Incontinence-Associated Skin Damage in Nursing Home Residents: A Secondary Analysis of a Prospective, Multicenter Study

Dr. Bliss and Ms. Zehrer disclose they are employees of 3M Health Care. Dr. Bliss has received funding for projects from Birchwood Labs, Inc, Kimberly Clark, Inc, and 3M Health Care and speaker honoraria from Healthpoint. Research for the project was funded by a grant from 3M Health Care.

  Due to the high prevalence of incontinence in nursing home residents, dermatitis in the perineal area is a common complication in this population. More than 50% of nursing home residents are incontinent of urine and or feces.^1-4 Although pressure ulcers have been studied widely, few studies report or describe incontinence-associated dermatitis (IAD) in adults in nursing homes or other settings.

  Differences exist in etiology between pressure ulcers and perineal dermatitis. Pressure ulcers are thought to be a “bottom-up” type of injury from a force exerted over a bony prominence, while dermatitis is an inflammation of the skin due to contact of superficial skin tissues with an irritant (eg, feces).^5-7 Manifestations of perineal dermatitis include redness, loss of superficial skin layers, and in more severe states, secondary infection, usually by fungi. Symptoms include discomfort, itching, burning, or pain.

  Using the Minimal Data Set (MDS) records and practitioner orders, Bliss et al¹ showed that 3,405 out of 59,558 (5.7%) of a large sample of nursing home residents had perineal dermatitis, of whom 73% were incontinent. Because the MDS, a comprehensive standard assessment of the health and functional status of nursing home residents, does not contain any items specific to IAD, Bliss et al^1,8 needed to intensively review practitioner orders for descriptors of perineal dermatitis. Prospective monitoring of nursing home residents for IAD has been completed as part of some investigations of skin care products; however, most of the study samples are small, involve few nursing homes, and often little more than the incidence of IAD is reported. Using prospective data from a large national sample of nursing home residents originally gathered as part of a cost effectiveness study of four IAD prevention regimens, a secondary analysis to provide much-needed information about perineal skin damage in nursing home residents was conducted. The main purpose of the study was to describe the occurrence and severity of IAD and skin damage in nursing home residents. As secondary aims, other types of perineal skin damage observed and products used in treating IAD were identified. The following research questions were developed: 1) What types of perineal skin damage develop among incontinent nursing home residents? 2) What are the incidence, prevalence, and time of onset of IAD in nursing home residents? 3) What is the severity of IAD in nursing home residents? 4) What characteristics are exhibited by nursing home residents who develop IAD compared to those who do not? 5) What types of skin care products are used to treat IAD?

Literature Review

  Information about IAD in long-term care can be gleaned mainly from studies that investigated perineal skin care regimens or products. A study by Bliss et al¹ focused directly on the prevalence of perineal skin damage in nursing home residents. The investigators analyzed the MDS records and practitioner orders of 59,558 nursing home residents in 31 states. The sample was predominantly female (70%), elderly (mean age = 83 [SD 8] years), and Caucasian (86%). The overall prevalence of perineal dermatitis in all residents was 3,405 out of 59,558 (5.7%). With regard to incontinence, 10% of the residents had urinary incontinence only, 15% had fecal incontinence only, and 48% had both urinary and fecal incontinence. Of the 35,504 residents who were incontinent, dermatitis was present in 2,472 (7%).

  Zehrer et al³ screened 398 of 521 nursing home residents in three upper Midwestern nursing homes for IAD during a cost comparison of three skin damage prevention regimens. At least 50% of residents in each of the homes were incontinent. Perineal skin damage was present in 16 (4%) at the baseline assessment. Although the characteristics of all screened residents were not reported, knowledge of the sample can be inferred from the enrolled residents. The 250 enrolled residents were predominantly female (76%) and Caucasian (98%) and the median age was between 81 and 90 years. About half (54%) of the residents had dementia. All participants were on a skin damage prevention regimen that included use of a pH-balanced cleanser and moisture barrier. During a 3-month surveillance period, six out of 183 (3.3%) new cases of IAD developed.

  Bale et al² compared the skin condition of residents in two nursing homes before (n = 79) and after (n = 85) implementation of a new skin care regimen that used a skin cleanser and a durable barrier cream for mild incontinence or intact skin or a skin cleanser and a barrier film for severe incontinence or damaged skin. The majority of residents were female (70%) and >80 years of age (72%). At the start of the study, most (51, 65%) of the residents were incontinent of both urine and stool; 29% had urinary incontinence only. Before the intervention, 20 out of 79 (25%) of residents had IAD. Incontinence-associated dermatitis severity was mild in approximately 5%, moderate in 12%, and severe in 3% of residents.

  Lewis-Byers et al⁴ compared the skin effects of a skin care regimen using soap and water and a moisturizing lotion after each episode of incontinence (control) versus using a no-rinse cleanser and a durable moisture barrier cream once per day (intervention) in 31 nursing home residents. Most of the sample (24 out of 31, 77%) had both urinary and fecal incontinence, four out of 31 (13%) had fecal incontinence only, and three out of 31 (9.6%) had urinary incontinence only. The incidence of skin damage during the baseline period was not reported. A skin condition score that ranged from 0 (intact skin) to 4 (eroded/ulcerated skin) was developed. At the start of the study, skin condition score (mean, SD) of the control and intervention groups was 0.54 (0.8) and 0.56 (1.15), respectively, indicating some residents had skin damage. During the 3-week study period, the skin condition of three of the 13 control group participants (23%) and two out of 18 (11%) intervention group members worsened or did not improve from an abnormal baseline. Larger studies of IAD in nursing home residents using prospective observational methods are lacking.

Methods

  Study design and regimens. A secondary analysis was conducted of a multisite, open-label, quasi-experimental study of the cost and efficacy of four regimens for preventing IAD in nursing home residents. The methods of the parent study have been reported and are summarized here.⁹ The four regimens each used a moisture barrier of different composition and a skin cleanser of the same manufacturer (see Table 1). Regimen W used an acrylate terpolymer-based barrier film, regimen X used an ointment with 43% petrolatum, regimen Y used an ointment with 98% petrolatum, and regimen Z used a cream with 12% zinc oxide + 1% dimethicone. The moisture barrier was applied three times per week in regimen W and after each episode of incontinence in regimens X, Y, and Z per manufacturer recommendations. Washable cloths or disposable wipes used in the regimens were required to be dry and plain without any additional skin care ingredients such as a cleanser or moisture barrier.

  Nursing home recruitment and enrollment. Of the 16 nursing homes participating in the parent study, four used one of the types of barrier product in their incontinence dermatitis prevention regimen. Nursing homes were stratified by location in one of four geographic regions of the US (Northeast, Southeast, Midwest, and West) so each region had a similar number of nursing home beds available. A randomized list of all nursing homes listed in the national registry of nursing homes within each of the four regions was generated and recruitment phone calls were made sequentially from the list to determine site eligibility. The criteria for participation included a minimum of 90 beds, a minimum of 40 residents with incontinence, and an IAD prevention program in place that utilized one of the four skin barrier products under study. In the case of regimen W, staff agreed to use it in their prevention regimen exclusively; nursing homes using regimen W were trained by study staff to apply the barrier film three times per week and followed the regimen for an additional 2 weeks before data collection. Additionally, each facility needed to provide a study coordinator nurse who did not have direct supervisory responsibility for nursing assistants who observed residents for skin damage. Descriptive characteristics of the nursing homes and data about daily nursing staffing levels during the study period were provided to the investigators by the Directors of Nursing and/or administrators of the nursing homes.

  Resident eligibility and data collection. Prospective data about residents (including skin condition) were collected by nursing home staff and were part of usual nursing documentation. The nursing home staff removed residents’ identifying information and numerically coded existing data (eg, from the MDS assessment forms) before their review by the investigators. To be included in this study, residents needed to be free of skin damage in the perineum, sacro-coccygeal region, or on the buttocks. Residents were screened for eligibility using MDS records and staff assessment of residents’ skin on the start date of study. Residents also needed to be incontinent of urine and/or feces per the MDS and be confirmed as incontinent by staff assessment on the start date of the study. Residents were excluded if they had any existing perineal skin damage, a history of skin sensitivity to skin barriers, a systemic skin disease per medical record/staff assessment, or did not qualify per staff recommendation. Therefore, prevalence of IAD was determined using the MDS records of all nursing home residents screened for study participation.

