TY - JOUR
AU - MD, Martin Zeitz,
AB - Background Few published studies examine the influence of psychological treatment on health care utilization in Crohn's disease. Methods The present substudy of a prospective, randomized, multicenter trial conducted in 69 of 488 consecutive Crohn's disease (CD) patients was designed to investigate the way in which healthcare utilization is influenced by psychotherapy and relaxation in addition to standardized glucocorticoid therapy. Before and after a 1-year period of standardized somatic treatment the psychotherapy and control groups were compared with regard to hospital and sick-leave days. Predictors of healthcare utilization were analyzed. Results The comparison between groups before and after psychological treatment showed a significantly higher decrease of mean hospital days (P < 0.03) and sick-leave days in the treatment group compared with the controls. When a covariate analysis was applied to compare the data at randomization, the difference in hospital days remained statistically a trend (P < 0.1). Multivariate regression analysis detected a significant gender and depression effect for hospital days (cor r2 = 0.114) and a significant gender and age effect for sick-leave days (cor r2 = 0.112). Conclusion A significant drop in healthcare utilization after psychological treatment demonstrates a clear benefit of this additional therapy. This is important, since the study failed to demonstrate significant changes in the psychosocial status or somatic course of study patients. Clinical and psychological factors influencing these outcomes are discussed. Crohn's disease, health care utilization, outcome study, psychological intervention Due to its chronic course with frequent relapses, inflammatory bowel disease (IBD) involves higher medical care utilization (doctor visits and hospital days per year) than other gastrointestinal (GI) diseases.1,2 Direct costs comprise more than 50% of all costs, including those for sick-leave and in-hospital days incurred as a result of IBD.3 Physical conditions and psychosocial factors are thought to influence the health status perception of IBD patients and hence also their medical care utilization.4 Thus, the severity of illness in IBD patients does not necessarily predict the hospital admission rate.5 Due to its chronicity, Crohn's disease (CD) not only leads to physical complaints but also causes many patients to develop psychological symptoms6,–12 that may influence their health-related quality of life13,–16 and care-seeking behavior. There is evidence that psychosocial factors accelerate the progression of CD.17,18 Controlled studies on psychotherapeutic interventions and educational programs have reported both good19,–22 and discouraging results.23,24 But very few studies have used assessments that include patients' physical, psychological, and healthcare status. Only two controlled studies have been conducted on healthcare utilization in CD, but no study has collected healthcare cost data from insurance companies.25,26 In a previously reported randomized trial, we found that psychotherapy did not affect the somatic and psychological outcome.27,28 This article focuses on results relating to patients' healthcare utilization. The study aim was to assess the effectiveness of psychological treatment provided in combination with standardized medical treatment over a 4-year observation period. We therefore analyzed the effect of a psychological intervention on medical healthcare utilization. We investigated the following hypotheses: 1) Psychological treatment reduces healthcare utilization and sick-leave days in CD patients, and 2) Sociodemographic and psychological factors predict healthcare utilization. Materials and Methods Recruitment and Screening Procedure During the 2-year recruitment period in this randomized and prospective study, all consecutive CD patients from the four participating centers were documented by recording their anamnestic and underlying somatic clinical data. The criteria for inclusion in the study were: confirmed diagnosis of CD, age between 18 and 55 years, at least one active disease episode (defined as requiring drug treatment) in the last 2 years, and informed consent to participate and to be randomized in a psychotherapy or nonpsychotherapy group. The exclusion criteria were: psychotherapy or resection for CD within the last 2 years and no further relapse thereafter; ongoing immunosuppressive therapy or need for resection in the near future; and colostomy or ileostomy. Study Design and Procedures Patients were randomly assigned to study groups. The randomization procedure served to hierarchically balance the most important prognostic factors in the following order: acute episode with a CD activity index (CDAI > 150)29 at the time of randomization (yes, no); involvement pattern (small bowel only, small and large bowel, large bowel only); previous intestinal resections (yes, no); and patient age (<30 years, >30 years). This balance was also valid for the healthcare subanalysis. After selecting a randomization ratio of 2:1 (see  Appendix 1), 40 patients were assigned to the psychotherapy group and 24 to the control group. Patients were clinically examined at baseline and every 3 months during the 2-year study period. Psychological examinations took place at baseline and after 12, 18, and 24 months. The same standardized drug treatment was provided in both groups (see below). All patients in the intervention group had therapy within the context of a psychological treatment program (see below). Patients in the control group had only eight control examinations. The study