems that arise from infection include: the occurrence of illness (with or without complications); decreased quality of life (QOL); and death.Drawing on the findings of the above-mentioned authors, a measurement guide that estimates the cost of managing COVID-19 in CHSLDs should, ideally, simultaneously measure the costs of these four CBPs as essential IPC measures and the costs of the problems generated (illness, loss of QOL, and death).
The scientific literature highlights a few measurement guides for infection management analysis.Some assess compliance with IPC measures, others focus on infection surveillance and COVID-19 monitoring in LTC.Indeed, since the start of the COVID-19 pandemic, the World Health Organization, the U.S. Department of Health and Human Services and Centers for Disease Control and Prevention, and Infection Prevention and Control Canada have published IPC guidelines and assessment guides for LTC facilities in the context of COVID-19.These guidelines concern infection surveillance and reporting, as well as staff training (Government of Canada, 2019; U.S. Department of Health and Human Services, 2016; U.S. Department of Health and Human Services & Centers for Disease Control and Prevention, 2020;World Health Organization, 2020).However, none assess costs of IPC measures in relation to the four associated CBPs.Bedoya and colleagues (2017) developed an observational guide that assessed compliance with IPC measures among primary care providers.The patient-tracking tool evaluated healthcare providers' compliance with, and knowledge of, IPC across five domains (hand hygiene, protective glove use, injections and blood sampling, disinfection of reusable equipment, and waste segregation).This was later expanded to measure compliance with IPC guidelines; including general practices (e.g., time spent with patients), waste segregation and disinfection, hand hygiene, and blood draws (Powell-Jackson et al., 2020).The guide has a space to record start and end times once per observer session, but not for each CBP.These guides do not provide any cost estimates of the resources required for observed CBPs or for managing sick patients.Capitano et al. (2003) estimated the cost of managing methicillin-resistant Staphylococcus aureus (MRSA) in LTC facilities using a standardized data collection tool.Only professional resource data related to infection management were included as costs measured.A time-motion study was conducted on individual procedures performed by healthcare staff.For each task, the average time in minutes was obtained to calculate the cost of care.The guide captured: resident demographics, infection characterization, pharmacological management, and patient care management.However, this slightly older guide does not allow for the measurement of the costs of IPC and MRSA.
More recently, Tchouaket et al. (2020) developed and validated a time-motion guide in an acute care setting to evaluate the costs of CBPs associated with IPC (hand hygiene, hygiene and sanitation, screening, basic and additional precautions).
The guide assesses: unit identification which includes information and training sessions and awareness campaigns, observed staff, hand hygiene, hygiene and sanitation, screening, wearing personal protective equipment, cleaning and disinfection of healthcare equipment, and additional precautions (by contact, droplets or airborne).These dimensions are subdivided into specific items.Observers follow healthcare personnel and, using an online version of the guide, systematically record the time spent to undertake each CBP using a chronometer.The observer also collects information regarding products and disposable and reusable materials used during these actions.This first guide, named here "Guide 1" was specifically developed to evaluate the costs required to complete CBPs in terms of: i) time taken to complete an action by healthcare personnel over a defined time frame; ii) materials used; and iii) products used.Using bottom-up micro-costing data collection, the goal of this guide is to provide accurate IPC cost data to inform stakeholders.This guide does not measure the costs of the medical consequences incurred by patients.
IPC in the context of a CHSLD differs from an acute care setting, where patients are intensely treated with the expectation of recovery, or discharge to another care setting.In a CHSLD, patients are permanent residents often arriving with, or developing, chronic comorbid illness, functional impairment, and reduced acuity.
Residents have ongoing contact with other residents.The staff-to-patient ratio in CHSLDs is lower than in hospitals and nurses may be less permanent than in acute care.Due to these and other inherent differences, in 1997 and 2008, the Society for Healthcare Epidemiology of America / Association for Professionals in Infection Control and Epidemiology published guidelines for IPC specifically with regards to LTC (Smith et al., 2008).It is therefore timely to adapt the time-motion guide (Guide 1) developed by Tchouaket et al. (2020) in an acute care setting for CHSLDs.In order to account for the lived experience of residents in the context of COVID-19 (isolation, increased preventive measures, restrictions on visitors and limited leisure activity), it is necessary to add to Guide 1 a measure of the cost of healthcare service use and of the reduction of QOL.
