Pressure Ulcer Prevention Care Bundle: A Cross-sectional, Content Validation Study

A care bundle is an organized set of interventions that encourages compliance with guidelines designed to improve quality of care. PURPOSE: This study was conducted to determine the content validity of a previously developed pressure ulcer prevention care bundle. METHODS: A cross-sectional study was performed in a university hospital in Turkey among 95 nurses employed in 8 intensive care units (ICUs) who were invited to use and assess a care bundle based on pressure ulcer guidelines found in the literature and developed by researchers. The care bundle included 48 statements divided into 8 categories. Participants in the care bundle content validation completed 3 paper-and-pencil instruments: a nurse demographic information tool, an item-by-item content validation of the care bundle rated on a 4-point Likert scale, and an evaluation of the care bundle’s pressure ulcer prevention capabilities using I agree, I do not agree responses to statements regarding comprehensiveness, ability to prevent pressure ulcers, feasibility, implementation, and complexity. Data were collected to a paper form and analyzed using descriptive statistics, mean scores, and the content validity index (CVI). RESULTS: Of a total of 95 potential nurse participants, 68 completed the survey instruments (62 [91.2%] women, overall average age 29.9 ± 5.7 years), for a response rate of 71.6%; 57 (83.8%) had bachelors degrees, 36 (52.9%) had between 5 and 10 years of experience, 24 (35.3%) had participated in a pressure ulcer education program, and 41 (69.3%) cared for patients with 1 to 2 pressure ulcers per week. The care bundle’s overall mean content validation score was 3.9 ± 0.1; this was deemed valid and appropriate after minor wording modifications on 2 items. Nurses rated the care bundle as comprehensive, feasible, necessary, and helpful for making clinical decisions; 12 participants had concerns regarding its complexity and implementation. CONCLUSION: The care bundle may help nurses develop appropriate interventions for patients. Future research should include assessment using larger groups of nurses and construct validation studies. 

According to quasi-experimental study,¹ an effective way to improve the quality of health care is to combine a number of interventions into a care bundle. A care bundle is an organized set of practices based on medical rules that encourages compliance with guidelines and enhanced quality of care by facilitating provision of evidence-based care.^2-4 Critical appraisal of existing research studies and documentation are needed to determine the optimal components of a care bundle. A number of interventional studies have examined care bundles that address catheter-related bloodstream infections in the intensive care unit (ICU),⁵ incontinence management,⁶ chronic airway disease,⁷ and pressure ulcer prevention.⁸ For pressure ulcers, the available guidelines and evidence-based  care should be used along with international guidelines^9-14 such as those developed by the National Pressure Ulcer Advisory Panel (NPUAP), the European Pressure Ulcer Advisory Panel (EPUAP), and the Pan Pacific Pressure Injury Alliance⁹; they include recommendations on training and education, pressure ulcer risk and skin assessment, skin care, nutrition management, activity management, moisture/incontinence management, and support surface management. As noted in quasi-experimental¹ and randomized experimental control studies,¹⁵  core components of pressure ulcer prevention must be based on up-to-date, high-quality data and well-suited procedures for decreasing the frequency of pressure ulcers. These studies have shown when components are grouped into a bundle, critically ill patients in ICUs benefit^1,15: pressure ulcer incidence was reduced from 15.5% to 2.1% with the care bundle approach used by Anderson et al¹ and from 32.86% (control group) to 7.14% (intervention group) in the study by Tayyib et al.¹⁵

Although quality improvement research shows a positive relationship between patient outcomes and care bundles used in ICUs,^1,8,15-17 the appropriate items to include in pressure ulcer prevention care bundles is not clear. In addition, these care bundles were not evaluated by ICU nurses for content validation. The use of care bundles not evaluated by practitioners, even when based on evidence, is difficult to justify; interventions and treatments may be invasive in the ICU, imposing challenges to preventing pressure ulcers. 

