Diabetic foot ulcers and their sequelae are a major cause

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1 REPORTS FROM THE FIELD CLINICAL PATHWAYS Development and Implementation of a Hospital Pathway for Patients with Diabetic Foot Lesions Chad T. Whelan, MD Abstract Diabetic foot ulcers and their sequelae are a major cause of morbidity and mortality and a leading cause of hospitalization in diabetic patients. To improve the care of patients at our hospital with infected diabetic foot lesions, a hospitalist-led team developed a clinical pathway. Key features of the pathway included probing to bone on physical examination, tissue culture, magnetic resonance imaging when osteomyelitis is a concern, formal vascular assessment, and early preoperative evaluation. The pathway was publicized through lectures and targeted s. A postimplementation survey showed improvements in knowledge, satisfaction, and self-reported behaviors. A framework for pathway development is suggested. Diabetic foot ulcers and their sequelae are a major cause of morbidity and mortality and a leading cause of hospitalization in diabetic patients. It is estimated that 15% of diabetic patients will develop a foot ulcer, and 15% of these patients will require an amputation. Approximately 50,000 diabetic patients undergo lower extremity amputation annually in the United States, with each incurring approximately $50,000 in total health care costs [1,2]. The care of patients hospitalized for diabetic foot lesions is complicated and demands a coordinated, multidisciplinary approach. Efforts must be directed toward preventing complications as well as effectively treating the complications that do develop. Osteomyelitis is a frequent complication, occuring in up to two thirds of patients admitted with infected foot ulcers [2,3]. Patients with osteomyelitis need prolonged antibiotic treatment, and many need surgical removal of the affected bone. There have been several studies evaluating the use of pathways and guidelines in providing preventive foot care for diabetics [4,5]. There are fewer published studies evaluating a clinical pathway approach for patients requiring admission for their diabetic foot infection. These approaches may require significant dedicated time for trained nurses to assure compliance with pathways [6]. Many institutions do not have the resources available to institute nurse case management programs of this type. At our urban academic medical center, no service had primary ownership of patients admitted with diabetic foot lesions. As a result, there was concern among medicine and surgical physicians that these patients might be receiving fragmented care. Futher, there was perceived dissatisfaction among providers such that certain clinical areas were considering referring these patients to outside institutions. While there was widespread support for organizational change, there was no individual or clinical area willing to spearhead this project. In January 2001, the medical center relieved its hospitalist group of some clinical responsibilities in exchange for leadership in systems improvements, including pathway development. Hospitalists are well positioned to be leaders in quality improvement projects that cross disciplines but principally affect hospitalized patients. The hospitalist program took on the problem of improving care for diabetic foot lesion patients. This paper describes a hospitalist-led project to develop and implement a multidisciplinary clinical pathway for the care of hospitalized diabetic patients with foot ulcers. Needs Assessment The team charged with developing the program was led by a hospitalist and included members of the orthopedic, general internal medicine, and infectious diseases faculty and members of nursing management. As part of the pathway development process, the team developed a survey to assess knowledge and satisfaction among emergency medicine and internal medicine housestaff and attending physicians. The majority of questions asked about the physician s clinical and organizational knowledge about taking care of patients with diabetic foot lesions. Clinical knowledge questions were of several types and included global selfassessment, true/false, and multiple-choice. To assess quality and efficiency of care, we also asked physicians about their behavior, focusing on the aspects of care that we predicted could have the most impact on quality and efficiency if they were improved. Although self-reported behavior is a less reliable measure than more objective process From the Department of Medicine, University of Chicago, IL. Vol. 10, No. 5 May 2003 JCOM 267

2 DIABETIC FOOT measurements, we felt that the information we obtained would be useful for early assessment of the project. Seventy out of 130 eligible physicians received surveys, which were distributed at conferences. 36 were returned, 32 of which were completed. Serious needs were identified in all areas (Table 1). For more than half of the questions, less than 70% of the respondents provided acceptable responses. For questions that had a single correct answer (eg, true/ false), only correct answers were considered acceptable. Likewise, for questions about behaviors that represented key components of care (eg, debridement, plain radiographs, probing to bone), only 100% of the time (5 on a 5-point scale) was acceptable. For other questions, a response of 4 or 5 on a 5-point scale was considered acceptable. For more than one third of the questions, less than 50% of respondents provided satisfactory responses. These results confirmed our original perceptions. Physicians were dissatisfied with caring for these patients, had significant knowledge deficits, and reported specific care behaviors that had important quality and