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A Budget Impact Analysis Comparing Use of a Modern Fecal Management System to Traditional Fecal Management Methods in Two Canadian Hospitals
Abstract
Research suggests that fecal management systems (FMS) offer advantages, including potential cost savings, over traditional methods of caring for patients with little or no bowel control and liquid or semi-liquid stool. A budget impact model accounting for material costs of managing fecal incontinence was developed, and 1 year of experiential data from two hospitals’ ICUs were applied to it.
Material costs were estimated for traditional methods (ie, use of absorbent briefs/pads, skin cleansers, moisturizers) and compared with material costs of using a modern FMS for both average (normal-range weight) and complex (bariatric with wounds) ICU patients at hospital 1 and any ICU patient at hospital 2. Reductions in daily material costs per ICU patient using FMS versus traditional methods were reported by hospital 1 ($93.74 versus $143.89, average patient; $150.55 versus $476.41, complex patient) and by hospital 2 ($61.15 versus $104.85 per patient). When extrapolated to the total number of patients expected to use FMS at each institution, substantial annual cost savings were projected (hospital 1: $57,216; hospital 2: $627,095). In addition, total nursing time per day for managing fecal incontinence (ie, changing, cleaning, repositioning patients, changing pads, linens, and the like) was estimated at hospital 1, showing substantial reductions with FMS (120 minutes versus 348 minutes for average patients; 240 minutes versus 760 minutes for complex). Nursing time was not included in cost calculations to keep the analysis conservative. Results of this study suggest the materials cost of using the FMS in ICU patients was substantially lower than the cost of traditional fecal incontinence management protocols of care in both hospitals. Comparative studies using patient level data, materials, and nursing time costs, as well as complication rates, are warranted.
Potential Conflicts of Interest: Mr. Yan is currently and Dr. Kommala was at the time of the study an employee of ConvaTec Inc, Skillman, NJ. This research was funded by ConvaTec Inc, and used a budget impact model developed by the company’s Health Economics group. These results were previously presented in preliminary form at the Canadian Association of Wound Care Conference in October 2009. The article was prepared with the assistance of BioMedCom Consultants Inc, Montreal, Canada.
Introduction
Transient fecal incontinence is common among acutely ill hospitalized patients.1,2 For example, in a pilot study1 of incontinence and associated skin injury at three US medical centers, fecal incontinence was reported in 107 out of 608 acute care patients (17.6%), ages 4 years and older, in intensive care units (ICUs) and in a prospective cohort investigation2 at the Minneapolis Veterans Affairs Medical Center in 50 out of 152 patients (33%), ages 64 years and older in acute or critical care units. Among the challenges of caring for patients with fecal incontinence within a facility are the allocation of nursing time and management of resources required to provide a high standard of care for the patient and to reduce the risk of burdensome secondary complications associated with fecal incontinence.3,4
Secondary complications arising from fecal incontinence include increased risk of skin breakdown or inflammation leading to perineal dermatitis, skin infections, and pressure ulcers.1,5 In Junkin and Selekoff’s pilot study,1 among the 107 patients with fecal incontinence, 25 (23.4%) also had pressure ulcers. In an observational study5 of 2,189 hospitalized adult patients, the odds of having a pressure ulcer were 22 times greater (95% CI: 9.2 to 52.7) among patients with fecal incontinence compared to those without; further, the odds ratio increased to 37.5 (95% CI: 21.84-63.19) in patients with both fecal incontinence and impaired mobility. These secondary complications have been shown to lead to poor outcomes and increased length of hospital stay. In a prospective study6 conducted among 2,000 hospitalized adult patients in Australia, having a pressure ulcer resulted in a median excess length of stay of 4.31 days. An additional consideration is that as of October 1, 2008, the Centers for Medicaid and Medicare Services (CMS) in the US discontinued assigning supplemental payments to hospitals for Stage III and Stage IV pressure ulcers acquired during a hospital stay.7
Traditional methods of fecal management typically aim to preserve skin integrity through frequent changes of pads/briefs and bed linen, employing makeshift collection bags, and using perineal skin cleansers, moisturizers, and protectants to prevent perineal dermatitis or skin breakdown from exposure to fecal material.3,4 These traditional methods are labor- and resource-intensive. In terms of minimizing secondary complications associated with fecal incontinence and mitigating risks for spread of infectious organisms, it is well recognized that more effective measures are needed.4,6
