Abstract: There is a growing interest in applying the tenets of palliative care to patients with nonhealing wounds. Palliative care measures are appropriate for patients with nonhealing wounds at any point along the continuum of care. The decision, however, to move a patient from a curative treatment plan toward a plan of care that focuses on symptom modification and wound stabilization requires the clinician to know if the wound is truly recalcitrant or simply under-treated. This article examines wound healing outcomes in a newly created subacute wound unit and begins to define an evidence- and outcomes-based approach to establishing a palliative wound program integrated into a fully comprehensive wound healing program.

I

t is expected that by 2030, 20% of the American population will be 65 years of age and older, and the number of Americans dying in nursing homes will likely increase from the current 20%.¹ In addition, by 2030, it is estimated that over 157 million Americans will suffer from chronic illnesses.² With this huge demographic shift, it is paramount that clinicians begin to address the needs of adult immobilized and frail patients for whom cure (ie, complete wound healing) may not be the ultimate goal of therapy.
       The authors practice at an outpatient, hospital-based wound clinic within a 650-bed level 1 trauma center on the south side of Chicago. The clinic provides an inpatient consult service, a physical therapy wound unit for both out- and inpatient wound care, and a subacute wound unit located offsite. In 2004, the overall program performed 13,000 patient visits.
       All clinical subunits of the program utilize a wide array of advanced modalities for healing, including growth factors, human skin equivalents, ultrasound, electrical stimulation, and plastic and vascular surgical techniques among others. The program also participates in numerous clinical research trials. In the past, the only measured successful outcome was the percentage of wounds healed. Although the patients’ wishes were considered, a rare case would have a goal for palliation instead of cure. The clinic’s data for healing outcomes have been published, and the clinical success of the wound unit is well established.³ As the program has matured over the years, more complicated and severely debilitated patients have been referred to the authors’ tertiary care hospital specifically for wound care issues. The hospital-based inpatient program has witnessed a dramatic increase in consultations and revisits over the years (Table 1). Many of these patients were referred from outlying nursing homes and were frail, elderly, and suffered from numerous chronic illnesses in addition to having nonhealing wounds as the principle reasons for admission. The increase in hospital patients with wounds is reflected in the authors’ point prevalence studies, which have shown an increase from 14% in 1999 to 22% in 2004. Many advanced therapeutic approaches and surgical interventions were too risky for the patient, or the likelihood of healing was remote. This new population poses significant clinical, economic, and ethical concerns for the team. The authors asked the following questions: How can we identify which of these patients will heal if all treatments are applied? Can we achieve similar healing outcomes for these chronically debilitated patients as we have previously obtained in our outpatient wound clinic? Are there statistically significant surrogate endpoints that might help us determine that a patient was unlikely to heal at an earlier point in therapy? These questions can only be answered after establishing clinical outcomes data for patients at each point along the continuum of care.

Table 1

       To begin, palliative care refers to controlling symptoms and suffering and improving the quality of life.⁴ The principles of palliative medicine can and should be applied concomitantly with curative treatment protocols. Over the course of treatment, however, some patients either fail to progress, or their clinical condition deteriorates to a point that aggressive measures are inappropriate. At this point, the clinical care converts from a curative model to a completely palliative model.
       The authors recently opened a subacute wound unit with 30 dedicated beds for patients with chronic wounds. A wound care physician rounds on all the patients weekly along with a wound nurse from the hospital unit to ensure continuity of care and the exchange of information between the units. Only after determining the healing rates, treatment duration times, and percentage of wounds not healed when the goals for care were healing can 2 distinct possible palliative populations emerge.
       The first group consists of patients in whom all treatment options have been delivered but either due to clinical conditions or local factors at the wound bed, they are unable to achieve healing. These patients might, however, benefit from decreasing the size of the wound, eliminating drainage, preventing infection, controlling for pain and odor, and moving to a home environment with a more stable wound. The goals for care at that point become wound stabilization and palliation. It would be useful to have clinical markers or predictive profiles for patients that would help identify this group earlier in the course of care. Not only would this be more cost effective, but the patients could avoid being exposed to numerous potentially invasive treatments that fail to improve their chances of healing.
       The second potential population consists of those patients in whom it is clinically obvious that healing is not an achievable goal. These patients are often nursing home residents with flexion contractures, cognitive impairment, and limited quality of life. The wound team needs to make a critical decision on these patients before implementing treatments. The following question is asked of a patient in this population: Would this patient’s life be significantly better from a quality-of-life standpoint if the wound was healed? If the answer to this question is no, a family conference is required to evaluate the expectations of the family and to determine if palliative goals and objectives are appropriate. Many of these patients have end-stage dementia or stroke and should be considered for hospice placement. A palliative consult team is useful at this point of care.
       Chronic wounds are defined as those that fail to progress through an orderly and timely sequence of repair or wounds that pass through the repair process without restoring anatomic and functional results.⁵ This definition needs to be expanded to consider those patients whose chronic wounds, despite recognition through risk assessment and adequate treatment, will not successfully heal.⁶

