Pressure Ulcer Prevalence and the Role of Negative Pressure Wound Therapy in Home Health Quality Outcomes
Healthcare policy makers, providers, and payors must find the optimal balance between providing high quality care and managing expenses. The estimated federal spending for Medicare and Medicaid beneficiaries in 2005 is $648 billion; for 2011, projected costs are more than $1 trillion.1
On-going discussions about methods to reduce the growth of healthcare expenditures are tempered by considerable concern about the negative impact of any cost-cutting initiatives on the quality of care provided. In response to the projected growth in healthcare expenditures, the federal government introduced initiatives through the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA)2 to manage costs and promote quality. These initiatives include programs that promote innovative use of technology, pay-for-performance (P4P) models, disease and chronic care management, and enrollment in Medicare Advantage (Medicare’s managed care option). Simultaneously, quality improvement strategies and initiatives have been set forth by federal agencies as well as independent organizations, including the Agency for Health Research Quality (AHRQ),3 the National Quality Forum (NQF),4 the Joint Commission on Accreditation for Healthcare Organizations (JCAHO),5 the Institute of Medicine (IOM),6 and the American Health Quality Association (AHQA).7
The Cost/Quality Focus in the Home Health Industry
Before MMA initiatives that specifically impact the cost/quality equation in the home health industry were introduced, the Centers for Medicare and Medicaid Services (CMS) presented home health providers with regulatory changes directed at managing cost and quality. In response to concerns about skyrocketing Medicare costs associated with rapid growth in the use of home health services by Medicare beneficiaries,8 the CMS implemented the Home Health Prospective Payment System (PPS) in October 2000.9 Under PPS, home health agencies receive a single payment for all care associated with an episode of care (up to 60 days) rather than receiving per-visit reimbursement as had been the case in the fee-for-service system. The amount of the PPS payment is determined at the start of a patient’s episode based on the patient’s clinical severity, functional dependence, and need for services. This bundled payment is designed to cover the costs of managing all aspects of patient care, including skilled care visits, support services, and supplies.
Shortly after implementing PPS, the CMS also embarked on a Quality Initiative directed at home health agencies that emphasized the need for ongoing quality improvement activities at the provider level.10 The Quality Initiative has two primary components — Outcomes Based Quality Monitoring (OBQM)11,12 and Outcomes Based Quality Improvement (OBQI).13 The former initiative requires agencies to monitor 13 adverse events determined by the CMS and investigate the care of patients who experience adverse events in order to identify potentially problematic or inadequate care or care practices. The latter initiative requires providers to focus performance improvement activities according to results obtained in 41 clinical and utilization outcomes areas determined by the CMS. Outcomes Based Quality Improvement further dictates a systematic approach to care investigation, implementation of best practices, and continual tracking or monitoring of progress. In addition to the OBQM and OBQI reports provided to agencies, the CMS makes a subset of the measures available to the public14; all data are available to state surveyors. State survey agencies use the reports as ammunition to target home health agency evaluations and sometimes hand select agencies for more frequent review. If a home health agency does not perform well on OBQM measures in comparison to the national norm, it is at risk for increased scrutiny by the state, which could result in condition-level deficiencies that may lead to Medicare decertification.