A second guide ("Guide 2") has already been developed by our team to assess both healthcare use and QOL in the context of CHSLDs.The first part of Guide 2 extracts information related to consultations, hospital transfers, exams, laboratory tests, medical imaging tests and medications of residents.The second part of Guide 2 assesses QOL, using the SF-36 scale (Hays & Shapiro, 1992) which is divided into eight dimensions: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions.This scale has reported high consistency for both the physical and mental health components, with Cronbach's alpha of 0.94 and 0.89, respectively (Gandek et al., 2004).
To our knowledge, no systematic guide has been developed for CHSLDs to measure the costs of IPC associated with the four CBPs outlined above and the costs of illness (healthcare use and QOL).Our ultimate goal is to measure costs associated with the management of COVID-19 in CHSLDs using a valid, reliable measurement guide adapted to the context of Quebec.Thus, a new guide was developed based on these previous ones; Guide 1 and Guide 2 were combined into a single "Cout-COVID19-SLD" guide to measure the management costs of IPC measures associated with COVID-19 (see Appendix 1).Cout-COVID19-SLD is composed of four main parts: 1) identification and description of the CHSLD facility that is participating; 2) measurements of the costs of prevention, i.e., those related to human resources and the expenses related to both materials and products used to perform IPC CBPs; 3) measurements of the direct costs of illness (e.g., medical consultations, hospital transfers, tests); and 4) measurements of indirect costs, i.e., the reduction of time spent on activities related to one's QOL (e.g., sports, leisure activities and socialization, religious activities).

OBJECTIVES
This article presents the protocol of a study that aims to validate and test a guide to measure the costs associated with the management (costs of preventive measures and costs of illness) of

METHODS
This protocol is based on a two-part prospective study.Phase 1 will use a Delphi approach with expert review, as used by Tchouaket et al. (2020).This approach will allow the adaptation and validation of the content of two guides developed in acute care to the context of CHSLDs, in order to obtain the Cout-COVID19-SLD guide.Phase 2 will pilot test the latter using a crosssectional study in CHSLDs.
Phase 1: The Delphi method for validating the content of the Cout-COVID19-SLD guide Delphi process: The Delphi method is a group survey technique widely used in qualitative and quantitative health research that permits consensus-building among experts, on a given topic, consulted over two or more rounds (Havers et al., 2019).Due to its anonymity and iterative process, the Delphi method is considered to be less prone to bias as expert participants can provide their opinion without feeling the need to agree with dominant personalities (Boulkedid et al., 2011).
Selection of experts: Depending on the heterogeneity of the sample, a Delphi panel can be comprised of between 5 and 30 experts (Clayton, 1997;Okoli & Pawlokski, 2004).The choice of experts will be based on professional experience in the field of IPC and COVID-19 management in a CHSLD.We consider that the centering of opinion from experts with different areas of expertise provides convergent validity.Thus, two to three experts in each of the following eight categories will be recruited from CHSLDs: i) IPC nurses; ii) licensed practical nurse; iii) orderlies; iv) hygiene and sanitation staff; v) physicians; vi) experts from the Comité sur les infections nosocomiales du Québec (Quebec's Committee on Nosocomial Infections); vii) researchers specializing in care offered in CHSLDs and healthcare analysis, and viii) family caregivers.Experts will be recruited from different geographic regions of Quebec.They will receive an email invitation to participate, explaining the study and the Delphi process, before providing written consent.No personal information will be released publicly.

Content validity:
In each round of consultation, quantitative and qualitative data will be collected and analyzed to assess agreement between experts.Experts will receive the Cout-COVID19-SLD and a user manual that explains its dimensions and items.They will be asked to evaluate the relevance of each using a 4-point Likert scale: 1 "not relevant"; 2 "relevant with major corrections"; 3 "relevant with few corrections"; and 4 "very relevant without corrections".Item and dimension relevance are defined as having an impact on the management of IPC and care of illness.IPC relevance refers to the costs involving CBPs (human or material resources used).The care of illness relevance (clinical relevance) refers to the care of COVID-19 infection or standard of care (e.g., consultation, medication, hospitalization, transfer of residents to hospitals).
