A Comparison of Cost and Efficacy of Three Incontinence Skin Barrier Products

   An estimated 15% to 30% of non-institutionalized older Americans (>age 65), and approximately 50% of institutionalized older adults are incontinent.¹ Incontinence is more than just an inconvenience to residents and caregivers. Maintaining healthy, intact perineal skin in the incontinent nursing home resident is a time- and resource-intensive challenge. Residents who are incontinent are at risk for developing incontinence dermatitis (ID) and may be predisposed to developing pressure ulcers.^2,3 In addition, ID is significantly correlated with pain⁴; thus, frequent occurrence of ID may diminish quality of life among nursing home residents.

   Products used to prevent ID vary greatly in formulation and technology. The oldest and still most commonly used formulations contain petrolatum. When used properly, petrolatum ointments are seemingly inexpensive and have time-proven efficacy.^5,6 However, because they easily wash off the skin and readily transfer to clothing, linens, and briefs,⁵ proper use dictates reapplication after every incontinent episode. Frequent application may add product and labor costs, burden the already overworked caregiver, and possibly increase caregiver burnout and protocol noncompliance.

   A relatively new incontinence skin care technology involves polymer-based barrier films. Evidence of the effects of barrier films in ID treatment or prevention protocols is sparse. However, in one study,⁶ a non-alcohol barrier film was shown to be more effective at treating ID than an alcohol-based barrier film. The investigators evaluated patients in this study for ID five times over a 2-week study period. The investigators recorded area and severity of the ID at each visit on a case report form. Of the 18 subjects, 14 (77.8%) with existing ID improved after treatment with the non-alcohol barrier film, compared to 4 of 16 subjects (25%) who improved after treatment with the alcohol-based barrier film. In another study⁷ involving 164 residents with incontinence in six nursing homes in the UK, perineal skin condition was maintained or improved after a new incontinence skin care protocol involving a no-rinse cleanser, a durable barrier cream, and a non-alcohol barrier film was implemented. As part of this new protocol, the no-rinse cleanser was used on all residents with incontinence, the durable barrier cream was used on residents with incontinence and intact skin or mild ID, and the non-alcohol barrier film was used on residents with incontinence and moderate to severe ID and/or broken skin. After the new skin care protocol was implemented, a significant reduction in the presence of ID (P = 0.021) and a significant reduction in the presence of grade 1 pressure ulcers (P = 0.042) occurred. The authors also reported a high compliance rate (99%) with the new protocol.

   The objective of this prospective, multi-site study was to compare the costs of using a non-alcohol barrier film to the costs of using two commonly used petrolatum ointments in an ID prevention protocol.

Methodology

   Nursing home recruitment. A randomized list of all nursing homes in the upper Midwest (Minnesota, Wisconsin, and Iowa) was generated by the study investigator. Recruitment phone calls were made sequentially from a randomized list to determine site eligibility for study participation. Site inclusion criteria included current use of one of three barrier ointments in an ID prevention protocol or use of a non-alcohol barrier film in an ID treatment protocol and willingness to use one of these products in a prevention protocol during the 6-month study. Attempts were made to recruit one site for each of three ointment products and two sites for the barrier film — one site would use the barrier film in a three-times weekly protocol and another site would use it in a once-daily protocol. The three barrier ointments were: 1) ConvaTec Aloe Vesta® 2-n-1 Protective Ointment, E.R. Squibb & Sons, Princeton, New Jersey (Ointment #1); 2) Smith & Nephew Nursing Care™ (now branded Secura™) Protective Ointment, Smith & Nephew, Inc., Largo, Florida (Ointment #2); and Baza® Protect, Coloplast Group, Humlebæk, Denmark (Ointment #3). The barrier film was 3M™ Cavilon™ No Sting Barrier Film (3M Company, St. Paul, Minn). Nursing homes eligible to participate were required to have at least 100 beds and approximately 40 residents with incontinence and intact perineal skin at the start of the study.

