Evaluation of Educational Intervention to Teach Principles of Evidence-based Medicine (EbM) in Biology Classes

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Reinhard Strametz, Goethe University
ClinicalTrials.gov Identifier:
NCT01567267
First received: March 14, 2012
Last updated: March 29, 2012
Last verified: March 2012
  Purpose

The purpose of this study is to identify the effect of a short term educational intervention for upcoming biology teachers to teach principles of Evidence-based Medicine (EbM) and Good Scientific Practice (GSP) to high-school biology students.


Condition Intervention Phase
Health Knowledge, Attitudes, Practice
Behavioral: Experimental educational intervention
Behavioral: Standard educational intervention
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Phase II Study of a Short Term Educational Intervention for Upcoming Biology Teachers to Teach Principles of Evidence-based Medicine (EbM) in Biology Classes at High-school

Further study details as provided by Goethe University:

Primary Outcome Measures:
  • Difference in knowledge about EbM/GSP [ Time Frame: Before (day1), during (day 2) and after (day 4) intervention ] [ Designated as safety issue: No ]
    Difference in knowledge about EbM/GSP measured by alternating standardized, pre-validated, single-best/short-answer questionnaires consisting of 20 questions each


Secondary Outcome Measures:
  • Difference in skills about critically appraising scientific literature [ Time Frame: Before (day 1), during (day 2) and after (day 4) intervention ] [ Designated as safety issue: No ]
    Difference in skills about critically appraising scientific literature measured by alternating randomized-controlled trials evaluated by a standardized checklist related to items of the CONSORT statement.

  • Skills in teaching principles of EbM and GSP to high school students in intervention group [ Time Frame: After educational intervention (day 5) ] [ Designated as safety issue: No ]
    Skill in teaching principles of EbM and GSP are evaluated for preparation of lessons using a standardized preparation form and performance of lessons evaluated by transcription of video tapes from each participant in the intervention group using a consented evaluation catalogue

  • Overall acceptance of educational intervention study participants [ Time Frame: During (day 2) and after intervention (day 4) ] [ Designated as safety issue: No ]
    Overall acceptance of educational intervention is evaluated by standardized questionnaires at day 2 and day 4 in the educational intervention group.

  • Overall acceptance of study lessons for biology high-school students [ Time Frame: After study lessons (day 5) ] [ Designated as safety issue: No ]
    Overall acceptance of study lessons for biology high-school students is evaluated by a standardized questionnaire at day 5.


Enrollment: 87
Study Start Date: February 2010
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Experimental educational intervention Behavioral: Experimental educational intervention
Educational intervention consisting of a 4-day-course in Evidence-based Medicine and Good Scientific Practice combined with the method of Problem-based Learning.
Active Comparator: Standard educational intervention Behavioral: Standard educational intervention
Educational intervention on the didactics of biology (4-day-course) not containing elements of Evidence-based Medicine, Good Scientific Practice or Problem-based learning.

Detailed Description:

Shared decision making is increasingly demanded by patients in order to take part in health care decisions. However this demand for autonomy can only be used for shared decision making if the patient has basic skills in critical health literacy. To transfer health care literacy to young and healthy consumers educational intervention programs at high-school might be a feasible and effective way. This preliminary phase 2 study is designed to investigate the effect of an educational intervention to be integrated in a curriculum for upcoming teachers in biology.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • students becoming biology teachers at participating university during enrollment period

Exclusion Criteria:

  • refusal to participate in study
  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: NCT01567267

Locations
Germany
University of Siegen, Section of biology and und their didactics
Siegen, Germany, 57068
Sponsors and Collaborators
Goethe University
Investigators
Principal Investigator: Reinhard Strametz, MD EbM Working Group, Institute for General Practice, Faculty of Medicine, Goethe University, Frankfurt/Germany
  More Information

No publications provided by Goethe University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Reinhard Strametz, MD, EbM Working Group, Institute for General Practice, Faculty of Medicine, Goethe University
ClinicalTrials.gov Identifier: NCT01567267     History of Changes
Other Study ID Numbers: EbM@Bio-01
Study First Received: March 14, 2012
Last Updated: March 29, 2012
Health Authority: Germany: Ethics Commission

Keywords provided by Goethe University:
Evidence-based Medicine
Good Scientific Practice
Problem-based Learning
Critical health literacy
Educational intervention

ClinicalTrials.gov processed this record on October 20, 2014