Modern methods of fecal incontinence management include devices specifically designed to divert fecal waste to collection bags, thus reducing soiling and the spread of infectious micro-organisms and helping preserve skin integrity.3,8-10 One such device is the Flexi-Seal® Fecal Management System (FFMS) (Flexi-Seal is a registered trademark of ConvaTec Inc; ConvaTec, Inc, Skillman, NJ). The FFMS is a temporary fecal diversion and containment system that consists of a soft flexible silicone tube approximately 1.55 M long, with a soft silicone catheter at one end that is inserted into the patient’s rectum and kept in place by a low-pressure retention balloon. A collection bag is located at the other end for containment of fecal waste and is changed as needed. This FFMS has been approved by the US Food and Drug Administration and is indicated for fecal management of patients with little or no bowel control and liquid or semi-liquid stool; its use is contraindicated in pediatric patients, for longer than 29 days, and in situations where rectal tissue is compromised.11 A prospective, single-arm clinical study10 of the FFMS enrolled 42 patients experiencing diarrhea and incontinence and followed 38 of them who used the FFMS for >24 hours; among these 38 patients, the FFMS was shown to be safe and effective in diverting fecal waste. Of 39 who had skin evaluations at baseline and at final visit, 36 (92%) had either maintained or improved skin integrity. Eight patients underwent both baseline and follow-up endoscopic proctoscopy that showed rectal mucosa remained healthy, indicating that FFMS placement in the rectum does not damage rectal mucosa, a potential risk of any device. An evaluation12 of the FFMS by selected National Health Service facilities in the UK also indicated that, from 243 surveys relating to individual patients in whom FFMS was used, patient skin integrity was maintained or improved in 238 (98%) cases.
To date, no studies have compared material costs or investigated nursing time between traditional fecal management methods and FFMS for acutely ill patients. The purpose of this study was to use a budget impact model (BIM) with experiential data from two hospitals in Canada to evaluate material costs for fecal management at each center. 
Methods
Budget impact model. A generic BIM in spreadsheet format was developed by the Health Economics group at ConvaTec to evaluate the annual budget impact of using FFMS versus traditional fecal management methods in a hospital ICU. Input from clinicians was sought to validate the model during its development. The BIM was provided as an Excel (Microsoft Corporation) template that allowed the user to include all materials/products and nursing time used for fecal management with traditional methods (eg, changes of pads/briefs and bed linen, employing makeshift collection bags, and use of perineal skin cleansers, moisturizers, and protectants) and with FFMS (see Figure 1). The BIM included fields of usage and unit costs of consumable materials associated with fecal management and treatment costs of complications related to fecal management (see data sources section below). Data were input to the BIM by a health economics researcher from the FFMS manufacturer; when all input data on usage and unit costs were entered, the model automatically performed an annual budget impact analysis, comparing differences in direct costs of consumables between traditional methods and the FFMS (see Figure 2).
The BIM also included fields for input of prevalence rates of complications related to fecal incontinence and cost of treating each complication from which the annual budget impact related to such complications could be generated. The annual budget impact at hospital 2 related to pressure ulcers was estimated separately from consumables by comparing prevalence rates between FFMS users and traditional method users. Treatment cost for each pressure ulcer occurrence then was applied to estimate the potential annual cost savings of avoiding pressure ulcers by using the FFMS. In addition, the BIM calculated total annual nursing time based on input of intervention time needed by a registered nurse and/or a patient care assistant for each fecal incontinence incident. The BIM also was capable of converting nursing time into costs by applying standard hourly wages for nurses and patient care assistants in Canada. Because use of the FFMS was projected to reduce nursing interventions, including this cost component would be expected to increase the cost savings with FFMS, so to keep the BIM conservative, nursing time was not included in the overall cost calculation; however, nursing time is reported separately without conversion to dollar figures for hospital 1.
Participating hospitals and data sources. The budget impact and nursing time of implementing FFMS were based on data obtained for 2009 from the Ottawa Hospital-Civic Campus (TOH-CC), Ottawa, Ontario, Canada, and the Hamilton Health Sciences (HHS), McMaster University Campus, Hamilton, Ontario, Canada. Both hospitals had experience using FFMS in ICU patients for whom traditional methods were not effective, who had more than three high-volume watery stools per day, who had actual or were at high risk for wound contamination from incontinence, and/or who were bariatric. In all instances, FFMS use was implemented at the discretion of the bedside nurse. The hospitals were invited by the FFMS manufacturer to answer a questionnaire containing usage and time variables that are listed as the major headings in Figure 1 (ie, cleaning supplies, disposables, and so on) from which data were obtained and input into the BIM to evaluate the budget impact of using FFMS at their individual institutions. Results were reported separately, because a valid comparison could not be made due to inherent differences between the facilities (eg, size, number of patients treated per year), as described below. Input data were collected on an aggregate level for patients based on two of the authors’ direct nursing experience at each hospital; no individual patient’s data were identified, rendering IRB approval not necessary.