was approved by the local ethics committee. Patients Due to the restrictive inclusion and/or exclusion criteria, only 108 of 488 consecutive patients were randomized in the Psychosocial Intervention in Crohn's Disease (PICD) study: 37 were randomized to the control group and 71 to the psychotherapy group. The largest group of nonparticipants comprised patients without any relapse in the 2 years prior to the basic documentation (see  Appendix 2). Comparison of the included and excluded patients disclosed no significant differences in the sex distribution, involvement pattern, or disease duration. As the inclusion/exclusion criteria indicate, the participants were younger on average than the nonparticipants, and fewer of them had undergone previous resections. Dropouts Due to Nonfulfillment of the Healthcare Utilization Criteria Thirty-nine of the 108 patients (36.1%) who met the inclusion and exclusion criteria could not be evaluated for healthcare utilization. Most of them failed to obtain the data from the German insurance companies within the collecting period. Fourteen other patients did not complete their psychosocial questionnaires and/or failed to present for control examinations and were thus ineligible due to nonfulfillment of the main somatic or psychological outcome criteria of the study. The dropout rate was 39.4% (n = 28) in the psychotherapy group and 29.7% (n = 11) in the control group. The patients who dropped out were younger on average, and fewer of them had undergone previous resection. Comparison with the eligible patients revealed no differences in the distribution of the involvement pattern, sex, or disease activity at the time of randomization. The most important somatic parameters were evenly balanced between the two treatment groups. This also holds true for the sociodemographic data: the groups did not differ with respect to family status, partnership, children, or education level. Assessment of Healthcare Utilization Data on hospital days (HD, n = 69) and sick-leave days (SLD, n = 56) were collected for 4 years from the various German health insurance companies with the informed consent of patients (no SLD data available for housewives, students, or unemployed patients). We were thus able to include data from 2 years of health outcome before randomization, 1 year after randomization during psychological treatment, and 1 year of follow-up. Analyses of costs (drugs, visits to the doctor, etc.) were planned but not performed due to insufficient data. Patients were also asked about SLD and HD at control examinations every 3 months during the 2-year study period to validate the data of the health insurance companies. Gastroenterological Assessment Once included in the study, patients were subjected to the following28: complete history, clinical and laboratory examinations, colonoscopy, esophagogastroduodenoscopy, x-ray of the small intestine, and CDAI calculations.29 The CDAI was also recorded during all follow-up examinations and was used to decide what drug treatment was necessary. Each patient's course was documented for 2 years. Somatic data were recorded every 3 months during remission and once a week during acute attacks. Since the course of CD varies in terms of the length and severity of acute attacks as well as the frequency of various complications, it cannot be described on the basis of a simple criterion (e.g., episode length, CDAI level). Thus, in accordance with the European Cooperative Crohn's Disease Study,30 we developed a ranking system categorizing the course of the disease within the 2-year follow-up from best to worst. The main groups (main rankings) were: relapse-free course; course with acute relapses; effectiveness of standard drug treatment; failure of standard drug treatment, but effective immunosuppressive therapy; failure of any drug treatment, including immunosuppressants, with and without the need for surgery. The number of relapses as well as the length and severity of the disease activity in an episode were determined by using the CDAI values for Groups 1–3. The mean CDAI of the quarterly control examinations was calculated for Group 4. These data permitted a subranking within the main groups. It was thus possible to rank each patient in relation to every other patient with regard to the course of the disease. This rating was provided at the end of the study by an evaluation committee including at least one gastroenterologist from each participating center. The raters were blinded with respect to the patient therapy group Psychosocial Assessment The patients' psychosocial status was determined28 on the basis of self-ratings of depression (Beck's Depression Inventory: BDI31), trait anxiety (STAI-X232), and the health-related quality of life (HRQL33). Treatment Drug Treatment Based on the study protocol of the European Cooperative Crohn's Disease Study (ECCDS),30 we used a fixed dosing scheme for administering corticosteroids during acute episodes: 60 mg of prednisolone daily as the initial dose followed by weekly reductions to 40 mg, 30 mg, 25 mg, 20 mg, and 15 mg. Patients were given 10 mg a day from week 7–19 and 10 mg every other day from week 20–28. Sulfasalazine was allowed in patients with colonic CD, 5-ASA in all cases. If remission or a significant reduction of the CDAI29 was not achieved after 6 weeks of drug treatment, the same scheme was repeated, beginning with 60 mg of prednisolone. No drug treatment was given during remission of the disease. Deviations from the drug protocol due to the protracted follow-up time and the variability of disease severity was referenced in detail previously.27 Psychological Treatment