Michael L. Russell

Successful program for recovery of dropouts to a clinical trial

This is a report of a successful program to return dropout participants to active participation at a single clinic of a multicenter long-term clinical trial, the Coronary Primary Prevention Trial of the Lipid Research Clinics Program. The specific objectives were to re-engage dropouts into active participation and to have them resume study medication. Thirty-six men had been absent from the Baylor-Methodist Clinic for 10 months to over four years. The program focused on resolving the presenting problems: psychosocial, somatic, and drug adherence. It was based on six general principles with corresponding goals and employed 13 activities and procedures in a specific operational sequence for reinstitution of the Coronary Primary Prevention Trial protocol. Counseling techniques were used to improve protocol adherence. The recovery program was monitored bi-weekly by computer. The dropout group did not appear to exhibit any biases and approximated the remainder of the Baylor-Methodist cohort demographically. At six months into the recovery program, 90 percent of the dropouts had been recovered. Seventy percent of the recovered participants re-established medication-taking behavior. The mean rate of adherence to medication for all of the recovered group was 35 percent of the prescribed dose, 8 g per day. Review of the data for the cholesterol differential between the two treatment groups demonstrated a favorable effect of the reinstitution of the study medication. The programs methods are applicable to clinical practice.

The Application of Competency-Based Education to Consultation-Liaison Psychiatry: I. Data Gathering and Case Formulation

In the first of three papers, the authors present a competency-based model for training in consultation-liaison psychiatry which addresses the issues of how residents are taught to collect and formulate patient data. This model emphasizes the use of behavioral statements to describe the process of how a consultation is done. By comparing the residents performance with prestated behavioral objectives, a method for residency supervision is offered. The second paper carries this one step further with the application of the model to clinical intervention strategies. The final paper discusses the implications of this approach to some of the issues that surround residency training in this field.

Competency-based psychiatric education.

The focus of training in a competency-based residency program is on ensuring that all residents attain prespecified levels of competence for particular objectives in each training activity. The authors examine the components of a competency-based program and describe the phases of development that their department went through in creating such a program. They conclude that the competency-based training model directly faces the issue of certifying competence by holding itself accountable in a demonstrable way for ensuring that its residents have mastered specific areas of knowledge, skills, and attitudes.

Examination of medical professions for counseling on medication adherence

The abilities of 68 professional staff members (physicians, physician assistants, dietitians, nurses, and counselors) from 12 clinics of the Coronary Primary Prevention Trial of the Lipid Research Clinics Program in 28 specific skills fundamental to interviewing and counseling for medication adherence were examined. Each staff member was provided with confidential data regarding his or her abilities, and each clinics trial director received the group data for his or her staffs possession and use of these skills. Analyses of trial-wide data showed substantial differences among clinics in possession and use of the skills, with overall greater strength in interviewing skills, as compared with assessment and counseling skills. No professional group consistently possessed most or fewest of these skills. It is suggested that trained non-physician personnel could be used to complement physician efforts to counsel patients for medication adherence.

The Application of Competency-Based Education to Consultation-Liaison Psychiatry: II. Intervention Knowledge and Skills

Although psychological and pharmacological intervention is an important aspect of the treatment of patients seen in consultation on medical and surgical wards, little attention has been directed to the method of training psychiatric residents in these areas. In this paper, the authors continue the application of the competency-based model of training to the problems of clinical intervention. Behavioral objectives are presented as a focus for residency supervision and their application to a clinical situation is illustrated. The objectives are designed to consider the activities of the consulting psychiatrist as he relates to the patient as well as other members of the treatment milieu.

Evaluation and training of medication adherence counselors in a clinical trial: application of a skill inventory to video-recorded interviews.

