Clinical trial NCT00750776: KvaliMed - a Quality Project With Focus on Patients in Antipsychotic Treatment
Official title: KvaliMed - a Quality Project With Focus on Patients in Antipsychotic Treatment
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Antipsychotic Treatment
Quality Assurance
Medical Treatment
Keywords: Quality assurance
medical treatment
Patient satisfaction
Lead sponsor: Psychiatric Centre Rigshospitalet
Sponsor class: OTHER
Collaborators: name: AstraZeneca
First posted: 2008-09-11
Enrollment: 212
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
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

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: GAF score >= 30 or have an improvement on >= 5 points at the GAF scale
timeFrame: 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 outcomes:
measure: 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
timeFrame: 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
measure: UKU: Share of patients that have a score <=1 on the selected 21 items from the UKU scale
timeFrame: 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.
measure: Compliance: Share of patients have according to the specialists evaluation have taken their antipsychotic medicine according to prescription
timeFrame: Compliance: At least 75% of the patients have according to the specialists evaluation taken their antipsychotic medicine according to prescription
measure: Patient satisfaction:Share of patients that scores in one of the to best categories i all selected 3 items in the TSQM scale.
timeFrame: 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.
Other outcomes:
Locations:
city: Slagelse
country: Denmark
facility: Research Site
state: Dianalund
city: Bjerringbro
country: Denmark
facility: Research Site
city: Brorup
country: Denmark
facility: Research Site
city: Esbjerg
country: Denmark
facility: Research Site
city: Holbaek
country: Denmark
facility: ResearcH Site
city: Hviding
country: Denmark
facility: Research Site
city: Kobenhavn
country: Denmark
facility: Research Site
city: Naestved
country: Denmark
facility: Research Site
city: Thyholm
country: Denmark
facility: Research Site
city: Varde
country: Denmark
facility: Research Site
Study officials:
affiliation: Research Centre for Psychiatry Vordingborg
name: Soren Blikenberg
role: PRINCIPAL_INVESTIGATOR
affiliation: Children Psychiatry Holbaek
name: Michael Maagensen
role: PRINCIPAL_INVESTIGATOR
affiliation: Odense University Hospital Odense C Psychiatric Hospital Slagelse
name: Karin Byrsting
role: PRINCIPAL_INVESTIGATOR
affiliation: Outpatient TreatmentCopenhagen K
name: Marianne Jacoby
role: PRINCIPAL_INVESTIGATOR
affiliation: Psychiatric Hospital Slagelse
name: Peter Christoffersen
role: PRINCIPAL_INVESTIGATOR
References: