Assessing Venous Ulcer Population Characteristics and Practices in a Home Care Community
H ospital restructuring and downsizing has caused an increased demand for community care. These developments, in combination with a shortage of registered nurses, has focused attention on ways to provide more effective and efficient care. Inappropriate management of a chronic health problem such as venous leg ulcers is expensive, both in terms of human suffering and resources such as community nursing services. District or home care nurses are recognized as the key professionals involved in leg ulcer management in the community.1-4
Information about the problem of venous leg ulcers in Canada is limited. Studies that profile individuals with leg ulcers have been undertaken in other western countries, but whether findings from these studies can be generalized to the Canadian population is not known.1,5-7 The first step in planning and developing an evidence-based leg ulcer service is to fully assess the population for whom the service is intended. Profile information was needed on this population and on the current community care provided. The actual number of individuals with venous leg ulcers, issues of health risk, health needs, and resource use have implications for planning and resource allocation.8 Population profile information on clinical, socio-demographic, and circumstance-of-living factors can serve both as a planning and evaluation baseline for improving outcomes.
In one Ontario region, population information was required to determine the appropriateness of developing a new community leg ulcer service similar to successful nurse-led clinics in the UK.9-12 Before developing the new leg ulcer service, the magnitude of the problem of leg ulcers had to be determined. A Regional Prevalence and Profile Study (RPP) was conducted in a large, mixed urban and rural region in Ontario.13 In the RPP study, researchers identified the number of individuals in the region with a leg ulcer (all etiologies) and generated a general characteristics profile. Individuals receiving care from home care, tertiary care, long-term care, and physician family practices were included.
People with venous ulcers require specific management and to that end were the focus of a second more comprehensive profile study. A secondary analysis was conducted on the cohort with venous disease assessed during the RPP. The objective of this Venous Leg Ulcer Study (VLU) was to describe the cohort of individuals with leg ulcers of venous etiology who received care from one large not-for-profit home nursing agency that provided 78% of the leg ulcer home care in one Ontario region during March 1999.
Venous leg ulcers are a chronic and often recurring condition. For afflicted individuals, physical, psychological, and economic consequences of this chronic disease frequently result in premature disability, reduced work productivity, and a loss of independence.14 The associated healthcare costs are also substantial. In the US, the estimated annual healthcare expenditures for venous disease are between $1.9 and $2.5 billion.4
The point prevalence of venous leg ulcers ranges from 0.6 to 1.6 per 1,000 for the total adult population, increasing to between 10 and 30 per 1,000 in the population over the age 85 years.1,5,7 Wide variation exists in the studies on the percentage of leg ulcers with a predominantly venous etiology, with a range of 37% to 81%.1,5-7,15-18 Studies conducted in the UK in the 1980s reported higher venous rates because of the exclusion of isolated foot and toe ulcers. Ulcers in these locations tend to be nonvenous in origin.1,6
Callam, Harper, Dale, and Ruckley19 characterized the chronic nature of the disease with three measures: 1) the duration of the ulceration, 2) ulcer recurrence, and 3) the ulcer diathesis, defined as the period of time since the onset of the first ulceration to the time of the survey. Reports from studies in other Western countries on the duration of leg ulcers indicate that more than 50% last longer than 1 year.6,7,15 Recurrence rates of leg ulcers range from 45% to 76% within 1 year, with venous leg ulcers having higher duration and recurrence rates than ulcers with a nonvenous etiology.1,7,15 Results of data collected on the ulcer diathesis indicate that between 28% and 45% of individuals with leg ulcers experience episodes of leg ulcers for more than 10 years.15,19
A number of factors are associated with venous disease (see Table 1). These include: advanced age, female gender, varicose veins, deep vein thrombosis, reduced mobility, pregnancy, previous surgery, limb fracture or trauma, social isolation, and a family history of leg ulcers.3,5-7,19-22
Nurse-led, evidence-based community leg ulcer clinics established in the UK have reported improved healing rates at reduced costs.9-12 Healing rates for leg ulcers improved from between 22% and 26% at 12 weeks before establishing the nurse-led clinics to between 42% and 69% after implementation. Appropriateness of similar programs in a Canadian context is unknown for several reasons. The magnitude of the problem of venous leg ulcers and the characteristics of the population are poorly understood. Key to proceeding with the adoption of nursing clinics in a Canadian jurisdiction is an improved understanding of the population. Factors such as age and mobility are important when contemplating the introduction of nurse clinics instead of home care. In Ontario, additional factors such as geography and proximity to service delivery and winter climate need to be considered.