This report describes the procedures and feasibility of an integrated evaluation and training program developed at the Baylor-Methodist Lipid Research Clinic to examine the skills used by the clinics professional staff in conducting medication adherence interviews with participants in the Coronary Primary Prevention Trial (CPPT). The specific aims of this project were to evaluate the staffs interviewing and counseling skills, identify strengths and deficits, provide needed training, and reexamine the staffs skills following this training. Each of five staff members conducted two 20-minute video-recorded interviews with two different simulated CPPT participants. A trained observer reviewed the video-recordings and evaluated, by an Inventory for Interviewing and Counseling Skills for Adherence to Medication (IICS-AM), each staff members possession and frequency of use of 17 interviewing skills and 10 counseling skills. The 27 skills on the IICS-AM were selected from the literature as being most frequently recommended for effective interviewing and counseling for medication adherence. These rating data were used to design a 14-week training program to acquire and promote the use of these skills. Following training, the video-recorded interview procedure was repeated and the data analyzed to identify the effects of the training program. The integrated evaluation and training procedures used in this project offer a practical, objective method for examining, improving, and monitoring the skills of the adherence counseling staff in a clinic participating in a multicenter clinical trial.

The Application of Competency-Based Education to Consultation-Liaison Psychiatry: III. Implications

In this paper the authors consider the implications of a competency-based model of education in relation to issues that affect the training of consultation-liaison psychiatrists. These issues include program design, the integration of consultation-liaison psychiatry to psychiatry in general, and the relationship of consultation-liaison psychiatry to medicine. Training programs in consultation-liaison psychiatry need to respond to the issues that derive from each of these areas. The authors argue that the competency-based model provides a framework which offers guidelines for designing a program that addresses these concerns.

Behavioral aspects of the use of medical markers in clinical trials

Nonadherence by trial participants to the study drug regimen threatens the satisfactory conduct of the best designed clinical trial. Reduced adherence confounds the interpretation of the studys results and may leave the studys primary question unanswered. Recent reports from multicenter clinical trials have reported adherence rates of 60%-90%. This presentation examines the use of a drug marker in counseling to improve participant adherence to a medication regimen. Potential benefits and problems are identified, and several recommendations are offered. Increasingly, behavioral counseling has been used by clinic staff members to improve the medication adherence of trial participants. Behavioral counseling is a data-based counseling process emphasizing patient collaboration with the clinician in identifying, diagnosing, and intervening in medication adherence problems. A valid, accurate drug marker would have direct application in both identifying and intervening on a medication adherence problem. However, a marker would not contribute substantially to the clinicians ability to diagnose accurately the nature of the medication adherence problem. A major concern is the manner in which the clinician introduces the drug marker into the counseling process. The use of data from a drug marker can have a strong positive or negative effect on the medication adherence problem. It also can significantly influence the continuing relationship between the clinician and the participant. Examples are presented. It is strongly recommended that the clinician identify the specific goals for the markers use prior to the introduction of data from a medical marker into the participant counseling process. Further, the manner in which the marker is introduced into the interview with the participant must be considered carefully.(ABSTRACT TRUNCATED AT 250 WORDS)

The Statistical analysis of adherence data obtained from markers

Adherence markers provide new kinds of clinical trial data. Adherence data on individual participants obtained from markers can be used for designing the trial sample size and stratification, evaluating the adequacy of randomization, directing the management of adherence, and analyzing and interpreting the trials final results. Examples of these are presented. Analyses of adherence data can employ conventional procedures. Box plot techniques are proposed for flagging extreme values of the distribution of adherence either at a single time point or in a time continuum. The effect of difference in distribution of the markers in two or more groups in a clinical trial is discussed. Survival analysis is illustrated as one technique in univariate and multivariate analysis of markers with covariate effects. Design considerations with markers in a clinical trial are discussed, with particular emphasis on some of the assumptions and biases that must be considered for the analysis.

Multimodal Evaluation in the Training of Psychiatrists

The young physician experiences a maturational process during residency training that involves fundamental changes in attitudes, identities, and abilities as a physician, a psychiatrist, and a person. A comprehensive multimodal evaluation methodology is proposed that provides information to the resident and faculty regarding the resident’s progress in each area. A detailed description of the implementation of a multimodal evaluation process in one residency training program is offered. A discussion of the advantages and limitations of this approach is also offered.