Development of the pressure ulcer prevention care bundle. To address specific issues with regard to preventing pressure ulcers among ICU patients (eg, immobility, fecal or urinary incontinence, and malnutrition), a care bundle was developed by 7 specialists (3 wound, ostomy, continence nurses and 4 surgical nurses for use in the authors’ hospital’s ICUs. Intervention studies and guidelines published since 2010 on MEDLINE, the Cumulative Index to Nursing and Allied Health Literature, the Cochrane Library (The Cochrane Collaboration), and Google Scholar were searched by the researchers between November 2017 and January 2018 using the terms pressure ulcer and prevention, pressure ulcer and guides, pressure ulcer and care bundle, and pressure ulcer and clinical map. Consequently, 6 guidelines and 230 publications were identified and the corresponding abstracts were examined. Any duplicate or irrelevant publications or publications for which access to the full text was not possible were excluded from the scope of the review. Ultimately, the full versions of 62 publications were examined. Based on these studies and guidelines,^9-14 an evidence-based pressure ulcer prevention care bundle was established (see Figure 1). 

Content. The pressure ulcer prevention care bundle consists of 8 items (participation in education, risk assessment, skin assessment, skin care, nutrition management, activity management, moisture/incontinence management, and support surface management), along with subitems. The 7 specialists approved the final care bundle (see Figure 2). 

The purpose of this study was to validate the content of this as yet unpublished care bundle. 

Study design, setting, and participants. A cross-sectional study was conducted to validate content of a pressure ulcer prevention care bundle. The study was performed in 8 ICUs of a university hospital in Ankara, Turkey, between June 1, 2018, and July 30, 2018. The units have a total of 67 beds and 95 nurses; all ICU nurses were invited during a meeting to participate in the care bundle assessment. The researchers informed them about the study objective; nurses opting to participate had 1 month to individually use the care bundle with patients and complete the study instruments. 

Ethical considerations. The Ethics Review Committee of the university certified the research (Turkey) (2018/161). Informed written consent was obtained from all participants. 

Instrumentation. Participation in the care bundle validation involved the completion of 3 paper-and-pencil instruments: the nurse demographic information tool, the evaluation tool for pressure ulcer prevention care bundle content validation, and an evaluation form on the pressure ulcer prevention care bundle. Participants signed consent forms along with the questionnaires; this provided validation of comments and ratings. 

Nurse information tool. This tool addressing nurse demographic characteristics was prepared by the researchers and utilized relevant literature.^9,18-22 This instrument included nurse age, gender, education, ICU experience, previous training on pressure ulcer prevention, and number of ulcers cared for weekly (see Table 1).

Evaluation tool for pressure ulcer prevention care bundle content validation. During content validation, participants were asked to review the entire care bundle, evaluating each decision step and concurring (or not) with the item’s significance (see Table 2 and Table 2 continued). This instrument allowed participants to assess statements in the pressure ulcer prevention bundle on a 4-point Likert scale, established by Lynn²³ and Waltz and Bausel,²⁴ where 1 = not relevant/appropriate, 2 = unable to assess relevance without revision, 3 = relevant but needed minor alterations, and 4 = very relevant and appropriate. Participants also could include a written comment about changes that were needed.

Evaluation tool for the pressure ulcer prevention care bundle. This tool, developed by the researchers, included 7 questions regarding the care bundle’s comprehensiveness, adequacy, necessity and feasibility in preventing pressure ulcers, implementation, and complexity. Study participants responded to statements with I agree or I do not agree (see Table 3).

Data collection and analyses. Data were collected to a paper form and entered into the SPSS Version 21.0 (IBM Corporation, Armonk, NY). All demographic variables and assessments for the pressure ulcer prevention care bundle were examined using descriptive statistics. For the 48 individual items/subitems of the care bundle, a content validity index (CVI) and mean scores were calculated. This was done by grouping items as nonrelevant/hard to assess (ratings 1 and 2) or relevant (ratings 3 and 4). Items ranked 3 and 4 were used to compute the CVI, which was >0.70 (on a scale 0 to 1.0).^25,26

Participant characteristics. Out of 95 potential nurse participants, 68 completed the survey instruments (62 [91.2%] women, overall average age 29.9 ± 5.7 years), for a response rate of 71.6%. Among them, 57 (83.8%) had bachelors degrees and 36 (52.9%) had between 5 and 10 years of experience. Twenty-four (24, 35.3%) had participated in a pressure ulcer education program, and 41 (60.3%) cared for patients with 1 to 2 pressure ulcers per week (see Table 1). 