Hospital 1. TOH-CC has a 26-bed ICU that treats approximately 1,330 patients per year, approximately 130 (10%) of whom have fecal incontinence; the average length of stay in the ICU is 5 to 7 days. The daily and annualized budget impact from TOH-CC was determined based on current use of the FFMS — ie, 24 ICU patients per year, which represents 18.5% of the 130 ICU patients with any clinical condition who also have little or no bowel control and liquid or semi-liquid stool for which FFMS placement would be indicated. Daily costs associated with fecal management at TOH-CC also were determined for a complex clinical scenario, that of a bariatric ICU patient with a wound.
Hospital 2. HHS treats approximately 41,000 ICU patients per year throughout all of its facilities. Daily fecal management cost data for FFMS and traditional methods were obtained for patients treated in the ICU. The annualized budget impact of FFMS was estimated based on a 5% prevalence of fecal incontinence throughout all its facilities — ie, 2,050 ICU patients per year with any clinical condition and little or no bowel control and liquid or semi-liquid stool for which FFMS placement would be indicated.
Data collection. Each hospital was responsible for determining and reporting daily usage of materials and their purchase prices, daily nursing time (for TOH-CC), and related complications. Each hospital managed fecal incontinence in patients according to internal protocols and criteria, and determined which portion of the eligible patient population was selected for FFMS according to its indication. At HHS, data on complications related to fecal management were obtained from results of previous patient chart reviews (not conducted for the purpose of this analysis) or from hospital prevalence data.
The detailed data collection process was as follows: A questionnaire was developed by the FFMS manufacturer, mapping the resource/cost components for each of the subheadings listed in Figure 1 and used for input to the BIM. The questionnaire was sent to the two authors affiliated with TOH-CC and HHS, respectively. During November 2009, they completed the questionnaire from their own hospital’s experience. The data compiled and entered into the questionnaire were based on personal nursing experience and feedback from clinical colleagues (eg, expert senior critical care nurses working at McMaster University Medical Center Intensive Care Unit, in the case of HHS).
At TOH-CC, ICU patients were categorized as average (uncomplicated patients, usually intubated, with diarrhea as a primary issue and no significant comorbidities such as wounds/ulcers or dressing soiling) or complex (patients with significant comorbidities such as the presence of any wound/ulcer at high risk for soiling dressings, and/or bariatric with ambulation/mobility/repositioning complexities); at HHS, all ICU patients with diarrhea as previously defined were assessed. Data collected reflected the quantity of supplies needed to manage each type of patient. Unit costs of consumables were obtained from the hospital’s purchasing department (HHS) or Detailed Management Report (TOH-CC), the latter a document outlining year to-date utilization of materials and costs incurred. Nursing time data collection at TOH-CC used a quantitative measurement scale developed by the TOH-CC, the TOH-CC Activity Workload Standards from the Nursing Workload collection system, which times nursing activities and assigns an average time to perform/complete each task. This tool was used to determine staffing patterns and productivity based on time of day and the acuity/workload at TOH-CC. Data input to the BIM is shown for TOH-CC and HHS in Tables 1 and 2, respectively. 
Results
Hospital 1. The budget impact of FFMS at TOH-CC was based on direct material costs only; secondary complication budget impact data were not available at this hospital. Table 3 presents daily material costs (in 2009 Canadian dollars) associated with an average ICU patient and with a complex ICU patient (bariatric patient with a wound), using traditional methods or FFMS. FFMS use resulted in cost savings for managing average patients — ie, $144 per day per patient using traditional methods compared with $94 using FFMS (35% reduction). FFMS use also led to a 68% reduction in the total daily fecal management costs of the complex case, from $476 per day using traditional methods to $151 per day using FFMS. 
For average and complex ICU patients, the total costs of materials per (7-day) course of diarrhea comparing traditional methods versus FFMS are $1,007 versus $656 for an average patient and $3,335 versus $1,054 for a complex patient.