Relevant indirect costs focus on the reduction of QOL due to COVID (e.g., time spent on leisure, sports activities, religious activities or socialization).
All items rated as 1 will be excluded in further rounds.All consensus items (those that are rated 4) will not be revised further.All items to be revised (2, 3) will be returned to the experts for further validation.A space will be provided for openended comments if the experts choose statements 1, 2 or 3.These comments and suggestions will provide our research team with comprehensiveness and comprehensibility on each item and dimension of the guide, as suggested by Terwee et al. (2018).Content validity will be assessed using the Content Validity Index (CVI), which will be set as a percentage, counting each item and dimension rated as "3" or "4" over the total number of replies for that item or dimension (Fortin & Gagnon, 2016).
Content validity will be examined at three levels.First, when the CVI for a dimension (CVI_D) is less than 0.80 (80%), the dimension will be considered "not acceptable".The dimension and its items will then be revised in line with the proposed corrections, and resubmitted in the next round.Second, when the CVI_D is greater than or equal to 0.80, the dimension will be "acceptable"; however, the CVI for each item (CVI_I) of the dimension will be reviewed.If the CVI_I of an item is greater than or equal to 0.80, it will be considered "acceptable" and retained.If not, the item will be considered "not acceptable", revised according to the corrections proposed by the experts, and resubmitted in the next round.Third, following the second round, a final round will be considered for each dimension and item for which the CVI_D and CVI_I are not "acceptable''.After this third round, the research team will review all concerns expressed by experts, and deem items and dimensions as not relevant or as needing reworking.
Reliability: To verify the inter-rater reliability between experts, we will perform Kruskall-Wallis, intraclass correlation coefficient and weighted Kappa tests for each dimension, with a 5% threshold, to determine the presence of any group effect between the eight categories of experts (Mokkink et al., 2018;Prinsen et al., 2018;Terwee et al., 2018).If the test is not statistically significant, responses will be considered acceptably constant between experts.Otherwise, the dimension and its items will be revised according to the corrections proposed.The dimension will then be resubmitted to the same experts.The analyses will be performed using SPSS version 26 (IBM Corp., 2019).
Phase 2: Pilot testing the Cout-COVID19-SLD guide Study sites: The test will be conducted in two of the 17 CHSLDs located in one of the 18 administrative regions of the province of Quebec, Canada.To know if our guide will be relevant across different contexts of infection, this will include one CHSLD that was significantly infected with COVID-19 in the first wave (considered as 10 or more cases), and one that was not (fewer than 10 cases).The choice of the study site was based on the fact that the research team had an established collaborative relationship with these differing sites.This will facilitate data collection in an abnormally restrained research environment due to COVID-19.
Data collection: Given the high risk of infection when conducting the time-motion observations of health care personnel, in part 1, 2 and 4 of the guide Cout-COVID19-SLD, we will replace the observational data with the collection of administrative data.Part 3 will be filled with information from resident records.The following administrative data related to IPC measures will be collected: human, financial, material, and technological resources and infrastructures.Resident records will provide information on the utilization of health services (consultations, hospital transfers, laboratory tests, medical imaging tests, and medications).Administrative information on leisure time (dance, yoga, art and entertainment activities, etc.), average duration and number of visits per week, and COVID-19related deaths will be collected.Data will be collected retrospectively monthly for a period of one year prior to the COVID-19 pandemic (January 1, 2019, to December 31, 2019) and one year since its start (March 1, 2020, to February 28, 2021) for all residents.In each CHSLD, the Cout-COVID19-SLD guide will be completed by both a manager and archival staff members.They will also provide written comments in a report that outlines any difficulties, challenges or other feedback concerning data collection.A research professional will facilitate data collection and retrieve the guides monthly.

Three-step data analysis:
The first step will consist of analyzing the reported feedback in order to improve the final version of Cout-COVID19-SLD.Pilot testing will provide pertinent information on how to administer the guide within the context of a CHSLD in light of their unique challenges, as reported from those who work closely with residents.
