Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

A Patient-Centered Approach to Improve Screening for Side Effects of Second Generation Antipsychotics (SGAs)

6 april 2015 bijgewerkt door: US Department of Veterans Affairs

A Patient-Centered Approach to Improve Screening for Side Effects of SGAs

The purpose of this study is to determine if individuals with serious mental illnesses exposed to a patient-centered computerized tool versus printed educational materials have higher rates of screening for the metabolic side effects of second-generation antipsychotic medications and different patterns of communication with their prescribers about screening.

Studie Overzicht

Gedetailleerde beschrijving

Project Background/Rationale: Second-generation antipsychotic (SGA) medications are widely used to treat psychotic disorders but are associated with metabolic side effects such as weight gain, glucose dysregulation, and hyperlipidemia that may contribute to the high rates of cardiovascular disease observed in individuals with serious mental illness (SMI). Adherence to guidelines for regular screening for the metabolic side effects of SGAs is inadequate. Patient-centered care, characterized by an effective partnership between clinicians and patients that promotes active participation by patients in their own care, improves health outcomes and satisfaction in the general population. In order to increase rates of screening for the metabolic side effects of SGAs, we propose to design a patient-centered computerized tool that provides veterans with SMI with personalized health information on how well their care adheres to screening recommendations. The computerized tool will use principles shown to enhance usability in persons with cognitive impairments.

Project Objectives: The objectives of this study are to determine the effect of exposure to a patient-centered computerized tool compared to enhanced treatment as usual (e-TAU) on: (1) rates of screening for and identification of health problems associated with the metabolic side effects of SGAs; (2) patterns of patient-centered communication around screening for metabolic side effects and VA patients' self-efficacy in communicating with their psychiatrists about screening; (3) VA patients' preferences for obtaining health information and participating in decision-making about screening; and (4) VA patients' perceptions of their psychiatrists' participatory decision-making styles around screening.

Project Methods: A total of 240 veterans with psychotic disorders prescribed SGAs and in regular contact with their prescribing clinicians in outpatient mental health clinics in the VA Maryland Health Care System will be recruited for this randomized controlled trial. Half of participants will be randomly assigned to the intervention condition in which they will view a brief computer program that provides personalized health information on adherence to guidelines for screening of metabolic side effects that is designed to facilitate discussion with psychiatrists about appropriate screening. The other half of participants will receive enhanced treatment-as-usual (e-TAU) consisting of printed information on the metabolic side effects of SGAs and general recommendations for screening. Participants will be exposed to the intervention or e-TAU up to 3 times immediately prior to a visit with their prescriber over the one-year study period. Rates of screening for the metabolic side effects of SGAs will be obtained from patients' computerized medical records. A single prescriber visit for each participant will be audiotaped and coded with the Roter Interaction Analysis System (RIAS) to characterize patterns of patient-clinician communication around screening for metabolic side effects. Baseline and 12-month follow-up interview assessments with veterans will be used to acquire information on self-efficacy, their preferences for obtaining health information and participating in decisions regarding side effect screening, and important covariates such as severity of psychiatric illness.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

239

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

    • Maryland
      • Baltimore, Maryland, Verenigde Staten, 21201
        • Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 70 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  • Agreement obtained from the treating clinician that the patient is clinically stable enough to participate in the study and can be contacted for recruitment
  • Agreement obtained from treating clinician to have a single visit with the patient audio taped
  • Patient age 18-70 years
  • Diagnosis of a psychotic disorder (schizophrenia, affective psychosis, major depression with psychotic features)
  • Currently prescribed any SGA medication (aripiprazole, clozapine, olanzapine, quetiapine, risperidone, ziprasidone) by a clinician in a VA Maryland Healthcare System (VAMHCS) mental health clinic
  • Had at least two outpatient visits with the prescribing clinician in the past year - Decisional capacity to provide informed consent
  • Ability to read at a 4th grade reading level

Exclusion Criteria:

  • Diagnosis of dementia or other organic brain syndrome or traumatic brain injury

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Onderzoek naar gezondheidsdiensten
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Patient-centered computerized tool
A brief computer program that provides personalized health information to patients prescribed second-generation antipsychotic medications on adherence to guidelines for screening of metabolic side effects
A brief computer program that provides personalized health information to patients prescribed second-generation antipsychotic medications on adherence to guidelines for screening of metabolic side effects
Actieve vergelijker: Written educational materials
Printed information on the metabolic side effects of second-generation antipsychotic medications and general recommendations for screening
Printed information on the metabolic side effects of second-generation antipsychotic medications and general recommendations for screening

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Percentage of Days in the Study Period That a Patient's Screening for Metabolic Side Effects of Second-generation Antipsychotic Medications Adheres to Guidelines: Body Mass Index
Tijdsspanne: 1 year
Guidelines recommend that body mass index be evaluated every 3 months
1 year
Percentage of Days in the Study Period That a Patient's Screening for Metabolic Side Effects of Second-generation Antipsychotic Medications Adheres to Guidelines: Blood Pressure
Tijdsspanne: 1 year
Guidelines recommend that blood pressure be evaluated every 3 months
1 year
Percentage of Days in the Study Period That a Patient's Screening for Metabolic Side Effects of Second-generation Antipsychotic Medications Adheres to Guidelines: Blood Glucose/HbA1c
Tijdsspanne: 1 year
Guidelines recommend that blood glucose/HbA1c be evaluated every year
1 year
Percentage of Days in the Study Period That a Patient's Screening for Metabolic Side Effects of Second-generation Antipsychotic Medications Adheres to Guidelines: LDL Cholesterol
Tijdsspanne: 1 year
Guidelines recommend that LDL cholesterol be evaluated every 2 years
1 year
Percentage of Days in the Study Period That a Patient's Screening for Metabolic Side Effects of Second-generation Antipsychotic Medications Adheres to Guidelines: HDL Cholesterol
Tijdsspanne: 1 year
Guidelines recommend that HDL cholesterol be evaluated every 2 years
1 year
Percentage of Days in the Study Period That a Patient's Screening for Metabolic Side Effects of Second-generation Antipsychotic Medications Adheres to Guidelines: Triglycerides
Tijdsspanne: 1 year
Guidelines recommend that triglycerides be evaluated every 2 years
1 year

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Onderzoekers

  • Hoofdonderzoeker: Julie Anne Kreyenbuhl, PhD, Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 maart 2010

Primaire voltooiing (Werkelijk)

1 maart 2012

Studie voltooiing (Werkelijk)

1 juni 2013

Studieregistratiedata

Eerst ingediend

9 mei 2008

Eerst ingediend dat voldeed aan de QC-criteria

14 mei 2008

Eerst geplaatst (Schatting)

15 mei 2008

Updates van studierecords

Laatste update geplaatst (Schatting)

27 april 2015

Laatste update ingediend die voldeed aan QC-criteria

6 april 2015

Laatst geverifieerd

1 augustus 2014

Meer informatie

Termen gerelateerd aan deze studie

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Klinische onderzoeken op Psychotische stoornissen

Klinische onderzoeken op Patient-centered computerized tool

3
Abonneren