The annualized budget impact of FFMS use at the TOH-CC ICU based on current usage in 24 average patients per year (see Table 3) showed total annual savings attributable to use of FFMS for fecal management at $8,425. When the annualized budget impact assessment was projected based on usage of FFMS in all indicated patients with fecal incontinence over 1 year at the TOH-CC (130 patients: 124 average cases and six complex cases), the estimated materials cost difference was $57,216.
Although nursing time data were not included in cost calculations to keep the BIM conservative, nursing time was collected by TOH-CC, as reported separately from other costs in Table 1. For an average patient, traditional methods of fecal incontinence management required 348 minutes of daily nursing time (174 minutes nurse time + 174 minutes orderly time), compared to 120 minutes per day for a patient using FFMS (65% reduction). For a complex case, daily nursing time decreased 68%, from 763 minutes with traditional methods to 241 minutes using FFMS.
Hospital 2. Daily material costs per patient (in 2009 Canada dollars) associated with fecal incontinence management at the HHS ICU, calculated on a per-patient basis, were $105 for traditional methods compared with $61 for FFMS use, a reduction of 42% (see Table 4). For the average course of diarrhea, which lasts 7 days at HHS ICU, the overall costs per course per patient for traditional methods were $734 versus $428 with FFMS.
It was estimated that 2,050 patients per year would be indicated for fecal incontinence management, representing 5% of admissions throughout HHS facilities. Table 4 provides the annualized costs for 2,050 patients managed either traditionally or with the FFMS for fecal incontinence. Annualized total costs for fecal management using FFMS on all indicated patients were estimated at $877,503, whereas traditional methods costs were estimated at $1,504,598, again resulting in an annual cost reduction of 42% and a savings of $627,095.
The budget impact analysis results for HHS did not include potential cost saving as a result of avoiding pressure ulcers in patients with fecal incontinence. Pressure ulcer prevalence in patients with fecal incontinence managed traditionally at HHS is estimated at 19.5%, and treatment costs per pressure ulcer case are $20,000. Because survey results from HHS indicated no pressure ulcers in patients managed using FFMS, the potential annual cost savings attributable to prevention of pressure ulcers, over and above direct material cost savings, may be as high as $7,995,000 (0.195 x 2,050 patients x $20,000).
Discussion
Fecal incontinence is known to place an economic burden on healthcare systems. A recent study13 using claims data from a US cohort (n = 1,470) showed the cost of care for patients with fecal incontinence was associated with 55% higher total healthcare costs compared to persons without the condition. In a prevalence survey study14 of fecal and urinary incontinence in a long-term care setting (n = 447), total annual incontinence costs of nursing care, laundry, urinary drainage devices, and disposable pads were $9,971 per patient. In the present budget impact analysis in acute care settings of the two participating hospitals, considerable direct cost differences were reported as a result of replacing traditional fecal incontinence management methods with a modern system (the FFMS). Implementing the FFMS reduced daily material costs of fecal management at TOH-CC by 35% for an average ICU patient and by 68% for a bariatric patient with a wound; and at HHS, by 42% per patient. Results demonstrated substantial savings that offset the device cost of the FFMS system.
Research in the area of cost of fecal incontinence management in acute care settings is scarce. However, findings from this analysis are supported by a previous retrospective case-matched (n = 106 cases and 106 controls) before-after study8 regarding a bowel management system for fecal incontinence in critically ill burn patients, which showed cost-effectiveness over traditional, reactive procedures (cleansing and dressing changes), despite initial cost outlays for the device. Annualized materials cost analysis for fecal management at both hospitals showed the same pattern of lower costs associated with implementation of FFMS compared to traditional management. At TOH-CC, annualized costs were 35% lower using FFMS, and it was estimated that if FFMS were in use for all indicated TOH-CC patients, annual cost savings would be approximately $57,216. At HHS, annualized costs were projected based on all indicated patients being managed using FFMS throughout all facilities as opposed to traditional methods; a potential yearly cost reduction of 42%, or $627,095, was estimated.
Providing patient care for fecal incontinence can be time-consuming. In one long-term care hospital setting of 447 patients of approximate mean age 73.5 years), prevalence of fecal incontinence was found to be 46%.14 Although the study did not discriminate between urinary and fecal incontinence when measuring time spent on incontinence care, daily time was 79.4 minutes per patient for those always incontinent; daily time spent on fecal incontinence may be expected to be more than this combined estimate. In the present study, cost savings were realized solely from material usage and did not include the cost of nursing time to keep the model conservative. However, given time investment for dealing with fecal incontinence, inclusion of nursing time may be expected to add to the cost savings with FFMS. TOH-CC reported a considerable amount of nursing time saved and available for reallocation as a result of using FFMS.
