search
Back to results

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

Primary Purpose

Rheumatoid Arthritis, Diabetes

Status
Completed
Phase
Phase 4
Locations
Switzerland
Study Type
Interventional
Intervention
Multi-faceted psychiatric intervention
Sponsored by
University of Lausanne Hospitals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Case complexity, INTERMED, Consultation liaison psychiatry, depression

Eligibility Criteria

19 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital Lausanne

Outcomes

Primary Outcome Measures

Psychological distress, quality of life

Secondary Outcome Measures

health care utilization

Full Information

First Posted
October 6, 2006
Last Updated
October 16, 2008
Sponsor
University of Lausanne Hospitals
search

1. Study Identification

Unique Protocol Identification Number
NCT00385528
Brief Title
Effects of a Multi-Faceted Psychiatric Intervention Targeted at the Complex Medically Ill: a Randomized Controlled Trial
Official Title
Effects of a Multi-Faceted Psychiatric Intervention Targeted at the Complex Medically Ill: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2006
Overall Recruitment Status
Completed
Study Start Date
November 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University of Lausanne Hospitals

4. Oversight

5. 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).
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis, Diabetes
Keywords
Case complexity, INTERMED, Consultation liaison psychiatry, depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
200 (false)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Multi-faceted psychiatric intervention
Primary Outcome Measure Information:
Title
Psychological distress, quality of life
Secondary Outcome Measure Information:
Title
health care utilization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Friedrich C Stiefel, MD
Organizational Affiliation
University of Lausanne Hospitals
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Lausanne
City
Lausanne
State/Province
VD
ZIP/Postal Code
1011
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
16168037
Citation
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. doi: 10.1080/j.1440-1614.2005.01684.x.
Results Reference
result

Learn more about this trial

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

We'll reach out to this number within 24 hrs