The CMS uses data collected in the Outcome and Assessment Information Set (OASIS) to determine PPS episodic payments and calculate the OBQM and OBQI quality indicators.15,16 The OASIS is a set of standardized assessments that agencies must complete periodically throughout each patient’s length of treatment as part of the Medicare Conditions of Participation (CoP). Agencies transmit the data to the state survey agency for reconciliation with the fiscal intermediary and analysis of quality and utilization outcome measures. To aid home health agencies in their quality improvement efforts, the CMS contracts with quality improvement organizations (QIOs) in each state to help agencies refine OBQI activities and care delivery systems.17 Based on Title XI of the Social Security Act, Part B, QIOs are given a Statement of Work (SOW) to guide their work with home health agencies.18 Changes in the SOW occur periodically and are referred to as “Rounds.” In the current 7th Round, QIOs are charged with helping agencies implement and use the OBQI process.19 In the 8th Round, scheduled to take effect August 2005, in addition to other subtasks aimed at assisting providers, the CMS will require QIOs to shift their activities away from a broad OBQI process focus to improving a specific OBQI measure — acute care hospitalization.20
While quality is most commonly assessed independently from cost, as with OBQI and OBQM, cost and quality measurement can sometimes overlap. The Agency for Healthcare Research and Quality (AHRQ), a federal entity that provides Fact Books to establish national benchmarks and identify target areas for quality improvement, has suggested that higher rates of preventable hospitalizations can help identify areas for potential cost containment and quality improvement in various segments of the US healthcare system.21 Based on analysis of data from the Healthcare Cost and Utilization Project (HCUP), National Inpatient Survey (NIS), and Prevention Quality Indicators (PQI), the AHRQ reports that for the year 2000 nearly 5 million admissions to US hospitals involved the treatment of a preventable condition, costing more than $26.5 billion. The AHRQ suggests that even a 5% reduction in preventable hospitalizations could result in cost-savings of more than $1.3 billion.
The Challenge of Wound Care
Owing to the financial pressure of PPS and increased scrutiny under the Quality Initiative, agencies are increasingly motivated to determine best practices for managing chronic wounds that minimize expenses related to visits and supplies while achieving/maintaining a high level of quality care.22-24 Patients with wounds present a more acute challenge to the cost/quality balance because wound care supplies can be expensive and wound management in home care often involves chronic, slow-healing wounds.25 Inconsistent wound assessment, documentation, and minimal use of adjunctive wound therapies for chronic wounds may contribute to increased costs because they can increase healing times and care visit frequency.26 Improved outcomes for wound care patients, especially for those with complex wounds, sometimes depend on advanced clinical skills in wound care management which also can add to the financial challenge faced by home health agencies.24 Providing advanced training to clinical staff or seeking out clinicians specializing in wound care can require an expensive investment in human resources. Given the current nursing shortage, recruiting and retaining nursing staff to manage these labor-intensive patients also can increase cost.
The inability to demonstrate quality outcomes for wound patients also can lead to increased scrutiny and discipline by state surveyors. Notably, emergent care for wound infection and deteriorating wound status are among the OBQM adverse events tracked by State surveyors.11 A CMS-sponsored “State of Science in Wound Care Management” multimedia broadcast27 emphasized that in order to reduce costs while striving for high quality outcomes, agencies need to adopt a wound management approach that is driven by outcomes rather than by nursing visits. In an outcomes-driven model, agencies focus on accurately assessing wound status, utilizing cost-effective wound care formularies and basic algorithms to determine appropriate therapy and to quickly identify wounds that are not responding to care and subsequently make appropriate changes. Cost-effective therapy was described as products or systems that promote optimal wound healing environments, control exudate, and provide a bacterial barrier for 2 to 3 days, thus reducing visit frequency.
Wound Care Technologies — Negative Pressure Wound Therapy
Various wound care technologies are available for treating complex chronic wounds. Ovington25 reports that more than 50 manufacturers produce more than 350 different types of wound care therapies. Many of these modalities are grouped under one of the following categories: transparent film, hydrocolloid, foam, calcium alginate dressings, or negative pressure wound therapy (NPWT). Of these technologies, NPWT in particular may present an attractive wound management system for the home health industry to investigate for its potential impact on the cost/quality balance. Some positive clinical outcomes using NPWT have been reported28-30 and in one study a reduction in hospitalization of surgical patients was observed.31 Furthermore, NPWT is reimbursable under the Medicare Part B Durable Medical Equipment (DME) benefit32; therefore, it may be more cost effective than some other wound technologies to home health providers. The only NPWT verified by the CMS is Vacuum Assisted Closure® (V.A.C.® Therapy, Kinetic Concepts, Inc. [KCI], San Antonio, Tex.).