efficiency implications. Pathway Development We decided that a pathway for patients with diabetic foot infections needed to address the following questions: Is the ulcer infected? If it is infected, what is the proper antibiotic regimen? Is the (infected) ulcer complicated by osteomyelitis? Is the ulcer complicated by arterial insufficiency? Will the ulcer require surgical treatment? Using the evidence from our review of the literature, results from the needs assessment, and our combined clinical experience, we developed a pathway (Figure). Key Features We requested that all patients admitted with an infected diabetic foot lesion have an examination that includes probing of the wound to see if bone is exposed and a plain film [7].We discourage overreliance on laboratory markers such as white blood cell count, erythrocyte sedimentation rate, and C-reactive protein because of their poor test characteristics in this population. For patients in whom osteomyelitis remains a concern, we recommend magnetic resonance imaging over bone scan given its better test characteristics in these patients [2,8 12]. While broad-spectrum antibiotics are often recommended for patients with infected diabetic foot lesions, we were able to identify specific subgroups of patients who could be predicted to respond to antibiotics with a more focused coverage. Specifically, these subgroups included patients who had acute onset infections without host factors suggesting immune compromise. However, when patients had more chronic wounds or infections, broader-spectrum antibiotics were recommended. Finally, in life-threatening infections, we recommended broad-spectrum antibiotics with excellent tissue penetration. We also recommended obtaining deep tissue cultures whenever possible to help guide antibiotic therapy. We emphasized early debridement of the wound, which may shorten time to healing [7,9,13 15]. We also suggested formal vascular assessment and assessment of cardiovascular risk. Arterial insufficiency may be a pathogenic factor in up to 60% of nonhealing diabetic foot ulcers. Since revascularization can reduce amputations, our pathway recommends early assessment of vascular supply [16 19].The sensitivity of the physical exam is not adequate to rule out vascular compromise, so formal vascular studies are suggested for all patients [2,9,19]. Similarly, since many of these patients will need surgical clearance for an orthopedic and/or vascular procedure, our pathway suggests early evaluation of perioperative risk. By evaluating the cardiovascular risk profile early, it may be possible to reduce delays caused by waiting for the vascular or cardiac risk stratification. Implementation Given the rotational nature of our clinicians, it can be very difficult to implement and maintain quality improvement initiatives. A large percentage of our clinicians are physicians in training who have limited time and energy to devote to developing or maintaining these types of interventions. In addition, the attending physicians have extensive clinical, administrative, and research commitments; also, when beginning a month of inpatient service, it may have been over a year since they were last on the inpatient wards. Therefore, we felt that changes to our system need to be continuously publicized so that all relevant providers are aware of these changes. The pathway was introduced in multiple lectures that were part of standard ongoing educational series in the emergency medicine and internal medicine programs. The lectures were given by an internist and an orthopedic foot specialist whenever possible. Most physicians in the target audience were addressed at one of the lectures. Real-time clinical reminders may improve physicians compliance with guidelines and pathways. While our present electronic medical record does not have the capability to generate these reminders, we needed some method of delivering reminders to our rotating physicians. We developed a brief reminder (Table 2) that was sent to each physician as she came onto a clinical service in which she might be called on to manage a patient with an infected diabetic foot lesion. We chose this method for several reasons. Paper reminders are often not read, are more costly, and require more person-hours 268 JCOM May 2003 Vol. 10, No. 5

3 REPORTS FROM THE FIELD CLINICAL PATHWAYS Table 1. Pre- and Postimplementation Survey Results (n = 32) Percentage with Acceptable Responses Pretest Posttest P Value Knowledge questions Comfort in determining if an ulcer is infected Comfort in determining if an infected ulcer is complicated by osteomyelitis * Comfort in determining appropriate treatment Know which surgical service to call for co-management (Y/N) Know when tissue sample is needed for culture Percentage of the time WBC abnormal when ulcer is complicated by limb * threatening infection Percentage of the time temperature abnormal when ulcer is complicated by limb-threatening infection Tests that are reliably positive in diabetic foot ulcers complicated by osteo * myelitis from among ESR, CRP, WBC, x-ray Study that has the best sensitivity and specificity to diagnose osteomyelitis in a patient with a diabetic foot ulcer from among triple phase bone scan, MRI, indium scan Tissue culture guided antibiotic therapy is appropriate (T/F) < Imipenem is superior to ampicillin/sulbactam for limb-threatening infection (T/F) Early surgical debridement improves ulcer healing (T/F) Early revascularization in the setting of arterial insufficiency improves ulcer healing (T/F) Behavior questions Percentage of the time you perform the following on patients admitted with an infected diabetic foot ulcer: Debridement * Plain x-rays Probe to bone on exam * Triple phase bone scan * Formal vascular studies MRI Percentage of the time you obtain the following in diabetic patients when you are concerned that their infected foot ulcer is complicated by osteomyelitis: Plain x-ray Probe to bone on physical exam Triple phase bone scan * Formal vascular studies MRI * Attitude/satisfaction questions Rate of satisfaction in your ability to care for general medicine inpatients in this system Rate of satisfaction in your ability to care for patients admitted for infected * diabetic feet Rate of satisfaction with surgical support or these patients * Frequency of significant delays while awaiting preoperative clearance Average time to debridement following request * CRP = C-reactive protein; ESR = erythrocyte sedimentation rate; MRI = magnetic resonance imaging; WBC = white blood cell count. *P < 0.1. P < Vol. 10, No. 5 May 2003 JCOM 269