The VLU study is a secondary analysis on the cohort with venous disease assessed as a part of the RPP study; therefore, the larger study will be described first. Ethics approval was obtained for both the RPP and the VLU study from the Ottawa Health Research Institute.
The Regional Prevalence and Profile Study (RPP). In phase I of the RPP study,13 a rigorous audit was performed using databases from home care, long-term care, tertiary care, podiatrists, and 44% of family physicians to identify all individuals with leg ulcers in the region. An individual was considered to have an active leg ulcer if: 1) a defect existed in the dermis below the knee including the foot, or 2) the ulcer had healed within the 3 months before the survey. Following the example of Callam, Ruckley, Harper, and Dale,1 newly healed ulcers were included because the exact time of healing is difficult to ascertain and because of the high recurrence rates. The maturational stage of healing may take months or years. During the period when fragile new tissue has not completed the maturational stage of healing, ulcer recurrence is more likely.23
In phase II of the RPP study, a survey team of trained registered nurses conducted a clinical assessment of consenting individuals in home care, long-term care, or respondents from newspaper advertisements. Cases identified through family physicians and podiatrists were not assessed because contact information on these clients was not requested in order to protect provider-client confidentiality. The comprehensive standardized assessment included socio-demographic characteristics, circumstances of living, health history, leg ulcer history, and a full clinical assessment of the leg and ulcers. Measurements of the ulcers were obtained (length x width x depth). An ankle-brachial pressure index (ABPI) measurement was performed using portable Doppler equipment.
The Venous Leg Ulcer Cohort Study (VLU). In the VLU study, the first step was to identify the individuals in the RPP who had venous disease. Individuals assessed in the RPP study were categorized into two groups according to the etiology of their ulcers: venous or nonvenous. This was accomplished using the RPP database. The clinical history and risk factors for venous disease and the characteristics of the clinical syndrome described in the Royal College of Nurses (RCN) clinical practice guideline24 formed the basis for identifying the venous and nonvenous cases. In addition, an ABPI of 0.8 or greater was required to classify the ulcer as venous, because a lower result indicates significant arterial disease.23 Individuals who presented with clinical features of diabetic neuropathy were excluded, as were individuals with isolated ulcers on the toes, heel, or plantar surface of the foot; ulcers located in these areas are more likely to result from a nonvenous etiology.1,25
For methodological and logistic reasons, the VLU cohort was limited to the home care nursing agency that provided care for the majority (78%) of the leg ulcer cases. The cases from other sectors assessed in the RPP study included: 1) clients who received care from one of the two smaller nursing agencies with home care contracts; 2) residents in long-term care facilities; and 3) individuals who self-reported their leg ulcer as a result of an advertisement in local newspapers. The cases from these three sectors were combined and treated as a separate group for the purpose of comparison to the VLU cohort. Due to the variation in nursing records and the logistics of accessing the client records at multiple sites, the inclusion of the cases from the other sectors was not feasible.
The identification of the ulcer as venous or nonvenous using the criteria from the RCN guideline was compared to the ulcer classification derived by a second researcher from a convenience sample of 68 nursing agency records, with a 94% (64 out of 68 cases) agreement in the ulcer classification using the two methods. Of the ulcers misclassified as venous using the RCN criteria, two were pressure ulcers, one was arterial, and a third was the result of a rare etiology. Given the high interrater reliability, the researchers felt confident in classifying the other clients using the RCN guideline if the information from a chart audit was not available.
The percentage of missing data was typical of secondary analysis conducted on studies of a similar size to the RPP. The highest percentage of missing data was for ulcer duration and diathesis (12% and 14.5%, respectively).