Negative pressure wound therapy is the application of subatmospheric pressure to promote wound healing. According to a recent NPWT review article,33 NPWT is ideally suited for the management of large, Stage III and Stage IV ulcers with inadequate or poor granulation tissue and heavy exudate. Negative pressure wound therapy consists of a sterile, open-cell foam dressing placed in the wound and covered with an occlusive dressing. A computerized therapy unit connected to the foam via tubing applies intermittent or continuous subatmospheric pressure to the wound while drawing exudate away from the wound into a sealed canister. The main reported mechanisms of action are the provision of a moist wound healing environment, removal of fluids and infectious materials, assisted perfusion, decreased bacterial colonization, and enhanced formation of granulation tissue.33 Negative pressure wound therapy requires infrequent dressing changes — for instance, once applied, per manufacturer recommendations, the system needs only be changed once every 48 hours unless the wound is infected. The therapy system is safe and easy to manage in the home care setting.
The effect of available technologies on wound healing and other clinical measures is frequently discussed, but limited data exist on whether any of these wound care technologies are associated with OBQI or OBQM quality indicators such as acute care hospitalizations, emergent care for wound infection, or deteriorating wound status.
Given the financial challenges presented by PPS and the increased focus on demonstrating quality outcomes, more research is needed to determine whether wound care technologies, such as NPWT, are associated with positive quality outcomes. Furthermore, the number of controlled clinical studies regarding NPWT and pressure ulcers is limited. Although promising results have been observed, few statistically significant differences have been reported.29-31 This suggests more research is needed to better understand the role of NPWT in the care of pressure ulcers. Information about the prevalence of advanced stage pressure ulcers managed in the home health care setting that may be appropriate for many wound care technologies is small and fragmented, thwarting potential knowledge and impact of effective therapies.
This retrospective study was conducted to: 1) determine the prevalence of Stage III and Stage IV pressure ulcers in the home health care population and 2) quantify the impact of NPWT in reducing acute care hospitalizations and emergent care in general, and wound infection or deteriorating wound status specifically.
Prevalence of pressure ulcers in home health. Although the prevalence of pressure ulcers across many healthcare settings warrants concern, drawing definitive conclusions from previous prevalence estimates is difficult. According to an Agency for Healthcare Policy Research (AHCPR, now AHRQ) panel of experts,34 in addition to studies that focus specifically on the home health setting, previous estimates of data acquisition methods and pressure ulcer classification systems suffer from insufficient control and few estimates are based on databases that contain a large number of patients from multiple sites. Additionally, many of the previous estimates are based on nearly 10-year-old data and data not representative of a full year.
Among studies estimating the prevalence of pressure ulcers in the home health care setting, a variation exists between mean and between-agency estimates. For example, in a survey of 177 home health agencies involving 21,529 patients, Meehan, O’Hara, and Morrison35 found a pressure ulcer prevalence of 6.8%, with between-agency estimates ranging from 0.5% to 35.7%. In a study of patients admitted to home care, Ferrell et al36 found a pressure ulcer prevalence of 9.12%. When the worst ulcer for each subject was considered, the prevalence of Stage III and Stage IV pressure ulcers was 27%. In addition, more than one third of patients admitted with a pressure ulcer had two or more ulcers and 30% of patients admitted to home care without a pressure ulcer were at risk for developing one while on the service.
Quality outcomes associated with NPWT and pressure ulcers. Few studies have investigated whether NPWT is associated with quality outcomes — specifically, reduction in hospitalization or emergent care. In a retrospective analysis of 47 surgical patients with open foot wounds with significant soft tissue loss, Page et al31 found that patients treated with NPWT had an 80% reduction in risk for one or more hospital admissions compared to patients treated with wet-to-moist dressings after controlling for age, serum albumin, and wound size (P = .02). However, no statistically significant difference was noted for cumulative wound cavity filling or wound closure. All patients had surgically debrided, non-infected wounds when therapy was initiated. Patients were excluded if they had persistent wound infection, necrotic tissue in the wound bed, or an interruption in treatment or alternative therapies during the wound cavity filling time. No studies were identified that investigated whether NPWT was associated with reduced hospitalization for home health patients with pressure ulcers. Similarly, no studies were identified that investigated whether NPWT was associated with reductions in emergent care or infections or home health patients with pressure ulcers.
