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DESCRIPTIVE REPORT Congestive Heart Failure: A Disease Management Approach in Long-Term Care Patients Al Barber, Kelly. Hollenack, and Michael Bottorff OBJECTIVE: To determine the cost effectiveness of a pharmacist- directed disease management program for patients with heart failure. PARTICIPANTS:Consultant pharmacists, nursing staff, nursing home administrators and clinical staff, attending physicians. DESIGN: A disease management approach for heart failure based on MAIN OUTCOME MEASURES: Hospitalizationsfor heart failure (prima- guidelines from the Agency for Health Care Policy and Research (AHCPR).The key elements in this approach included program prepa- ry or contributing diagnosis). ration, clinical education, protocol implementation, outcomes measurement, and continuous quality improvement. Speciallytrained consultant pharmacists received approval for the heart failure program from the administration and clinical staff at each long-term care facil- ity and provided in-service programs for the nursing staff. Finally, recommendations were made to attending physicians to improve the RESULTS:For every $1 invested in this program, $2.44 could be saved in heart failure-related hospitalizationcosts. CONCLUSIONS:Results indicate that this program is cost effective in this setting. KEYWORDS: Clinical guidelines, Congestive heart failure, Disease pharmacotherapyfor heart failure patients within the facility. management. SETTING: Skilled long-term care facilities in Ohio. J Managed Care Pharm 1999: 516-520 In the opening paragraph of the clinical practice guideline Heart Failure: Evaluation and Care of Patients with Leftyentricular Systolic Dysfunction, the Agency for Health Care Policy and Research (AHCPR) stated, "More than two million Americans have heart failure, and about 400,000 new cases are diagnosed each year. Mortality is high, with five-year mortality rates in the range of 50%. Many of the almost one million hospitalizations that occur each year for this condition might be prevented by improved evaluation and care. "I In a letter to providers dated November 8, 1995, the Ohio Department of Human Services outlined why heart failure is a major and growing public health problem: ~ Congestive heart failure (CHF) is the only major cardiovascular disease whose incidence is increasing. ~ In this country, $7 billion is spent annually for CHF hospiAUTHORS .Â. AL BARBER, M.A. RPH., is former Director of Research, NCS HealthCare, Beachwood, OH; KELLY HOLLENACK, RPH., is Director of Clinical Programs, NCS HealthCare; MICHAEL BOTTORFF, PHARM.D., is Professor of Clinical and Hospital Pharmacy, College of Pharmacy, University of Cincinnati, Cincinnati, OH. AUTHOR CORRESPONDENCE: Kelly Hollenack, RPh, NCS HealthCare, PO. Box 248, Hilliard, OH 43026. ACKNOWLEDGEMENT: The authors would like to acknowledgeLaurie Epitropoulos,RPh., Diversified Pharmaceuticals, Columbus, OH, formerly with NCS HealthCare, for her work in the early development of our heart failure disease management program. This research was funded in part by grants from Merck & Co. and Boehringer- talizations.2 ~ Poor patient compliance with preventive programs and therapy (i.e., diet and exercise) tends to greatly increase mor- bidity and mortality ~ Significant variations in the treatment of heart failure has led to the need for widely accepted guidelines for the management of this disease. The American Medical Directors Association (AMDA) released Clinical Practice Guideline for Heart Failure in December 1996. Its goal was a simpler, user-friendly guideline that focused on application in the long-term care institutional setting3 At the time the AHCPR guidelines were issued, NCS HealthCare was an independent provider of pharmacy ser- Mannheim. vices to approximately 25,000 patients in the Midwest, primarily in Ohio. Because CHF is a significant problem for its Copyright@ 1999 Academy of Managed Care Pharmacy, Inc. All rights reserved. primarily elderly patient population, NCS decided to develop 516 Journal of Managed Care Pharmacy jMCP NovemberlDecember 1999 Vol. 5, No.6 Congestive Heart Failure: A Disease Management Approach in Long-Term Care Patients and implement a comprehensive, interdisciplinary diseasemanagement program that would include education of the patient-care team, treatment recommendations to improve therapy, monitoring of clinical and economic outcomes, and continuous quality improvement. This process was developed to be driven by consultant pharmacists working with the patient-care team in each facility. PLAN DEVELOPMENT The first step in plan development was to conduct a literature review and compile a reference library related