For the intervention group, all participating centers provided basic short-term psychodynamic psychotherapy (20 hours) and a relaxation treatment program (10 autogenic training sessions). The total length of psychotherapy was not to exceed 1 year (the mean duration of therapy across the four study centers was 47.0 weeks (SD 31.2); the mean duration of the total number of verbal therapy sessions was 26.2 weeks (SD 20.5); the mean duration of the number of relaxation therapy sessions was 17.6 weeks (SD 10.4)). The aim of verbal psychotherapy was to provide health education and health-promoting behaviors, to give patients greater responsibility and control over their treatment, and to improve their coping skills and adjustment to the disease. Another aim was to alleviate possible disease-related psychological distress and maladaptive interpersonal patterns. Although no manual was used, the psychotherapy provided was based on the principles of psychodynamic psychotherapy and was standardized within the study centers.28 Statistical Analysis The study evaluated both the patient selection and the homogeneity of the two therapy groups with respect to important somatic and psychosocial parameters. All group comparisons were performed with the Mann–Whitney U-test for continuous or ordinal variables and Fisher's exact test for categorical variables. For the main analysis of healthcare utilization, the two treatment groups were compared with regard to their overall HD and SLD scores assessed 2 years before randomization (divided by two) and at the 1-year follow-up after psychological treatment with the t-test. The alpha errors of the two tests were adjusted according to Bonferroni–Holm in order to ensure an overall significance level of α = 0.05. The analysis of healthcare utilization was based on the assessment of each eligible patient in the group to which he or she was randomized, regardless of whether or to what extent he or she participated in psychotherapeutic interventions, and/or whether or not he or she was treated with corticosteroids according to the protocol. A second step comprised covariance analysis and multivariate regression analysis of the whole sample of 69 CD patients to detect factors influencing healthcare utilization. All calculations were performed using the Statistical Analysis System (SAS Institute, Cary, NC). Ethical Considerations The study was approved by the Ethics Committee of the Medical University of Luebeck according the Declaration of Helsinki. Results Anamnestic Data Major influencing factors did not differ between the CD treatment groups in the healthcare substudy of the randomized controlled trial (Table 1). Table 1 Anamnestic Data of Crohn's Disease Patients in the Healthcare Utilization Study     View Large Table 1 Anamnestic Data of Crohn's Disease Patients in the Healthcare Utilization Study     View Large Clinical Examinations In a first step, we collected the somatic and healthcare data from the quarterly control examinations and calculated the CDAI for each timepoint. Median CDAI values were higher in the control group compared with the psychotherapy group. The difference of CDAI between the control group and the psychotherapy group did not change significantly over time (Fig. 1a). Figure 1 View largeDownload slide Crohn's Disease Activity Index (CDAI, median), days in hospital and sick-leave days (self-report, median) in the course of time − treatment (n = 43) and control group (n = 26), data were selected every 3 months, 3rd–24th month after randomization). Figure 1 View largeDownload slide Crohn's Disease Activity Index (CDAI, median), days in hospital and sick-leave days (self-report, median) in the course of time − treatment (n = 43) and control group (n = 26), data were selected every 3 months, 3rd–24th month after randomization). An intergroup comparison of healthcare utilization data (patients' self report) obtained in the 2 years after randomization revealed a better course of HD and SLD in the psychological intervention group than in the control group (Fig. 1b,c). Patients were often randomized during in-patient treatment during active disease, which explains the high values of HD and SLD at randomization. Data From the German Health Insurance Companies The mean HD during the 2 years before randomization was 11.1 (SD 8.1) in the total patient population; it was higher in the psychotherapy group (12.3, SD 8.5) than in the control group (8.7, SD 6.7, P = 0.07). The mean SLD during the 2 years before randomization was 98.1 (SD 7.7). This initial value was lower in the control group than in the psychotherapy group but did not differ significantly between the two groups. The overall HD and SLD scores calculated for the total patient population within 2 years after randomization were 24.38 (SD 15.1) HD and 92.58 (SD 60.4) SLD. The target criteria for intergroup comparison were the difference between healthcare utilization parameters HD and SLD 2 years before randomization divided by two and the year after psychological treatment (fourth year of study). Under therapy, there was on average a reduction of annual hospital and sick leave days. Assessment of annual HD confirmed the favorable average somatic course of the psychotherapy group, and the finding was statistically significant (P = 0.03). It revealed a significant tendency (P = 0.09), even when including the different initial values of the two groups (covariance analysis). Compared with the time before randomization, HD increased in the first year and dropped in the second year thereafter. Interestingly, the decrease was significantly higher in the psychotherapy group than in