Other potential cost-savings related to the prevention of secondary complications such as pressure ulcers also were not included in the model. The cost of pressure ulcers in the UK has been estimated at £1.4–£2.1 billion annually, with nursing time contributing to the largest portion of costs.15 Pressure ulcers have been found to increase an average length of hospital stay by 4.3 days6 and generate substantial healthcare costs.16 In the US, the CMS estimated the cost of Stage III and Stage IV pressure ulcers for the year 2009 at $43,180 per hospital stay and included these complications on their list of non-reimbursable, hospital-acquired conditions.17 Three studies8-10 have documented encouraging results regarding cost savings due to maintenance or improvement of skin health with the use of a fecal diversion and containment system.
In the present study, frontline nursing feedback and results of a previous chart review of clinical data at HHS determined that no patients with the FFMS developed pressure ulcers related to fecal incontinence. Similar results were found by Padmanabhan et al,10 who reported 92% of patients maintained or had improved skin integrity with use of FFMS; and by the Department of Health in the UK,12 which reported 98% of patients with FFMS evaluated had maintained or improved skin integrity.
Additional benefits of the FFMS relating to ease of use of the device as well as patient and caregiver satisfaction have been documented. In one clinical evaluation10 of these parameters, 83% to 90% of reports by caregivers agreed or strongly agreed that FFMS was practical, caregiver- and patient-friendly, time-efficient, and efficacious. Moreover, from the patient perspective, the FFMS may alleviate embarrassment and discomfort experienced by patients with fecal incontinence.13
Limitations
This BIM was designed to compare direct costs attributable to fecal incontinence management; therefore, costs of training and educating nursing staff as to indications for placement, contraindications, and use of FFMS are initial expenses not taken into account. Ease-of-use for trained hospital staff using modern fecal management systems is expected to improve as these products evolve. Recent technical improvements to FFMS as a result of clinical observation have resulted in the newer Flexi-Seal® Signal® (ConvaTec Inc, Skillman, NJ) FMS, with added features that increase the ease-of-use for nursing staff. As with any model, some estimates may introduce uncertainty; for the HHS case, potential cost savings with FFMS due to prevention of secondary complications were calculated based on overall prevalence of pressure ulcers and treatment cost data rather than through direct measure of pressure ulcer cases. This is a modeling analysis and not a randomized clinical trial; the use of FFMS was left to the clinical judgment and practices of each hospital. However, the BIM used to document costs prevents possible rater bias in calculating costs of materials and nursing time for fecal incontinence management. Furthermore, the consistency of results between the two hospitals attests to the strength of these findings.
Conclusion
This budget impact analysis demonstrated the direct cost benefits of adopting FFMS for indicated patients at two Canadian hospitals by reducing the use of materials. In addition, nursing time data available from one of the hospitals showed a substantial amount of valuable nursing time available for reallocation to other clinical priorities. Additional cost benefits potentially resulting from avoidance of reductions in secondary complications, such as pressure ulcers, were also shown. Future research using patient level data rather than experiential is warranted.
Acknowledgments
The BIM used in this study was developed by the ConvaTec Inc. Health Economics group. Data for the model were provided independently by participating hospitals. These results were previously presented in preliminary form at the Canadian Association of Wound Care Conference, October 2009. The authors would like to thank Yanjing Chen for her important contributions to the manuscript. This research was funded by ConvaTec Inc, and the article was prepared with the assistance of BioMedCom Consultants Inc, Montreal, Canada.
Mr. Langill is a Nurse Educator Intensive Care Unit, The Ottawa Hospital, Civic Campus, Ottawa, Ontario, Canada. Mr. Yan is a health economist, Global Health Economics Strategy & Communication; and, at the time of the study, Dr. Kommala was Chief Medical Officer and Vice President, Global Clinical Affairs & Medical Communication, ConvaTec Inc, Skillman, NJ. Mr. Michenko is an Education and Development Clinician, Hamilton Health Sciences, Hamilton, Ontario, Canada. Please address correspondence to: Songkai Yan, MS, ConvaTec Inc, Skillman NJ; email: songkai.yan@convatec.com.
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