New Educational TechnologiesNCT01804868
Web Tutorial Based on Case Vignettes for Teaching Literature Critical Assessment to Nursing Students
A study testing case vignette tutorial and passive web presentation on research regulation in people with New Educational Technologies, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Objective: The aim of this study is to assess the efficacy of a web tutorial based on case vignettes as a complementary tool for teaching literature critical assessment to nursing students, in terms of: 1) knowledge, 2) tutorial quality and acceptability and 3) students' point of view on research participation. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- New Educational Technologies
- What is being tested?
- case vignette tutorial and passive web presentation on research regulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 506 participants
- Where
- 1 siteFrance
- Study dates
- May 2013to Sep 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- second-year students who have completed teaching modules on clinical research methodology.
Who cannot join
- none.
Trial locations and contacts
1 site in 1 country.
France1 site
Centre d'Epidémiologie Clinique, hôpital Hôtel Dieu, Assistance Publique-Hôpitaux de Paris
Paris, 75181
About this study
Official title: Efficacy of a Web Tutorial Based on Case Vignettes for Teaching Literature Critical Assessment to Nursing Students: a Randomized Controlled Trial
Objective: The aim of this study is to assess the efficacy of a web tutorial based on case vignettes as a complementary tool for teaching literature critical assessment to nursing students, in terms of: 1) knowledge, 2) tutorial quality and acceptability and 3) students' point of view on research participation.
Participants: Nursing second-year students from 3 universities in Paris (Paris Descartes University, Paris Diderot University and Paris 13 Nord).
Read more
Design: A randomized controlled trial will assess the teaching efficacy of a case vignettes based tutorial compared to no tutorial. In order to preserve a minimal blinding of participants, the comparator will be a basic passive teaching presentation on internet. The students will be randomized in two parallel groups. They will be evaluated on a final case vignette, and will be invited to follow the other intervention after evaluation. The allocation of participants will be done by a computerized randomization list, the sequence will be created by an independent statistician with a ratio 1: 1: 1. Since the students follow courses in different nursing institutes for each university which may have different teaching content and organization, the randomization will be stratified by nursing institute. Allocation concealment will be provided because only the statistician will have access to the randomization list. All the participants will receive an individual mail linking them to his group dedicated website. In order to preserve a minimal blinding of participants, the comparator will be a passive presentation and the participants will not be informed of the intervention evaluated and will have the opportunity to follow the other intervention after the evaluation. In parallel, both groups will follow normally their university courses.
Intervention: A case vignette is a clinical scenario based on clinical practice. It will ask a clinical problem the student will have to answer by reading a research article on a randomized clinical trial. Then he will have to answer questions about this article which are related to the major methodological points of a randomized trial. All these steps are available on a secure website.
Outcomes: The primary endpoint will be the student's knowledge of critical assessment of randomized controlled trials. It will be measured by students' score on an evaluation case vignette with multiple choice questionnaires. The secondary endpoints will be the quality perception and acceptance of the tutorial and if the tutorial has modified their perception of research participation. Responses will be ranged by a 5-point Likert scale.
Potential interests: This study takes place in the field of nursing universitary teaching. Nursing students have entered recently the universitary education system which enhances the nursing research, an emerging field in France.
The investigators hope that this complementary teaching tool will enhance the knowledge and participation of nurses in research.
Sample size expected: 506 participants.
Read the detailed description
Statistical analysis :
Qualitatives variables will be presented with the number and percentage of participants and of missing data for each outcome. Quantitative variables will be presented with the number and percentage of participants, mean, standard deviation and range. Assymetrical variables will be presented with the median and the interquartile range.
Quantitative outcomes will be compared between groups with a Fisher test in a linear mixed model. (the fixed effect will be the allocation group and the random effect will be the nursing institute so as to take into account the similarity of the students for each institute).
Qualitative outcomes will be compared using a mixed effect logistic regression model (the fixed effect will be the allocation group and the random effect will be the nursing institute so as to take into account the similarity of the students for each institute).
The data analysis will be carried out as an 'intention-to treat analysis' in all randomized participants.
For the primary outcome, missing data will be dealt with the multiple imputation method. Sensibility analysis will be used to confirm the results for the primary outcome.
Two-tailed tests will be applied at a standard level of 5%. The statistical analysis will be performed with SAS 9.3 statistical software.
- Conditions
- New Educational Technologies
- Being tested
- case vignette tutorial, passive web presentation on research regulation
- Keywords
- case vignette, nurse, critical assessment, randomized controlled trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
case vignette tutorialOther
Also called case vignette tutorial for teaching literature critical appraisal to nursing students
The web tutorial will be composed of 4 case vignettes. A case vignette is a clinical scenario based on clinical practice. It will ask a clinical problem the student will have to answer by reading a research article on a randomized clinical trial. Then he will have to answer questions about this article which are related to the major methodological points of a randomized trial. All these steps are available on a secured website.
passive web presentation on research regulationOther
The presentation will be a web-based voice commented video presentation on research regulation. It will allow to preserve a minimal blinding of participants, since the participants will not be informed of the intervention evaluated and will have the opportunity to follow the other intervention after the evaluation.
| Study group | Role | What they receive |
|---|---|---|
| case vignette tutorial | Experimental | The web tutorial composed of 4 case vignettes. Receives: Other: case vignette tutorial |
| passive web presentation on research regulation | Active comparator | The presentation will be a web-based voice commented video presentation on research regulation. Receives: Other: passive web presentation on research regulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
student's knowledge of critical assessment of randomized controlled trials
student's score on an evaluation case vignette with multiple choice questionnaires (range 0-25)
Measured: 21 days
Secondary outcomes (3)
student's quality perception of the tutorial
measured on a 5-point Likert scale
Measured: 21 days
student's acceptance of the tutorial
measured on a 5-point Likert scale
Measured: 21 days
Impact of the tutorial on student's perception of research participation
Question: "After completing this training, would you participate / recommend a close member or a patient to participate to a randomized controlled trial?' Answers will be measured on a 5-point Likert scale.