Data analysis. The RPP data was entered in SPSS version 10 (SPSS Inc., Chicago, Ill.) at the Ottawa Health Research Institute from which a dataset of the cohort of individuals with venous disease was constructed. The cohort comprised the main provider nursing agency, and statistical testing was performed on two subgroups: 1) males and females and 2) individuals with active ulcers and individuals with healed ulcers at the time of the survey. To determine if the VLU cohort was representative of the regional venous leg ulcer population, statistical analysis tested for differences between this cohort and the cohort comprised of the combined cases from the other nursing agencies, long-term care, and newspaper respondents. The t test for differences in means tested age, duration of ulceration, and number of previous episodes of ulceration. The chi-square test for independence tested for differences related to specific characteristics (gender, health problems and risk factors, mobility, and circumstances of living). The t test and chi-square tests were repeated multiple times; therefore, a conservative significance level of 0.01 was used. Differences of 15% or greater were considered as clinically and administratively important regional population characteristics.
Geographic dispersion was assessed using postal codes and street addresses to pinpoint each case on a regional map. This mapping exercise provided a visual display that highlighted where the client clusters were in relation to the current home nursing districts to assist in a delivery plan close to the clients’ places of residence.
Individuals identified with leg ulcers resulting from a venous etiology. In phase I of the RPP, 733 cases with leg ulcers resulting from a variety of etiologies were identified in the region. Assuming the proportion of individuals with lower limb ulcers was similar for physicians not surveyed or who declined to respond to inquiries, the conservative estimate for the number of individuals with a lower limb ulcer was 1,038 for the region. Calculated as a rate per 1,000 population over the age of 25, the rate of lower limb ulcers for the region was 2.0 per 1,000 (the prevalence rate is calculated as 1.8 per 1,000 when ulcers that healed within the previous 3 months are excluded13).
Of the 733 cases identified, 263 were assessed during phase II. Of these, 107 had a leg ulcer of a predominately venous etiology, representing 41% of those assessed. Eighty-three of the 107 cases (78%) were from a single nursing agency and formed the study cohort.
When this cohort was compared with the cohort of the combined cases from the other sectors, no significant statistical differences were found in age, gender, circumstances of living, clinical history, or clinical features of venous disease including ulcer size, duration of ulcer, or the diathesis of ulceration. Also, no significant difference was found between the group with healed ulcers (within the previous 3 months) and the group with active ulcers.
Focusing on the cohort as a group, variation was noted in the clinical features and the clinical history and known risk factors for venous disease that comprise the clinical syndrome described in RCN.24 No one clinical feature, health problem, or associated risk factor was common to all individuals with venous ulcers. Table 2 provides a summary of the clinical characteristics and the clinical history and risk factors associated with venous disease. Despite the classification of the ulcer etiology as venous, several individuals presented with clinical features and health problems or known risk factors associated with nonvenous disease (see Table 3).
Patients with venous leg ulcers comprise a complex group with a range of health problems. Of 83 patients, 38 (46%) had four or more comorbid conditions, while 15 (18%) had six or more. Seven patients (less than 9%) reported that a leg ulcer was their only health problem.
Socio-demographics and circumstances of living. The study population was 61% female (51 out of 83) with a mean age of 73 years (median 77 years, range 28 to 98 years). Of the 83 clients assessed, 64 (75%) were 65 years or older, 49 (59%) were 75 years or older, and 19 (23%) were 85 years or older. The mean age of females was 76 years (median 80 years), compared to 69 years for the males (median 74.0 years). Males comprised a higher proportion of the cohort that was younger than 65 years. The female-to- male ratio in the VLU population is 1.5 to 1. In the category over 65 years, the VLU female-to-male ratio is similar to the actual regional female-to-male ratio of 1.4 to 1.26
The mean age of first leg ulcer occurrence was 65 years (median 71 years). Although leg ulcers are an ailment that predominately affects the elderly, 28 (34%) of individuals reported developing their first leg ulcer before the age of retirement (age 65 years).