Objectives

       The primary objective for this project was to calculate the healing rates over the first 6 months of practice at a newly created subacute wound unit. Secondary objectives included establishing surrogate endpoints that could be used to allow for a more realistic assessment of an individual patient’s chances for healing. This information could be used to alter therapy or to consider a palliative approach for a patient based on a quantitative approach.

Design

       A prospective, outcomes management study was conducted at a single subacute wound unit. An intent-to-treat approach was incorporated, excluding only those patients who were seen on a “consult only” basis. Each patient’s medical record included a spreadsheet with weekly entries including wound etiology, length, width, and depth, treatment modality, primary and secondary dressing, percentage of wound bed covered by granulation, slough or eschar, and wound volume.This data was recorded by hand excluding patient name, medical record number, or any other identifiable piece of information to maintain patient medical record confidentiality. The raw numbers were then entered into a SPSS statistical software package (SPSS, Chicago, Ill). Patients were admitted to the subacute wound program directly from the authors’ acute care hospital. The patients were seen daily by a physical therapy team and wound nurse and at least weekly by a wound physician. The wound team members have been working together for at least 4 years, and wound assessment, measurement techniques, and treatment protocols have been determined and validated. Moist wound healing was the primary treatment technique, and a wound care formulary was followed. Advanced wound treatment modalities were also used, including negative pressure therapy, electrical stimulation, periwound megahertz ultrasound, pulse lavage, and ultraviolet light C band. Data was calculated using SPSS statistical software. All wounds treated from the date the program opened through the first 6 months were included (August 2004–February 2005).

Results

       A total of 108 patients with 133 wounds were prospectively entered into the database. Only patients who were seen once for consultation were excluded (6 patients). The data was collected on an intent-to-treat basis. Two outcomes were defined as clinical success in this study. The first was the gold standard measure of total healing. Since the program relied heavily on surgical interventions, the total healing cohort was further divided into those wounds healed secondarily versus those healed by surgical means. Another parameter, marked improvement, was defined by a greater than 50% wound volume reduction. This parameter was reported by the authors in a prior publication, and it is clinically relevant for the subacute wound population.⁷ A significant reduction in wound volume can enable the patient to move to another point along the continuum of care (ie, home health) with less complex dressing requirements. Wounds were either healed or markedly improved in 68.4% of cases. Of this sub-group, 22.56% were markedly improved (Kaplan-Meier median 5.0 weeks), and 77.44% were totally healed (Kaplan-Meier median 6.0 weeks) (Figure 1).

Figure 1

Of those wounds totally healed, 63.9% were healed secondarily, and 36.1% were healed by surgical means (Table 2). Of those patients with nonhealing wounds (n=31 patients), 5 or 16.1% were subsequently enrolled in palliative programs with nonhealing endpoints established as goals of care. Thus, of the 108 initial patients treated with curative protocols, 4.6% were ultimately palliative care candidates (Table 3). Other nonhealing patients were discharged to home with home health nursing, outpatient clinic follow up, or physical therapy.
       These patients may or may not eventually heal with these protocols, but they are not going to continue with the aggressive treatment timeframe goal of healing within 16 weeks as is customary for routine patients. These patients may eventually transfer over to a fully palliative protocol as well if their conditions warrant. By plotting wound volumes over time, there is a clear distinction between those that either heal (secondary intention only) or markedly improve compared to those that do not achieve healing within the first 2 weeks of treatment. Patients that were closed surgically were not included in this portion of the analysis, as these wounds often maintain large sizes and then are suddenly taken to zero volume via surgical means, making the graph difficult to analyze. There is less clinical significance for this pattern of volume reduction; however, these patients appear more like nonhealers with regard to initial 4-week volume reduction curves.

