The Effect of a Patient Education Intervention on Knowledge and Venous Ulcer Recurrence: Results of a Prospective Intervention and Retrospective Analysis
Patient education may help reduce the recurrence of venous ulcers. To examine the effectiveness of a home-based patient education program on disease and self-care knowledge and ulcer recurrence rates, a prospective study and retrospective analysis of patient outcomes was conducted among 3 groups of patients. Group A (n = 28) had received the education intervention and assessments as part of an earlier study and were recruited to participate in a 36-week follow-up.
Group B patients (n = 22) participated in the prospective component of this study and were assessed after 2, 9, and 36 weeks. Data from control group patients (group C, n = 45) were abstracted following a retrospective chart review. Group A and B participants had a healing venous ulcer for at least 5 weeks before the education intervention. Group C patients had been treated for 41 weeks, had a positive wound healing trajectory until week 5, and did not receive additional education. Demographic data for each group were abstracted from the patients’ charts. The educational intervention consisted of a 45-minute, one-on-one presentation in the patient’s home that included visual aids, a brochure, and a handout addressing important aspects of care and activity. Pre- and post-intervention knowledge was assessed using the Checklist for Patient Learning, which includes 2 subscales to measure knowledge of disease process (6 items, range 0–6) and knowledge of self-care activities to prevent recurrence (7 items, range 0–7), with higher scores indicating more knowledge. Wound healing and recurrence, as observed by the patient’s wound care provider and reported by the patient, was noted as Yes or No. Descriptive statistics and unpaired t-tests were used to analyze the data. In all 3 groups, >50% of patients were female and 65 to 74 years of age. In group A and B, knowledge scores at the 36-week assessment were higher than those at baseline (4.13 ± 0.437 and 10.7 ± 0.421, respectively, for group A and 4.22 ± 0.231 and 10.9 ± 0.871, respectively, for group B). The 36-week scores did not differ significantly between groups A and B (P = .687). Recurrence rates were lower in group A and B (50% and 45%, respectively) than in the control group (69%). The results of this study confirm patient education improves disease and self-care knowledge scores and may reduce venous ulcer recurrence rates. Studies including larger patient cohorts and longer follow-up times are warranted.
Because venous ulcer incidence has been shown in community-based assessments to increase with age, prevention is an important issue.1 Venous ulcers occur at a rate of 0.6 to 1.6 per 1000 individuals in the general population and increase to a rate of 10 to 30 per 1000 individuals in persons older than 85 years.1 Recent empirical research including case studies, pre/post intervention, and cohort studies examining venous ulcer recurrence indicate this condition recurs in as many as 70% of all patients.2-5 As the life expectancy of the baby boomer population increases and more patients live well into their 80s and 90s, it is anticipated the number of patients experiencing a recurrence of venous ulcers will increase, underscoring the need to prioritize this clinical issue.6
Patient education appears to be a needed component in improving the ability of health care providers to facilitate patient engagement in self-care activities to help prevent the recurrence of venous ulcers. Finlayson et al7 were able to demonstrate this point using a cross-sectional survey and retrospective medical record review of 122 community-dwelling patients with recurrent venous ulcers. In this investigation, self-efficacy and self-care knowledge were found to be directly related to patient adherence to self-care activities, including the use of topical creams and compression therapy. Patients with higher levels of self-efficacy and self-care knowledge were less likely to experience recurrence and had shorter healing times following recurrence. Brown8 conducted a systematic review of the literature and identified key components of patient education that included the use of compression therapy and the need for physical activity, mobility, and leg elevation, indicating these components should be emphasized when facilitating patient education and patient engagement in self-care.
