We believe that TMAP [The Texas Medication Algorithm Project] is the first large-scale use of medication algorithms, Rush said, "certainly in a community mental health setting. A project like this may help to lay the groundwork for improved public mental health treatment here and in other states as well." Medication algorithms, according to the project directors, consist of "a series of treatment steps, each of which is defined in turn by the clinical response of the patient to the preceding step."
The Texas Department of Mental Health/Mental Retardation (TXMHMR) is sponsoring a project on the use of medication algorithms in the community mental health center population. Kenneth Z. Altshuler, M.D., and A. John Rush, M.D., of the University of Texas Southwestern Medical Center and Steve Shon, M.D., medical director of TXMHMR, serve as project directors.
"We believe that TMAP [The Texas Medication Algorithm Project] is the first large-scale use of medication algorithms," Rush said, "certainly in a community mental health setting. A project like this may help to lay the groundwork for improved public mental health treatment here and in other states as well."
Medication algorithms, according to the project directors, consist of "a series of treatment steps, each of which is defined in turn by the clinical response of the patient to the preceding step." Over the past several years, treatment algorithms have been of interest to a growing number of researchers and clinicians. Recently, Allen Frances, M.D., professor and chair, department of psychiatry, Duke University Medical Center, John P. Docherty, M.D., professor and vice chair, department of psychiatry, Cornell University Medical College, and David A. Kahn, M.D., associate clinical professor, department of psychiatry, University College of Physicians and Surgeons have published the results of their tri-university (Duke, Cornell, Columbia) "Expert Consensus" surveys (Psychiatric Times February; Bipolar Disorders Letter March). Using the responses from a panel of recognized experts, they have constructed treatment algorithms for schizophrenia and bipolar disorder.
"Part of the inspiration for TMAP comes from the Expert Consensus Guidelines," said Rush. The algorithms derived from these guidelines, recently published in the Journal of Clinical Psychiatry, were incorporated at an early stage into the design of the treatment protocols. The developers of the Expert Consensus algorithms have also served as formal consultants to the Texas project.
TMAP includes modules addressing all three major mental illnesses targeted by the state system: schizophrenia, bipolar disorder and major depression. "We've made some modifications to the Expert Consensus Guidelines to make them fit our system better," Rush stated. "And we have developed our own algorithm for major depression with the help of both local and national authorities."
Broad Consensus Sought
At the invitation of TXMHMR, prominent academicians in the state and outside consultants began a collaboration with the Texas mental health community to develop optimum medication treatment guidelines. Patient advocacy groups, family members and physicians working in the community clinics have been consulted throughout the development of the project.
Others involved in the committee leading the project include Charles Bowden, M.D., professor of psychiatry, University of Texas, San Antonio; Robert Hirschfeld, M.D., department of psychiatry, University of Texas Medical Branch, Galveston; and Marcia Toprac, Ph.D., director of TXMHMR research. Clinicians applying the algorithms at project sites have been selected from the ranks of physician employees of TXMHMR.
"Texas is a logical place to test the use of algorithms on a large scale," Rush said at a recent conference. "Due to the financial constraints on the TXMHMR system, we have to focus on medication treatment and patient education, with relatively little in the way of formal psychosocial therapies. So in this setting it may be easier to discern the effect of optimizing our medication treatment."
Pilot Phase Now Underway
Phase 1 of the project began in September 1996. Goals of the pilot phase are to determine if medication algorithms are practical in a community mental health setting, and if they are acceptable to both clinicians and patients. More than 50 psychiatrists and clinical coordinators at 14 different inpatient and outpatient sites across the state are participating.
"The algorithms are not a rigid, inflexible set of instructions, like a cookbook," consultant Kahn stated. "Instead, by having the recommendations of an expert panel, the psychiatrist has an objective guideline to support decisions, while retaining the freedom to tailor the guidelines to the individual patient."
During the pilot phase, patients enrolled in the project are followed closely for symptom response. Monitoring tools include the Brief Psychiatric Rating Scale (BPRS), a new social assessment tool called Multonomah, and clinician and patient rating scales. The main criterion for deciding to enroll a patient with one of the major mental disorder diagnoses is simply the clinical judgment that a medication change is needed. Any patient who has had less then optimal response to their current medication regimen is thus deemed eligible. A sample of the enrolled patients receive a detailed diagnostic interview (the Structured Clinical Interview for DSM-IV[SCID]) as a check on the accuracy of diagnosis by their primary treatment team.
"At this stage, the TMAP is not a formal research study," according to Shon. "We want to see whether it's practical to use these algorithms in a real-life setting, and what problems arise. Then we will be ready for a more formal approach with control groups. Eventually, we'll be able to quantify the difference it makes in clinical outcomes and cost." He added that changes can be made to the algorithms based on how they are actually applied in the field.
Phase 2 of the project, which will include control groups, is scheduled to begin in summer 1997. Comparison will be made between patient outcomes treated under the algorithm versus "treatment as usual" at matched pairs of sites.
Some doctors in the Texas system initially voiced concerns about being "told how to practice medicine," or having to follow a set of rules dictated by an outside authority. Better understanding of the true nature of the algorithms has led to a broad general acceptance of the project. Actual use of the algorithms will be necessary to tell if they are workable in daily practice, however. At the end of the pilot phase, both clinicians and patients will be asked to rate their degree of acceptance of the algorithms.
A related question is whether the algorithms as currently constructed apply well to the target population. It is possible that guidelines promulgated by academic clinicians may not be optimal for patients in the public sector. It is also possible that community mental health center patients differ enough from private sector patients that modifications in the algorithms would have to be made.
Using the Algorithms
In one sense, applying a medication algorithm to patient care is no different from practice as usual."If you keep up with the literature, go to conferences and so forth, this is pretty much what most psychiatrists are going to be doing anyway," one project participant stated.
In other ways, using the algorithms can sharpen the clinical decision-making process. "The difference is that the algorithm forces you to think through each decision more thoroughly. Also, I'm more focused on optimum treatment, not just 'good enough' results," the participant added.
Several doctors who feared the prescriptive nature of an algorithm have found that concern to be groundless. "One of the basic rules is that you only do what you and the patient are comfortable with," the project directors said. "If you decide to omit a certain step, or substitute a different medication, just give us your rationale." Such deviations from the explicit algorithm will be "grist for the mill" in the development process. The algorithms can be modified at various stages throughout the project to reflect significant variations in their practical use.
The Big Picture
Shon has great hopes for TMAP. "We may help improve the quality of treatment in this state, and possibly the nation," he said. "One of the end results could be that the public sector becomes the leader in quality psychopharmacologic treatment, in no way inferior to the private sector." He adds that there has been a great deal of support from mental health advocacy groups, who see the project as a sign of the state's commitment to providing the best possible care, not just minimal care. He has also received inquiries from several other state mental health departments, indicating an interest extending beyond the borders of the Lone Star state.
Frances A, Docherty JP, Kahn DA. Expert Consensus Guideline Series: Treatment of bipolar disorder. J Clin Psychiatry. 1996;57(suppl 12A):1-88.
Frances A, Docherty JP, Kahn DA. Expert Consensus Guideline Series: Treatment of schizophrenia. J Clin Psychiatry. 1996;57(suppl 12B):1-58.