Health Knowledge Attitudes and PracticeEBMINGPNCT01801683
Evidence Based Medicine in General Practice
A study testing Intervention-using PEARLS in people with Health Knowledge Attitudes and Practice, run by University of Split.
Trial summary
Evidence-based medicine (EBM) is the basis of work for physicians- practitioners in all specialties, including family medicine. Various issues in diagnosis, treatment and prognosis appear in daily work with patients and a physician should provide answers based on the best evidence stemming from research. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Health Knowledge Attitudes and Practice
- What is being tested?
- Intervention-using PEARLS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- No sites listed yet
- Study dates
- Jan 2012to May 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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All mentors (GPs) mentors of the sixth year medical students
Who cannot join
- Refusal to participate
- -
About this study
Official title: Application of Evidence Based Medicine in General Practice
Evidence-based medicine (EBM) is the basis of work for physicians- practitioners in all specialties, including family medicine. Various issues in diagnosis, treatment and prognosis appear in daily work with patients and a physician should provide answers based on the best evidence stemming from research. In spite of having access to EBM databases in every GP's office in Croatia, searching and finding answers in consultation with a patient"on the spot" in real time is missing from practice.
OBJECTIVES: To determine GP's knowledge and attitudes about EBM before and after applying modified academic detailing "EBM intervention." provided by sixth- year medical students We assume that GP's knowledge and attitudes about EBM will change as a result of "EBM intervention" applied by students.
Read the detailed description
STUDY DESIGN:An interventional non-randomized before-and-after study included 98 GPs (49 in the intervention group of mentors and 49 controls) and 174 medical students attending Family Medicine clinical rotations. A telephone survey on knowledge and attitudes towards EBM was conducted among participating physicians before and six months after the rotation. During the rotation, each mentor chose two cases from real life, and the students' task was to form an answerable clinical question, find the evidence-based answer and to write a brief report. The mentor reviewed the report and discussed it with the student.
STUDY SETTING : The sixth year medical students within Family Medicine courses at MedicalSchool in Split, Zagreb and Rijeka have rotations at their mentors' offices. Before arrival of the students, mentors will respond to the questionnaire for physicians prepared for research purposes, and answer the same questionnaire six months after the "EBM intervention." SUBJECTS: mentors /bearers of instructional practices in family medicine constitute the intervention group and the same number of physicians similar in all features to those from the intervention group except that they are not mentors/bearers of instructional practices constitute the control group. The intervention group will be subjected to students' "EBM intervention", and the control will not.
INTERVENTION: The sixth year medical students have practice at their mentors' offices within Family Medicine course. Each mentor chooses two patients / cases from real life, appearing to be diagnostic, therapeutic or prognostic problems in the outpatient work. A student's task is to make a question according to Patient Intervention Comparison Outcome (PICO) scheme, find the best evidence / answer to that question and write a brief report in accordance withPractical Evidence about Real Life Situations PEARL. The report is then brought to the mentor for review and discussion. So, it is a students' "EBM intervention", which will (?) affect the knowledge, attitudes and practice (work style) of a family physician.
MAIN OUTCOME MEASURES: Self-evaluation of knowledge and attitudes after the intervention, which would be a surrogate outcome measure for GP's change in behaviour and work style (adoption of EBM practice).
- Conditions
- Health Knowledge Attitudes and Practice
- Being tested
- Intervention-using PEARLS
- Keywords
- EBM, general practice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention-using PEARLSOther
Also called a brief report in accordance with Practical Evidence about Real Life Situations PEARLS
The intervention applied in this study was the modified academic detailing method, performed by sixth-year medical students as academic detailers. The students qualified for that role because they were taught about EBM in several courses during their undergraduate curriculum. During the family medicine rotation, each GP mentored six students in total. In Split each student visited two mentors for two weeks. In the course of rotation each mentor chose two patients (cases) from real life who represented diagnostic, therapeutic or prognostic challenge. The students' task was to form an answerable question, using the Patient, Intervention, Comparison, Outcome (PICO) scheme, find the best evidence-based answer to that question and to write a brief report according to Practical Evidence about Real Life Situations (PEARLS) pattern. The mentor then reviewed the report and discussed it with the student.
| Study group | Role | What they receive |
|---|---|---|
| Intervention: PEARLS (evidence based reports) | Other | Intervention was modified academic detailing method, performed by sixth-year medical students/academic detailers.Each mentor chose two patients from real life who represented diagnostic, therapeutic or prognostic challenge. The students formed an answerable question, using PICO, and wrote report according to PEARLS. Receives: Other: Intervention-using PEARLS |
| Control group of GPs | No intervention | GPs not mentors who do not receive academic detailing intervention using PICO/PEARLS. |
What is being measured
The primary outcome is the main question the study is designed to answer.
: Self-evaluation of knowledge and attitudes after the intervention, which would be a surrogate outcome measure for GP's change in behaviour and work style (adoption of EBM practice).
Measured: February 2013-October 2013 (up to 8 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2013 (estimated)
- Study startJan 2012
- Primary completionApr 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health Knowledge Attitudes and PracticeStudies of the same condition, open and under way.
