SpondyloarthritisNCT02696551
Impact of Medical Education of Physician Action 2
A study testing Medical education in people with Spondyloarthritis, run by Shanxi Dayi Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Spondyloarthritis
- What is being tested?
- Medical education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Mar 2016to Dec 2016
- 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
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.
Trial locations and contacts
1 site in 1 country.
Liyun Zhang, MD contact
China1 site
Shanxi Dayi Hospital
Taiyuan, Shanxi, 030032
Liyun Zhang, MD, 86-351-8368114
About this study
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.
- Conditions
- Spondyloarthritis
- Being tested
- Medical education
- Keywords
- Medical education, Spondyloarthritis, Physician action
- Medical subject headings
- Spondylarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical educationOther
| Study group | Role | What they receive |
|---|---|---|
| Interventional hospital | Experimental | Interventional hospital, which will receive 3-month medical education Receives: Other: Medical education |
| Non-interventional hospital | No intervention | Non-interventional hospital, which will not receive 3-month medical education. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean of number of positive SpA feature of newly diagnosed patients with inflammatory back pain, before and after the (no-)event
Measured: 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
Measured: 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
Measured: 1 month before (no-) education vs. 3 months after (no-) education
Secondary outcomes (5)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 1 month before (no-) education vs. 3 months after (no-) education
Change of utilization rate of biological medication before and after the (no-)event
Measured: 1 month before (no-) education vs. 3 months after (no-) education
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionSep 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SpondyloarthritisStudies 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
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanxi Dayi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02696551
- Sponsor's protocol ID
- The IMPACT2 Project
- Status last verified
- Feb 2016
- First submitted
- 23 Feb 2016
- Last updated
- 3 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Medical Education of Physician Action 2
- ClinicalTrials.gov ID
- NCT02696551
- Acronym / sponsor ID
- The IMPACT2 Project
- Conditions
- Spondyloarthritis
- Keywords
- Medical education, Spondyloarthritis, Physician action
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Shanxi Dayi HospitalUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 2 Mar 2016 (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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional hospital | Experimental | Other: Medical educationInterventional hospital, which will receive 3-month medical education |
| Non-interventional hospital | No intervention | –Non-interventional hospital, which will not receive 3-month medical education. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| Medical education | Other | Interventional hospital |
Primary outcome
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
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
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
5 secondary outcomes
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
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
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2016.
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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.
Liyun Zhang, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medical education in people with Spondyloarthritis, run by Shanxi Dayi Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Mar 2016. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Liyun Zhang, MD (86-351-8368114), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. 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 3 Mar 2016.