The majority of individuals indicated that they were English-speaking (63 out of 81, 78%); nine out of 81 (11%) spoke French, and nine (11%) spoke languages other than English or French. The percentage of people speaking other languages is representative of the regional population.26
Twenty-nine individuals out of 76 (38%) reported living alone, and 31 out of 76 (40%) lived with a spouse. More females (12 out of 48, 25%, compared to four out of 28, 14%) lived with family or friends, while a higher proportion of males lived with a spouse (14 out of 28, 50%, compared to 17 out of 48, 35%). Of the 83 individuals, 49 (59%) lived in a house, while 30 (33%) lived in an apartment. When the location of clients receiving care was pinpointed on a regional map, the three main clusters of clients requiring leg ulcer care were in regions where high proportions of senior housing were found.
Thirty-eight of the 83 individuals (46%) reported that they were independent with mobility (did not require physical aids or assistance). A higher proportion of females (28 out of 49, 57%) than males (14 out of 31, 45%) required aids or physical assistance. Although five of the 83 individuals (6%) indicated that they were housebound, 81 (98%) reported they were able to travel outside of their home. Of the 81 individuals who were able to leave home, 58 (72%) traveled by automobile and of these, 37 (64%) were driven by family members or friends. Fewer females (eight out of 51, (16%) than males (10 out of 32, 31%) drove themselves.
A number of differences were found when comparing the male and female populations. The differences that may have clinical and administrative significance when determining attendance at a community clinic are summarized in Table 4.
The chronic nature of venous leg ulcers. The mean ulcer diathesis (time from onset of first episode of ulceration to the current time) was 14 years (median 8 years, SD 17, range 1 to 63 years). Twenty-two out of 71 individuals (30%) reported ulcer episodes of more than five years and 10 out of 71 (14%) of more than 20 years.
The average duration of the current ulceration was 15 months (median 6, SD 2.3 years, range 4 weeks to 14 years). Of the 54 individuals in this category, 19 (33%) had an ulcer for more than 1 year and 10 (19%) had an ulcer for more than 2 years.
Fifty-one of 80 individuals (64%) reported they had leg ulcers previously. The range of previous episodes of ulceration was one and 25. Twelve out of 77 (15%) had experienced five or more previous episodes of leg ulcers. Of the 46 reporting previous ulcers, 22 (48%) said the ulcer had taken more than 6 months to heal and 11 (24%) said healing took more than 1 year.
Characteristics of current ulcers. At the time of the March 1999 assessment, 19 out of 83 individuals (23%) had leg ulcers that had healed within the previous 3 months. Of the 64 with an active ulcer, 35 (55%) had one ulcer, while 18 (28%) had two ulcers, and 11 (17%) had three or more ulcers. Four individuals were described as having redness and weeping over all aspects their legs.
Of the 64 individuals with active leg ulcers, 11 (17%) had bilateral ulcerations. The 64 individuals with active ulcers had a total of 121 ulcers. The most common locations of the ulcer were the ankle (48 out of 121, 40%) and the calf (41 out of 121, 34%). Although individuals with isolated foot ulcers were excluded, 10 of the 121 (8%) were found on the foot and five (4%) on the toes in combination with a leg ulcer.
Ulcer measurements were taken on a total of 98 ulcers in 64 individuals. Ulcers smaller than 1 cm2 accounted for 15 (15%) of the ulcers, while 63 (64%) were between 1 cm2 and 8.9 cm2. Twenty (20%) were large ulcers of 9 cm2 or greater.
Healthcare professionals seen for previous ulcerations. The general practitioner was the main medical provider for individuals receiving ulcer care; 48 of the 83 (58%) current ulcer patients and 37 of the 51 (73%) with previous ulcers consulted a general practitioner. Thirty-five of the 83 individuals (42%) in the VLU cohort had seen a dermatologist for a current ulcer and 35 (20%) had seen a surgeon. For the 48 who had a previous ulcer, 27 (56%) had seen a dermatologist, 18 (38%) had seen a surgeon, 35 (73%) had received care from a home care nurse, and seven (15%) indicted they had provided self-care.