Page et al’s31 inclusion of hospital readmission as an outcome measure is unusual. Most studies examining the effect of NPWT have focused on wound reduction or other clinical measures of healing, such as wound cavity filling and wound closure. Although many NPWT pressure ulcer studies report promising results, statistically significant differences are not observed, suggesting more research is needed to better understand the effects of NPWT on pressure ulcers. For example, in a randomized control trial of 28 patients with full-thickness pressure ulcers, Ford et al28 observed that patients treated with NPWT had an overall pressure ulcer volume reduction of 51.8% compared to 42.1% for patients treated with other wound care products, but the difference was not statistically significant (P <0.1). Decreased inflammation and an increase in capillaries also was observed but these differences also were not significant (P <0.1). In another randomized trial of 22 patients with pelvic pressure ulcers, Wanner et al29 found no difference in time needed to decrease wound volume by 50% between patients treated with NPWT and patients treated with wet-to-dry or wet-to-wet dressings soaked with Ringer’s solution. Although these results did not support their hypothesis that NPWT would improve wound healing, they concluded that NPWT was advantageous because its effectiveness was similar to traditional dressings but less expensive because the reduced frequency of dressing changes saved nursing staff time. In a case series of 10 patients with Stage IV pressure ulcers treated with NPWT, Isago et al30 reported that after 4 to 7 weeks of therapy, wound areas had reduced an average 55% and depth reduced by an average of 61%. Because this study did not include a control group, ascertaining whether these results are significantly different from another type of wound care technology is not possible.
To calculate prevalence of pressure ulcers in the home health care setting, data from the Outcome Concept Systems (OCS) OASIS data warehouse were analyzed. Outcome Concept Systems is a Seattle-based data company that maintains the largest OASIS database outside of the CMS. As of May 2005, the OCS OASIS database contained approximately 13 million individual OASIS records, representing 5 million complete cases of home care. Although this is a proprietary database comprised of patient records that represent the population served by OCS home health agency clients, these clients are diverse in terms of their geographic, urban/rural, agency affiliation, size, and profit-status representation (see Table 1). The OASIS data set is administered consistently across all agencies in accordance with the Medicare Conditions of Participation (CoPs).
Data from 1.94 million start-of-care OASIS assessments completed between January 1, 2003 and December 31, 2004 were used to calculate pressure ulcer prevalence. Prevalence was calculated by stage and status of the most problematic pressure ulcer and further categorized four ways: 1) the pressure ulcer was the only wound reported, 2) a stasis ulcer also was present, 3) a surgical wound was also present, and 4) for all instances of pressure ulcer. The average number of visible pressure ulcers also was calculated by stage. The prevalence denominator was the number of start-of-care assessments completed during each timeframe for all patients, and for the more detailed analysis, for all pressure ulcer patients. Numerators were defined as a subset of the start-of-care assessments using the OASIS M0-items (see Table 2).
Acute care hospitalization and emergent care rates of home health patients with Stage III and Stage IV pressure ulcers using NPWT were compared to those using any other wound care therapy (comparison group) using the following methodology: NPWT was defined as the use of the only NPWT verified by the CMS. Outcome Concept Systems identified 390 home health agencies utilizing both NPWT and OCS data analysis services. These agencies were asked to submit data that could be used to link patient OASIS records to NPWT usage records. Of the 367 agencies contacted, 320 submitted data (some had gone out of business, were no longer OCS clients, or did not return calls). Patient matches were identified in 292 agency databases.
Patients were identified in the OCS database as NPWT patients when NPWT records could be linked to OASIS data through a set of unique patient identifiers. To enhance homogeneity of the study population and reduce the confounding effects of concomitant conditions, only patients that met the inclusion and exclusion criteria were selected (see Table 3). Comparison groups were created by dividing eligible patients into those receiving NPWT and those receiving any other wound care modality. The comparison group was tracked from start of care through end of care. The latter group was obtained only from agencies not utilizing NPWT. All other modalities were grouped because discerning with certainty the exact type of technologies used was not possible. Case matching resulted in 60 patients in the NPWT and 2,288 in the comparison group.
