A Randomized Controlled Trial of a Private-Sector Inpatient-Initiated Psychoeducation Program for Schizophrenia

Individuals eligible for the study included patients aged 18 or older with a diagnosis of schizophrenia who were voluntarily admitted to the Christian Hospital Northwest inpatient service in St. Louis, Missouri, between July 2001 and March 2003. All study participants had to be well enough to participate in the program and willing to be randomly assigned to usual care or the STEPS program. During the study enrollment period, 57 of 85 (67%) consecutive study-eligible patients enrolled in the study, with 28 declining participation. An additional 59 patients had illness so severe that they could not provide informed consent, complete study assessments, or join in organized activities of a psychoeducation program. A six-month follow-up study was completed, with 31 (54%) of the original 57 located and reassessed. There were no statistically significant differences between those reassessed and those lost to follow-up in terms of any demographic variable, duration of illness, symptom severity at baseline, recent history of use of inpatient or outpatient substance abuse services at baseline or use of other psychiatric services at baseline, or randomization to STEPS or the usual program.

Approval for both the index and follow-up parts of the study was obtained from the institutional host of the study, the Washington University School of Medicine Institutional Review Board. All participants provided written informed consent before the assessments at both time points and before treatment group randomization.

At baseline a computerized randomization program selected 26 patients for the STEPS program and 31 for usual care. All patients in both groups continued all other aspects of their treatment, meeting with their usual psychiatrists and being encouraged to take their medication as prescribed. Their psychiatrists and the research assessment team were blinded to patients' random assignment to STEPS or to usual care.

Usual care is the standard treatment routinely provided by psychiatric inpatient units and is received by all patients at this hospital, including those participating in STEPS. All patients at this hospital attend four to five hours of educational mental health classes seven days a week that are nonspecific to type of illness and address basic self-care and healthy lifestyles, coping skills, self-esteem, socialization skills, anger and stress management, communication with the treatment team, and the importance of participating in treatment (including taking medication and attending appointments). Group sessions allowed patient ventilation about personal issues or the hospital environment.

The STEPS program is tailored to the progress of patients through the system of care, starting during the inpatient stay and proceeding through achievement of residential stability with families or even independent living. All patients in STEPS participate in usual care as described above. The inpatient segment of the STEPS program offers additional daily structured educational activities for understanding the illness and symptoms of schizophrenia (Symptoms Education Class), and it offers a Managing Your Illness class, which provides coping skills specific to the symptoms (for example, managing hallucinations, paranoia, and delusions), daily living skills specific to the problems of schizophrenia, social skills, and personal development, all geared toward managing the illness. Program activities continue posthospital discharge through partial hospitalization and evening programs in the community and an annual full-day workshop open to the public. Families are encouraged to participate for as long as they wish in the program at every level, including attendance at inpatient family meetings, discharge planning meetings, monthly drop-in meetings for informal support and information, and semiannual picnic programs ( 12 ).

A computerized version of the Diagnostic Interview Schedule (DIS) ( 13 ) was administered by a trained rater before program participation. With the patient's permission, a close family member provided collateral information to supplement the patient history on the number of previous psychiatric inpatient admissions and utilization of other services by the patient in the past six months. Symptom severity was measured at baseline by the Scale for the Assessment of Positive Symptoms and by the Scale for the Assessment of Negative Symptoms ( 14 ).

The computerized DIS data were put into an electronic data set, and diagnoses were scored from the raw data. Data from questionnaires and interviews were entered and merged with diagnosis data into a SAS data set. Data are presented as numbers and percentages for categorical variables and as means with standard deviations for numerical variables. Patient and family information about service use was combined into a single item for each service use category. Categorical variables were compared by using chi square analyses (substituting Fisher's exact tests when expected numbers in cells were less than five). Student's t tests were used to compare numerical variables, using Satterthwaite comparisons for data with unequal variances as well as nonparametric analysis (PROC NPAR1WAY in SAS) for determining differences in rehospitalization rates between the two study conditions. Effect sizes were calculated using Hedges' correction for small sample bias to be consistent with findings reported in the review by Lincoln and colleagues ( 10 ).

