- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02696551
Impact of Medical Education of Physician Action 2
March 1, 2016 updated by: Shanxi Dayi Hospital
This is a retrospective and prospective designed study, included hospitals are 1:1 assigned into two groups: ①Interventional hospital, which will receive 3-month medical education; ②Non-interventional hospital, which will not receive 3-month medical education.
During 1 month before education, all the electronic records of outpatients and inpatients who visit the included rheumatologists will be collected and the data of test and evaluation results of spondyloarthritis (SpA) patients diagnosed according to new Assessment of Spondylo-Arthritis International Society (ASAS) criteria will be collected from outpatient electronic records and inpatients medical charts; in the 3 months after education, the same data will be collected and compared with the data before education, and the impact of medical education on physician behaviour will be analyzed.
Meanwhile, the understanding and acceptance level will be evaluated by the questionnaire, the differences before and after education and the impact of education on physician cognition will be evaluated.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Shanxi
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Taiyuan, Shanxi, China, 030032
- Shanxi Dayi Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Interventional hospital will be selected based on following criteria:
- having complete outpatients and inpatients electronic records;
- more than 50% of registrars and/or consultants in the department participated the professional education event;
- the department head is willing to participate the clinical audit and provide the information from outpatients and inpatients records for data collection;
- except for rheumatic diseases have been clearly diagnosed.
Non-interventional hospital will be selected based on following criteria:
- having complete outpatients and inpatients electronic records;
- no professional education event covered;
- the department head is willing to participate the clinical audit and provide the information from outpatients and inpatients records for data collection;
- except for rheumatic diseases have been clearly diagnosed.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Interventional hospital
Interventional hospital, which will receive 3-month medical education
|
|
No Intervention: Non-interventional hospital
Non-interventional hospital, which will not receive 3-month medical education.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Mean of number of positive SpA feature of newly diagnosed patients with inflammatory back pain, before and after the (no-)event
Time Frame: 1 month before (no-) education vs. 3 months after (no-) education
|
1 month before (no-) education vs. 3 months after (no-) education
|
Proportion of patients with a image examination of sacroiliitis ( x-rays, CT, or MRI) in the audit period, before and after the (no-)event
Time Frame: 1 month before (no-) education vs. 3 months after (no-) education
|
1 month before (no-) education vs. 3 months after (no-) education
|
Proportion of patients with a assessment of disease activity in the audit period, before and after the (no-)event
Time Frame: 1 month before (no-) education vs. 3 months after (no-) education
|
1 month before (no-) education vs. 3 months after (no-) education
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Proportion of patients with a clear diagnosis (Diagnostic for Spondyloarthritis with new ASAS criteria) or receiving a new diagnosis in the audit period, before and after the (no-)event
Time Frame: 1 month before (no-) education vs. 3 months after (no-) education
|
1 month before (no-) education vs. 3 months after (no-) education
|
Mean of the number of physical examinations of disease activity in the audit period, before and after the (no-)event
Time Frame: 1 month before (no-) education vs. 3 months after (no-) education
|
1 month before (no-) education vs. 3 months after (no-) education
|
Change of questionnaire scores of physician in the audit period, before and after the (no-)event
Time Frame: 1 month before (no-) education vs. 3 months after (no-) education
|
1 month before (no-) education vs. 3 months after (no-) education
|
Change of utilization rate of Non Steroidal Anti Inflammatory Drugs (NSAIDs) before and after the (no-)event
Time Frame: 1 month before (no-) education vs. 3 months after (no-) education
|
1 month before (no-) education vs. 3 months after (no-) education
|
Change of utilization rate of biological medication before and after the (no-)event
Time Frame: 1 month before (no-) education vs. 3 months after (no-) education
|
1 month before (no-) education vs. 3 months after (no-) education
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2016
Primary Completion (Anticipated)
September 1, 2016
Study Completion (Anticipated)
December 1, 2016
Study Registration Dates
First Submitted
February 23, 2016
First Submitted That Met QC Criteria
February 25, 2016
First Posted (Estimate)
March 2, 2016
Study Record Updates
Last Update Posted (Estimate)
March 3, 2016
Last Update Submitted That Met QC Criteria
March 1, 2016
Last Verified
February 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- The IMPACT2 Project
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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