  Monitoring for incontinence-associated dermatitis. An inservice conducted by the investigators about appropriate skin care for preventing incontinence dermatitis and recognizing IAD was provided to all nursing home staff before the start of the study. Staff education was enhanced by a three-dimensional model of the perineal area¹⁰ and a tool showing color photographs of different degrees of IAD severity. Educational content was standardized across all homes, which was facilitated by a written set of key points that were addressed at each of the inservice sessions. Staff had an opportunity to have their questions about IAD prevention care answered.

  Rate of incontinence frequency. Nursing home staff performed a 3-day surveillance of the rates of incontinence in each nursing home. They reported each episode of incontinence (urinary, fecal, or both urinary and fecal incontinence) of all residents in the home for three consecutive days including the day, evening, and night shifts. Data were recorded on a study form placed at the bedside of each resident and monitored by the study coordinator.

  Skin damage education and assessment. Appropriate prevention care was reinforced with posters displayed in key locations on all study units in the homes. An acronym was developed to assist in the staff education (see Figure 1) – “BIG” (buttocks, inner thigh, and groin) – and used to remind staff of the body areas that needed to be addressed in incontinence care, including where to apply the skin barrier and to monitor for IAD. The message “Make a BIG Difference” encouraged a belief that staff could positively impact skin health. The nursing staff was provided with “BIG” 3M™ Post-It® brand notepads to assist with reporting skin breakdown to the study coordinator.

  The incidence of IAD and other types of skin damage were determined from data collected by nursing home staff during a 6-week prospective surveillance of the efficacy of the skin care regimens. Nursing home staff monitored residents’ skin daily for new cases of IAD or other types of damage over a 6-week follow-up period. When skin damage was observed, the staff informed the nurse study coordinator, who assessed the resident’s skin to confirm the presence or absence of IAD, graded the severity (mild, moderate, or severe), and noted the location.

  Using the best available published information,^11-13 the following definitions of IAD severity were developed for use in the study. Mild IAD was defined as light redness, intact skin, and slight discomfort. Moderate IAD was defined as medium redness, presence of skin peeling or flaking, small areas of shallow broken skin or small blisters, and medium amount of discomfort. Severe IAD was defined as dark or intense redness, presence of a rash, deeper skin peeling or erosion, large blisters or weeping skin, and pain.

  Because residents started the study free of perineal skin damage, the onset of IAD (defined as the development of a new occurrence of IAD since the start of study monitoring) could be determined. Onset of IAD was calculated as the difference between the day IAD was assessed and confirmed by the study coordinator and the day monitoring for IAD began in the nursing home. The study coordinator also documented other types of skin damage. The data collection form allowed categorization as “pressure ulcer,” “mechanical trauma,” or “other.” No attempt was made to influence or modify the coordinator’s usual criteria for these categorizations.

  Once IAD was confirmed, data collection for the prevention protocol ended for that resident. Treatment for IAD was not prescribed by the study team; nursing homes determined treatments as usual. The nursing home staff reported the skin care products used for treatments and any change in treatment, for example, due to worsening or healing of IAD or treatment preference.

  Ethical compliance. This study was approved by the University of Minnesota Committee for the Protection of Human Subjects in Research. It was conducted in compliance with Good Clinical Practice and the Health Insurance Portability and Accountability Act (HIPAA) regulations.^14,15 All products were commercially available and used in accordance to product labeling.

  Data analysis. No statistical difference was found in the incidence of incontinence dermatitis (W = 3.6%, X = 2.1%, Y = 4.0%, Z = 4.1%, P = .55) or any skin damage (regimen W = 6.2%, X = 2.1%, Y = 6.1%, Z = 4.1%, P = .07) among the four prevention regimens. Hence, all residents were combined in this analysis to examine the type and severity of skin problems that developed in incontinent nursing home residents. The findings of among-group comparisons of other variables that relate to this combined analysis are included if they were not previously reported elsewhere.