Although few empirical studies examine patient education as a means to help reduce the recurrence of venous ulcers, the research9-11 available indicates educational interventions can be effective. For instance, Freeman et al9 describe the results of a “Look After Your Legs” program through qualitative interviews with participants. In this study, a group of 9 community-dwelling persons between the ages 75 and 90 years with healed or almost-healed venous leg ulcers were recruited to attend monthly educational sessions focused on empowerment for self-care to prevent ulcer recurrence. The program provided weekly support groups and monthly assessment and patient education to help reduce recurrence; less than half of patients enrolled experienced recurrence of their wound after 6 months. Interviews with program participants further revealed increased self-efficacy and empowerment for engagement in self-care activities. These outcomes prompted the authors to advocate for educational support for patients as a tool for reducing venous ulcer recurrence.
Edwards et al10 examined outcomes from a randomized, controlled trial in which 56 patients with chronic venous ulcers were assigned to an educational group (n = 28) or standard care group (n = 28). Over 12 weeks, the education group was provided weekly venous ulcer assessment via ulcer tracings using the dot-point method of calculating area and calculating Pressure Ulcer Scale for Healing (PUSH) scores; treatment; education, advice, and clinical support for managing venous leg ulcers; social interaction; and goal-setting to assist with functional and social activities, all in a relaxed setting. Patients enrolled in the control arm of the research received community health nursing in their homes, comprehensive health assessments including ankle brachial pressure index assessments, referral for circulatory assessments if needed, standard ulcer treatment based on patient needs, advice and support regarding leg ulcers, and follow-up care. Data obtained from this investigation demonstrate patients in the educational group had better outcomes on several measures; in particular, significant reductions were noted in mean pain scores (P = .004), the degree to which pain affected sleep (P = .003), healing rates (46.2% for the group receiving education versus 25.9% for control), and lower PUSH scores (P = .002). Based on the results, the authors recommended the use of patient education as a foundation for healing and recurrence prevention in chronic wounds.
The Leg Ulcer Prevention Program developed by Kapp et al11 further demonstrates the efficacy of patient education for increasing both knowledge and engagement in self-care activities aimed at preventing recurrence. In this study, 156 community-dwelling patients (average age 79.5 ± 10.67 years) with new or existing venous leg ulcers completed a 6-session educational program along with pre- and post-program assessments. Sessions lasted between 20 and 60 minutes, with post-program assessments completed immediately following the last session. The assessments included true/false and multiple choice questionnaires as well as behavioral self-assessments to evaluate disease and self-care knowledge. Disease and self-care knowledge were evaluated to determine the ability of the patient to engage in activities to promote healing and prevent recurrence of the wound. Changes in disease and self-care knowledge from pre- and post-program implementation were significant (P = .000). Additionally, patient reports of self-care activities indicated more patients were engaged in healthy eating, regular exercise, and compression therapy following the intervention. The authors recommended education as a tool for reducing the recurrence of venous ulcers.
The research by Edwards et al10 illuminated an increased risk of venous ulcer recurrence in patients that are not educated regarding self-care activities, do not understand the importance of treatment, and do not have the ability to engage in self-care practices to prevent the ulcer from recurring. Most of these issues can be addressed through a comprehensive patient education program; however, data from evidence-based practice research12 indicate this element of patient care is noted to be the most overlooked component of patient care.
In previous evidence-based practice research undertaken by this author, patient education, which included providing patients with knowledge of their disease and self-care activities needed to prevent recurrence, resulted in a 50% recurrence rate at 9-weeks’ follow-up.13 Of the 30 patients enrolled in this evidence-based practice project, 15 experienced wound recurrence at 9 weeks and 15 patients had no sign of recurrence. Although no control or comparison group was used in this research, the rate for recurrence was lower than the 70% recurrence rate reported in the literature.2-5 These findings support utilizing patient education, including efforts to build the patient’s knowledge of the disease and self-care activities to reduce venous ulcer recurrence in the short-term.