   Resident recruitment. A licensed nurse at each of the study sites was designated as Study Coordinator (SC) for that site. The SC reviewed patient charts to determine which residents within their facility qualified for enrollment on the designated starting day of the study. To be included in the study, residents needed to be incontinent of urine, feces, or both. Residents were excluded if they had existing ID, a history of allergies or sensitivities to skin care products, required catheterization, or for any other reason determined by the coordinator (eg, resident participation was impractical, protocol would conflict with other medical treatments, and the like.). Once enrolled, demographic data for each resident were collected from chart assessments. This included age (grouped by decade), gender, ethnicity, and the presence of dementia.

   Assignment of study products. Each facility was assigned one barrier product for use on all study residents. Assignments were made based on prior experience with the study products (as outlined previously in the nursing home recruitment process). The nursing home assigned the once-daily barrier film application protocol switched to the three times weekly application protocol after 6 weeks of follow-up. Staff in all four nursing homes were trained before initiation of the study on product use and proper incontinence skin care procedures. All participating caregivers were Certified Nursing Assistants (CNAs).

   Time-motion measurements. Time-motion observations and measurements obtained from a convenience sample of residents and caregivers were collected over an approximately 24-hour period. Sample size was determined by availability of residents and caregivers at the time of the measurements. Time-motion data included amount of barrier product applied per episode, time to apply the barrier, and time to clean up the incontinent episode.

   Incontinence frequency data. For two consecutive days (day, evening, and night shifts) CNAs documented the frequency of incontinence episodes from all study participants in the facility. Data were recorded on a bedside Case Report Form (CRF) for each participating resident. Incontinence frequency data were not collected for Ointment #1 due to early withdrawal of the facility from the study.

   Efficacy data. During a 90-day period of time, new cases of skin damage were recorded for all residents using the barrier film and Ointment #2. Efficacy data were not collected for Ointment #1 due to early withdrawal of the facility from the study. Caregivers reported all cases of suspected ID daily to the SC. The SC examined the resident to confirm the presence of ID and graded the perineal skin on a four-point scale as follows: Normal skin (no redness, discoloration, rash, blistering, peeling, lesions, erosion, ulceration or discomfort); mild skin damage (pale or light redness, skin intact, no blisters, erosion, ulceration and no or slight discomfort); moderate skin damage (brighter or darker redness, small blisters, peeling, flaking, may be uncomfortable); or severe skin damage (intense redness, rash, erosion or ulceration and peeling, painful).

   Any grade of skin damage was recorded as ID on the CRF and the resident was discontinued from the study.

   Statistical and economic analysis. For continuous variables, frequencies, means, and standard deviation were generated. For categorical data, the number and percent of residents in each category were summarized. For resident age, collected as a categorical variable (grouped by decade), the median also was generated. At the conclusion of the study, all subjects were coded as “yes” or “no” for having developed ID at any time during the study. This incidence measure was compared between treatments using Fisher’s Exact Test. Incontinence clean-up time was compared between treatments using one-way analysis of variance (ANOVA). An analysis comparing cost differences between the four barrier protocols was performed using decision-analysis software¹³ and a cost equation. All costs are reported in US dollars for the year 2003 (in which the study was mostly conducted).

   Product cost. Unit product costs were estimated using 2003 published distributor list prices (the distributor’s cost or invoice price from the manufacturer).^8-10 Average distributor list prices were calculated when more than one distributor list price was published. Barrier prices were translated to a cost-per-gram figure for the economic analysis (see Table 3). For Ointment #1, an 8-oz (226 g) tube was listed at $5.90, which translates into $0.0261/g. For Ointment #2, a 5.6-oz (158.7 g) tube was listed at $4.31, or $0.0271/g. For the barrier film, a 28-mL (21.84 g) spray bottle was listed at $7.75 ($0.3549/g).

   Data on frequency of barrier applications were not collected directly during the study but were predetermined by the study protocol as once-a-day or three times per week for the two barrier film application protocols and being equal to the number of incontinent episodes per day for the two ointments.

