Effects of a Multi-Faceted Psychiatric Intervention Targeted at the Complex Medically Ill: a Randomized Controlled Trial

Sponsor
University of Lausanne Hospitals (Other)
Overall Status
Completed
CT.gov ID
NCT00385528
Collaborator
(none)
200
1
41
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Study Details

Study Description

Brief Summary

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).

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Multi-faceted psychiatric intervention
Phase 4

Detailed Description

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 Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single
Primary Purpose:
Treatment
Official Title:
Effects of a Multi-Faceted Psychiatric Intervention Targeted at the Complex Medically Ill: a Randomized Controlled Trial
Study Start Date :
Nov 1, 2002
Study Completion Date :
Apr 1, 2006

Outcome Measures

Primary Outcome Measures

  1. Psychological distress, quality of life []

Secondary Outcome Measures

  1. health care utilization []

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • PAtients between 19-65 years old,

  • inpatient rheumatology patients and diabetes outpatients,

  • case complexity above 21 on the INTERMED

Exclusion Criteria:
  • cognitive failure,

  • not french speaking,

  • terminal illness

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Hospital Lausanne Lausanne VD Switzerland 1011

Sponsors and Collaborators

  • University of Lausanne Hospitals

Investigators

  • Principal Investigator: Friedrich C Stiefel, MD, University of Lausanne Hospitals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00385528
Other Study ID Numbers:
  • OCS-3200-066718
First Posted:
Oct 9, 2006
Last Update Posted:
Oct 17, 2008
Last Verified:
Oct 1, 2006
Keywords provided by , ,
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 17, 2008