Tables 2,3

Discussion

       Palliative care is misunderstood by most clinicians. Inconsistent education on palliative care and hospice topics exists among healthcare providers. Few randomized clinical trials support evidence-based decision making, and reimbursement is suboptimal. Similar issues plague the wound care industry as well. After the authors published the results from the hospital-based outpatient wound clinic, they realized that 26–28% of those reported wounds did not heal.⁷ Who were those patients? What would a clinical profile of a nonhealer look like? Did all of those patients have healing as their primary goal? The concept that a goal of care could be a stable nonhealing wound was introduced in a 1999 publication.⁸ One of the concerns surrounding the term “palliative wound care” was that patients might be labeled “palliative” simply because they were too difficult or costly to heal. Categorizing a patient as “palliative” could be an excuse for poor outcomes. It is therefore imperative that healing rates are established at all sites of care along the continuum to assist clinicians when contemplating a palliative approach with an individual patient.
       Bolton et al.⁹ published an outcomes article using a validated, standard clinical approach for patients in home health and long-term care facilities. In 12 weeks of therapy, 52% of pressure ulcers healed in the home health environment, while 31% healed in long-term care.⁹ Only 30.6% of stage IV pressure ulcers were healed at 6 months in a study of patients in the VA system by Berlowitz.¹⁰ Nosocomial pressure ulcers are also thought to be predictive for mortality with a 68.9% 180-day mortality in 1 study.¹¹ This is 1 of the few articles that discusses the ultimate fate of those patients who do not achieve healing. Obviously, any aggressive attempts at closure for this population would have exposed the patients to unnecessary risks. The authors have described results from an aggressive, hospital-based wound clinic program that generates 175 direct admissions per year specifically for wound care-related problems. Of these inpatients, many are then transferred to the subacute wound unit. Using all of the technologies available to a tertiary care, level 1 trauma center with a dedicated, hospital-based wound program, 4.6% of cases are subsequently transferred to a fully palliative program.
       The authors are now developing protocols and guidelines to expand the subacute wound program to include a comprehensive palliative wound program. This program will be located within the same unit as the original program and will utilize the same wound care staff with the addition of chaplain services, social service, and pain and hospice consultants when required. This population of patients will also come from the authors’ acute care hospital, but the majority of these patients are admitted from the emergency room rather than the wound clinic. Many nursing homes admit patients with catastrophic illnesses in whom skin breakdown creates enormous limitations on their clinicians to provide the cornerstone elements of palliative care, which are comfort, dignity, and the freedom to accomplish quality-of-life objectives.¹² There is a tremendous growth in hospitalized patients who are chronically ill but not terminal, and this has led to an explosion on hospital-based palliative care units.¹³ Where will these patients be transferred? Who will have the expertise to manage these large and often complex wounds? Patients from nursing homes also have a disproportionate prevalence of dementia, which is also known to affect pressure ulcer prevalence in the palliative population.¹⁴
       It is the authors’ belief that these patients can be cared for within the confines of a wound healing unit. Patients who are deemed “palliative” still can and do receive such modalities as pulse lavage and ultraviolet light, both of which reduce infection rates and eliminate odor. Many of the patients are treated with advanced moist healing dressings that control bacteria, eliminate pain, and are left in place for several days at a time, minimizing painful dressing changes and unnecessary patient turning. Special support services can help relieve pressure, decrease pain, and assist with gentle patient movement to prevent further tissue breakdown. Nutritional services are readily available for the patients on the wound unit, and these patients can simply be added to current caseloads. The wound care clinicians already spend tremendous amounts of time with patients and families and often have a better relationship than any other physicians treating the patient. Wounds that are treated appropriately even when healing is not the goal can markedly improve in 50% of the cases, even in a hospice unit.¹⁵

Conclusion

       Although the majority of patients can be healed or markedly improved with an aggressive, multidisciplinary wound program, a percentage of patients would benefit from a purely palliative approach. A much larger group of patients would benefit from palliative care if the total hospital inpatient population is evaluated. Future studies are planned to merge the Minimum Data Set information with clinical outcomes measures to regress variables and attempt to identify a “predictive profile” of a patient that will not heal and could, therefore, be moved to a palliative care program earlier. The authors will continue to monitor and plot wound volume reductions over time to see if these early results are consistent as the number of patients enrolled becomes more substantial.