4 DIABETIC FOOT Patient with diabetic foot ulcer Initial evaluation: Rule out acute limb-threatening ischemia Plain films, probe to bone to rule in osteomyelitis Determine if ulcer is infected No infection No limb-threatening ischemia Infection DC to home with rapid follow-up Moderate or severe or failing outpatient management Admit to medicine Stat orthopedic foot consult preferably in ED to decide if urgent surgery needed and for deep tissue biopsy If clinically appropriate, hold antibiotics until deep tissue biopsy taken. If immediate antibiotics indicated, take superficial tissue sample and give antibiotics Mild DC to home with rapid follow-up on appropriate antibiotics Urgent surgery needed Antibiotics: Non limb-threatening: Cefazolin OR Nafcillin OR Clindamycin Limb-threatening: Ampicillin-sulbactam OR Clindamycin AND ciprofloxacin OR Piperacillin tazobactam Life-threatening: Vancomycin AND imipenem Bedside debridement and culture Antibiotics per BOX based on severity of infection Order CRP and ESR Strict nonweight bearing Wet-to-dry dressings Glycemic control Education No urgent surgery needed Clinical improvement and stabilization DC to home on appropriate therapy to complete course of antibiotics Enroll in outpatient protocol Continued orthopedic involvement and monitoring MRI to rule out osteomyelitis Formal vascular laboratory assessment Early evaluation of cardiac risk in patients likely to need surgical intervention Figure. Clinical pathway for patients presenting to emergency department (ED) with diabetic foot ulcer. CRP = C-reactive protein; DC = discharge; ESR = erythrocyte sedimentation rate; MRI = magnetic resonance imaging. to maintain. We felt that generalized reminders to all physicians would either be too frequent to carry impact or too distant in time from when they would be useful. This reminder system was maintained by the hospitalist involved in the project and required about 15 minutes of work each month. Evaluation of Pathway The emergency medicine and internal medicine physicians were surveyed again 8 months after the pathway was implemented in order to evaluate its effectiveness. Of note, the introductory lectures were given between 9 and 12 months prior to this survey. Seventy surveys were distributed and 35 were returned, 32 of which were completed. Given the small sample size, we were interested in evaluating statistical significance at both the P < 0.1 and P < 0.05 levels. In 14 of the 17 questions in which the preimplementation survey had a less than 70% satisfactory response rate, improvement was seen on the postimplementation survey that reached at least the P < 0.1 level using 270 JCOM May 2003 Vol. 10, No. 5

5 REPORTS FROM THE FIELD CLINICAL PATHWAYS Table 2. Reminder Subj: DIABETIC FOOT PATHWAY The diabetic foot pathway is in effect, please use it. If you have a patient who has a diabetic foot ulcer, please use the standing orders for this pathway. Key features of the pathway: Dr. Toolan from orthopedics should be consulted early in all cases Part of the physical exam should be probing to bone to rule in osteomyelitis Lab markers including WBC, blood cultures, CRP, and ESR are not reliable markers for infection/osteomyelitis in these patients We would like to see a tissue culture (preferably deep) taken from all patients MRI should be the imaging study of choice when osteomyelitis is a concern if plain films are negative Vascular studies are probably indicated on all patients as the exam is a poor predictor of blood supply and revascularization can improve outcomes Think about preoperative evaluation early the Fisher exact test. In only one response was there a statistically significant drop in acceptable answers. We have received real-time anecdotal feedback during the first year of implementation. While most of the general feedback was positive, we did receive constructive critiques as well. These primarily involved improving availability of pathway materials or suggesting wider dissemination beyond our original target audience. While the orthopedic foot service was never formally evaluated given its very small number of physicians, they were generally pleased with the system and are looking forward to its continuing. Finally, several medicine house officers are now identifying the consults coming from the orthopedic foot service to be a model for other consulting services. Discussion In response to a specific institution need, we have developed, implemented, and evaluated a clinical pathway for caring for hospitalized patients with infected diabetic foot lesions. In creating this pathway, we have developed a framework that we are using for additional inpatient pathway development (Table 3). Given their commitment to systems improvements, hospitalists will lead these projects. As our electronic medical record is updated to provide us with real-time clinical decision support, we hope to import our existing library of pathways into that system. Our group of