  Due to the larger number of residents without IAD, a subsample of residents without IAD was randomly selected in a 2:1 ratio to compare characteristics between those with and without IAD using selected MDS data. Cognitive status was determined using the Cognitive Performance Scale, which is calculated using items on the MDS.¹⁶ Four residents with IAD did not have MDS data available and so were not included in the analysis comparing residents with and without IAD.

  Descriptive statistics are presented as frequencies for categorical data and means with standard deviations or medians and ranges for interval data depending on the distribution of the measure. Correlations between interval data were assessed using Pearson’s correlation. Associations between categorical data were determined using a chi-square test of association or Fisher’s exact test if cell sizes were too sparse. Differences in interval measures between those with and without IAD were assessed using an independent t-test for normally distributed data and a Mann-Whitney U test for non-normal data. Comparisons between interval data and treatment regimens were accomplished using a Kruskal-Wallis analysis of variance (ANOVA) as measures were not normally distributed.

Results

  Nursing home characteristics. The 16 nursing homes were in 15 states – 37.5% were urban, 25% suburban, and 37.5% rural in location; 69% were for-profit companies. The average resident census in the homes was 126 (SD 35) residents. Nursing assistant staffing (nursing assistant hours per resident per day) was greater in group X (2.6 [SD .3] hours), than in W (2.4 [SD .9] hours, P = .0001), Y (2.4 [SD .4] hours, P = .001), and Z (2.4 [SD .3] hours, P = .0001) per Tukey HSD.

  Incontinence rates and prevalence. Of the 1,918 nursing home residents screened for enrollment, 1,213 (63.2%) were incontinent. The prevalence of IAD was 3.5% (68 out of 1,918); 981 residents (51%) qualified for prospective surveillance of incontinence dermatitis development (ie, they were incontinent, free of any perineal skin damage, and did not meet the other exclusion criteria). Of the 981 residents who participated in IAD monitoring, 771 (78.6%) were incontinent of both urine and feces, 192 (19.6%) were incontinent of urine only, and 18 (1.8%) of feces only. The median number of incontinent episodes per day was 6.67 (.33 to 15).

  Characteristics of nursing home residents. Of the 981 participants, 786 (80%) were female. Of the 1,918 nursing home residents, 1,213 (63%) were 65 years of age or older; 259 of the 981 study participants (26%) were >90 years of age. Of the 74% who were 90 years or younger, the mean age was 79 (SD 8) years. Most (786, 80.1%) of the residents in the study were Caucasian, followed by African American (186, 19.0%), Hispanic (six, 0.6%), Asian or Asian/Caucasian (two, 0.2%), and Native American (one, 0.1%). The Cognitive Performance Scale score (median [range]) of all residents was 3.0 (0 to 6); the theoretical range was 0 to 6.

  New skin damage of enrolled residents. Skin damage developed in 45 (4.6%) of the enrolled nursing home residents. In 33 enrolled residents (3.4%), skin damage was determined to be IAD. These were patients with new cases of IAD who started the study free of perineal skin damage. More than one type of skin damage etiology was noted in 14 residents. Of the 45 residents who had skin damage, 33 (73%) had IAD, 14 (31%) had pressure-related damage, seven (16%) had some kind of mechanical trauma, and 10 (22%) had other reasons for skin damage (eg, infection or unknown reason).

  Incontinence dermatitis location, severity, onset, and duration. In many cases, incontinence dermatitis involved multiple body areas. Incontinence-associated dermatitis was present most often on the buttocks and in the anal area and least often on the sacrum and coccyx (see Table 2). The severity of most cases of IAD was mild to moderate but a few cases (12%) were severe at the onset (see Table 2). 

  The median onset (ie, time to occurrence) of IAD was 13 (6 to 42) days. Onset of IAD was slowest in regimen W (20.5 [13 to 32] days) compared to regimen X (11 [7 to 21] days), Y (13 [10 to 37] days), and Z (12 [6 to 42] days), but the difference among regimens was not statistically significant (Kruskall-Wallis X² = 5.31, P = .15). In more than one third of residents who developed IAD (13 out of 33, 39%), the condition persisted longer than 2 weeks as determined from reports of IAD treatment. Of those cases of IAD that resolved within the duration of study surveillance, the median length of time for healing was 10 (1 to 17) days, and no difference in healing time was noted among the four regimen groups (regimen W = 13 days, X = 10.5 days, Y = 12 days and Z = 8 days, Kruskall-Wallis X² = 1.36, P =.71). No significant correlations were established between the severity of IAD and the time to onset (r = .27, P = .16) or the time to resolution (r = 3.8, P = .15).

  Characteristics of residents with incontinence who developed IAD. Table 3 compares the characteristics between residents who did and did not develop IAD. The majority of residents with incontinence who developed IAD were female, elderly, and Caucasian; however, no significant difference was found in gender or race between those who did and did not develop IAD. All residents who developed IAD were 65 years of age or older, but age was similar to those who did not develop IAD. Few residents in either group were bedfast. Residents who developed IAD had moderate to moderately severely impaired cognitive performance, which was not statistically different from those without IAD. All residents who developed IAD had fecal incontinence while none of those who did not develop IAD did; this difference was significant (P = 0.3). Rates of urinary and double incontinence were similar between the groups. Absorbent briefs were similarly used in most residents (97% and 87%) in both groups.

  Treating IAD. Treatments for IAD determined by the nursing home staff are listed in Table 4 and include 10 different skin products. In four cases of IAD, the product was changed – once to an acrylate polymer-based film due to an increase in IAD severity and once to petrolatum when severity decreased. Changes in severity were not noted for the other changes in therapy.

Discussion

  This study is one of the first to report the characteristics of IAD in a large sample of elderly nursing home residents. The sample size and random selection of nursing homes from across the US impart generalizability to the findings. The overall prevalence of incontinence among screened nursing home residents (63.2%) agrees with published rates.^1-4 The 3.4% prevalence of IAD was similar to the 4% reported in other nursing homes that also used an IAD prevention protocol³; it was considerably lower than the 25% reported in a nursing home whose usual skin care practices included use of soap and water and various lotions.² The overall incidence of new cases of incontinence dermatitis over a 6-week observation period was also low (3.4%) and supports the observed benefit of having a defined IAD prevention regimen.³

  It is important to consider that this low incidence occurred during use of a defined skin care regimen, study observations, and nursing assistant staffing levels that have been associated with lower rates of a number of adverse outcomes of nursing home residents.^17-19 Nursing assistant care time of 2.25 hours or longer per resident has been reported to be associated with a lower incidence of pressure ulcers.¹⁸ Nursing assistant care time in all regimens in this study exceeded that level. This rate of IAD may represent a target level for occurrence of IAD in a nursing home environment where management and staff support and monitoring are present. The results support implementation of a defined IAD prevention regimen and current practice recommendations to include a pH-balanced moisturizing cleanser and a skin moisture barrier as part of the regimen.^20-24

  Incontinence-associated dermatitis often occurred with other forms of skin damage, including pressure ulcers. Nurses were able to document the presence of pressure ulcers, mechanical trauma, and other types of damage using their usual criteria. Mechanical trauma implies damage from friction or skin tears (eg, from tape of absorbent products) and the category of “other” primarily represented skin damage that nurses identified as infection.

  Pressure ulcers and IAD are thought to have different etiologies but current findings provide evidence they can co-exist. Nurses can have difficulty discriminating between stages of pressure ulcers and confuse superficial pressure ulcers with damage from incontinence or “moisture lesions.”^25,26 Pieper and Mott²⁵ tested 228 hospital nurses on their knowledge of pressure ulcers and reported a low percentage of correct responses (38% to 79%) for four of the seven questions about staging pressure ulcers. DeFloor and Schoonhoven²⁶ presented 56 photographs to 44 pressure ulcer experts to determine the inter-rater reliability of the European Pressure Ulcer Advisory Panel classification of pressure ulcers. The experts were described as pressure ulcer nurses, researchers (both nurses and physicians), and staff nurses. The photographs were of normal skin, blanchable erythema, blisters, superficial pressure ulcers, and an incontinence lesion. Each type of expert misclassified a pressure ulcer as an incontinence lesion a total of eight times and an incontinence lesion as a superficial pressure ulcer 14 times. Lack of a standard, practical, and psychometrically sound instrument for assessing IAD and its severity may contribute to this difficulty in the clinical setting and is a limitation for research, including this study. Identification of skin damage as a pressure ulcer has significant implications not only for patient care, but also for reporting and benchmarking quality of nursing home care. Nursing staff need to understand and recognize different types and etiologies of skin damage.