to heart failure and disease management. These materials were then utilized to conduct provider education and to reference therapy recommendations. Next, NCS established criteria for patient inclusion in the program. Any patient with CHF, history of myocardial infarction, andJor new symptoms of systolic heart failure-left ventricle (LV) enlargement; ejection fraction <40%; and physical signs and symptoms of heart failure, including orthopnea, edema, and nocturnal dyspnea-was included. NCS decided with known contraindications to ACE inhibitor therapy such as serum creatinine >3.0 mgldL, serum potassium >5.5 mEqlL, and systolic blood pressure dOO mm to exclude patients Hg. The program's primary objective was to use a diseasefocused approach based on consultant pharmacist recommendations in the treatment of CHF to reduce hospitalizations recommendation was thoroughly researched and referenced. Experience showed that legible, concise, and referenced recommendations have a much higher physician acceptanèe rate. Finally, these recommendations were reviewed by an interdisciplinary team for accuracy and appropriateness for the patient population. Outcomes goals and measurement instruments were developed that were easy to collect and interpret. The primary purpose of any outcomes measure should be to demonstrate that the intervention or therapy has value. NCS chose to determine value from the payor perspective. The primary goal was to reduce hospitalizations related to heart failure, especially rehospitalizations. A reduced hospitalization rate would have obvious value for both the payor and the facility by improving census and for the patient by improving quality of life and maintaining function. The Ohio Department of Human Services is the primary payor for about 60% of the residents NCS serves in Ohio. In a medical assistance letter mailed to all Ohio physician providers in November 1995, the department stressed the need for widespread adoption of the AHCPR guidelines. This letter provided treatment guidelines and a drug therapy algorithm for the treatment of congestive heart failure.' Of note was the department's willingness to pay for diagnostic testing (including screening echocardiograms) and drug therapy that has been shown to be cost effective in such trials as SAVE: SOLVD,5 and CONSENSUS.6 education. NCS thought it essential to train consultant pharmacists not only about clinical guidelines but also how best The final step was to develop a mechanism to complete the disease management loop by using outcomes data to provide a continuous quality improvement process. By knowing which parts of the process were the most cost effective, NCS to communicate this information to other health care profes- could concentrate its finite resources in those areas. sionals. Another important part of this pharmacist education program is periodic competency testing to ensure a uniform level of knowledge and skills. Information about the proposed METHODOLOGY related to heart failure. A timeline was developed beginning with pharmacist then communicated by each pharmacist to the nursing facilities they serve during quality assurance meetings and directly to the administrator, director of nursing, and program is medical director. The next step was to develop an in-service training program for nurses, nurses' aides, and other direct care providers. This program included practical information related to the disease process, patient assessment, drug therapy, dietary concerns, and desired goals (outcomes) of treatment. The program was approved for one contact (0.1 CEU) for nurses by the Ohio Pharmacist recommendations for the CHF disease management program included the addition of ACE inhibitor therapy or an increase in the dose of current therapy to target doses, based on guidelines developed by AHCPR and AMDA. Patients were then placed into two groups based on physician acceptance (RA) or rejection (RR) of these recommendations. Heart failure hospitalizations were measured during the six months following. Hospitalizations were defined as any hospital admission with LV enlargement with or without other Nurses Association and presented by consultant pharmacists. The primary goal of physician education is to provide symptoms such as edema or jugular venous distention OVD). Finally, the difference in the hospitalization rate as a percentage between the two groups (absolute risk reduction) was information about the AHCPR guidelines and their clinical rationale. NCS also addressed the specific educational needs of attending physicians who are primarily trained in family prac- determined. The statistical significance of this difference was determined by using Fisher's exact test (left-sided), a nonparametric test for dichotomous variables. tice or internal medicine. An important phase in program development involved creating intervention recommendations to be used by consultant pharmacists to request diagnostic testing, laboratory monitoring, and drug therapy additions or changes. Each Vol 5, No.6 Implementation NCS consultant pharmacists were thoroughly trained and provided with the resources needed to go into nursing facilities and train other members of the patient-care team. These NovemberlDecember 1999 }MlP Journal of Managed Care Pharmacy 517 Congestive Heart Failure: A Disease Management Approach in Long-Term Care Patients Table 1. Consultant Pharmacists Recommendation Codes and Descriptions CODE HFI I DESCRIPTION Check ejection fraction due to new onset of symptoms of heart failure. HF2 Check ejection fraction due to history of myocardial infarction (M!). HF3 Addition of diuretic for patients with symptoms of volume overload. HF4 Addition of ACE inhibitor for patients with diagnosis of . heart failure. HF5 HF6 Increase current ACE inhibitor therapy to target doses. Addition of coronary vasodilator due to symptoms of heart failure. HF7 Alternative selection of calcium channel blocker without negative ionotropic effect for heart failure (HF) patients with concomitant angina or hypertension. HF8 Dietary sodium restriction in HF9 Monitor weight, avoid excessive fluid intake for HF a heart failure patient. record as heart-failure related. The direct clinical outcomes include physical findings, physical symptoms, adverse reactions, and changes in diagnostic testing (see Table 2). This information was collected from the clinical record, nursing and patient interviews, and hospital admission and discharge records. Hospitalizations were recorded over a six-month period following the acceptance or rejection of the pharmacist recommendation. Surrogate outcomes markers are indirect measures of effect often tied to changes in treatment, cost of pre, and quality of life. These factors include changes in drug therapy (including oxygen), changes in activities of daily living, exercise tolerance, and hospitalizations (see Table 3). In the longterm care setting this information is readily available as part of the care plan and Minimum Data Set (MDS). These surrogate endpoints are markers of a clinical outcome. Hospitalization obviously reflects a serious negative clinical event such as pneumonia. However, pneumonia as an acute disease is difficult to value, whereas a hospitalization related to pneumonia can be readily assigned a cost. Similarly, in a long-term care a definite assignable cost associated with resiinability dents' to feed themselves (i.e., the salary and benefits of the person who must feed them). In the NCS program, cost effectiveness must be demon- facility, there is strated from the perspective of the payor. The cost of heart patients. pharmacists provided in-service training in each client facility to the direct care staff, including nurses, nurses' aides, therapists, and others. These training programs emphasized the symptoms and physical findings related to heart failure. Early detection and treatment of volume overload is a critical step in reducing hospitalization related to heart failure. Nine specific, referenced recommendations or interventions for heart failure detection, diagnosis, monitoring, and treatment, based primarily on the AHCPR guidelines (see Table 1), were provided to the consultant pharmacists for use during their drug regimen review process. Physicians were encouraged to communicate their rationale for not accepting the recommendations, to help the pharmacist and nursing staff under- stand the physician perspective, and to help target patients who might benefit the most from future recommendations 'Table 2. Cost-Effectiveness Analysis Intervention Pharmacist recommends addition of ACE inhibitor therapy or increasing dose of current therapy to target dose based on AHCPR and AMDA guidelines Total number of recommendations Recommendations accepted (RA) Heart failure (HF)-related hospitalizations at six months Recommendations rejected (RR) Heart failure-related hospitalizations at six months 302 139 (46%) 5 (4%) 163 (54%) 21 (13%) Absolute risk reduction 9%* (i.e., patients with comorbidities, such as chronic renal disease, or other contraindications to a certain drug therapy recommended for CHF). Consultant and dispensing pharmacists also Total number of interventions II shared the goal of preventing drug-drug and drug-disease interactions, as might be the case with the addition of a potassium-sparing diuretic to a regimen that already included an Cost per intervention $205 (drug costs for six months