Medical Communicators 
Best Practice Research

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ACE Inhibitor Use in CHF
Kurt Ullman

ACE Inhibitors cornerstone to effective CHF treatment

    Heart failure affects an estimated 2 million people at any one time in the US. It is a killer disease with five-year mortality rates running near 50 percent. Heart failure is also an expensive disease, costing over $38 billion each year . Medicare paid $24 billion for hospitalization and actual hospital charges were double that. The mean charge for a heart failure-related hospitalization has been set as high as $8,500. Because of the dual factors of high prevalence and high cost, improvements in the care of these patients can have a large impact on hospital costs and the quality of life for the patient.

    It is well established that proper management of this disease can reduce both mortality and morbidity. Research has established that ACE Inhibitor (ACEI) usage can have an impact on survival and disease progression. The Acute Ramipril Efficacy Study found treatment with an ACEI decreased all cause mortality by 27% and the risk of developing severe heart failure by 23% when compared to placebo.  The Trandolapril Cardiac Evaluation study showed ACEI use decreased mortality by 22% and risk of severe failure by 29%.  Finally, The Studies of Left Ventricular Dysfunction Prevention Trial showed that use of enalpril decreased the risk of hospitalization for heart failure by 36%.

    Protocols for the treatment of left ventricular systolic dysfunction (LVSD) have been well studied in the recent past. Within the last five years, there have been four sets of practice guidelines issued. One was part of a larger task force report on heart failure practices put out by the American College of Cardiology and the American Heart Association.  Another was compiled by the RAND Corporation under contract to the federal Agency for Health Care Policy and Research (AHCPR).  In 1998, a third group of practice guides were printed in the Journal of the American Geriatrics Society . More recently, the Advisory Council to Improve Outcomes Nationwide in Heart Failure (ACTION HF) released yet another consensus document.

Despite demonstrated success, ACEI usage remains low

Clinical practice

    Most of the clinical trials suggest that 80-90% of the patients taking ACE-Inhibitors tolerate them well.  Despite this proven clinical success and the widespread availability of corroborating reports and guidelines, studies show that many, if not most, practitioners fail to prescribe ACE Inhibitors or to follow the guidelines for their use effectively. This has held true in reports from academic medical centers and community hospitals and across the many specialties involved.

    For example, Mendelson and Aronow looked at ACEI use in an academic hospital-based geriatrics practice. Just over 48% (142/294) of patients studied were receiving ACE Inhibitor therapy.   Similar patterns were found in community settings as well. Philbin studied those admitted to ten community hospitals during 1992 and found only 66% of those eligible for ACEIs actually getting them.  He also examined the same criteria for those admitted during 1995 and found encouraging results. All of the areas researched showed statistically significant increases in the ensuing three years.  None, however, were to the 80% level found in the trials.

    Stafford and his group looked at national prescription patterns in 1994 using the National Ambulatory Care Surveys (NACS) database. ACEI use in that year was 30.6% of those deemed eligible.  They looked at data from the five-year period starting in 1989. As before, this group noted increases in ACEI use from the baseline year. However, unlike the others, who only developed results from two discrete years, Stafford looked at each separately. They found the increase in use was not uniform and had actually peaked at 31.1% in 1992, fallen to 24% in 1993 and settled at the final number in 1994.

Physician variables

    The type of physician has usually been predictive of how close to the guidelines treatment comes. This has held true in percentages of ACEIs prescribed and percentage of those at or near the target dose. In the published research, cardiologists came closest to the ideal, but there was still ample room for improvements. Family and general practitioners tend adhere to the guidelines with less rigor. Internists and geriatricians are somewhere in the middle.

    Chin and Wang found similar usage rates among cardiologists, general practitioners, and a combination of the two of about 75%. However, only 54% to 70% of patients were on adequate dosages.    Seventy-five percent usage is high—most specialties don't use ACEIs to that level. The low percentage of patients on adequate dosage, however, is common.

    Stafford’s group found that specialty had a significant effect on ACEI usage. Visits to a cardiologist were more likely to have the ACEI reported (45.6%) than those to primary care (21%) and other specialty physicians (29.6%). Among primary care doctors, general practitioners were lowest (12.5%), followed by family practitioners (21%) and general internists (24.9%).