In all instances, care utilization rates were calculated for the following categories:
• acute care hospitalization (for more than 24 hours) for any reason
• emergent care (ER visit, emergency house call, or emergency visit to a clinic, doctor’s office or outpatient clinic)
• acute care hospitalization for wound infection, deteriorating wound status, or new lesion/ulcer
• emergent care for wound infection, deteriorating wound status, or new lesion/ulcer.
Patients receiving NPWT were tracked during the time NPWT was applied plus 7 days following removal to take into account any wound infection or deterioration that may have related to NPWT.
Outcome Concept Systems staff, independent of KCI, conducted all analyses and data management. Microsoft Excel, SQL, and Access (Redmond, Wash.), and SPSS (Chicago, Ill.) software packages were utilized throughout the study to facilitate data imports, merges, and calculations. T-tests were used to determine statistical significance of between-group differences.
Pressure ulcers. Pressure ulcers were relatively common among home health patients. In 2003 and 2004, 134,147 out of 1,941,039 (6.8%) of home health care patients had pressure ulcers at start of care. Table 4 outlines prevalence measures by different strata. Most patients with pressure ulcers (98,779 out of 134,147, 74%) did not have other wounds, such as venous ulcers or surgical wounds at start of care. Further, out of 134,147 problematic pressure ulcers, 31,097 (23.2%) were reported as Stage III or Stage IV at start of care and 41,305 (31%) were reported as “not healing.” The average number of visible pressure ulcers by stage also was calculated for all ulcers by stage. Of patients with pressure ulcers at start of care, the average number of visible ulcers was 1.58 in 2003 and 1.56 in 2004 (see Table 4 and Table 5). Patient characteristics in the NPWT group were similar to those in the comparison group (see Table 6).
A significantly lower percentage of NPWT patients (35%) experienced hospitalization when compared to the comparison group (48%, P <.05) (see Table 7 and Table 8). None of the NPWT patients needed emergent care for wound-related problems, compared to 189 (8%) of the comparison group (P <.01) and three (5%) of the NPWT group required hospitalization for a wound-related problem compared to 310 (14%) in the comparison group, (P <.01).
When stratified by pressure ulcer stage, many of these associations remained statistically significant. For example, seven (24%) of the NPWT patients with Stage III pressure ulcers experienced hospitalizations and one (3%) experienced hospitalizations for wound problems, compared to 756 (44%, P <.05) of patients in the comparison group with Stage III pressure ulcers who required pressure ulcer-related hospitalization and 194 (11%, P <.01) hospitalizations for wound-related problems. Similarly, a lower percentage of patients with Stage IV pressure ulcers receiving NPWT had hospitalizations for wound-related problems (two, 7%) compared to patients in the comparison group with Stage IV pressure ulcers (116, 20%; P <.01). In terms of emergent care, patients with neither Stage III or Stage IV pressure ulcers receiving NPWT required emergent care for wound problems, compared to 126 (7%, P <.01) of patients with Stage III and 63 (11%, P <.01) of patients with Stage IV pressure ulcers in the comparison group.
The prevalence of Stage III and Stage IV pressure ulcers at start of care and ulcers reported as “not healing” suggests that a considerable percentage of home health pressure ulcer patients are admitted to home health care with complex wounds.
Prevalence measures for pressure ulcers reported in this study fall within range of previously reported home health care data. Overall pressure ulcer prevalence reported in this study was 6.8%, compared to 9.12% by Ferrell et al36 and 6.8% by Meehan et al.3 Unlike previous studies that relied on data from well under 50 agencies or from fewer than 20 states,35-37 prevalence reported in this study is based on data from almost 800 agencies and included nearly 2,000,000 start-of-care assessment records covering a full year of OASIS start-of-care assessments. Both the study sample size and study duration, which reduces the impact of seasonal variation, enhances the generalizability of these results, although it does not guarantee they are nationally representative from a statistical point of view.