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2013 (estimated)
- Study startMay 2013
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for New Educational TechnologiesStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 506 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Isabelle Boutron, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de ParisPhilippe Ravaud, MD, Professor, Study director, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01804868
- Sponsor's protocol ID
- RAV005
- Status last verified
- May 2013
- First submitted
- 4 Mar 2013
- Last updated
- 21 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Web Tutorial Based on Case Vignettes for Teaching Literature Critical Assessment to Nursing Students: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01804868
- Acronym / sponsor ID
- RAV005
- Conditions
- New Educational Technologies
- Keywords
- case vignette, nurse, critical assessment, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 506 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 5 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objective: The aim of this study is to assess the efficacy of a web tutorial based on case vignettes as a complementary tool for teaching literature critical assessment to nursing students, in terms of: 1) knowledge, 2) tutorial quality and acceptability and 3) students' point of view on research participation.
Participants: Nursing second-year students from 3 universities in Paris (Paris Descartes University, Paris Diderot University and Paris 13 Nord).
Design: A randomized controlled trial will assess the teaching efficacy of a case vignettes based tutorial compared to no tutorial. In order to preserve a minimal blinding of participants, the comparator will be a basic passive teaching presentation on internet. The students will be randomized in two parallel groups. They will be evaluated on a final case vignette, and will be invited to follow the other intervention after evaluation. The allocation of participants will be done by a computerized randomization list, the sequence will be created by an independent statistician with a ratio 1: 1: 1. Since the students follow courses in different nursing institutes for each university which may have different teaching content and organization, the randomization will be stratified by nursing institute. Allocation concealment will be provided because only the statistician will have access to the randomization list. All the participants will receive an individual mail linking them to his group dedicated website. In order to preserve a minimal blinding of participants, the comparator will be a passive presentation and the participants will not be informed of the intervention evaluated and will have the opportunity to follow the other intervention after the evaluation. In parallel, both groups will follow normally their university courses.
Intervention: A case vignette is a clinical scenario based on clinical practice. It will ask a clinical problem the student will have to answer by reading a research article on a randomized clinical trial. Then he will have to answer questions about this article which are related to the major methodological points of a randomized trial. All these steps are available on a secure website.
Outcomes: The primary endpoint will be the student's knowledge of critical assessment of randomized controlled trials. It will be measured by students' score on an evaluation case vignette with multiple choice questionnaires. The secondary endpoints will be the quality perception and acceptance of the tutorial and if the tutorial has modified their perception of research participation. Responses will be ranged by a 5-point Likert scale.
Potential interests: This study takes place in the field of nursing universitary teaching. Nursing students have entered recently the universitary education system which enhances the nursing research, an emerging field in France.
The investigators hope that this complementary teaching tool will enhance the knowledge and participation of nurses in research.
Sample size expected: 506 participants.
Detailed description
Statistical analysis :
Qualitatives variables will be presented with the number and percentage of participants and of missing data for each outcome. Quantitative variables will be presented with the number and percentage of participants, mean, standard deviation and range. Assymetrical variables will be presented with the median and the interquartile range.
Quantitative outcomes will be compared between groups with a Fisher test in a linear mixed model. (the fixed effect will be the allocation group and the random effect will be the nursing institute so as to take into account the similarity of the students for each institute).
Qualitative outcomes will be compared using a mixed effect logistic regression model (the fixed effect will be the allocation group and the random effect will be the nursing institute so as to take into account the similarity of the students for each institute).
The data analysis will be carried out as an 'intention-to treat analysis' in all randomized participants.
For the primary outcome, missing data will be dealt with the multiple imputation method. Sensibility analysis will be used to confirm the results for the primary outcome.
Two-tailed tests will be applied at a standard level of 5%. The statistical analysis will be performed with SAS 9.3 statistical software.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| case vignette tutorial | Experimental | Other: case vignette tutorialThe web tutorial composed of 4 case vignettes. |
| passive web presentation on research regulation | Active comparator | Other: passive web presentation on research regulationThe presentation will be a web-based voice commented video presentation on research regulation. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- second-year students who have completed teaching modules on clinical research methodology.
Key exclusion criteria (1 listed)
- none.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| case vignette tutorialAlso: case vignette tutorial for teaching literature critical appraisal to nursing studentsThe web tutorial will be composed of 4 case vignettes. A case vignette is a clinical scenario based on clinical practice. It will ask a clinical problem the student will have to answer by reading a research article on a randomized clinical trial. Then he will have to answer questions about this article which are related to the major methodological points of a randomized trial. All these steps are available on a secured website. | Other | case vignette tutorial |
| passive web presentation on research regulationThe presentation will be a web-based voice commented video presentation on research regulation. It will allow to preserve a minimal blinding of participants, since the participants will not be informed of the intervention evaluated and will have the opportunity to follow the other intervention after the evaluation. | Other | passive web presentation on research regulation |
Primary outcome
student's knowledge of critical assessment of randomized controlled trials
Time frame: 21 days
student's score on an evaluation case vignette with multiple choice questionnaires (range 0-25)
3 secondary outcomes
student's quality perception of the tutorial
Time frame: 21 days
student's acceptance of the tutorial
Time frame: 21 days
Impact of the tutorial on student's perception of research participation
Time frame: 21 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2014.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Isabelle Boutron, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
Philippe Ravaud, MD, Professor study director
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing case vignette tutorial and passive web presentation on research regulation in people with New Educational Technologies, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
student's knowledge of critical assessment of randomized controlled trials (time frame: 21 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2014.