Assessment of physician behaviour regarding metabolic monitoring of patients treated with SEROQUEL® (quetiapine fumarate) Tablets and SEROQUEL® (quetiapine fumarate) Extended Release Tablets in selected countries in the European Union (EU)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/20622
• EU PAS number:
  EUPAS3287
• Study ID:
  20622
• Official title and acronym:
  Assessment of physician behaviour regarding metabolic monitoring of patients treated with SEROQUEL® (quetiapine fumarate) Tablets and SEROQUEL® (quetiapine fumarate) Extended Release Tablets in selected countries in the European Union (EU)
• DARWIN EU® study:
  No
• Study countries:
  Germany

  Hungary

  Italy

  Romania

  Spain

  Sweden

  United Kingdom
• Study description:
  This is a study which will assess the effectiveness of an update to health care provider education materials in scope of the EU Risk Management Plan and Summary of Product Characteristics for SEROQUEL® (quetiapine fumarate) Tablets and SEROQUEL XR® (quetiapine fumarate) Extended Release Tablets with respect to evaluation and monitoring for hyperglycaemia and other metabolic parameters. There are 2 components to the assessment of effectiveness proposed in this study: process indicators (receipt and understanding of materials) and outcome indicators (healthcare provider behaviour and effect on patients). To realize these 2 indicators for the evaluation of the effectiveness of the metabolic education: an objective, easy to understand and complete healthcare provider survey is described by this study and the use of an Electronic Medical Records approach, as a potential means to assess the monitoring of patients is described in a separate study.This study involves the evaluation of the effectiveness of the distribution of metabolic educational materials sent to healthcare providers in the EU. It will be conducted via an evaluation survey that uses a questionnaire to assess the receipt of the educational material, whether the material was read, and to assess healthcare provider behaviour regarding theconduct of monitoring of metabolic parameters for patients treated with SEROQUEL and SEROQUEL XR. The survey will be conducted among healthcare providers who were targeted to receive the educational materials following local guidance and directives.
• Study status:
  Finalised

Research institutions and networks

Institutions

AstraZeneca

Study timelines

Date when funding contract was signed

Planned: 31/01/2013

Actual: 31/01/2013

Study start date

Planned: 01/03/2013

Actual: 01/03/2013

Date of final study report

Planned: 20/12/2013

Actual: 10/12/2013

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

AstraZeneca

Study protocol

Initial protocol

D1443C00127 Risk Minimization Physician Survey Protocol1

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)