The current research demonstrates patient education can be effective. However, some limitations to the research are noted. In particular, Freeman et al,9 Kapp et al,11 and Gonzalez13 utilized a pre- and post-intervention assessment of patients without comparison to demonstrate a correlation between education and venous ulcer recurrence. The research undertaken by Edwards et al10 utilized a control group for treatment, demonstrating causality for the use of patient education in preventing the recurrence of venous ulcers10; however, this research was conducted over a 12-week period, leaving some questions regarding the long-term (6-month) efficacy of patient education. The present study was undertaken to understand the long-term efficacy of patient education and to assess a cause-effect relationship between education and the prevention of venous ulcer recurrence.
The current research involved 3 parts. In the first part, the current research sought to extend follow-up assessment of an initial group of patients (group A) that participated in an evidence-based practice project to evaluate the effect of patient education on knowledge retention and venous ulcer recurrence.13 Second, a new group of patients (group B) was provided the same educational intervention as group A to evaluate knowledge outcomes and venous ulcer recurrence at 9 weeks and 36 weeks following the educational program. Finally, a retrospective chart analysis was conducted to identify a control group (group C) of patients with venous ulcers who did not receive the educational intervention. Wound recurrence for all 3 groups was compared.
Design. The research design used for this investigation involved a retrospective control group study to evaluate the effectiveness of an educational program to reduce the recurrence of venous ulcers. Figure 1 provides a visual timeline for the completion of each phase of this investigation to guide understanding of the specific methodology utilized for the project. Convenience sampling from a pool of community-dwelling patients served by a large wound care center operating in central Florida was used to identify patients for each group.
Measuring recurrence at 6 months (group A). Participants from a previous evidence-based practice project13 (group A) were contacted to assess disease and self-care knowledge (using instruments described below) and venous ulcer recurrence at 36 weeks. The author, who was responsible for undertaking the original evidence-based practice project, collected additional follow-up data from group A, which initially was enrolled between January 1, 2013 and January 22, 2013 and included 30 community-dwelling patients with venous ulcers receiving home care services for wound management. Inclusion criteria for participants stipulated presence of an initial venous ulcer with treatment for at least 5 weeks, positive wound healing trajectory, English spoken as the primary language, and consent to participate in education provided in the home. Disease and self-care knowledge were assessed at baseline, following the intervention, and at 2 and 9 weeks following the educational program. Scores from each of the measurement periods were compared.
Enrollment of new patients (group B). From July 2013 to September 2013, a second group of patients (group B) was recruited and enrolled in the educational program conducted by the author. Recruitment and education protocols established for group A, and as described previously, were utilized for group B. The setting for the project included the homes of patients initially diagnosed with venous ulcers. Care for new patients enrolled in the program was coordinated through the same wound care organization as Group A. Patients recently diagnosed with an initial venous ulcer were referred to the facility by their primary care physician and recruited for the study by staff nurses working for the outpatient facility; these patients had similar disease trajectories as the original group — ie, a venous ulcer for 5 weeks or more with observable signs of healing. Disease and self-care knowledge of the patients was assessed at baseline, immediately following the intervention, and at the 2-, 9-, and 36-week follow-up after the educational intervention. In addition, venous ulcer healing was assessed at the 2 week follow-up and ulcer recurrence was assessed at 9 weeks and 36 weeks following the completion of the educational program.
Control group: retrospective chart analysis. In order to establish a control group, a retrospective chart review was conducted to identify patients that had received care at the facility beginning at the time of the initial study period (January 2013) through the beginning of the second phase of the project (September 2013). The author utilized the electronic health record system to identify all patients receiving care for venous ulcers at the wound care facility during the target dates. Each patient record was manually reviewed to determine if the patient had been treated by the facility for 41 weeks, whether the patient had a positive wound healing trajectory up until week 5, and that no additional educational supports were provided to the patient as noted in the chart. In order to ensure uniformity in comparison, data from the control group were measured at 14 and 41 weeks. This timeframe for the control group was selected owing to the fact that patients in groups A and B had received treatment for at least 5 weeks before the educational intervention.