Quantitative analysis. Overall agreement with the care bundle items was 3.9 with a CVI of 0.99 (out of 1). Two (2) items (Risk Assessment: With Braden and Activity Management: Prevent skin friction) required wording modification. The subitems achieving a CVI <0.99 included: Risk assessment: If there is a change in patient’s condition; Skin assessment: Assessment of skin around/underneath medical devices every 12 hours; and Activity management: In bed: every 2 hours, in chair: every 1 hour; Unless contraindicated, place in supine position or 90˚ side position or semiseated position; and Do not position at 90˚ angle, Do not position directly on area of redness, and Do not position directly on medical device. The 2 subitems that required slight revisions (With Braden and Prevent skin friction) were removed, and Using a valid assessment (Braden etc.) and Prevent skin friction and shear were added during the final algorithm revision. The final algorithm revisions were made in accordance with the literature.⁹ 

The pressure ulcer prevention care bundle was evaluated to determine whether its use was comprehensive, adequate, necessary, and feasible in preventing pressure ulcers; demanded extended time in practice; helped with regard to clinical decision-making; and complexity. All (100%) of the nurse participants rated the care bundle as comprehensive for help in making clinical decisions; 12 participants (17.6%) found the bundle complex and to require too much time to implement (see Table 3).

According to review and interventional studies,^2-4 care bundles improve quality of care and encourage compliance with procedures. The best available care should be used to determine pressure ulcer care bundle guidelines, which include international guidelines.^9-14

The NPUAP and others⁹ approved evidence-based practices for preventing pressure ulcers, pressure ulcer risk and skin assessment, skin care, nutrition management, activity management, moisture/incontinence management, and support surface management. The current study grouped the pressure ulcer prevention strategies into a care bundle for critically ill patients. To the author’s knowledge, this is the first study to examine the content validity of a pressure ulcer prevention care bundle among ICU nurses. 

Care bundles for adults were found to be have a strong CVI (0.99 out of 1), and as such its components were suitable.  Two (2) original decision points/steps needed changes: With Braden was modified to Risk assessment: Using a valid assessment (Braden etc.) and Activity assessment: Prevent skin friction was modified to Prevent skin friction and shear. Quantitative data analysis for other component/decision processes deemed the care bundle components appropriate, and the pressure ulcer prevention care bundle was accepted in its final form (see Figure 2). 

Participant comments were generally supportive and positive, and the suggested wording changes were incorporated to reflect best practice. 

The care bundle is not intended for the pediatric and neonatal population and may not be applicable beyond use in the ICU. Another study limitation is that some nurses were reluctant to participate, limiting feedback. 

In this study, a care bundle for preventing pressure ulcers was content validated, achieving a mean item rating of 3.9 ± 0.1. The 48 items/subitems had a strong CVI (average 0.99), and the pressure ulcer prevention care bundle was found to be appropriate with minor modifications. The content-validated pressure ulcer prevention care bundle may help nurses develop interventions for ICU patients. Future research should focus on assessment of outcomes using the care bundle in large groups, along with construct validation testing. 

Dr. Yilmazer is an instructor and Dr. Tuzer is an assistant professor, Ankara Yildirim Beyazit University Faculty of Health Sciences, Department of Nursing, Ankara, Turkey. 

 Please address correspondence to: Tuba Yilmazer, RN, PhD, Ankara Yildirim Beyazit University, Faculty of Health Sciences, Department of Nursing, Ankara, Turkey 06800; email: tyilmazer@ybu.edu.tr.