   Personnel cost. In most nursing homes in America, incontinence skin care is administered by CNAs. Using 2001 job salary statistics provided by the Bureau of Labor Statistics (BLS)¹¹ and the Consumer Price Index (CPI),¹² the average hourly wages for CNAs in America was estimated to be approximately $9.90 in the year 2003. In addition, according to BLS, the average cost of benefits for workers in America is approximately 28% of total compensation.¹³ Carrying this estimate forward, the cost of benefits for CNAs is calculated to be approximately $3.85 per hour, giving a total estimated labor cost of $13.75 per hour in the year 2003. This labor cost rate was used for all protocol study groups in the economic model.

   Ethical considerations. This study was conducted in compliance with Good Clinical Practice and the Health Insurance Portability and Accountability Act regulations (HIPAA).^14,15 Data collection methods ensured resident and caregiver privacy. Because the products used were all commercially available and used in accordance with approved labeling and the information collected could not be traced back to individual residents or caregivers, Ethics Review and informed consent were not necessary for this study.

Results

   Recruitment. No nursing homes that used Ointment #3 could be identified during the recruitment process and it was subsequently dropped from the study. The first four sites that qualified for the remaining four barrier protocols and were willing to participate were selected for the study. Of the 521 residents screened for enrollment, 250 residents (48%) qualified and were enrolled into the study (see Table 1). The Ointment #1 study site did not report reasons for disqualifying screened residents.

   Study duration. Three of the recruited nursing homes completed the entire study. The fourth nursing home (Ointment #1) withdrew early due to changes in nursing home management (not study related). This facility collected time-motion data only; efficacy and incontinence frequency data were not collected. Data collection was initiated on December 23, 2002 and completed on May 3, 2003. All four study sites were initiated on or before February 3, 2003 (within a 43 day period). Sufficient time did not exist to replace the fourth site.

   Resident demographics. The majority of residents enrolled in this study were women (75.6%) and Caucasian (98.0%). Median age of enrolled residents was between 81 and 90 years. Age distribution of enrolled residents was as follows (data unavailable for one resident in the Ointment #1 group): <60 years (n = 8 or 3.0%); 61 to 70 years (n = 10 or 4.0%); 71 to 80 years (n = 38 or 15.3%); 81 to 90 years (n = 127 or 51.0%) and >90 years (n = 66 or 26.5%). All enrolled residents were incontinent of urine or feces and had intact perineal skin at the start of the study. Dementia was reported in 54% of the study residents. None of the enrolled residents reported allergies to skin care products or had a urinary catheter in place at the start of the study. One resident in the barrier film, once-daily group required placement of an internal urinary catheter during the course of the study.

   Incontinent episodes per day. Daily incontinent episodes averaged 5.9 (±1.594) for the Ointment #2 group; 4.72 (±2.297) for the barrier film, once-daily application group; and 3.76 (±2.309) for the barrier film, three times weekly application group (see Table 2). Because of early withdrawal from the study, incontinence episodes were not recorded for the Ointment #1 group. The overall average was 4.61 (±2.307) episodes per day across all of the residents in the three nursing homes in which this variable was measured. For modeling purposes, this average was used for all four protocols in the economic analysis. Fecal incontinence episodes were relatively infrequent and averaged 0.62 episodes per day. However, due to recording limitations, it cannot be determined whether fecal incontinence episodes occurred with or without urinary incontinence. Therefore, fecal incontinence episodes are excluded from the economic model.

   Barrier amount per application. The average amount of barrier film applied by the caregivers was 1.09 g (±0.493) and 1.15 g (±0.901) for the once-daily and three times weekly groups, respectively (see Table 2). These two figures are averaged together and rounded to an estimated 1.1 g per application for barrier film in the economic model. For Ointment #1 and Ointment #2, the average amount of product applied by the caregivers was 4.38 g (±3.390) and 7.77 g (±3.880), respectively. These two figures were averaged and rounded to an estimated 6.1 g per application for ointment products in the economic model.

