Ignite Creation Date:
2024-05-05 @ 5:06 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00385528
Status:
COMPLETED
Last Update Posted:
2008-10-17
First Post:
2006-10-06
Brief Title:
Effects of a Multi-Faceted Psychiatric Intervention Targeted at the Complex Medically Ill a Randomized Controlled Trial
Sponsor:
University of Lausanne Hospitals
Organization:
University of Lausanne Hospitals
Study Overview
Official Title:
Effects of a Multi-Faceted Psychiatric Intervention Targeted at the Complex Medically Ill a Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2006-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 N125 84 rheumatology and 41 diabetes patients or care as usual N122 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
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 N125 84 rheumatology and 41 diabetes patients or care as usual N122 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 2 184 208 met exclusion criteria such as not speaking French N43 severe cognitive disturbances N27 or hospitalization for less than 3 days N28 62 refused to participate N55 Of the remaining patients N 701 648 N454 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 N13 did not receive any treatment due to no indication for a psycho-social intervention or patients lacking motivation N13 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
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 N13 did not receive any treatment due to no indication for a psycho-social intervention or patients lacking motivation N13 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None