Sample size assessment. In order to assess the statistical relevance of the sample size, a power analysis was conducted utilizing a statistical power of 0.80 and an alpha value of 0.05 along with an effect size of r = 0.50. Based on these calculations, a total sample size of 29 would be needed to demonstrate a large effect size. The current sample includes 50 participants receiving the educational intervention (groups A and B combined) and 45 patients for the control group (group C). As such, the sample size is adequate for making the results relevant.
Instrument. Demographic data for each of the patients were collected through a review of the patient’s chart. Age, gender, race, and comorbid conditions were recorded. The latter included the presence of diabetes, arthritis, hypertension, dyslipidemia, heart disease, peptic ulcers, and ulcerative colitis.
The instrument used for the patient education program was the Checklist for Patient Learning, utilized in the initial evidence-based practice project.13 The instrument included 2 subscales to measure knowledge of disease process (6 items) and knowledge of self-care activities to prevent recurrence (7 items). Disease knowledge items included understanding of the development of venous ulcers, identification of venous ulcers as a chronic condition, articulation of 3 self-care activities, understanding the importance of managing pain, using language commensurate with treatment, and ability of the patient to engage in conversation about the disease. Self-care activities reviewed on the checklist included patient awareness of the need for compression stocking use, leg elevation, exercise, moisturizing, preventing bruising, assessing for recurrence, and when to seek assistance for care. The Checklist was developed for the project by the author and reviewed by 2 wound care experts and 2 nurse educators but did not undergo formal content validation to assess validity. Following review and feedback from the wound care experts and nurse educators, the instrument was revised and a final version was created for use.
Each positive response was assigned a score of 1 and a negative response was scored as 0. Patients were provided a prompt such as, “Can you tell me how venous ulcers develop?” A prompt was used for each item on the checklist to assess patient understanding of the information that had been taught during the educational intervention. The scale range is 0 to 13: the disease knowledge subscale score range is 0 to 6 and the self-care knowledge subscale range is 0 to 7 with higher scores indicating higher levels of patient knowledge. This instrument was used to assess patient knowledge at the 2-, 9-, and 36-week follow-up in groups A and B. Patients also were asked about wound healing at the 2-week follow-up and the presence of recurrence at the 9- and 36-week follow-up (see Figure 2).
Intervention and outcome measures. The intervention for this research included the use of a patient education program to improve patient knowledge of the disease process and self-care activities as well as to prevent the recurrence of venous ulcer. New patients (group B) enrolled in the program were provided a 45-minute educational program in a one-on-one setting in the patient’s home. The program followed the same structure and format as the original educational intervention provided to group A and included the use of visual aids, including a brochure and handout covering the most important aspects of the condition and self-care activities needed to help prevent recurrence. The program was delivered by the author to ensure consistency of the education program for all participants. Outcome measures included disease and self-care knowledge as measured by the Checklist for Patient Learning as well as healing (at 2 weeks) and recurrence (at the 9- and 36-week follow-up).
Wound healing was assessed by the wound care specialist providing care, and patients were asked to report if the specialist had noted wound healing to them during treatment. Wound recurrence also was assessed by the specialist providing care; patients were asked to report if the specialist observed wound recurrence during treatment. Wound healing was considered present if the specialist noted a reduction in the size of the wound as measured and reported in the patient’s chart from the previous visit. Wound recurrence was considered present if after healing, the presence of another wound was detected at the same site on the patient’s leg.
Data collection. Group A patients received follow-up phone calls at 36 weeks. For new patients (group B) enrolled in the education program, data were collected at 5 time points: 1) before the educational program, 2) immediately following the educational program, 3) at the 2-week follow-up, 4) at the 9-week follow-up, and 5) at the 36-week follow-up. In the first 2 phases of data collection, the author was responsible for obtaining informed consent and providing a home-based one-on-one education program to increase patient disease and self-care knowledge. During this time, all patients received routine home care for wound management as prescribed by their health care provider.