   Time to apply barriers. The average amount of time to apply the barrier film product was 1.00 (±0.665) minutes and 0.73 (±0.536) minutes for the once-daily and three times weekly groups, respectively (see Table 2). These two figures were averaged and rounded to an estimated 0.9 minutes per barrier film application in the economic model. For the Ointment #1 and Ointment #2 groups, average time to apply the barrier was 0.45 (±0.315) minutes and 0.67 (±0.517) minutes, respectively, for an average of 0.6 minutes per ointment application in the economic model.

   Clean-up time. The average amount of time to clean up an incontinent episode for the barrier film groups was 1.43 (±1.039) minutes and 2.27 (±1.314) minutes for the once-daily and three times weekly groups, respectively (see Table 2). For the Ointment #1 and Ointment #2 groups, average time to clean up an incontinent episode was 1.95 (±1.154) minutes and 1.91 (±2.464) minutes, respectively. These differences were not statistically significant (ANOVA, P = 0.4677) and because the objective of the study was to estimate the cost difference in protocols due to barrier application, clean-up times were excluded from the economic analysis in order to focus on cost differences of the barrier protocols.

   Effectiveness. During the 90-day follow up, six out of 183 (3.3%) new cases of ID developed for all enrolled residents in the three groups. The incidence of ID was not significantly different between protocols (Fisher’s Exact Test, P = 0.4448). In the once-daily barrier film protocol nursing home, three (3.9%) new cases of ID were reported: Two cases occurred with the once-daily protocol and one case occurred after the study site switched to the three times weekly protocol. Of the two cases that occurred during the once daily protocol, one was assessed as severe and the other as moderate ID. The severe case occurred during a flu outbreak and staff reported that the resident had diarrhea. The moderate case was accompanied by a yeast infection. The resident who developed ID after the facility switched to the three times weekly protocol had moderate ID, and the SC reported protocol non-compliance with use of a non-study barrier at the time of the ID. For the barrier film, three times weekly protocol site, two (3.0%) new cases of ID occurred, one mild and the other moderate. Both cases involved pressure to the buttocks. For the Ointment #2 protocol site, one (2.6%) new case of mild ID was noted. The Ointment #1 group did not participate in efficacy follow-up due to early withdrawal from the study.

   Economic analysis. Daily cost of barrier (without labor) was lowest for barrier film applied three times weekly ($0.17), followed by barrier film applied once daily ($0.39), Ointment #1 applied with each incontinent episode ($0.73), and Ointment #2 applied with each incontinent episode ($0.76). With labor included in the analysis, costs to apply the products ranged from $0.26 for the barrier film applied three times weekly to $1.40 for Ointment #2 applied with each incontinent episode (see Tables 3 and 4).

Discussion

   Results of this study suggest that the incidence of ID is low when using barrier products to protect the skin of nursing home residents. However, the validity of these findings is limited by a small sample size, cross-over of one nursing home to a different barrier product, and the use of nursing homes in one geographical location. The actual purchase price of these barrier products varies but when frequency of application is taken into account, the daily product and labor costs of seemingly inexpensive petrolatum products is high. For a typical 150-bed nursing home with an incontinence prevalence rate similar to the national average of 50%,¹⁶ the results of this study suggest an average annual barrier application cost of $4,654 for the product that is used three times per week compared to $19,984 or $20,805 for ointments applied with each incontinent episode. Changing from an ointment protocol to a barrier film protocol used either once daily or three times weekly could save the typical nursing home 47% to 78% per year in product and 56% to 81% in labor costs.

Conclusion

   Results of this study show that polymer-based barrier films can be successfully incorporated into ID prevention protocols. Results of an economic model constructed from data derived from this study indicate that barrier film protocols are an affordable alternative to petrolatum ointments in ID prevention protocols. Larger and more tightly controlled cohort clinical trials are necessary to draw definitive conclusions regarding comparative efficacy of barrier films and ointments protocols in preventing ID.

Acknowledgment

   The authors gratefully acknowledge Debra M. Thayer, MS, RN, CWOCN, for editorial review and her expertise in incontinence care and associated skin damage.

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