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 type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cross-sectional

  Other
• Non-interventional study design, other:
  Survey of healthcare providers

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  QUETIAPINE FUMARATE

Population studied

• Short description of the study population:
  Health Care Professionals who were targeted to receive the metabolic educational materials and either currently prescribe or have the potential to prescribe SEROQUEL or SEROQUEL XR.
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  800

Study design details

• Main study objective:
  The main objective of this study is evaluation of the effectiveness of the distribution of metabolic educational materials sent to healthcare providers in the EU.
• Outcomes:
  An objective assessment is based upon survey responses related to healthcare provider behavior regarding the monitoring of patients (measures of outcome) and having received and read the educational materials (measures of process).
• Data analysis plan:
  Information obtained from responses to each question of the survey will be reported as descriptive statistics. The survey questionnaire contains questions about the specialty of the physician sample completing the survey, questions specific to whether referrals are made to other healthcare providers for metabolic monitoring, whether the healthcare provider conducts monitoring of patients, general questions regarding receipt of the educational materials, and behavior aboutreading the materials. Each risk minimization behavior included in this study (monitoring of weight, hyperglycaemia, lipids, metabolic risk) will be evaluated individually. The following will be reported, as appropriate, as part of this analysis:- Percent of respondents selecting desired response to each question relating to each risk minimization activity and 95% confidence interval- Percent of respondents demonstrating success of composite risk minimization activities and 95% confidence interval.

Documents

Study results

D1443C00127 Clinical Study Report

Study publications

Brody R.S., Liss C.L., Wray H., Iovin R., Michaylira C., Muthutantri, A., Damst…