- 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
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Split
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Davorka Vrdoljak, University of Split
- Investigators
- Davorka Vrdoljak, MD Gp PhD, Principal investigator, University of Split
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01801683
- Sponsor's protocol ID
- Mef01326
- Acronym
- EBMINGP
- Status last verified
- May 2015
- First submitted
- 19 Feb 2013
- Last updated
- 28 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Evidence Based Medicine in General Practice
- ClinicalTrials.gov ID
- NCT01801683
- Acronym / sponsor ID
- EBMINGP / Mef01326
- Conditions
- Health Knowledge Attitudes and Practice
- Keywords
- EBM, general practice
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- University of SplitUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 1 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.
Evidence-based medicine (EBM) is the basis of work for physicians- practitioners in all specialties, including family medicine. Various issues in diagnosis, treatment and prognosis appear in daily work with patients and a physician should provide answers based on the best evidence stemming from research. In spite of having access to EBM databases in every GP's office in Croatia, searching and finding answers in consultation with a patient"on the spot" in real time is missing from practice.
OBJECTIVES: To determine GP's knowledge and attitudes about EBM before and after applying modified academic detailing "EBM intervention." provided by sixth- year medical students We assume that GP's knowledge and attitudes about EBM will change as a result of "EBM intervention" applied by students.
Detailed description
STUDY DESIGN:An interventional non-randomized before-and-after study included 98 GPs (49 in the intervention group of mentors and 49 controls) and 174 medical students attending Family Medicine clinical rotations. A telephone survey on knowledge and attitudes towards EBM was conducted among participating physicians before and six months after the rotation. During the rotation, each mentor chose two cases from real life, and the students' task was to form an answerable clinical question, find the evidence-based answer and to write a brief report. The mentor reviewed the report and discussed it with the student.
STUDY SETTING : The sixth year medical students within Family Medicine courses at MedicalSchool in Split, Zagreb and Rijeka have rotations at their mentors' offices. Before arrival of the students, mentors will respond to the questionnaire for physicians prepared for research purposes, and answer the same questionnaire six months after the "EBM intervention." SUBJECTS: mentors /bearers of instructional practices in family medicine constitute the intervention group and the same number of physicians similar in all features to those from the intervention group except that they are not mentors/bearers of instructional practices constitute the control group. The intervention group will be subjected to students' "EBM intervention", and the control will not.
INTERVENTION: The sixth year medical students have practice at their mentors' offices within Family Medicine course. Each mentor chooses two patients / cases from real life, appearing to be diagnostic, therapeutic or prognostic problems in the outpatient work. A student's task is to make a question according to Patient Intervention Comparison Outcome (PICO) scheme, find the best evidence / answer to that question and write a brief report in accordance withPractical Evidence about Real Life Situations PEARL. The report is then brought to the mentor for review and discussion. So, it is a students' "EBM intervention", which will (?) affect the knowledge, attitudes and practice (work style) of a family physician.
MAIN OUTCOME MEASURES: Self-evaluation of knowledge and attitudes after the intervention, which would be a surrogate outcome measure for GP's change in behaviour and work style (adoption of EBM practice).
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention: PEARLS (evidence based reports) | Other | Other: Intervention-using PEARLSIntervention was modified academic detailing method, performed by sixth-year medical students/academic detailers.Each mentor chose two patients from real life who represented diagnostic, therapeutic or prognostic challenge. The students formed an answerable question, using PICO, and wrote report according to PEARLS. |
| Control group of GPs | No intervention | –GPs not mentors who do not receive academic detailing intervention using PICO/PEARLS. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All mentors (GPs) mentors of the sixth year medical students
Key exclusion criteria (2 listed)
- Refusal to participate
- -
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 |
|---|---|---|
| Intervention-using PEARLSAlso: a brief report in accordance with Practical Evidence about Real Life Situations PEARLSThe intervention applied in this study was the modified academic detailing method, performed by sixth-year medical students as academic detailers. The students qualified for that role because they were taught about EBM in several courses during their undergraduate curriculum. During the family medicine rotation, each GP mentored six students in total. In Split each student visited two mentors for two weeks. In the course of rotation each mentor chose two patients (cases) from real life who represented diagnostic, therapeutic or prognostic challenge. The students' task was to form an answerable question, using the Patient, Intervention, Comparison, Outcome (PICO) scheme, find the best evidence-based answer to that question and to write a brief report according to Practical Evidence about Real Life Situations (PEARLS) pattern. The mentor then reviewed the report and discussed it with the student. | Other | Intervention: PEARLS (evidence based reports) |
Primary outcome
: Self-evaluation of knowledge and attitudes after the intervention, which would be a surrogate outcome measure for GP's change in behaviour and work style (adoption of EBM practice).
Time frame: February 2013-October 2013 (up to 8 months)
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 28 May 2015.
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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.
Davorka Vrdoljak, MD Gp PhD principal investigator
University of Split
Questions about this trial
What is this clinical trial studying?
A study testing Intervention-using PEARLS in people with Health Knowledge Attitudes and Practice, run by University of Split.
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 2 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 28 May 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
: Self-evaluation of knowledge and attitudes after the intervention, which would be a surrogate outcome measure for GP's change in behaviour and work style (adoption of EBM practice). (time frame: February 2013-October 2013 (up to 8 months)). 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 28 May 2015.