The VLU cohort study of people with venous leg ulcers receiving home care provided essential information about the population of people with venous leg ulcers, which will facilitate planning the new leg ulcer service. People with venous leg ulcers were found to be predominantly older and have an average of four comorbid conditions. More women than men had venous ulcers; women were less mobile. One-third lived alone while half required assistance with mobility (physical aids or assistance). The majority were able to travel outside of their home and did so by automobile; most were dependent on others to drive. The majority of people was English-speaking; 11% spoke French and 11% spoke languages other than French or English. The leg ulcer recurrence rate in this population was high (64%) and the time since first ulcer occurrence (diathesis) was 14 years. The average duration of current leg ulcers was 15 months and most (85%) ulcers were larger than 1 cm2. General practitioners were the main providers of medical care and 60% had been referred to a dermatologist, surgeon, or both.
Ideally, leg ulcer case sampling methods would have included community databases held at home care or the nursing agency. Unfortunately, this was not possible, and identification of the ulcer etiology using these sources was also out of the question. The results of this study appear valid because the proportion of ulcers of venous origin (41%) found in the region was similar to other international studies using a similar leg ulcer definition.12,17,21
The importance of distinguishing between venous and nonvenous ulcers is crucial, because treatment methods and nursing care differ greatly. The bandages applied for treating venous ulcers can have serious adverse affects if applied inappropriately or incorrectly to arterial ulcers. Training nurses to correctly assess for venous leg ulcers and apply these bandages is essential to preventing untoward effects. Therefore, understanding the proportion of venous ulcer cases assisted the decision-makers in determining the number of nurses and training requirements before establishing the new service.
The complexity of the venous leg ulcer population has major implications for the most appropriate provider of leg ulcer care. The scope of practice for the registered practical nurse (RPN) focuses on the care of stable clients whose health can be predicted or anticipated and whose care needs have predictable outcomes.27 The VLU population does not have stable health or predictable outcomes. They are coping with several other chronic illnesses in addition to the leg ulcer. These comorbid conditions negatively influence the healing of the ulcer and complicate the treatment decisions. The application of high compression bandaging is the “gold standard” for the treatment of venous leg ulcers,28 but the decision to use compression (and which level of compression) must be balanced in the context of the entire client assessment. For example, a significant proportion — 21% — had diabetes. Individuals with diabetes frequently have abnormally high ABPI readings as a result of arterial calcification. A decision to treat a patient with diabetes with compression based on an incorrect high ABPI reading could have serious consequences. Therefore, nurses caring for this complex venous leg ulcer population need to be vigilant in identifying both the risks and benefits of the treatment plan. Based on the combination of a complex client group and the necessity for evidence-based decision-making, a new service would need to be staffed by registered nurses with additional training.
The chronic nature of the disease measured by the duration of ulceration, recurrence rate, and ulcer diathesis emphasizes the persistence of the condition. Three-quarters of the individuals with leg ulcers had ulcers that were 1cm2 or larger. Size and duration of ulceration are factors known to influence healing; it appears likely that more active and early intervention might reduce the number of large and slow-healing ulcers.29 The information on ulcer size and duration suggests that immediate healing results may not be achieved with a change to the new service. The high recurrence rate supports the notion that an individual who has developed an ulcer will always have the potential for recurrence. Appropriate client services for the treatment of leg ulcers would include access to early intervention and a focus on improved client education and secondary prevention to reduce recurrence rates. The data were used to substantiate the need for a service that permits access to early intervention and ongoing care focused on ulcer prevention.
Access to early intervention is further complicated by the lack of available medical expertise. The general practitioner is the main medical provider of healthcare, but few family doctors see sufficient numbers of patients with leg ulcers to develop extensive expertise with this group. In a recent survey of family physicians in one Ontario region, only 16% agreed that they were confident in their ability to treat leg ulcers.30
International studies have reported that few leg ulcer patients have received referrals to a specialist for their leg ulcer.2,19 International leg ulcer guidelines recommend referrals to physician specialists for nonhealing wounds after 3 months of treatment.24,31,32 Interestingly, this study found that 60% of individuals had seen a specialist physician for their leg ulcer. Despite the higher referral rate, the healing results and recurrent rates were remarkably similar to countries reporting low referral rates. The reasons for the lack of improved outcomes with specialist referrals are beyond the scope of this paper and may be as varied as whether specialists prescribe evidence-based care, the length of time to referral, and client adherence to prescribed regimens.