    A study from Louisiana shows that even inpatient treatment for CHF is not an indicator of proper ACEI usage. One third of the patients admitted during the study were already receiving ACEI. However, only 85% of these patients were discharged on them, meaning that 15% had the ACEI discontinued during their hospital stay. Of the 66% who were not on ACEI at admission, only 35% of these were placed on the medication at discharge.

Interventions to increase use of ACEIs

Is ACEI underutilization a TQM problem?

    Differences between the guidelines and clinical practice are essentially a Total Quality Management (TQM) question and should be addressed by the mechanisms available at that specific facility. However, ACEI therapy does have some specific concerns that do not fit nicely into the usual TQM program.

    Perhaps the major difference is that it is a multi-specialty problem. Many TQM initiatives are centered in one department with one set of participants. The questions raised by ACEI therapy cover many different departments from Cardiology to Family Practice to Geriatrics and beyond. Another hurdle is that these departments have different levels of concern. Given the statistics above, it would appear that most cardiology areas need less intensive interventions since they are already closer to the 80%+ of appropriate patients on ACEIs that was the standard of tolerance in clinical trials. Other specialties may have less than half of their appropriate patients on effective doses of medication.

    Finally, it is a diffuse problem. Instead of just one hospital or a single practice looking at a subject of concern and acting on it, there are a number of different constituencies that have to buy-in to this process. It also covers the entire continuum of care and can be an issue of care coordination in the office, at the patient's home, as well as during an acute care stay.

The MISCHF study

    Philbin and others are currently working on the only known randomized, controlled clinical trial trying to measure the efficacy of a program for changing practice patterns across multiple centers. Although the results of the Management to Improve Survival in Congestive Heart Failure (MISCHF) are not yet released, some insights into management of the issue were gained in pilot studies already in press.

    Strategies were developed to target the initiatives at those weaknesses in existing practice that were most prevalent, most likely related to suboptimal outcomes and most costly. When authoritative clinical guidelines were available, they were to be followed.

    Early on, the group decided to focus on seven simple and targeted TQM initiatives that could be comprehensible, focused, and not intimidating. The specific initiatives developed for implementation in Phase II included:

•  A series of educational programs for physicians and health professionals, delivered by recognized experts, emphasizing important clinical issues in CHF
•  A comprehensive program of feedback of Phase I data to clinicians and administrators to provide them with an understanding of their performance.
•  An examination of the statistical relationships between the use of specific monitoring, diagnostic and treatment technologies and risk-adjusted outcomes
•  The development of a pharmacy task force that, using guidelines and Phase I data, addressed issues of proper drug prescription through collaboration with the clinical pathway development task force.
•  An emergency department task force to focus on improvements in the prehospital phase of care
•  An upgrading of specific patient care processes that focussed on the continuum of care and faced issues such as case management and discharge planning.
•  Design and implementation of a clinical pathway to encompass the idealized process of care proposed by other task forces that was customized to the needs and resources of the individual hospital.

    There is also a lack of literature describing methods to implement programs across geographically dispersed multi-specialty group practices (MSGP) and independent practice associations (IPA). PhyCor (PC) physician management company researched ways to integrate TQM into everyday operations.

    PC’s activities are built around what they call a “physician/driven, patient-centered” model. It is made up of     physician/administrator teams to make clinical and financial strategic decisions and area/ regional leadership councils to coordinate and integrate regional medical management and TQM decisions among local groups and IPAs.
     Condition-specific care management councils were established to allow a forum for networking, information sharing and advancing best practices across the various IPAs and MSGPs. Each was made up primarily of doctors.  The specific objectives of the councils are to:

• Develop disease-specific protocols and instruments for collecting heath, functional and outcomes data;
• Refine nationally recognized evidence-based guidelines;
• Identify best practice results within affiliated clinics and IPAs as well as opportunities for improvement
• Identify tools for medical risk assessment/stratification and management;
•  Identify innovative patient education resources;
•  Lead the implementation of TQM at their home clinics;
•  Participate in developing performance indicators of excellence;
•  Recommend strategies for implementing initiatives; and
•  Suggest continuing education needed for improvements as identified.