This is the first published study comparing hospital admission and emergent care utilization between patients using NPWT and patients using other wound care technologies, quality measures that are especially important to home health agencies and that are aligned with the standards detailed in the OBQI process.38 In the OBQI process, agencies are encouraged to evaluate a problematic outcome and identify care processes linked with that outcome that include at least 30 patients. In this study, the target outcomes are acute care hospitalizations and use of emergent care and the rate of problematic events was lower in patients receiving NPWT. The next logical step in the OBQI process is to develop a plan of action to implement and monitor care processes associated with excellence.
Using inclusion and exclusion criteria allowed researchers to match NWPT cases to non-NWPT comparisons to offer some adjustment for relevant risk factors that could potentially act as confounders in this study. Although this matching reduced the sample size, the number of NPWT patients included in emergent care and hospital admission comparisons was nearly three times larger than the number of NPWT patients included in studies conducted by Ford et al28 and Wanner et al.29 The number of NPWT patients also exceeded the number included in the retrospective analysis by Page et al,31 which also found an association between the use of NPWT and reduced hospital admissions. Still, the validity of these results needs to be confirmed with a larger sample size as well as prospective clinical study designs.
Although the agency client base of the OCS data warehouse is broad in terms of volume and characteristics, it does not definitively include a nationally representative sample; thereby, overall generalizability of the study results is limited. This limitation is mitigated to some extent by the large sample size used in calculating prevalence measures but the sample size of the comparison group is smaller, increasing concerns about generalizability of the results. Additionally, using a comparison group composed of all other wound care modalities is limiting — ie, comparisons between distinct types of wound care technologies, such as NPWT compared to calcium alginate dressings, would have been more informative. This was not possible given the limitations of the variables contained in the database.
The potential for information bias is also present as is the case in all retrospective comparisons that rely on data contained in a large database. Data utilized were collected through standardized assessment practices, mitigating 1) the possibility that substantial differences existed in the quality of the information obtained from NPWT and the comparison group and 2) the threat of bias due to non-response and loss to follow-up. However, errors could have occurred in data collection and data entry that might have affected how patients were selected or how study measures were calculated. Certainly, concerns have been raised about the assessment competencies of clinical staff using OASIS in general and for assessing wounds specifically.39 In addition to concern about baseline assessment skills among clinicians, concern also exists regarding differing levels of baseline knowledge between clinicians. In a study comparing the accuracy of OASIS completion by home health nurses and therapists, Madigan, Tullai-McGuinness, and Fortinsky40 observed that when a discrepancy exists between clinician responses, nurses’ responses agreed more often with the “correct” answer than the therapists’ responses. To improve the accuracy of wound assessment, the Wound Ostomy and Continence Nurse Society (WOCN), the CMS, researchers, and individual home health organizations have provided education in the form of guidance documents, self-learning modules, “hands-on” learning, and multimedia educational broadcasts.27,39,41,42
Pressure ulcers are a common concern in home health care. Given the multifaceted demands of achieving high quality outcomes for patients with pressure ulcers in a cost-conscious environment, home health agencies are compelled to implement wound care therapies associated with positive outcomes that also can reduce expenses. Negative pressure wound therapy appears to be a viable option. Because it requires fewer dressing changes than traditional gauze dressings and is associated with reduced use of emergent care and hospital admissions for patients with Stage III and Stage IV pressure ulcers, NPWT can potentially help home health agencies improve patient care, decrease unexpected health care costs, and decrease cost associated with number of visits. This study also provides QIOs with an example of how steps in the OBQI process can be used to identify “best practices” for achieving reduction in acute care hospitalization in home health, thus aiding in their new call to action with the upcoming 8th Statement of Work.45
While the results of this study suggest that NPWT is associated with reduced hospital admissions and emergent care utilization for home health patients with advanced stage pressure ulcers, more research is needed to compare other quality outcomes such as quality of life, pain, and time to healing as well as costs of care. The latter should include the direct and labor costs of implementing, maintaining, and using the system; cost associated with the duration of care for patients on the system; and potential savings achieved by preventing unplanned emergent care or hospitalizations. Pay-for-performance demonstration projects outside of home health in which emergent care and hospitalization rates may impact reimbursement are also underway.43,44 Negative pressure wound therapy would be an interesting wound care technology to implement and evaluate in these settings.
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