Table 1 provides details of characteristics of the study sample of 57 patients, by group. Slightly more than one-half of the sample was male and African American, the mean age was 37.2 years, and the mean number of years of education was 12.0. Few were married. The mean duration of schizophrenic illness was about 15 years, and more than half had been hospitalized in the six months before the index hospitalization.

At follow-up 31 of 57 (54%) were reassessed. (Funding constraints for the research did not permit aggressive tracking and reenlistment of study participants.) Those in STEPS were not detectably different from those in usual care on any of the baseline variables. The mean±SD length of inpatient stay was 10.7±9.4 days, and patients in STEPS did not differ from those in usual care on this variable. Study attrition between index and follow-up was not associated with gender, age, ethnicity, level of education, marital status, symptom level, or duration of illness at the time of the index hospitalization.

Over the six-month follow-up period, participants in STEPS demonstrated a significant reduction in hospitalization, compared with those receiving usual care. Results showed that nine of 16 (56%) of the usual care patients were rehospitalized in the six-month follow-up period, compared with only three of 15 (20%) STEPS participants ( χ ² =4.29, df=1, p=.038), an effect size of .76. After reanalysis of the data to assume that all patients who were not reassessed at follow-up had been rehospitalized, the difference dropped to rehospitalization among 24 of 31 (77%) usual care program participants and 14 of 26 (54%) of STEPS participants ( χ ² =3.54, df=1, p=.060), an effect size of .50. The mean number of rehospitalizations during the six-month follow-up period in the usual care group was 1.6±2.2, compared with .3±.6 in the STEPS group (z=2.24, df=17.3, p=.033), with an effect size of .80.

This randomized clinical trial demonstrated that participation in the STEPS psychoeducation program significantly reduced subsequent rehospitalization. An important aspect of this study is the private-sector psychiatric treatment setting of this successful psychoeducation program, a program that translated well-established effectiveness demonstrated in academic or other rarified treatment settings to real-world settings of the private-care sector.

Several methodological strengths of this study merit mention. The STEPS psychoeducation intervention was compared with a control group receiving usual care, and data collection was blind to randomization status. Data were gathered prospectively for the purpose of examining effects of the STEPS program on subsequent hospitalization. Structured diagnostic interviews were used to document the diagnosis of schizophrenia among all patients. The study was limited, however, by the severity of illness of the study population; many were too ill to engage in research or psychoeducation activities, and problems of study attrition in this very ill population over the follow-up period reduced the study's statistical power and the potential representativeness of the data. Despite these difficulties, the study documented a lower rate of subsequent hospitalization among those who participated in STEPS and completed the study.

Larger, more comprehensive studies are needed to replicate these findings and identify the active components of the STEPS program that might be responsible for the apparent reduction in subsequent hospitalization. Given the remarkable cost savings demonstrated in the study by McFarlane and colleagues ( 8 ) of a psychoeducation program in an outpatient setting, it should not be surprising to find even larger potential for savings for psychoeducation programs initiated in inpatient settings, where the greatest amount of psychiatric care costs are incurred ( 8, 15 ).

This research was supported by a grant from Barnes-Jewish Hospital Innovations. Dr. Vickar is the medical director of STEPS ^SM, a program he developed in 1985. The service mark for STEPS ensures that any organization that uses the materials complies with the program as described and as approved by Dr. Vickar. There are no royalties associated with it, and it is not a franchise or network. The contents of this report do not represent the views of the Department of Veterans Affairs.

The authors report no competing interests.

Dr. Vickar is affiliated with the Department of Psychiatry, Christian Hospital, 11125 Dunn Rd., Suite 213, St. Louis, MO 63136 (e-mail: [email protected]). Dr. Vickar is also with the Department of Psychiatry, Washington University in St. Louis. Dr. North is with the Department of Veterans Affairs North Texas Health Care System, Dallas, Texas. Dr. North is also with the Department of Psychiatry, University of Texas Southwestern Medical Center at Dallas, with which Mr. Downs is affiliated. Ms. Marshall is with Trinity Hospice, Sunset Hills, Missouri. An earlier version of this study was presented at the Institute for Psychiatric Services, Boston, October 29 to November 2, 2003, and at the Institute for Psychiatric Services, Chicago, October 2 to 5, 2003.