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Empirical Studies

Integrating Wound Care Research into Clinical Practice

October 2007

  Defined as “integrating individual clinical experience with the best available external clinical evidence from systematic research,”1 evidence-based medical practice is commonly accepted as the standard of care in medicine. In wound care, assimilating research into clinical practice involves integrating research methodology and evidence-based medicine (EBM). The assumption is that such practices will improve clinical care.   Implementing EBM in wound care may not be easy, especially in a busy spinal cord injury (SCI) specialty unit that treats a large number of wounds on a daily basis. Pressure ulcer care following SCI is a major issue; it is one of the most prevalent complications and one of the main reasons for rehospitalization following SCI.2 It is one of the most frequent admission diagnoses at the authors’ regional SCI unit (a tertiary referral center). These data are consistent with a retrospective study by Chen et al3 of nine Model Spinal Cord Injury Systems (MSCIS) in the US from 1984 to 2002 that demonstrated a significant trend of increasing pressure ulcer prevalence.

  The purpose of this paper is to review the 5-year process of standardizing prevention and treatment protocols in the authors’ setting in an attempt to integrate research and implement evidence-based care. This endeavor was undertaken because pressure ulcer is one of the most frequent admission diagnoses in the authors’ care unit and clinicians wanted a new and evidence-based approach to pressure ulcer care. Over this period, the unit evolved from a tertiary SCI center that provided routine, physician-based clinical care for pressure ulcers to a facility that uses an interdisciplinary, evidence-based approach that integrates the tenets as well as best-practice recommendations found in the literature. Before this effort, the approach to pressure ulcer care was not interdisciplinary. Issues and experiences discussed include 1) integrating research methodology and scientific evidence in wound care, 2) a consideration of the extent of evidence-based practice in the authors’ SCI unit, and 3) the impact of EBM on overall wound care outcomes related to integrating research methods.

Integrating Research Methodology in Wound Care

  In clinical practice, it is often easy to consider research as an exclusive entity. In a busy inpatient unit or outpatient clinic, performing research may be perceived as irrelevant or a barrier to work efficiency. To the contrary, incorporating research into clinical practice in wound care has many direct clinical benefits and advantages.

  Integrating research into clinical practice does not necessarily imply participation in a research project – it may simply mean thinking like a researcher in the clinical setting. This may not only improve efficiency, but it also may improve patient care. Methodically planning and implementing treatment facilitates the standardized and systematic application of procedures and allows clinicians to critically assess the efficacy of new and/or existing treatment, improve standard of care through use of state-of-the-art knowledge and technology, and facilitate development and implementation of research programs.

  It is understood by clinicians that wound care is a complex matter that involves many aspects and processes. In the authors’ experience, integrating research methodology can streamline many of these processes, which include wound assessment, planning and provision of treatment, outcome (wound size) evaluation, and wound evaluation documentation. Each of these processes can benefit from the use of research methodology.

  As part of the endeavor to incorporate research methodology and EBM into clinical practice, an interdisciplinary skin care team was formed comprising a physiatrist, wound care nurse, physical therapist, occupational therapist, dietitian, wound care research engineer, and research nurses. Involving a diverse group of research- and clinically oriented individuals has allowed research methodology to become part of the routine on the SCI unit. Many team members attend the weekly interdisciplinary skin care rounds, seeing all SCI patients with wounds every week, regardless of attending physician. After the round, the team makes recommendations to the care team that are compliant with the clinical practice guidelines. The team invites the patient’s attending physician and caregivers to participate. In addition, patients are evaluated for eligibility for wound care research studies on the round.

Wound Assessment

  In research methodology, it is important to consider all of the factors that can confound a situation. Similarly, the global assessment of factors that affect wounds is equally important. Because multiple factors affect wound status, confounding variables must be controlled in order to study the efficacy of a particular treatment. Bale4 noted that wounds are a symptom rather than a disease and patients may present with multiple or complex pathology – eg, a compromised nutritional status and anemia can profoundly affect wound healing. Therefore, a research study that examines the use of a new modality for wound treatment will need to control for nutritional status and anemia in order to accurately evaluate the effect of the modality on wound healing; similarly, these factors wound require consideration in a clinical setting.