the control group (Fig. 2). Figure 2 View largeDownload slide Days in hospital in the course of disease were provided by insurance companies. Total days in hospital are given for the treatment group (n = 43) (open bars) and the control group (n = 26) (shaded bars). Days in hospital related to Crohn's disease only are indicated by hatched bars. T-test (4th year − 1st + 2nd year) P = 0.03. Figure 2 View largeDownload slide Days in hospital in the course of disease were provided by insurance companies. Total days in hospital are given for the treatment group (n = 43) (open bars) and the control group (n = 26) (shaded bars). Days in hospital related to Crohn's disease only are indicated by hatched bars. T-test (4th year − 1st + 2nd year) P = 0.03. Both groups showed an increase in the SLD in the first year after randomization and a drop in the year after the intervention. Comparing the year before randomization (2 years divided by two) and the year after the intervention disclosed a mean intergroup difference in favor of the psychological treatment (Fig. 3). Figure 3 View largeDownload slide Sick-leave days in the course of disease were provided by insurance companies. Total sick-leave days are given for the treatment group (n = 34) (open bars) and the control group (n = 22) (shaded bars). Sick leave days related to Crohn's disease only are indicated by hatched bars. T-test (4th year − 1st + 2nd year) not significant. Figure 3 View largeDownload slide Sick-leave days in the course of disease were provided by insurance companies. Total sick-leave days are given for the treatment group (n = 34) (open bars) and the control group (n = 22) (shaded bars). Sick leave days related to Crohn's disease only are indicated by hatched bars. T-test (4th year − 1st + 2nd year) not significant. A simple monetary calculation of these results showed a 6.5 times higher benefit for psychological treatment when taking into consideration the HD, SLD, and costs of the psychological treatment (Table 2) and disregarding other possible costs and benefits. Table 2 Effect of Psychotherapy on Hospital Days and Sick-leave Days During the Course of Disease: Estimated Financial Benefita     View Large Table 2 Effect of Psychotherapy on Hospital Days and Sick-leave Days During the Course of Disease: Estimated Financial Benefita     View Large Predictor Analyses The variables that predicted SLD in a univariate correlation analysis were gender, depression, anxiety, and severity of illness. In a multivariate analysis, only the first two variables remained in the model. Gender, depression, and age predicted HD in the univariate analysis, but only gender and age remained significant in the multivariate model (Table 3). Table 3 Factors Influencing Sick-leave Days and Days in Hospital     View Large Table 3 Factors Influencing Sick-leave Days and Days in Hospital     View Large Discussion The present substudy of a prospective, randomized trial conducted in 69 of 488 consecutive CD patients was designed to investigate the way in which healthcare utilization is influenced by psychotherapy and relaxation in addition to standardized glucocorticoid therapy. We found a high rate of care-seeking behavior in our patient population. This enabled us to examine the effectiveness of psychological treatment in this high-utilizing sample. Before and after a 1-year period of standardized somatic treatment, the psychotherapy and control groups were compared with regard to hospital and sick-leave days. The comparison between groups before and after psychological treatment showed a significantly higher decrease of mean HD (P < 0.03) and SLD in the treatment group compared with the controls. When a covariate analysis was applied to compare the data at randomization, the difference in HD remained statistically a trend (P < 0.1). Thus, the present study was able to demonstrate the effectiveness of a psychological treatment in reducing the health care utilization of CD patients. With a view to presenting an appropriate description of the somatic course of the disease over a 2-year period, we developed a ranking scheme based on the ECCDS protocol,30 ranging from the best to the worst clinical course. This enabled very careful evaluation of the somatic outcome criterion and the CDAI in the patients. The results according healthcare seem interesting in view of the fact that the study failed to support significant somatic improvement following the psychological intervention (the results on the somatic course of the disease in the care utilization substudy did not differ from those previously published in the main study27). The influence of a psychological intervention on healthcare utilization contrasts with the fact that the control group had higher CDAI levels than the psychotherapy group in the course of the study. The argument that the psychotherapy group was more healthy and therefore could profit more from the therapy has to contrasted with the fact that the psychotherapy group had more HD and SLD than the controls in the years before randomization. So both groups were comparable not only in clinical influencing factors at randomization (Table 1), but also according to healthcare utilization. This seems also interesting in view of the fact that the study failed to support a significant psychological improvement following psychological intervention. In the course of this substudy, there were also no significant changes in the psychological outcome criteria depression (BDI31), anxiety (STAI32) and health-related quality of life33 between therapy and control group.28 Psychological data indicated few psychological symptoms in our study