KvaliMed - a Quality Project With Focus on Patients in Antipsychotic Treatment

This study has been terminated.
(Due to lack of financial support)
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Anders Fink-Jensen, MD, DMSci, Psychiatric Centre Rigshospitalet
ClinicalTrials.gov Identifier:
NCT00750776
First received: September 10, 2008
Last updated: April 14, 2013
Last verified: April 2013
  Purpose

Rating and registration in KMS database of all patients in anti-psychotic treatment with 8 selected items from PANSS, GAF, 21 selected items from UKU, 3 selected items from TSQM. and measurement of compliance. Frequency of use of rating scales per participating health care professional.


Condition
Antipsychotic Treatment
Quality Assurance
Medical Treatment

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: KvaliMed - a Quality Project With Focus on Patients in Antipsychotic Treatment

Further study details as provided by Psychiatric Centre Rigshospitalet:

Primary Outcome Measures:
  • GAF score >= 30 or have an improvement on >= 5 points at the GAF scale [ Time Frame: All measures are rated every ½ year at least.GAF: At least 85 % of the rated patients must have a score >= 30 or have an improvement on >= 5 points at the GAF scale ]

Secondary Outcome Measures:
  • PANSS: Share af patients that have a score >= 3 on each an every of the following items P1, P2, P3, N1, N4, N6, G5, G9 [ Time Frame: PANSS: At least 70% of the patients have a score <= 3 on each an every of the following items P1, P2, P3, N1, N4, N6, G5, G9 ]
  • UKU: Share of patients that have a score <=1 on the selected 21 items from the UKU scale [ Time Frame: UKU: At least 75 % of the patients have a score on <=1 on the selected items UKU scale.At least 30 % of the patients are examined for metabolic syndrom. ]
  • Compliance: Share of patients have according to the specialists evaluation have taken their antipsychotic medicine according to prescription [ Time Frame: Compliance: At least 75% of the patients have according to the specialists evaluation taken their antipsychotic medicine according to prescription ]
  • Patient satisfaction:Share of patients that scores in one of the to best categories i all selected 3 items in the TSQM scale. [ Time Frame: Patient satisfaction:At least 65 % of the patients scores in one of the to best kategories in all the selected 3 items in the TSQM scale. ]

Estimated Enrollment: 212
Study Start Date: August 2003
Study Completion Date: August 2012
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients that are treatet with antipsycotic medicine - by a specialist in psychiatry - the patients can stay at the hospital or receive outpatient treatment

Criteria

Inclusion Criteria:

  • All patients where a physician has decided to treat the patient with antipsychotics.
  • All patients that are treated within the Danish health care system

Exclusion Criteria:

  • Patients that are treated in accordance with "Law concerning freedom deprivation and other compulsion in psychiatry
  • Patients that are in judicial measure
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00750776

Locations
Denmark
Research Site
Slagelse, Dianalund, Denmark
Research Site
Bjerringbro, Denmark
Research Site
Brorup, Denmark
Research Site
Esbjerg, Denmark
ResearcH Site
Holbaek, Denmark
Research Site
Hviding, Denmark
Research Site
Kobenhavn, Denmark
Research Site
Naestved, Denmark
Research Site
Thyholm, Denmark
Research Site
Varde, Denmark
Sponsors and Collaborators
Psychiatric Centre Rigshospitalet
AstraZeneca
Investigators
Principal Investigator: Soren Blikenberg Research Centre for Psychiatry Vordingborg
Principal Investigator: Michael Maagensen Children Psychiatry Holbaek
Principal Investigator: Karin Byrsting Odense University Hospital Odense C Psychiatric Hospital Slagelse
Principal Investigator: Marianne Jacoby Outpatient TreatmentCopenhagen K
Principal Investigator: Peter Christoffersen Psychiatric Hospital Slagelse
  More Information

No publications provided

Responsible Party: Anders Fink-Jensen, MD, DMSci, Professor, senior consultant, DMSci, Psychiatric Centre Rigshospitalet
ClinicalTrials.gov Identifier: NCT00750776     History of Changes
Other Study ID Numbers: NIS-NDK-DUM-2002/1
Study First Received: September 10, 2008
Last Updated: April 14, 2013
Health Authority: Denmark: Danish Dataprotection Agency

Keywords provided by Psychiatric Centre Rigshospitalet:
Quality assurance
medical treatment
Patient satisfaction

Additional relevant MeSH terms:
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on October 21, 2014