The Checklist for Patient Learning was utilized to evaluate immediate changes in patient knowledge levels following the education program. At 2, 9, and 36 weeks following the educational intervention, the author called the patient and administered the Checklist for Patient Learning to collect data regarding patient knowledge of disease and self-care practices. During the 2-week follow-up phone calls, patients were asked about wound healing as noted by their wound care specialist. Data regarding wound healing by the treating specialists was relayed by the patient during the phone assessment. During the 9- and 36-week follow-up phone calls, patients were asked about wound recurrence as noted by their wound care provider, utilizing a similar protocol. Information reported by the treating specialist to the patient was relayed to the author.
Group A patients received follow-up phone calls at 36 weeks. Patients were asked about the wound care specialist’s assessment of wound healing and recurrence, and the author completed the Checklist for Patient Learning to collect data regarding patient knowledge of disease and self-care practices using the same form used for the initial education and assessment of the patient. No data regarding additional care provided to this group of patients were obtained.
Data from control patients (group C) were obtained through a retrospective review of charts from the health care facility and included patient gender, age, race, and comorbid conditions. These data were entered into an Excel (Microsoft Corporation, Redmond, WA)spreadsheet along with a Yes or No designation for wound healing at 14 weeks and wound recurrence at 41 weeks.
Data analysis. All variables, recorded using paper/pencil, were entered into an Excel spreadsheet. Descriptive statistics (percentages) were used to analyze participant characteristics and wound healing/wound recurrence. Data from each phase of data collection using the Checklist for Patient Learning were analyzed using unpaired t-tests. A P value of .05 was used to evaluate the statistical significance of the results. Unpaired t-tests were used to compare post-intervention and 2-week, 9-week, and 36-week follow-up scores for patient knowledge as measured through the Checklist for Patient Learning in new patients (group B). Unpaired t-tests also were used to evaluate differences in the Checklist and subscale scores for new patients (group B) and initial patients (group A). Recurrence rates for all patients enrolled in the educational program were combined (groups A and B) and compared with recurrence rates for the 45 patients that did not receive the educational intervention.
Informed consent and IRB approval. Institutional Review Board approval for the initiation of the educational intervention was obtained on December 17, 2012. All patients agreeing to participate in the intervention were required to sign a letter of informed consent. The form was read aloud to all participants to ensure understanding, and a signed copy of the letter was given to all participants for review and record keeping.
Demographic data. The original study evaluated the effectiveness of patient education for improving patient knowledge and preventing recurrence among 30 patients. However, follow-up phone calls were only completed with 28 of the initial participants (group A): 1 patient had suffered a stroke and was unable to consent to participate and another declined to provide 36-week follow-up data. The study sample (group B) consisted of 22 new patients enrolled in the patient education program, and the control group (group C) comprised 45 patients. The average age of group B patients was 66.7 ± 0.9998 years, and the average age for group C patients was 66.1 ± 1.221 years (see Table 1).
Checklist for Patient Learning scores. Examination of mean scores for new patients (group B) indicated a nonsignificant decline in knowledge from post-intervention (12.0 ± 0.338) to 2-week (11.8 ± 0.451), 9-week (11.0 ± 0.676), and 36-week follow-up (10.9 ± 0.871), suggesting knowledge had been retained. However, statistically significant differences in scores were found when comparing baseline scores to post-intervention (P = .002), 2-week (P = .002), 9-week (P = .002), and 36-week (P = .003) follow-up scores. Increases in scores were noted for the entire Checklist for Patient Learning and for the disease and self-care knowledge subscales: 36-weeks disease subscale (P = .020) and self-care knowledge subscale (P = .021). These results are comparable to data collected regarding the initial group of 28 patients enrolled in the study (group A) (see Table 2).
Unpaired t-tests comparing groups A and B at post-intervention (P = .121), 2 weeks (P = .544), 9 weeks (P = .433), and 36 weeks following the intervention (P = 0.687) indicate no substantial difference in the scores between the groups (see Table 3). Learning retention for group A at 36 weeks following the educational intervention showed it was significant for the entire Checklist for Patient Learning (P = .041) as well as for the subscales disease knowledge (P = .039) and self-care knowledge (P = .022) (see Table 4).