patients. This is consistent with data indicating that patients with IBD perceive their level of psychosocial distress as low5 and their health-related quality of life as quite good,11 despite their symptoms. Analgesic dependency occurred in very few cases in the treatment and control groups. Since only patients from GI clinics were included and patients who wanted psychological treatment were excluded from the randomized trial for ethical reasons, our patients represent a clearly nonpsychiatric sample and are therefore not comparable to the patients of Kaplan and Korelitz,34 who found a higher percentage of analgesic dependency in their study. It was interesting that healthcare utilization (HD, SLD) in this CD study group was higher than in other studies.2,5,25,26 There is no doubt that the intervention group clearly benefits from the psychological intervention in terms of care utilization and probably also in a cost/benefit analysis Other factors could be responsible for this result. In psychological treatment studies it is impossible to completely control a placebo effect in a double-blind trial. But it is possible to control conditions of the spontaneous course of disease: Both groups got the same number of GI examinations (n = 7) in the 2 years of study; moreover, we controlled the number of doctors visited over time, which was the same in the treatment and control groups. But through the additional hospital visits for the psychological therapy this treatment had a “specific” and an “unspecific” effect on healthcare utilization. Moderating factors of the specific effect seem to be more effective disease self-management, better patient adherence, and more security in illness behavior during disease crises. A longer waiting time before (or avoidance of) bowel surgery may be another reason. To cope better with the illness or with stressful life events may lead to fewer psychic symptoms19,–21 and a better HRQL4,15,16 and may influence the possibility of going to the hospital or going to work.5 These aspects could only be partly detected by our psychological measurement,28 but we assume they are meaningful for the change in healthcare utilization in the psychological treatment group. Regarding the kind of applied psychological treatment in this study, it should be taken into consideration that 20 hours of psychological and interpersonal management and 10 hours of relaxation were a “high dose,” with a good effect on minimizing healthcare utilization. Inadequate treatment results can be minimized by spending some time communicating with CD patients35 and by applying a sophisticated psychological treatment program (not only for information or education36,37) that focuses on changing patients' coping capabilities and illness behavior.23,24 Interestingly, these effects of a psychological intervention on high care utilization do not seem to be specific for CD but are also found in patients with other chronic diseases like asthma38 or rheumatoid arthritis.39 The fact that women had much higher HD and SLD values than men suggests that factors other than the somatic course of illness could be important in this study on healthcare utilization.40 Multivariate regression analysis detected a significant gender and depression effect for SLD (cor r2 = 0.189) and a significant gender and age effect for HD (cor r2 = 0.114). This is in agreement with other studies.5,7,25 For the interpretation of the results from the present study it should be appreciated that patients from specialized GI divisions of university medical centers with relapses in the last 2 years were selected in this randomized trial, but patients without relapses or those with surgery within the 2 years before randomization were excluded. Study subjects represent patients with disease distribution along the intestinal tract comparable with other studies41,42, but there were more female patients41 and patients were older43,44 than in other trials. Looking at the number of HD and SLD examined in this study we must take into consideration the healthcare situation in Germany. Due to difficulties in collecting healthcare utilization data from German insurance companies led to a relatively high dropout rate of randomized patients. Thus, only 64% of PICD patients could be included in the healthcare substudy. The observation period for healthcare utilization was 4 years; we do not know if the effects of the psychological treatment will continue after the 1 year of follow-up. Some characteristics limit the generalizability of the current results. Since psychically disturbed patients who were interested in psychological treatment were excluded, very few patients with depression, anxiety, or a low HRQL were included in the study and thus the study did not include the full spectrum of CD patients. Study results therefore relate to a high-level healthcare population without severe psychiatric comorbidity. Care-seeking behavior proved to be important for evaluating specific consequences of the disease. Due to its economic importance, this disease indicator can be modified to become a target criterion for therapy. As demonstrated in earlier therapy studies on CD patients, high utilizers are likely to benefit from psychological treatment. 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TI - Psychological treatment may reduce the need for healthcare in patients with Crohn's disease
JF - Inflammatory Bowel Diseases
DO - 10.1002/ibd.20068
DA - 2007-06-01
UR - https://www.deepdyve.com/lp/oxford-university-press/psychological-treatment-may-reduce-the-need-for-healthcare-in-patients-onzYmYCyR0
SP - 745
EP - 752
VL - 13
IS - 6
DP - DeepDyve
ER -