  Factors may be “causative” or “correlational” – terms often used in research methodology that also apply to wound healing. Causative factors show cause and effect; correlational factors demonstrate an association but not a direct cause and effect. For instance, immune and nutritional issues5 have been found to be causative factors in wound healing and cigarette smoking6 has been associated with pressure ulcer formation in individuals with SCI; however, no clear physiological relationship has been identified. Another example would be the relationship between weight and pressure ulcer development following a SCI. Research has found underweight to be a correlational risk factor.7

  The implementation of research methodology has allowed the authors’ care team to consider the various factors that affect wounds, leading to more comprehensive wound assessment. Incorporating a team approach has precluded the potential for each discipline to focus on its own specific issues without considering global risk assessment. The impact of an interdisciplinary approach will be addressed later in this paper.

Treatment Planning

  Every step in a research study should be pre-planned and standardized so the same procedures will be applied in a systematic and orderly fashion for different research subjects. Similarly, clinical treatment for pressure ulcers should be pre-planned and standardized to allow logical progression of treatment strategy. Blind selection of treatment is not encouraged. Clinicians should use objective data to make treatment/product determinations.

  An example is the initiation of negative pressure wound therapy (NPWT). Its use in the treatment of chronic wounds should follow a standardized protocol so that criteria are clarified – ie, NPWT is recommended for use in chronic, difficult-to-heal wounds after the wound has been thoroughly debrided and is free of active, untreated infection8 (eg, cellulitis). Another example is the selection of a wheelchair cushion for pressure relief – the most expensive cushion is not necessarily the seating surface with the lowest interface pressure. An objective measurement technique, such as pressure mapping, should be used when selecting the most appropriate cushion.9,10 Whenever available, clinical guidelines should be consulted for treatment selection. The Agency for Health Care Policy and Research (AHCPR) Treatment of Pressure Ulcers: Clinical Practice Guideline,11 for example, does not support the use of skin cleansers or antiseptic agents such as sodium hypochlorite solution for the cleansing of wounds because these products may be cytotoxic to the wound tissues. These practices are supported by the findings of the National Pressure Ulcer Long-Term Care Study.12

  In the authors’ experience on the SCI unit, once wound treatment planning was standardized, many practices were changed to reflect a more uniform and logical approach: antiseptic solutions no longer were routinely applied and NPWT was used according to standardized criteria and application settings. Following standardized guidelines helped clinicians resist temptation to use new technologies in wound care until criteria and indications for use were in place. In this facility’s experience, since the treatment recommendations now come from one team, standardization was easier to achieve.

Treatment Implementation

  The implementation of research procedures is precisely standardized and controlled. Staff/caregiver education and the use of wound care standardized procedures using protocols and/or clinical guidelines can ensure consistency.13 Because positive wound healing outcomes are achieved when standardized wound treatment protocols are implemented,14 local procedures, practice guidelines, and competencies may need to be developed. The authors’ SCI unit developed competencies and trained staff in order to standardize wound treatments.

Outcome Evaluation

  Outcome evaluation, an essential part of research, assesses the success of a research intervention. Without accurate evaluation, an intervention may be falsely determined to be efficacious. In clinical practice, robust outcome evaluation is critical to the assessment of a wound treatment.

