We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01567267
Recruitment Status : Active, not recruiting
First Posted : March 30, 2012
Last Update Posted : March 3, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Health Knowledge, Attitudes, Practice Behavioral: Experimental educational intervention Behavioral: Standard educational intervention

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 87 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
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
Study Start Date : February 2010
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : May 2019
Arms and Interventions

Arm Intervention/treatment
Experimental: Experimental educational intervention
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
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.


Outcome Measures

Primary Outcome Measures :
  1. Difference in knowledge about EbM/GSP [ Time Frame: Before (day1), during (day 2) and after (day 4) intervention ]
    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 :
  1. Difference in skills about critically appraising scientific literature [ Time Frame: Before (day 1), during (day 2) and after (day 4) intervention ]
    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.

  2. Skills in teaching principles of EbM and GSP to high school students in intervention group [ Time Frame: After educational intervention (day 5) ]
    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

  3. Overall acceptance of educational intervention study participants [ Time Frame: During (day 2) and after intervention (day 4) ]
    Overall acceptance of educational intervention is evaluated by standardized questionnaires at day 2 and day 4 in the educational intervention group.

  4. Overall acceptance of study lessons for biology high-school students [ Time Frame: After study lessons (day 5) ]
    Overall acceptance of study lessons for biology high-school students is evaluated by a standardized questionnaire at day 5.


Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: March 30, 2012    Key Record Dates
Last Update Posted: March 3, 2017
Last Verified: March 2017

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