plus labor costs) Cost per heart failure-related hospitalization $5,500 (includes only direct hospitalization medical costs) Cost of interventions to prevent one heart failure-related hospitalization $2,255 ($205 Cost effectiveness $5,500/$2,255 ACE inhibitor and a potassium supplement. Outcome Measurement NCS consultant pharmacists collected data on physician acceptance or rejection of pharmacist recommendations, direct clinical outcomes, and hospitalizations identified in the discharge 518 Journal of Managed Care Pharmacy jMCP NovemberlDecember 1999 required to prevent one hospitalization II) x = for each $1 spent Vol. 5, No.6 $2.44 saved Congestive Heart Failure: A Disease Management Approach in Long-Term Care Patients significant proportion of total disease costs. Surrogate markers take on added importance as short-term predictors of long-term cost savings. The selection of those surrogate markers that have high failure hospitalizations represents Table 3. Direct Clinical Outcomes and Surrogate Outcomes a predictive value based on sound clinical trials is important. The addition of a drug known to have benefit in heart failure patients (i.e. an ACE inhibitor) or an increase in the dose of such a drug toward target daily doses would be such a marker. Change in Diagnosis: Congestive Heart Failure (CHF) Compensated Symptomatic decompensated Left ventricular (LV) dysfunction or Overt Cardiomegaly Diastolic failure Systolic failure Diagnostic Testing RESULTS Ejection fraction NYHA functional class Although much of the outcomes data is still being analyzed, the results related to heart failure hospitalizations are very encouraging. Out of 302 pharmacist recommendations for Chest X-ray Labs Volume Overload Symptoms/Physical Findings adding an ACE inhibitor or increasing the dose of existing therapy, 139 (46%) were accepted and 163 (54%) were rejectthere were five hospitalizations (4%) ed. In the RA group, compared with 21 hospitalizations (13%) in the RR group, for an absolute risk reduction of 9%. Absolute risk reduction is much more meaningful than relative risk reduction, which can be very misleading when the event percentages are low, as in this example. The risk reduction achieved in this program means that for every 11 patients treated, one hospitalization related to heart failure can be avoided. NCS estimated a cost per intervention of $205, which includes pharmacists' labor and drug six-month period. Thus, the total cost to prevent one hospitalization is $2,225 ($205 per intervention x 11 interventions). At an average direct cost per hospitalization of costs for a $5,500, based on 1998 data from the Health Care Financing Administration, the NCS program yields a benefit/cost ratio of 2.44 to 1, or $2.44 in hospital costs avoided for every $1 spent on intervention. Hepatic engorgement Orthopnea Shortness of breath Paroxysmal nocturnal dyspnea Rales Dyspnea at rest Peripheral edema Nocturia Jugular venous distention Sacral edema Dyspnea on exertion Other Symptoms/Physical Findings Syncope Pallor Tachypnea Weakness Third heart sound O'2~HOMES' IStJ~f}:ÔGATE Drug Therapy for Heart Failure Oxygen Use Routine Flow rate As needed (PRN) Number of times used in past . month. Cognitive Patterns Psychosocial Well-being Activity Pursuit Patterns The primary reason for physician rejection, when noted, was that the patient was stable and additional therapy was not needed. The typical recommendation to add an ACE inhibitor called for lisinipril 2.5 mg daily If the patient was already on an ACE inhibitor, the typical recommendation was to increase the dose of the current therapy by 50%-100% (Le., captopril 12.5 mg bid to 12.5 mg tid or 25 mg bid). This therapy was generally well tolerated with Ascites a dropout rate of <5%. Physical Functioning and Structural Problems Activities of Daily Living (ADL) self-performance '(ADL) support provided Activities of Daily Living Bathing Mobility Appliances/devices used Change in ADL self-performance in last 90 days Exercise Tolerance Ambulatory with mechanical assist Six-minute walk test Discussion and Limitations The lack of comparative group demographics presents one limitation in this study's results. Was the recommendationrejected group sicker than the other group and therefore more likely to have an increased rate of hospitalization? The NCS program instructs the pharmacists to identify those patients most likely to benefit from a change in therapy Often these patients suffer unstable heart failure as indicated by recent hospitalization or fluid overload requiring physician intervention. It is surprising to note that physicians most often rejected these recommendations because they considered their CHF patients stable, with