Ulcer recurrence. The new patient group had a lower rate of ulcer recurrence when compared with initial patients from group A at the 9-week follow-up (36% versus 50%) (see Table 5). At the 36-week follow-up, similarities can be noted between groups A and B. Group A continued to show a 50% recurrence rate, and group B showed a 45% recurrence rate. However, rates for both groups were lower than the 69% recurrence rate reported for the control group (group C) at 36 weeks. Recurrence rates were noted to be lower for the new patient group (group B), which has a lower rate of comorbid conditions when compared with the initial patient group (55% versus 90%) (see Table 1).
The findings from this investigation indicate statistically significant gains in knowledge were made for new patients (group B) enrolled in the educational intervention. These gains were maintained at 2 , 9, and 36 weeks and are similar to outcomes observed in the initial group of patients (group A). At the 36-week follow-up, patients that initially had been enrolled in the study (group A) also demonstrated statistically significant improvements in knowledge regarding both disease process and self-care activities. Venous ulcer recurrence rates were lower at 9 weeks in the new patient group (group B) when compared at 36 weeks to group A. However, recurrence rates remained stable in the initial patient group (group A) from the 9- to 36-week follow-up rates. The results indicate both groups had similar learning outcomes with no statistically significant differences in assessment scores at 2, 9, and 36 weeks after the intervention.
Although the venous ulcer recurrence rates reported for all patients enrolled in the education program (50% for the initial group, 45% for the second group) were higher than those reported in the literature when patient education is provided (30%),9 the recurrence rate is less than the 70% reported when no intervention is provided to support self-care activities of the patient.2-5 Additionally, recurrence rates for the control group (group C, 69%) were also higher than those for group A (50%) and group B (45%). Thus, the results suggest patient education can be effective for improving patient knowledge in both the short- (2- and 9-week follow-up) and long-term (6-month follow-up) as well as for reducing the recurrence rate of venous ulcers during these same intervals.
Despite the fact that the educational intervention shows promise for improving patient knowledge and reducing recurrence of venous ulcers, the need for longitudinal data with large sample sizes remains. Data regarding lifetime outcomes for patients regarding recurrence of venous ulcers are limited.1,6,7 Additionally, research regarding self-care activities involved in the treatment of venous ulcers indicates additional issues exist (ie, pain and social support8,12) beyond patient education that can influence adherence and appropriate self-care. These issues were not addressed in this investigation and should be considered in future research.
The sample size for new patients (group B, n = 22) and initial patients (group A, n = 28) is relatively small when compared with the total number of patients experiencing venous ulcers. Further, no effort was made to control for comorbid conditions. Recurrence rates are noted to be lower for the new patient group (group B), which may have affected outcomes for the study. Variances in wound care provider assessment also may have influenced results for evaluating wound healing. Limitations are also present as a result of the use of a nonvalidated instrument for assessing patient knowledge. Further, causality cannot be inferred from the findings as the research does not represent a true randomized, controlled trial.
The results from the study indicate that a one-on-one education program delivered in the patient’s home may significantly contribute to improved patient knowledge and may help reduce venous ulcer recurrence rates. Patient knowledge scores improved in both intervention groups. In addition, ulcer recurrence rates at 36 weeks were lower in the intervention than in the retrospective control group. Although the ability to generalize the findings to the larger population of patients with venous ulcers is limited, the results support the continuation of research in this area and efforts to expand patient education as a central means to improve patient knowledge and reduce the recurrence of this condition.
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Potential Conflicts of Interest: none disclosed
Dr. Gonzalez is a wound care specialist and Clinical Assistant Professor, Florida International University, Miami, FL. Please address correspondence to: Arturo Gonzalez, DNP, ARNP, ANP-BC, CWCN-AP, Florida International University, 1001 SW 22 Street, Miami, FL 33219; email: artgonza@ u.edu.