  The primary outcome measurement in wound care often is wound size. This necessitates use of a standardized outcome measurement tool, ideally with high intra-rater and inter-rater reliability. Potentially, any standardized manual measurement method or digital measurement tool15 will work. The challenge is to find a wound measurement tool that is clinically feasible (quick, easy to use, and relatively low-cost) and will provide the accuracy and reliability necessary, such as the National Pressure Ulcer Advisory Panel’s (NPUAP) Pressure Ulcer Scale for Healing (PUSH) tool.16

  This has been one area of major improvement in the authors’ unit. Wound measurement has been standardized by training medical and nursing staff to obtain manual length/width measurement using the same method and orientation. Furthermore, a unit wound care nurse was designated to ensure the same person measures the wounds every week, further increasing measurement consistency and reliability.15 The wound care research program employs digital measurement techniques that may be incorporated into clinical practice in the future.

Wound Documentation

  Outcome evaluation data must be documented. The documentation on the authors’ unit is usually done in the same template with pre-determined and regular frequency. This template was developed by the skin care team. Precise data entry allows scientific analysis of outcomes data. In clinical practice, the lack of accurate and clear documentation of wounds is a recognized problem.17-19 By documenting wound location, size, and descriptive variables on a regular basis using a wound data template, all wounds can be tracked and monitored uniformly. The resultant standardized data also facilitate future retrospective study of wound progress. The authors’ unit has made great progress in wound documentation. Use of a standardized, electronic wound documentation template for wound care notes was implemented and digital wound images, taken weekly, are stored with electronic medical records. This information is available for staff review. Implementation of these strategies required hospital computer staff to develop and integrate relevant capabilities into the electronic documentation system, underscoring the need for facility support.

Summary of SCI Unit Changes

  The development and implementation of the aforementioned tools and strategies took approximately 5 years. It should be noted that the endeavor required not only administrative support for the formation of the interdisciplinary team, but also the collaboration and cooperation of medical center support services to provide the technical assistance and training necessary for program development.

Assessing the Extent of Clinical Evidence-Based Practice

  Clinical practice guidelines from organizations such as the Consortium for Spinal Cord Medicine,20 the Agency for Health Care Policy and Research (AHCPR),11 and the European Pressure Ulcer Advisory Panel (EPUAP),21 are good resources for evidence-based practice recommendations. However, as a result of the paucity of pressure ulcer care research, some of the guideline recommendations have a limited evidence-base and are founded on expert consensus. Yet despite these limitations, these guidelines are the best resources for clinicians. But are they being used?

  Review of the published literature shows current wound care practice is not necessarily consistent with evidence-based practice. Helberg et al22 performed a pressure ulcer prevalence survey in 51 hospitals and 15 nursing homes in Germany between 2001 and 2002 (n = 11,584). They compared their findings to current evidence-based wound care practice recommendations and found the percentage of pressure ulcer treatments that was consistent with current evidence was universally low for Stage I, Stage II, Stage III, and Stage IV pressure ulcers in acute care and nursing homes. For example, for Stage III and Stage IV pressure ulcers, less than 50% of the treatments were consistent with current evidence in acute care and nursing home settings.

  Sharp et al23 found “a range of inconsistencies within and across nursing practice domains. Nurses generally do not use a tool to assess pressure ulcer risk potential, but rely on a range of practice procedures and risk indicators to determine risk potential of developing pressure ulcers.” In other words, nurses generally do not use a standardized tool such as the Braden Scale in the assessment of pressure ulcer risk. Instead, they often rely on their practice and experience.

  Several studies provide different reasons for the limited implementation of evidence-based wound care practices. In a 2-year study of the implementation of clinical practice guidelines in seven facilities (including acute, intermediate, extended, and home care) in an urban Canadian health region, Clark et al24 identified the barriers to implementing evidence-based clinical practice guidelines, which include lack of visible senior nurse leadership; insufficient time to acquire computer skills and implement new guidelines; difficulties with the computer system, including malfunctioning of hospital computers; and limited competencies related to learning the computerized decision support system. In a retrospective review of 6,283 instances where pressure ulcer prevention guidelines were applicable, Saliba et al25 studied adherence to Agency for Healthcare Quality and Research pressure ulcer prevention guidelines in the treatment of 834 nursing home residents in 35 VA nursing homes. Their results showed low adherence to practice guideline recommendations and highly variable adherence from one nursing home to another. Between 1994 and 1997, Xakellis et al26 performed a retrospective and prospective quasi-experimental longitudinal study of the effects of implementing a guideline-based pressure ulcer prevention program on 205 subjects in a 77-bed, long-term care facility. Their results showed an initial but not long-term decrease in the incidence of pressure ulcers.