no need to change therapy Vol. 5. No.6 Hospitalizations in previous 12 months due to ~eart failure Continuous Quality Improvement Disease management is the process of improving clinical outbe referred comes. Therefore, disease management could also to as "outcomes management." In order to manage and improve outcomes, the process must be continually moni- require~an active intervention physician response. The facility quality assurance to improve especially the medical director can be invaluable team and tored and revised. This effort NovemberlDecember 1999 }MíP Journal of Managed Care Pharmacy 519 Congestive Heart Failure: A Disease Management Approach in Long-Term Care Patients in this effort. Their buy-in to the disease management process and guidelines can give a local legitimacy similar to that provided by specialist committees in acute care. Longterm care facilities also are very interested in global facility assets ers will not succeed. Successful disease management programs must always be a win-win proposition for all involved. With the success of these early efforts, NCS is currently outcomes data to show the value of their care. Positive outcomes related to specific diseases provide the facility with a implementing this heart failure management program in all its client facilities, which serve more than 220,000 residents in 32 states. Although this task will be formidable, the basic significant marketing advantage over a facility with outcomes data that are not conclusive or, worse yet, do not exist. From principles of planning, implementation, outcomes measurement, and continuous quality improvement remain the same. the facility perspective, predictable and measurable outcomes have definite value. 1. Konstam M, Dracup K, Baker D, et al. Heart Failure: Evaluation and Care of Patients With left-Ventricular Systolic Dysfunction. Clinical Practice CONCLUSION The need for planning prior to the implementation of any disease management program cannot be overemphasized. Developing a step-by-step implementation process and identifying outcomes measures as an integral part of that process are critical. Outcomes measurement cannot be "tacked on" to a disease management program and expected to show value. NCS is currently integrating clinical software that will allow pharmacists to track multiple patient outcome variables and will include more data regarding patient demographics. This effort will allow NCS to improve the clinical significance of the benefits of its disease management programs. Education and training are critical to provide the rationale for the disease management process. Provider acceptance of the guidelines and treatment algorithms is essential to improv- ing patient outcomes. Education and training must also be ongoing. New developments must be communicated to the front-line practitioners in a timely manner. For physicians, facility staff, patients, and their families to accept a disease management program, the development and maintenance of trust is necessary. Sound recommendations based on accepted clinical guidelines help to ensure that trust. Programs in which one player wins at the expense of the oth- 520 Journal of Managed Care Pharmacy References ... }MlP NovemberfDecember 1999 Guideline No. 11. AHCPR Publication No. 94-0612. Rockville, MD: Agency for Health Care Policy and Research, Public Health Service, U.S. Department of Health and Human Services. June 1994. 2. Tompkins A (Ohio Department of Human Services). Medical Assistance leuer No. 356. 1995 Nov 8. 3. Musher J, JohnsonJ, Beier M, et al. Heart Failure: Clinical Practice Guideline. American Medical Directors Association. 1996. Silver Spring, MD. 4. Pfeffer MA, Braunwald E, Moye LA, et al. Effect of captopril on mortality and morbidity in patients with left -ventricular dysfunction after myocardial infarction: results of the survival and ventricular enlargement trial. N Engl J Med 1992; 327: 669-77. 5. SOlVD Investigators. Effect on enalapril on survivaJ in patients with reduced left-ventricular ejection fractions and congestive heart failure. N Engl J Med 1991. Aug 1; 325: 293-302. 6. CONSENSUS Trial Study Group. Effects of enalapril on mortality in severe congestive heart failure. N EnglJ Med 1987; 316: 1429-35. Additional Readings ... 1. Gonzalez ER, Crane VS. Designing a disease management program: get started. Formulary June 1995; 30: 326-40. How to 2. langley PC, Langley-Hawthorne CE, Martin R, et al. Establishing the basis for successful disease management contracting. Am J Man Care September 1996; Vol.2, NO.8: 1099-108. 3. Zitter M. The disease-centered approach to managing health care delivery The Zitter Group; Special Report Disease Management. Vo\. 5, No.6