In planning for the new service, clients need to receive early intervention and care that is evidence-based and coordinated by skilled providers. Successful leg ulcer clinics in the UK9-12 recommend that community nurses trained in leg ulcer care conduct the client assessment, including the ABPI, and initiate compression bandaging or referral to a specialist physician according to a established criteria. Reorganizing care with an expanded nursing role has resource implications for education and training and the purchase of equipment to perform the ABPI.
Despite the fact that impaired mobility was an issue for more than half of the cohort, few were confined to their homes. These data indicate that the delivery of leg ulcer care in a centralized clinic location would be feasible. Mapping geographic locations where clients lived identified clusters of clients and the best location for proposed leg ulcer clinics in close proximity to where clients live. However, the majority of leg ulcer clients traveled by automobile and most were dependent on others to drive. Few claimed to live close to a city bus route. Clinic programs in the UK provide transportation for clients attending the leg ulcer clinic. With a clinic approach to care, these data served as an alert to carefully consider transportation needs.
The differences in the proportion of men and women in the cohort revealed the need to consider that women may be less likely to attend a clinic. Older age and arthritis, significantly higher in the women, are associated with increased mobility problems. In planning appropriate services, receiving care in the home needs to remain an option. Clients unable to attend a clinic require access to the same quality of care.
Finally, the representation of minority languages (other than English and French) underscores the multicultural nature of this community. The small number of clients who speak any one language may mean that hiring nurses who speak languages other than French and English is not feasible. However, services need to be linguistically and culturally sensitive. With the continued influx of new Canadians to this region, this diversity is likely to grow.
A limitation of this study is the small size. In the RPP study, a rigorous process was undertaken to identify all individuals with leg ulcers in the region from the various sectors. Despite the rigor, a number of cases may have been missed, especially recently healed ulcers, as most of these cases would not have received ulcer care at the time of the survey. Missed cases would underestimate the magnitude of the problem.
Another limitation in this study is that the ulcer classification was done retrospectively. At the time of the RPP, nurses lacked the skill to classify ulcers according to probable etiology. The retrospective categorization of ulcers as venous and nonvenous was based on the method described in the Royal College of Nurses clinical practice guideline.24 Sophisticated vascular diagnostic testing would have reduced the chance of misclassification of ulcers, especially for the more obscure etiologies. However, vascular testing in the community was not feasible given the number of leg ulcers and the limited resources. To quantify the accuracy of the ulcer classification, the results achieved using the RCN criteria were compared to the chart audit.
Despite the limitations in this study, the findings (socio-demographic, circumstances of living, and the chronic nature of the disease) are similar to large studies from other western countries.1,3-7,17 Confidence in the generalizability of the findings from this study is, therefore, strengthened. Focusing on only one nursing agency strengthened confidence in the quality of data but was also a limitation. No statistical differences on key variables between the VLU cohort and cases from the all other sources combined were noted. Thus, the researchers were reasonably confident that the findings reflect the regional population of people with venous leg ulcers.
This study reinforced the importance of evidence-based planning when developing healthcare services for a population. This in-depth planning study contributed to an understanding of the number of cases, the complexity of the population, and the persistence of the condition. Clients who receive care in a community leg ulcer clinic may have better outcomes than clients who receive care at home.9-12 For clinics to meet client needs, issues such as transportation, language and cultural differences, and care options for clients unable to attend a clinic need to be resolved. Clients require access to evidence-based care initiated in the early stages of the ulcer development. Continuity of care and coordination of care are also important for improving client outcomes. “Best practice” for venous leg ulcers is supported by strong research28 and involves a significant contribution by community nurses.33 The next step is to consider whether clients are actually receiving this care. - OWM