  Nursing staff education should be directed at establishing and improving identification of IAD. Descriptive terms used for documentation of types of skin breakdown (eg, IAD versus pressure ulcer) need to be clear and distinct from one another. Instructions for documentation should provide explanations of terminology. Periodic inservice education, as performed for this study, was welcomed by the nursing home staff and can reinforce the current IAD prevention protocol or address changes to the protocol. Appropriate prevention and treatment measures for skin damage will reduce unnecessary interventions that add cost to nursing care. The findings reveal that a wide variety of treatments used for IAD were reported by the nursing homes. Future studies are needed to evaluate the effectiveness, time to healing, and cost of different IAD treatments.

  This study provides much-needed information about the severity, onset, and healing rate of IAD in nursing home residents. About half of the observed new cases of IAD were of mild severity and just over one third were moderate. Severe cases of IAD at onset were less common. Using similar descriptions of IAD severity, Bale et al² observed that moderately severe IAD was most frequent in residents who were not receiving a defined IAD prevention regimen. Of the few cases of IAD reported by Zehrer et al,³ an equal number were mild to moderate severity (two cases each) and one was severe. The severity of IAD in this study was not significantly related to the time of onset of IAD. Incontinence-associated dermatitis often affected more than one body location; the most common areas affected were the buttocks and perianal area. One quarter of residents had IAD on their thighs, which suggests the importance of staff remembering to apply a moisture barrier in this location.

  Current evidenced-based information about the onset and duration of IAD in nursing home residents and adult populations in most healthcare settings has been lacking. The current findings show that the onset of IAD in nursing home residents (median = 13 days) was considerably longer than the 2 days observed by Lyder²⁷ in a small sample of patients in a psychogeriatric hospital unit. The patients who developed IAD in Lyder’s study were incontinent of both urine and stool, wore an absorbent brief, and were not on a structured skin care regimen. In the present study, a similarly large percentage of residents with and without IAD had double incontinence and wore absorbent briefs. Having a skin barrier applied may well have lengthened the time to the development of IAD and the severity at onset in residents in this study. Another explanation is that patients in Lyder’s study may have had difficulty reporting the occurrence of incontinence, which may have delayed cleansing, but such information was not reported. The factor that was significantly different between those with and without IAD in this study was the presence of fecal incontinence. It is possible that the severity (amount and or frequency) of fecal incontinence in residents with the condition only was greater than that of those with double incontinence. A limitation of this study is that the severity of incontinence was not measured.

  In approximately one third of nursing home residents, healing incontinence dermatitis took longer than 2 weeks. The time to resolution was not significantly related to the severity of IAD; the different treatments used by the nursing homes, which were not prescribed by the study, may have influenced this outcome. Future studies that compare the ability of treatment regimens to reduce the time to IAD healing or to evaluate the effect of yeast infection in the course of skin breakdown would be of value.

Conclusion

  Incontinence-associated dermatitis is a significant risk for elderly nursing home residents, especially those with fecal incontinence. Nursing staff must be vigilant. Incontinence-associated dermatitis occurs with pressure ulcers and in several locations in the perineal area. Educating nursing home staff about the manifestations of IAD, the distinction between IAD and a pressure ulcer, and appropriate IAD prevention and treatment is essential for quality nursing home care. Use of a defined skin care regimen that includes a pH-balanced cleanser and moisture barrier appears to contribute to a low rate of occurrence and lesser severity of IAD in nursing home residents.

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