The program also points to three key resources for supporting TQM. These include
1. access to information and knowledge management resources to allow the collection,
2. measurement and analysis of clinical outcomes,
3. and the provision of a mechanism  for physicians to review and compare their practices against key benchmarks.

    Information/knowledge management acknowledges that key stakeholders have unique needs for data and information. Some may be related to clinical needs (doctors, patients) and some to financial (payers, institutional providers). PC has put this information into a combined Intranet and Internet technology called PhyCor Online. This system allows physicians access to the applications needed to collect, measure and analyze clinical outcomes. Individual providers, clinics and IPAs will be able to compare themselves against a number of benchmarks.

    Education and training is being addressed by the PhyCor Institute for Healthcare Management. It is specifically set up to:

• Produce measurable improvements in effectiveness and efficiency of clinical care
• Demonstrate the advantages of systems approach to healthcare
• Promote the concept of managed care as care of populations
• Promote the use of decision making models and the adoption of evidence-based medicine
• Apply TQM through outcomes measurement and management of facilitating the discovery and adoption of best practices.

    Through PC's initiatives, their physicians, groups and IPAs have been given access to information needed to benchmark themselves locally, regionally and nationally against peer groups. They also have access to service, clinical and financial data useful in population-based health and disease management. Finally they are now better able to understand regional and national trends and apply them to local needs.

Replication of clinical innovations in multiple practices

   In the mid-1990s, Kaiser Permanente in North Carolina (KPNC) developed and piloted several clinical practice innovations. They soon noticed that they had no effective way to distribute these innovations throughout their various medical practice units. This meant that many successful improvements to programs and services languished unused at the pilot level.

    In late 1994, a Regional Clinical Guidelines Coordinating Committee was formed to oversee the transfer of these clinical innovations throughout the system. The committee was composed of department chiefs from each geographic area with appropriate support staff.

    They first identified a clinical innovation with the potential for successful transfer. The source practice could be either a seed (pilot) or an established one.  An appropriate source unit (SU) was defined as one with documented results that were desirable and transferable. Organizational and resource constraints were important considerations at this level.

    The receiver unit (RU) was selected next. During this phase, a need is identified by the RU and  preliminary studies are undertaken to see if transfer from the source would be beneficial. This generally required comparing the two units’ performance across appropriate variables. The usefulness of the comparisons depends on both units using similar measurement methods.

    Once the decision to transfer has been made, planning begins. During this part of the program, receiver and source units forge communications links. This is so the RU can discuss their needs and special conditions while the SU transfers their knowledge. The source unit becomes the mentor for the receiving unit.

    The units begin the process of replication. A transfer team is established and members assigned a number of key roles.

•  Innovation coordinator- responsible for leading each unit through the steps of selecting, planning, piloting and standardizing. They work with the administrator and physician manager to select a target date. Then they worked with on-site sponsors (a doctor in the specialty area) to prepare the unit.
•  Innovation expert- responds to technical questions and helps with communications. Usually the designer of the innovation or someone with deep knowledge of the program being replicated.
•  Local expert- responsible to listen and respond to feedback about the implementation process. They were to have unique knowledge about the unit and the personal issues involved and in a position to help resolve them and remove barriers.
•  Receiving team-consists of local administrator, lead physician and others interested in the process.

    According to KPNC, the output of the standardize phase is a readiness to expand the practice to other areas in the organization. In other words, the receiving unit now becomes the source unit, ready to work with a newly selected receiving unit.

    Two planning tools proved to be invaluable in organizing the work to be done. The master schedule helped the implementation team plan and coordinate the various activities. It guided the coordinators when presenting and selecting target dates as well as to reduce overlap and overuse of resources. The master schedule also aided the receiving unit in their need to coordinate with other projects, busy patient days and staff vacations and holidays.

    The second important planning device was the activity matrix. The Innovation Coordinators used it to plan and track progress on each detailed activity during each cycle of replication. It lists specific activities that recommended during the planning and pilot stages. Among these are pre-implementation work, on-site preparation, implementation and post-implementation work.

    These procedures worked so well that at one time KPNC had 48 transfer cycles (3 innovations in 16 different medical practice units in three geographical areas) all going simultaneously.
 
 

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