  Given the rather sobering results from these studies, it is important to examine what creates the barriers to implementing clinical practice guidelines. The barriers identified from the above studies can be summarized as follows:
    • Difficulty in changing the current practice of an individual
    • Variability in clinical practice among the staff, even within the same facility
    • Variability in readiness to learn new skills by different staff members
    • Time needed to learn and implement new skills
    • Leadership support from the facilities
    • Limited availability and accessibility of equipment (eg, computers).

  These factors echo the authors’ experience on their unit and assert that implementation of evidence-based clinical practice requires more than just changes in nursing practice. Attitudinal and behavioral changes among staff as a result of knowledge acquisition are considerations and do not always occur concurrently; hence, response to new concepts and practices will vary. However, despite learning differences among staff, education is important. Sinclair et al27 evaluated an evidence-based education program for the prevention of pressure ulcers among 595 RNs and 59 LPNs employed in three acute care hospitals with a total bed capacity of 1,760. Using the Pressure Ulcer Knowledge Test for pre- and post- program knowledge measurement, the authors found the program to be effective in increasing the awareness and knowledge base of RNs and LPNs regarding pressure ulcer practice standards.

  Furthermore, the successful implementation of clinical practice guidelines necessitates an organizational approach28 that involves other hierarchies of the healthcare organization, including facility management readiness to change and provide support such as equipment and supplies. Organizational support is critical in promoting evidence-based nursing practice.29 A change in the organizational culture and structure to support evidence-based practice also is important.30 In addition, clinical practice guidelines are dynamic and based on evidence that is likely to change over time, further complicating the adoption of and change in evidence-based clinical practice.

  Before the skin care team was created on the authors’ unit, the clinical management of pressure ulcers was based mostly on physician and nursing experience and preference without any emphasis on adherence to clinical practice guidelines or evidence-based practice. This was consistent with other medical centers.31 The focus of care management was the medical treatment of pressure ulcer rather than a holistic management approach or pressure ulcer prevention. The expertise of many disciplines was underutilized.

  Since the skin care team round was initiated, the unit has been able to standardize many of its treatment regimens, aligning them with clinical practice guideline recommendations. Many difficulties, such as the time it takes to educate the staff members on clinical practice guidelines and the difficulty in minimizing the variations in wound care practice among different staff members, had to be overcome. However, leadership support and computer availability helped reduce these implementation barriers.

Did Wound Care Outcomes Improve?

  A 4-year, retrospective study32 of pressure ulcer prevalence in a university hospital in the US (n = 690) and a 3-year clinical perspective analysis33 of a university hospital in Denmark (n = 24,816) have shown that establishing an interdisciplinary skin care team improves prevention and treatment of pressure ulcers and other skin wounds. In the authors’ experience, utilizing a skin care team approach in the delivery of evidence-based practice has advantages and disadvantages. Clearly, state-of-the-art management strategies and standardized management plans for pressure ulcer care are advantages, as is the exchange of information among the team members from different disciplines to allow for more creative and innovative problem-solving. However, implementing a team approach can make the care process more labor- and resource-intensive. Training different team members on standardized measurement methods and digital photography requires extra time and effort. Barriers to the formation of an interdisciplinary team, especially given the limited resource in healthcare, can be daunting. For example, at the authors’ facility, one of the staff nurses was selected to be trained as a wound care nurse but because overall nursing staffing did not change, the unit essentially lost one staff nurse. In addition, team members need to be receptive to the novel ideas and expertise of others on the team. The potential exists for personal conflicts and disagreements, although this has not been the case at the authors’ facility.

