Effects of a Multi-Faceted Psychiatric Intervention Targeted at the Complex Medically Ill: a Randomized Controlled Trial
|First Received Date ICMJE||October 6, 2006|
|Last Updated Date||October 16, 2008|
|Start Date ICMJE||November 2002|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||Psychological distress, quality of life|
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT00385528 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
||health care utilization|
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Effects of a Multi-Faceted Psychiatric Intervention Targeted at the Complex Medically Ill: a Randomized Controlled Trial|
|Official Title ICMJE||Effects of a Multi-Faceted Psychiatric Intervention Targeted at the Complex Medically Ill: a Randomized Controlled Trial|
Background: somatic patients with psychiatric co-morbidities are a major challenge for the health care system. This study evaluated a psychiatric intervention targeted at the complex medically ill identified by means of the INTERMED, an instrument to assess case complexity.
Methods: of 885 rheumatology inpatients and diabetes outpatients who were assessed for eligibility, 247 were identified as complex (INTERMED score > 20) and randomized to the intervention (N=125, 84 rheumatology and 41 diabetes patients) or care as usual (N=122, 78 rheumatology and 44 diabetes patients). Intervention consisted of counseling by a psychiatric nurse, referral to a liaison psychiatrist, or a multidisciplinary case conference. Baseline and follow up at months 3, 6, 9 and 12 measured prevalence of major depression (MINI), depressive symptoms (CES-D), physical and mental health (SF-36), quality of life (EuroQol), hospitalizations (rheumatology patients) and HbA1c levels (diabetic patients).
Of the 885 that assessed for eligibility (see Figure 2), 184 (20.8%) met exclusion criteria, such as not speaking French (N=43), severe cognitive disturbances (N=27) or hospitalization for less than 3 days (N=28); 6.2% refused to participate (N=55). Of the remaining patients (N= 701), 64.8% (N=454) did not qualify as complex patients (INTERMED score < 20). The remaining 247 patients were randomized, 125 (84 rheumatology inpatients and 41 diabetes outpatients) to the intervention and 122 to care as usual (78 rheumatology inpatients and 44 diabetes outpatients). With regard to sociodemographics and baseline measurements (including the above mentioned strata of the rheumatology patients and the different types of diabetes), intervention and care as usual group did not differ at baseline (see Table 1). More than half of the sample (61% of the intervention group and 56% of the care as usual group) suffered from major depression.
In the intervention arm, most patients (N = 107) received an intervention conducted by the psychiatric liaison nurse; the interventions, effectuated as single interventions or combined, consisted of "facilitating emotional expression" (73%), "giving practical advice" (71%), "promoting life narrative" (48%) and "providing psycho-educational interventions" (44%). For about half of the patients in the intervention group (N = 76) also other types of interventions were proposed, such as referral to a liaison psychiatrist (N = 36), psychiatric advice to the treating physician (N = 32) or interdisciplinary case conferences (N = 8). A minority of patients (N=13) did not receive any treatment (due to no indication for a psycho-social intervention or patients lacking motivation) (N=13). The liaison nurses, who effectuated the intervention and organized psychiatric referral, psychiatric advice to the treating physician and interdisciplinary case conferences, were supervised weekly for an hour by a senior psychiatrist (FS) or an experienced psychiatric liaison nurse (YD).
Between 62% and 70% of the patients of the intervention arm and between 57% to 69% of patients of the usual care arm provided complete follow up data at the four time points (see Figure 2). Patients with missing data did not differ from patients with complete data with regard to age, sex, educational and professional status, baseline quality of life and depression on each of the four follow up assessments.
Effects of intervention
In Table 2 and Figures 3-7, comparisons between patients in the intervention arm on and usual care arm on the main outcomes are presented. Overall, the intervention was associated with less depression and higher levels of quality of life during follow up. Using statistical tests to evaluate differences at each of the separate follow up points, statistically significant differences are observed with regard to the prevalence of major depression at 12 months, physical health at 3 months and quality of life at 3, 6, and 12 months (see Table 2).
|Study Type ICMJE||Interventional|
|Study Phase||Phase 4|
|Study Design ICMJE||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
|Intervention ICMJE||Behavioral: Multi-faceted psychiatric intervention|
|Study Arm (s)||Not Provided|
|Publications *||de Jonge P, Huyse FJ, Slaets JP, Sollner W, Stiefel FC. Operationalization of biopsychosocial case complexity in general health care: the INTERMED project. Aust N Z J Psychiatry. 2005 Sep;39(9):795-9.|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Completion Date||April 2006|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||19 Years to 65 Years|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||Switzerland|
|NCT Number ICMJE||NCT00385528|
|Other Study ID Numbers ICMJE||OCS-3200-066718|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||University of Lausanne Hospitals|
|Collaborators ICMJE||Not Provided|
|Information Provided By||University of Lausanne Hospitals|
|Verification Date||October 2006|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP