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.