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

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Liyun Zhang, MD
  • Phone Number: 86-351-8368114

Study Locations

  • China
    • Shanxi
      • Taiyuan, Shanxi, China, 030032
        • Shanxi Dayi Hospital

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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:

  1. having complete outpatients and inpatients electronic records;
  2. more than 50% of registrars and/or consultants in the department participated the professional education event;
  3. the department head is willing to participate the clinical audit and provide the information from outpatients and inpatients records for data collection;
  4. except for rheumatic diseases have been clearly diagnosed.

Non-interventional hospital will be selected based on following criteria:

  1. having complete outpatients and inpatients electronic records;
  2. no professional education event covered;
  3. the department head is willing to participate the clinical audit and provide the information from outpatients and inpatients records for data collection;
  4. 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Interventional hospital
Interventional hospital, which will receive 3-month medical education
Other: 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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shanxi Dayi Hospital

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2016

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2016

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 23, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 25, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 2, 2016

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 3, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 1, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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