The second step will be to estimate the direct costs associated with the management of COVID-19.Costs for IPC measures for each period for each CBP and patient management will be calculated.The difference between the two periods will provide an estimate of the additional financial costs generated by COVID-19 in terms of: investment costs in preventive measures and costs associated with infected patients.A quarterly and annual analysis will be undertaken.Wilcoxon signed rank test (Polit & Beck, 2020) will be used to test the significance of the observed cost difference between time periods.The additional costs associated with the management of patients will be estimated using a comparative case-control approach.This approach will compare the costs of care for residents with COVID-19 (cases) to costs incurred for similar (matched) residents without .Matching by propensity score as well as tests of difference in observed costs will be conducted.
The third step will be to estimate the indirect costs of COVID-19 associated to residents (i.e., costs associated with the loss of QOL).The reduction in leisure time and the reduction in visiting time will be estimated by comparing the two time periods and reported as lost hours.A comparison will be made between cases and controls.Also, we will estimate the loss of income caused by COVID-19 to the professional conducting the leisure time activity by multiplying the time lost by their median hourly wage.Quarterly and annual analyses will be conducted to obtain a variation in indirect costs over all periods.
All direct and indirect costs will be estimated over a one-year horizon, in 2021 Canadian dollars.We will use a discounting approach to actualize all costs gathered over different years to 2021.The rate of discount (3%, 5%, and 8%) will be used as suggested by Montmarquette and Scott (2007) and Tchouaket et al. (2017).We will use the perspective of a healthcare facility.Sensitivity analyses will be conducted by varying the hourly wages, physician consultation rates, prices and quantities of products used, and discount rates.All statistical analyses will be done using a 5% threshold.

DISCUSSION AND CONCLUSION
This project will: i) validate and pilot test a guide that will allow the systematic calculation of the costs of IPC measures in CHSLDs; ii) provide an estimation of the direct and indirect costs of COVID-19 for the care of residents; iii) inform decision-makers on the health and financial impacts of the pandemic as estimated in a CHSLD; iv) inform managers and healthcare workers about the consequences of the pandemic with regards to the care and QOL of residents, and v) allow for better IPC planning and care in CHSLDs to deal with outbreaks or a potential pandemic.Challenges and mitigation strategies in the context of COVID-19: One challenge is attrition of experts during the Delphi process.The selection of potential experts will thus be done throughout the province of Quebec.We will solicit 28 experts in order to maximize the chances of recruiting 14-21 experts.A second challenge will be to obtain authorization from the CHSLDs for Phase 2. To facilitate this, we have chosen to collect administrative and archival data only, thus reducing the study burden.We have adapted this study to meet pandemic restrictions.An important limitation of this study is that data collection is centred around administrative data and resident records.Ideally, to better estimate the human resource cost of COVID-19 management, and as suggested by Kaplan and Anderson (2004), time should be collected from direct observation of healthcare professionals using a time-driven activity-based costing framework.
Knowledge transfer strategies and perspectives: Ongoing interactions between researchers, managers and clinical workers will occur throughout the project using a collaborative approach in the research process.Regular meetings will be organized to plan data collection, mobilize experts, include CHSLDs, and discuss and implement results.Results will be made available to target audiences through published manuscripts, research reports, and conferences.This project will serve to better plan future research surrounding the socio-economic impacts of COVID-19 in CHSLDs.
Authors' contribution: ET, SR, DS, JL, RBD, KK, IB, NP, and SB made substantial contributions to the study conception and its design for this research protocol.All authors were involved in drafting and revising critical intellectual content in the manuscript.All authors gave their final approval of the version to be published.

Feasibility:
The project is funded from June 2020 to February 2022 jointly by the Quebec Network on Nursing Intervention Research (Réseau de recherche en interventions en sciences infirmières du Québec, or RRISIQ) and Réseau-1 Québec.Ethics approval for Phase 1 has been obtained (Project: 2021-1266 approved by the Research Ethics Committee of the Université du Québec en Outaouais).A draft of the Cout-COVID19-SLD guide has been developed.Nurses specialized in CHSLDs have joined the research team to support the validation of the guide.