hospitalists will also take a lead clinician role in developing and maintaining decision support tools using a similar approach to the one we are using for paper pathways. Table Steps to Successful Implementation of a Clinical Pathway 1. Identify a clinical problem that is relatively common and for which variability in practice patterns may adversely affect important outcomes 2. Develop a team of appropriate personnel who can work together through difficult compromises yet assign an individual to provide leadership for the project 3. Perform an extensive literature review in order to understand the key components of quality and efficient care 4. Perform a pre-development needs assessment that can be used to guide pathway development 5. Develop the pathway with specific outcome goals in mind. Plan for a method to measure the success of the pathway at reaching these goals 6. Publicize the pathway in a way or ways that will reach the largest number of interested people 7. Develop a strategy to maintain enthusiasm and compliance with the pathway prior to implementation 8. Implement the plan after publicizing using a well-developed roll out plan 9. Assess the successes and failures of the pathway regularly, preferably with objective data 10. Update the pathway based on feedback and changes in the literature that affect the pathway We feel that this pathway has several innovative features. Unlike many pathways in which the primary goal is to reduce costs or improve quality, this pathway was initially designed to improve satisfaction and address knowledge deficits. While we hope to demonstrate cost and quality improvements, success in these other domains is also important. Guidelines and pathways are difficult to maintain, partly because clinicians often do not follow them [20]. If we can develop guidelines that give tangible benefits to clinicians, we may be able to improve their compliance. Innovative guidelines that are educational or improve provider satisfaction may provide such benefits. While ultimately we plan to have an electronic medical record that can provide real-time reminders, we feel that our present targeted reminder system is an effective means of accomplishing similar goals. The system is highly cost- and time-efficient. It delivers the reminders to a given provider only a limited number of times so that it does not become burdensome and only at times when the provider is in a clinical role in which the reminder might prove useful. Although it is difficult to separate out the specific effect of these reminders, we feel they were likely effective for 2 reasons. First, 6 out of the 7 pathway features identified in the reminder had significant improvement in the postimplementation survey. Secondly, the postimplementation survey was given at least 8 months after any specific Vol. 10, No. 5 May 2003 JCOM 271

6 DIABETIC FOOT lecture on this topic. We plan to continue to use this reminder system until our electronic medical record system can provide real-time reminders. We have already incorporated reminders about other pathways and quality improvement projects into similar s. Finally, we feel that the use of hospitalists in pathway development is desirable. Given their clinical interests and commitment to improving the environment in which they work, hospitalists are natural people to turn to for developing inpatient-based guidelines. In their daily activities hospitalists interact with multiple consulting services, nurses and nursing leadership, and hospital administrators. Since we feel it is important for each of these groups to be participants in the pathway development process, hospitalists can be excellent coordinators for these projects. In our institution we plan on using hospitalists on every major inpatient pathway for these reasons. While we feel this project has been a success, it is important to think about its generalizability. Diabetic foot infections are a common cause of hospitalization. We feel that the care suggested in our pathway follows standard guidelines and does not require highly specialized care. Academic medical centers with rotating physicians will likely struggle with the same issues that we face. However, nonacademic medical centers may also face similar issues. They have multiple physicians who spend a minority of their time in the hospital and whose interests in systems improvement may be more focused on their outpatient clinical operations. Therefore, we feel that the usefulness of hospitalists for these projects is likely universal. Finally, the implementation and maintenance of this pathway did not require any extensive financial investments. The reminder system is not timeintensive and relies on technology that is widely available and inexpensive. There are some limitations to this project. We implemented this at a single academic medical center that had a group of hospitalists interested in systems improvements. Different institutional settings may have different problems. While our initial results are promising, they should be viewed with caution. Our response rates were lower than we had hoped for and we were unable to complete the survey process for the surgical and emergency medicine housestaff for logistical reasons. Finally, we do not have true clinical or cost outcomes to determine the effect of this intervention in these domains. Currently this pathway is undergoing its scheduled yearly review. It is again being presented to the appropriate physicians in lecture format. Minor changes in the antibiotic recommendations are being reviewed based on formulary changes. Finally, a tool to measure clinical and cost outcomes is being developed that we hope will demonstrate similar successes in these areas. 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