  As a result of the evidence-based initiative at the authors’ facility, the following short-term wound care outcome changes have been noted:
    • Wound measurement method has been standardized
    • Wound documentation is now standardized using a wound note template
    • Digital imaging is part of weekly documentation
    • Decisions on wound management involve interdisciplinary discussion
    • Treatment recommendations have been standardized
    • Ongoing state-of-the-art wound care research programs are an integral part of the clinical unit
    • Clinical and research staff interact directly
    • Patient satisfaction has improved (authors’ unpublished study).

  These important short-term outcome changes are a direct result of the integration of research methodology and clinical practice in wound care because no other changes were made to pressure ulcer care practice during the same period.

  The most obvious changes occurred in the wound documentation process. Using a standard documentation template may help with the implementation of clinical practice guidelines.34 In the past, different nurses with varying wound care experience and expertise documented the pressure ulcers occurring on the authors’ unit. Measurement documentation frequency was haphazard and methods were inconsistent and not standardized – they contained various terms and descriptions. Photographs were not obtained. Therefore, monitoring pressure ulcer progress based on documentation was difficult. Now, pressure ulcer documentation is consistent and clinicians are able to track the progress of a pressure ulcer easily by reviewing the standardized progress notes or the weekly digital photos attached to the patient’s electronic medical records. No formal evaluation of wound healing improvement has been conducted as yet. The authors also observed increased patient participation with the new skin care team approach. Patients have become more involved and knowledgeable with their pressure ulcer care, including the weekly change in their wound size, the type of dressings used, and the appearance of the pressure ulcers on the digital photos. Presumably, this will eventually lead to better outcomes.

  In order to ascertain the success of the endeavor, a retrospective cohort study has been planned using objective data and performing empirical evaluation. The main question remains: Integrating research methodology into wound care practice appears to have improved many factors that impact short-term outcomes in wound care but has this endeavor improved the overall outcomes of wound care – ie, long-term changes, including a decrease in pressure ulcer prevalence? Ultimately, the authors’ SCI unit would like to confirm that short-term changes secondary to integrating research methodology into clinical care facilitate a decrease in the incidence and prevalence of pressure ulcers, as well as the time required to heal them. An obstacle to assessing the impact of the new approach is that pre- and post- implementation pressure ulcer incidence and prevalence studies have not been performed. From a research point of view, measuring the direct impact of these short-term changes on long-term outcomes would be difficult due to the multiple challenges inherent to wound care that may prevent clinicians from achieving wound healing goals. While short-term changes address clinician and systems issues, other significant multidimensional, complex patient issues factors also must be addressed in order to effectively improve long-term outcomes. Factors that impact wound status may not be feasibly addressed by skin care teams without longitudinal follow-up and a care plan that takes, for example, nutrition, acknowledgment of anemia and other comorbidities, pressure-relief method, and psychosocial factors into consideration. Furthermore, over a long-term period, the changes in the demographics and risk factors of the patients referred to the authors’ facility have made comparing prevalence and incidence of pressure ulcers between the cohorts pre- and post-implementation problematic. Therefore, while an interdisciplinary effort may successfully address particular short-term outcomes, long-term success in wound care will probably require a much broader approach that goes beyond the scope of practice of the authors’ existing skin care team.

Conclusion

  Incorporating research methodology into clinical practice in wound care has many benefits and advantages, both clinically and professionally. Implementing research methodology and EBM into practice is challenging, given the complexity of wound management. Plus, one needs to be mindful that the implementation of one particular EBM-based practice change may not result in a measurable positive outcome in wound care practice. Instead, a holistic approach that involves cultural and practice changes involving patients, caregivers, and the medical system needs to be fostered in order to bring about long-term positive outcomes. In other words, while integrating research methodology and EBM are important pieces in the puzzle of successful wound care, they must be complemented by the systems and social support necessary to complete the care picture.

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