Abstract and Introduction
Abstract
As healthcare providers prepare for pay for performance (P4P) and outcomes-based reimbursement strategies, it is increasingly important to document clinical results. Historically, healing rates have been reported from hospital-based, outpatient wound clinics. Time-to-healing curves from one site of care may not accurately reflect the entire healing "episode of care." Few outpatients from a wound clinic require hospitalization and even fewer are admitted to sub-acute care. Care setting and population risk strata must be clearly identified before comparing wound outcomes data. Aim. Primary objectives were to determine comparability of complete healing and 50% wound volume reduction of current and prior sub-acute care programs. Predictive value of Minimum Data Set (MDS 2.0) items on admission was also explored in discriminating healing versus nonhealing patients. Methods. Wound outcomes were analyzed for all patients (N = 101) treated at a dedicated sub-acute wound unit from January 2006 through April 2007 in a prospective, longitudinal, intent-totreat, cohort study. Results were compared to prior sub-acute care wound outcomes reported by a similarly composed team using similar protocols. Results. Of 101 evaluable patients with 209 wounds, 41.6% healed in a median of 7.9 weeks while 31.6% achieved >50% volume reduction. Outcomes were similar to prior sub-acute results, but less than the 72%-74% healing rate reported by a similar team in hospital outpatient clinic programs. Minimum Data Set comorbidities analyzed did not significantly predict nonhealing. Conclusion. To allow risk-adjusted P4P and reimbursement metrics, wound outcome reports should include clinical team involved, protocol utilization, care setting, and case mix severity to control for variables associated with different settings.
Introduction
Healing rates have become both clinical and marketing tools for many wound care centers. The recording and reporting of clinical results are imperative in today's health care marketplace. Published articles, however, rarely stratify a patient's risk in outpatient settings. Patients not seen in clinic for 30 consecutive days are considered lost to follow-up and that clinical episode is closed out from the data set. For example, a patient presents for a consult with a venous leg ulceration of 1-year duration that was unsuccessfully treated in a primary care physician's office. The wound carries a heavy bioburden and fibrin load requiring an office-based debridement followed by 3 weeks of moist dressings and compression. The patient fails to improve and is admitted to the hospital for 1 week of treatment including intravenous (IV) antibiotics and surgical debridement. On discharge from the hospital, the patient is transferred for a 6-week stay in a sub-acute unit. A total of 8 weeks later, the same patient returns to the outpatient clinic from home due to a plateau in healing after 2 weeks of home health therapy and is re-enrolled in the clinic as a new patient. The wound is now 75% smaller in area than at the time of the original consult. Compression and moist dressings are again applied and the wound completely heals in 5 weeks. The various outcomes from this single case include, 1 year of treatment without improvement in a primary care office, a new consult lost to follow-up without healing in 3 weeks in the wound clinic, a hospital stay of 5 days with an increase in wound size status post surgical debridement, a 6 week sub-acute stay with a 50% volume reduction in 6 weeks, home health care for 2 weeks with no change in wound size, and a completely healed wound treated in 5 weeks in the outpatient clinic. The "episode of care" outcome, however, describes a venous leg ulceration that required 69 weeks of therapy including primary care visits, wound clinic treatment for 8 weeks, home health care for 2 weeks, a sub-acute care stay of 6 weeks, and 1-week hospitalization. This clinical example is a common scenario and represents the importance of defining the site of care when analyzing wound healing data. Each point along the continuum of care acts as a "silo" of care and not part of a larger system of care. Additionally, current reimbursement policies create the potential for each site of care to maximize economic outcomes that may not make clinical or economic sense if the entire "episode of care" was integrated across settings. Concepts such as pay for performance are a step in the right direction, but also focus on achieving benchmarks from individual sites of care and, therefore, fail to achieve true integration across care settings.
The authors have created an integrated care approach to wound healing using a combination of strategically aligned groups that do not function under the same corporate umbrella. Patients are seen in an outpatient, not for- profit, hospital-based wound clinic. In addition, inpatient wound care is provided for a second hospital that belongs to a completely different not-for-profit organization. The clinic admits directly to both of the hospitals in which inpatient care is provided. The authors' sub-acute wound unit is a privately owned for-profit center with no formal business relationship to either hospital. The home health agencies are operated by each of the 2 previously described hospitals. The authors' prosthetics and orthotics group provide services at all locations and are a small privately held firm. The specialists that consult and work with the authors' team are mainly from private practice models. The entire team, including physicians, are salaried and have no volume or procedure-driven economic incentives at any of the sites of care. The single most difficult aspect of providing care in this model is case management. Not only does it represent the most time consuming component of overall patient care, it is the least economically productive. It seems paradoxical that the most critical piece of the final clinical outcome carries with it no form of reimbursement. The current model encourages procedure volume and fails to reward outcomes.
With that as a backdrop, if there is to be any change in the financial structure of wound care, wound care clinicians need to collect, analyze, and publish outcomes from all sites of care and for all strata of patient risk and wound complexity. Therefore, the authors set out to validate earlier published results from a sub-acute wound program run by the authors a few years ago. Validating those outcomes would confirm reproducibility of the clinical model across settings. The hypothesis was that a systematic approach to patient care could be reproduced in a similar, but new facility, given that the clinical wound team was held constant.
Objective
The primary objective of the study was to identify the healing outcomes both as a percentage of the total population and in relation to time of treatment. Another primary objective of the study was to validate the results from an original pilot program conducted at a similar private, for-profit facility that was part of a large, national chain of nursing homes. A secondary objective was to identify any patient characteristics on admission to the unit, using the US Centers for Medicare and Medicaid Minimum Data Set 2.0, which could be used to predict final outcomes. (The Minimum Data Set 2.0 is a US Centers for Medicare and Medicaid [CMS] initiative that was introduced as a part of the Nursing Home Reform Act of the Omnibus Budget Reconciliation Act of 1987).
Study Design
The entire study was conducted at the authors 25-bed, sub-acute wound unit dedicated to the treatment of patients admitted with nonhealing wounds. The unit resides within a 300-bed, privately owned, for-profit nursing home/long-term care facility, one of several facilities owned by the company. The executive team was highly involved and encouraged the development of a clinically focused, outcomes driven unit. The nurse and physical therapists on the unit treat only patients with chronic wounds and have worked with the authors implementing prior programs. Patients originate from a hospital based wound clinic that receives more than 2500 patient visits per year (on average). A previously published systematic approach and treatment protocol is utilized for all patients with nonhealing wounds of any etiology. The clinic has generated an average of 150 hospital admissions per year for the past 6 years. A percentage of patients are then transitioned from the inpatient unit to the sub-acute wound unit for advanced inpatient care. This group of patients is either too debilitated or their wound care requirements exceed those fulfilled in the home or outpatient clinic. Results obtained from this sub-group of patients constitute the basis of this report.
The current sub-acute program was created January 1, 2006. All patients admitted to the program between January 1, 2006 and May 1, 2007 were included in intent to- treat analysis, with a statistical significance criterion of P ≤0.05. The only patients excluded were those with either no wound (ie, a wound recently closed with a myocutaneous flap, admitted for offloading and antibiotics) or patients who had a single visit (patients seen once and then transferred to an acute care hospital). This group contained 8 patients. Each patient was admitted to an internal medicine or family medicine unit for general medical care by the attending physician. A wound physician saw the patient on admission and weekly on rounds. A comprehensive wound treatment plan was designed and care was delivered by the nurse and wound care physical therapists. All advanced wound care products were available, as well as IV antibiotics, total parenteral nutrition, rehabilitation services, pharmacy, and nutritional consultative support. Wound modalities including negative pressure wound therapy, ultrasound -- both Megahertz and MIST™ Ultrasound Therapy (Celleration, Eden Prairie, Minn) -- electrical stimulation, and ultraviolet light, were employed when indicated. The physical therapist or physician performed wound debridement as needed. Each week the wound physician selected the modality and dressing treatment plan to meet the needs of the wound and the patient as identified by standardized assessments. Orthotic and prosthetic consultation was available on site for offloading and compression. A physician specializing in infectious disease evaluated all patients weekly to monitor culture results and antibiotic levels. The wound nurse and wound clinic staff communicated daily to organize patient transition to and from the hospital for staged procedures, and ensured that on discharge patients were transitioned smoothly back to the outpatient program.
As part of the admitting process, the nursing home conducted a formal intake history and completed the Minimum Data Set (MDS 2.0) forms. The nursing home MDS coordinator completed this form on admission, every 90 days, and each time a patient was either admitted to the hospital setting or when a significant clinical event occurred. The MDS data were captured electronically and translated into a format compatible with SPSS™ software. Each weekly clinical visit was entered into this electronic database. Parameters including wound length, width, depth, dressings utilized, procedures performed, admissions to the acute care setting, as well as wound area and volume, were recorded. When the patient's wound was either healed, or the patient was ready to be transitioned to the next site of care, a final disposition was recorded electronically -- wound outcomes were reported as "healed,""more than 50% volume reduction," or "50% or less volume reduction. "A large database was constructed combining the admitting MDS information with the complete clinical record for each patient's entire sub-acute care stay. After all information was entered for an individual patient, all identifiers were eliminated to protect patient privacy.
The study was a prospective, longitudinal, outcomes analysis from a sub-acute wound care unit. Patients were not randomized.All patients with wounds and more than 1 visit were included in the intent-to-treat analysis. The comprehensive wound assessment and treatment system was utilized as standard of care. The results were compared to previously published outcomes as a historical control.